Trial Outcomes & Findings for Care Improving Cognition for ADolescents on the Autism Spectrum (NCT NCT04562688)
NCT ID: NCT04562688
Last Updated: 2026-06-15
Results Overview
The total number participants who completed the training-based assessments were evaluated. All were participants were administered the assessments before and after the intervention period. The training-based assessments include 12 computerized tasks focused on attention, memory and social cognition.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
16 weeks
Results posted on
2026-06-15
Participant Flow
A total of 6 participants (5 lost to follow-up and 1 withdrew consent) exited the study before randomization.
Participant milestones
| Measure |
CICADAS Only (Arm A)
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
21
|
|
Overall Study
Started Intervention
|
18
|
21
|
21
|
|
Overall Study
At 16 Weeks
|
11
|
17
|
20
|
|
Overall Study
At 32 Weeks
|
10
|
15
|
20
|
|
Overall Study
COMPLETED
|
10
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
1
|
Reasons for withdrawal
| Measure |
CICADAS Only (Arm A)
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Care Improving Cognition for ADolescents on the Autism Spectrum
Baseline characteristics by cohort
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.05 years
STANDARD_DEVIATION 2.04 • n=20 Participants
|
13.77 years
STANDARD_DEVIATION 2.07 • n=20 Participants
|
14.19 years
STANDARD_DEVIATION 1.63 • n=40 Participants
|
14.00 years
STANDARD_DEVIATION 1.899 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
11 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
41 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe total number participants who completed the training-based assessments were evaluated. All were participants were administered the assessments before and after the intervention period. The training-based assessments include 12 computerized tasks focused on attention, memory and social cognition.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=18 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=18 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Digital Assessment Completion Rate
|
11 Participants
|
15 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe mean number of program sessions completed were evaluated.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=18 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=19 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Program Adherence
|
34 number of sessions completed
Standard Deviation 26.4
|
42.73 number of sessions completed
Standard Deviation 23.9
|
57.61 number of sessions completed
Standard Deviation 26.04
|
PRIMARY outcome
Timeframe: 16 weeksThe reported number of adverse events due to program use were evaluated.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=18 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=21 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Reported Number of Adverse Effects
|
1 number of adverse effects
|
1 number of adverse effects
|
0 number of adverse effects
|
PRIMARY outcome
Timeframe: 16 weeksThe total number of participants who completed the Post-Intervention assessments were evaluated.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=18 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=21 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Number of Participants Who Complete the Post-Intervention Assessments
|
11 Participants
|
17 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 32 weeksThe total number of participants who completed the follow-up assessments were evaluated.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=18 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=21 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Number of Participants Who Completed the Follow-up Assessments
|
10 Participants
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures breadth of repetitive behavior with subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior. Scoring range: 0-129; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Score for Repetitive Behavior Scale - Revised (RBS-R)
At Baseline
|
21.17 score on a scale
Standard Error 2.17
|
16.93 score on a scale
Standard Error 1.97
|
16.09 score on a scale
Standard Error 2.02
|
|
Total Score for Repetitive Behavior Scale - Revised (RBS-R)
At 16 Weeks
|
20.19 score on a scale
Standard Error 2.35
|
12.98 score on a scale
Standard Error 2.06
|
13.81 score on a scale
Standard Error 2.04
|
|
Total Score for Repetitive Behavior Scale - Revised (RBS-R)
At 32 Weeks
|
17.62 score on a scale
Standard Error 2.57
|
11.97 score on a scale
Standard Error 2.16
|
10.65 score on a scale
Standard Error 2.06
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures severity of autism spectrum symptoms as they occur in natural social settings. Scoring Range: 0-174; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
84.88 score on a scale
Standard Error 4.97
|
83.60 score on a scale
Standard Error 4.52
|
88.59 score on a scale
Standard Error 4.63
|
|
Total Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
71.60 score on a scale
Standard Error 5.95
|
72.22 score on a scale
Standard Error 5.00
|
76.54 score on a scale
Standard Error 4.70
|
|
Total Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
78.65 score on a scale
Standard Error 6.49
|
71.16 score on a scale
Standard Error 5.51
|
67.26 score on a scale
Standard Error 4.88
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-24; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
13.39 score on a scale
Standard Error 1.07
|
12.78 score on a scale
Standard Error 0.98
|
13.45 score on a scale
Standard Error 1.00
|
|
Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
11.13 score on a scale
Standard Error 1.26
|
13.29 score on a scale
Standard Error 1.07
|
12.08 score on a scale
Standard Error 1.01
|
|
Awareness Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
11.77 score on a scale
Standard Error 1.37
|
12.25 score on a scale
Standard Error 1.17
|
10.41 score on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-36; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
11.94 score on a scale
Standard Error 1.35
|
12.13 score on a scale
Standard Error 1.14
|
13.38 score on a scale
Standard Error 1.06
|
|
Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
12.76 score on a scale
Standard Error 1.48
|
11.76 score on a scale
Standard Error 1.25
|
11.52 score on a scale
Standard Error 1.11
|
|
Cognition Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
14.78 score on a scale
Standard Error 1.13
|
14.88 score on a scale
Standard Error 1.02
|
14.53 score on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-48; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
29.55 score on a scale
Standard Error 1.96
|
28.77 score on a scale
Standard Error 1.78
|
31.04 score on a scale
Standard Error 1.83
|
|
Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
24.87 score on a scale
Standard Error 2.30
|
24.49 score on a scale
Standard Error 1.95
|
26.28 score on a scale
Standard Error 1.85
|
|
Communication Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
27.89 score on a scale
Standard Error 2.51
|
25.12 score on a scale
Standard Error 2.14
|
23.28 score on a scale
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-30; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
13.15 score on a scale
Standard Error 1.18
|
12.59 score on a scale
Standard Error 1.08
|
13.82 score on a scale
Standard Error 1.10
|
|
Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
11.81 score on a scale
Standard Error 1.39
|
10.11 score on a scale
Standard Error 1.18
|
12.84 score on a scale
Standard Error 1.12
|
|
Motivation Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
12.83 score on a scale
Standard Error 1.52
|
10.02 score on a scale
Standard Error 1.29
|
11.95 score on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-36; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 32 Weeks
|
13.55 score on a scale
Standard Error 1.40
|
11.85 score on a scale
Standard Error 1.19
|
10.21 score on a scale
Standard Error 1.04
|
|
Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2)
At Baseline
|
14.00 score on a scale
Standard Error 1.05
|
14.59 score on a scale
Standard Error 0.95
|
15.76 score on a scale
Standard Error 0.98
|
|
Restricted and Repetitive Behaviors Score for Social Responsiveness Scale, Second Edition (SRS-2)
At 16 Weeks
|
11.78 score on a scale
Standard Error 1.30
|
12.23 score on a scale
Standard Error 1.07
|
12.08 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measure of behavioral and emotional functioning; Composite scales: Internalizing Problems sums Anxious/depressed, Withdrawn-depressed, and Somatic complaints scores; Externalizing Problems combines Rule-breaking and Aggressive behavior; Total Problems sums scores of all problem items. Scoring Range: 0-134; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Problems Score for Child Behavior Checklist (CBCL)
At Baseline
|
29.74 score on a scale
Standard Error 3.06
|
27.96 score on a scale
Standard Error 2.78
|
24.59 score on a scale
Standard Error 2.91
|
|
Total Problems Score for Child Behavior Checklist (CBCL)
At 16 Weeks
|
30.15 score on a scale
Standard Error 3.46
|
17.21 score on a scale
Standard Error 2.96
|
19.70 score on a scale
Standard Error 2.90
|
|
Total Problems Score for Child Behavior Checklist (CBCL)
At 32 Weeks
|
26.04 score on a scale
Standard Error 3.77
|
18.82 score on a scale
Standard Error 3.11
|
16.28 score on a scale
Standard Error 2.96
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-64; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Internalizing Problems Score for Child Behavior Checklist (CBCL)
At Baseline
|
17.64 score on a scale
Standard Error 1.80
|
15.73 score on a scale
Standard Error 1.63
|
14.30 score on a scale
Standard Error 1.71
|
|
Internalizing Problems Score for Child Behavior Checklist (CBCL)
At 16 Weeks
|
17.66 score on a scale
Standard Error 2.07
|
9.49 score on a scale
Standard Error 1.76
|
11.92 score on a scale
Standard Error 1.69
|
|
Internalizing Problems Score for Child Behavior Checklist (CBCL)
At 32 Weeks
|
15.70 score on a scale
Standard Error 2.26
|
10.60 score on a scale
Standard Error 1.85
|
10.73 score on a scale
Standard Error 1.75
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-70; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Externalizing Problems Score for Child Behavior Checklist (CBCL)
At 16 Weeks
|
12.50 score on a scale
Standard Error 2.17
|
7.73 score on a scale
Standard Error 1.88
|
8.03 score on a scale
Standard Error 1.86
|
|
Externalizing Problems Score for Child Behavior Checklist (CBCL)
At 32 Weeks
|
10.21 score on a scale
Standard Error 2.34
|
8.23 score on a scale
Standard Error 1.96
|
5.48 score on a scale
Standard Error 1.90
|
|
Externalizing Problems Score for Child Behavior Checklist (CBCL)
At Baseline
|
12.11 score on a scale
Standard Error 1.98
|
12.23 score on a scale
Standard Error 1.80
|
10.25 score on a scale
Standard Error 1.87
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Assesses impairments in executive function across Global Executive Composite, Behavior Regulation, Emotional Recognition, and Cognitive Regulation Indices. Scoring Range: 60-180; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At Baseline
|
132.58 score on a scale
Standard Error 4.04
|
131.75 score on a scale
Standard Error 3.67
|
133.18 score on a scale
Standard Error 3.85
|
|
Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 16 Weeks
|
127.69 score on a scale
Standard Error 4.78
|
118.27 score on a scale
Standard Error 4.01
|
126.27 score on a scale
Standard Error 3.85
|
|
Global Executive Composite Score for Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 32 Weeks
|
125.35 score on a scale
Standard Error 5.41
|
118.19 score on a scale
Standard Error 4.31
|
119.70 score on a scale
Standard Error 3.90
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 12-36; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At Baseline
|
25.39 score on a scale
Standard Error 0.97
|
26.39 score on a scale
Standard Error 0.89
|
25.47 score on a scale
Standard Error 0.93
|
|
Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 16 Weeks
|
24.83 score on a scale
Standard Error 1.14
|
22.59 score on a scale
Standard Error 0.96
|
24.09 score on a scale
Standard Error 0.93
|
|
Behavioral Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 32 Weeks
|
24.12 score on a scale
Standard Error 1.29
|
22.99 score on a scale
Standard Error 1.03
|
22.29 score on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 32-96; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 16 Weeks
|
68.55 score on a scale
Standard Error 3.36
|
64.17 score on a scale
Standard Error 2.88
|
71.06 score on a scale
Standard Error 2.84
|
|
Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 32 Weeks
|
67.72 score on a scale
Standard Error 3.76
|
62.45 score on a scale
Standard Error 3.07
|
67.50 score on a scale
Standard Error 2.86
|
|
Cognitive Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At Baseline
|
71.52 score on a scale
Standard Error 2.97
|
70.06 score on a scale
Standard Error 2.71
|
74.54 score on a scale
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 16-48; Lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At Baseline
|
35.67 score on a scale
Standard Error 1.43
|
35.30 score on a scale
Standard Error 1.30
|
33.19 score on a scale
Standard Error 1.36
|
|
Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 16 Weeks
|
34.03 score on a scale
Standard Error 1.65
|
31.23 score on a scale
Standard Error 1.40
|
31.14 score on a scale
Standard Error 1.36
|
|
Emotional Regulation Index Score From Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
At 32 Weeks
|
33.41 score on a scale
Standard Error 1.86
|
32.28 score on a scale
Standard Error 1.50
|
29.86 score on a scale
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Neuropsychological test of set-shifting, the capability to show flexibility when exposed to changes in reinforcement. Lower score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Reaction Times for Wisconsin Card Sorting Test (WCST)
At Baseline
|
2366.35 milliseconds
Standard Error 120.71
|
2227.68 milliseconds
Standard Error 109.76
|
2187.40 milliseconds
Standard Error 112.45
|
|
Reaction Times for Wisconsin Card Sorting Test (WCST)
At 16 Weeks
|
1917.23 milliseconds
Standard Error 144.30
|
1646.10 milliseconds
Standard Error 119.51
|
2053.26 milliseconds
Standard Error 114.99
|
|
Reaction Times for Wisconsin Card Sorting Test (WCST)
At 32 Weeks
|
1861.01 milliseconds
Standard Error 144.95
|
1745.03 milliseconds
Standard Error 125.88
|
1822.15 milliseconds
Standard Error 116.06
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-100%; lower score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Errors for Wisconsin Card Sorting Test (WCST)
At Baseline
|
0.28 percent
Standard Error 0.03
|
0.29 percent
Standard Error 0.03
|
0.26 percent
Standard Error 0.03
|
|
Total Errors for Wisconsin Card Sorting Test (WCST)
At 16 Weeks
|
0.27 percent
Standard Error 0.04
|
0.24 percent
Standard Error 0.03
|
0.24 percent
Standard Error 0.03
|
|
Total Errors for Wisconsin Card Sorting Test (WCST)
At 32 Weeks
|
0.21 percent
Standard Error 0.03
|
0.24 percent
Standard Error 0.03
|
0.18 percent
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-100%; lower score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At 32 Weeks
|
0.14 percent
Standard Error 0.02
|
0.14 percent
Standard Error 0.02
|
0.12 percent
Standard Error 0.01
|
|
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At Baseline
|
0.17 percent
Standard Error 0.01
|
0.18 percent
Standard Error 0.01
|
0.16 percent
Standard Error 0.01
|
|
Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At 16 Weeks
|
0.16 percent
Standard Error 0.02
|
0.14 percent
Standard Error 0.01
|
0.16 percent
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-100%; lower score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At Baseline
|
0.12 percent
Standard Error 0.02
|
0.11 percent
Standard Error 0.02
|
0.12 percent
Standard Error 0.02
|
|
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At 16 Weeks
|
0.11 percent
Standard Error 0.02
|
0.10 percent
Standard Error 0.02
|
0.08 percent
Standard Error 0.02
|
|
Non-Perseverative Errors for Wisconsin Card Sorting Test (WCST)
At 32 Weeks
|
0.07 percent
Standard Error 0.02
|
0.10 percent
Standard Error 0.02
|
0.07 percent
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Test of selective attention and inhibitory control, in which participants are asked to indicate the target letter while ignoring an array of "flanking" congruent/incongruent letters. Scoring Range: 0-100%, higher score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Congruent Correct for Flanker Task
At Baseline
|
80.81 percent
Standard Error 3.48
|
80.78 percent
Standard Error 3.13
|
86.85 percent
Standard Error 3.21
|
|
Congruent Correct for Flanker Task
At 16 Weeks
|
87.16 percent
Standard Error 3.83
|
81.33 percent
Standard Error 3.32
|
85.66 percent
Standard Error 3.26
|
|
Congruent Correct for Flanker Task
At 32 Weeks
|
83.16 percent
Standard Error 4.12
|
84.55 percent
Standard Error 3.57
|
87.23 percent
Standard Error 3.29
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring Range: 0-100%; higher score is better.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Incongruent Correct for Flanker Task
At Baseline
|
76.91 percent
Standard Error 3.60
|
79.35 percent
Standard Error 3.22
|
84.69 percent
Standard Error 3.30
|
|
Incongruent Correct for Flanker Task
At 16 Weeks
|
76.00 percent
Standard Error 4.13
|
77.84 percent
Standard Error 3.50
|
82.28 percent
Standard Error 3.39
|
|
Incongruent Correct for Flanker Task
At 32 Weeks
|
80.03 percent
Standard Error 4.45
|
79.93 percent
Standard Error 3.82
|
84.73 percent
Standard Error 3.42
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
The accuracy interference score is calculated by subtracting the mean accuracy for the congruent items from the mean accuracy for the incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli. Baseline Score Range: Min -27.27, Max 28.76; At 16 Weeks Score Range: Min -23.50, Max 16.38; At 32 Weeks Score Range: Min -30.00, Max 30.91
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Accuracy Interference for Flanker Task
At Baseline
|
-3.90 score on a scale
Standard Error 2.35
|
-1.43 score on a scale
Standard Error 2.08
|
-2.19 score on a scale
Standard Error 2.13
|
|
Accuracy Interference for Flanker Task
At 16 Weeks
|
-8.57 score on a scale
Standard Error 2.77
|
-2.86 score on a scale
Standard Error 2.36
|
-3.48 score on a scale
Standard Error 2.23
|
|
Accuracy Interference for Flanker Task
At 32 Weeks
|
-2.96 score on a scale
Standard Error 2.88
|
-2.64 score on a scale
Standard Error 2.50
|
-2.31 score on a scale
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
The reaction time interference score was calculated by subtracting the mean reaction time for the correct congruent items from the mean reaction time for the correct incongruent items. Lower score indicates better performance, reflecting less difficulty inhibiting responses to incongruent stimuli.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Reaction Time Interference for Flanker Task
At Baseline
|
18.21 milliseconds
Standard Error 19.10
|
8.20 milliseconds
Standard Error 16.91
|
5.52 milliseconds
Standard Error 17.30
|
|
Reaction Time Interference for Flanker Task
At 16 Weeks
|
-18.92 milliseconds
Standard Error 22.43
|
25.12 milliseconds
Standard Error 19.12
|
38.00 milliseconds
Standard Error 18.12
|
|
Reaction Time Interference for Flanker Task
At 32 Weeks
|
30.79 milliseconds
Standard Error 23.39
|
8.47 milliseconds
Standard Error 20.27
|
37.13 milliseconds
Standard Error 18.12
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures health-related quality of life. Scoring range: 0-100; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Scale for Pediatric Qualify of Life Inventory (PedsQL)
At Baseline
|
59.44 score on a scale
Standard Error 3.26
|
59.74 score on a scale
Standard Error 2.96
|
63.85 score on a scale
Standard Error 3.08
|
|
Total Scale for Pediatric Qualify of Life Inventory (PedsQL)
At 16 Weeks
|
60.95 score on a scale
Standard Error 4.01
|
67.46 score on a scale
Standard Error 3.20
|
63.99 score on a scale
Standard Error 3.40
|
|
Total Scale for Pediatric Qualify of Life Inventory (PedsQL)
At 32 Weeks
|
65.76 score on a scale
Standard Error 4.19
|
70.60 score on a scale
Standard Error 3.37
|
69.30 score on a scale
Standard Error 3.13
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring range: 0-100; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At Baseline
|
56.59 score on a scale
Standard Error 3.23
|
56.06 score on a scale
Standard Error 2.94
|
61.19 score on a scale
Standard Error 3.05
|
|
Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At 16 Weeks
|
59.90 score on a scale
Standard Error 3.83
|
66.06 score on a scale
Standard Error 3.21
|
62.16 score on a scale
Standard Error 3.05
|
|
Psychosocial Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At 32 Weeks
|
64.64 score on a scale
Standard Error 4.18
|
66.47 score on a scale
Standard Error 3.38
|
66.99 score on a scale
Standard Error 3.11
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Scoring range: 0-100; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At 16 Weeks
|
69.39 score on a scale
Standard Error 5.43
|
69.47 score on a scale
Standard Error 4.50
|
68.81 score on a scale
Standard Error 4.21
|
|
Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At 32 Weeks
|
72.07 score on a scale
Standard Error 6.14
|
77.79 score on a scale
Standard Error 4.84
|
73.62 score on a scale
Standard Error 4.30
|
|
Physical Health Score for Pediatric Qualify of Life Inventory (PedsQL)
At Baseline
|
65.28 score on a scale
Standard Error 4.44
|
67.04 score on a scale
Standard Error 4.04
|
69.04 score on a scale
Standard Error 4.20
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.49 score on a scale
Standard Error 0.16
|
1.53 score on a scale
Standard Error 0.15
|
1.71 score on a scale
Standard Error 0.15
|
|
Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.59 score on a scale
Standard Error 0.20
|
1.24 score on a scale
Standard Error 0.16
|
1.49 score on a scale
Standard Error 0.15
|
|
Affiliative Touch Aversion Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.41 score on a scale
Standard Error 0.21
|
1.18 score on a scale
Standard Error 0.17
|
1.56 score on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-36; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.97 score on a scale
Standard Error 0.13
|
1.69 score on a scale
Standard Error 0.12
|
1.88 score on a scale
Standard Error 0.12
|
|
Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.66 score on a scale
Standard Error 0.17
|
1.59 score on a scale
Standard Error 0.13
|
1.85 score on a scale
Standard Error 0.12
|
|
Auditory Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.91 score on a scale
Standard Error 0.17
|
1.44 score on a scale
Standard Error 0.14
|
1.69 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-20; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.89 score on a scale
Standard Error 0.17
|
1.71 score on a scale
Standard Error 0.14
|
1.63 score on a scale
Standard Error 0.13
|
|
Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.88 score on a scale
Standard Error 0.13
|
1.87 score on a scale
Standard Error 0.12
|
1.77 score on a scale
Standard Error 0.12
|
|
Auditory Hyposensitivity to Voices Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.88 score on a scale
Standard Error 0.17
|
1.67 score on a scale
Standard Error 0.13
|
1.72 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-16; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.38 score on a scale
Standard Error 0.10
|
1.23 score on a scale
Standard Error 0.09
|
1.21 score on a scale
Standard Error 0.09
|
|
Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.05 score on a scale
Standard Error 0.13
|
1.11 score on a scale
Standard Error 0.10
|
1.20 score on a scale
Standard Error 0.09
|
|
Digestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.43 score on a scale
Standard Error 0.13
|
1.26 score on a scale
Standard Error 0.11
|
1.21 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-12; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.09 score on a scale
Standard Error 0.07
|
0.95 score on a scale
Standard Error 0.06
|
1.12 score on a scale
Standard Error 0.06
|
|
Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.02 score on a scale
Standard Error 0.09
|
0.98 score on a scale
Standard Error 0.07
|
1.10 score on a scale
Standard Error 0.06
|
|
Ingestive Problems Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.04 score on a scale
Standard Error 0.09
|
0.96 score on a scale
Standard Error 0.08
|
1.13 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-24; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
2.01 score on a scale
Standard Error 0.15
|
1.66 score on a scale
Standard Error 0.13
|
1.80 score on a scale
Standard Error 0.14
|
|
Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.77 score on a scale
Standard Error 0.17
|
1.56 score on a scale
Standard Error 0.14
|
1.70 score on a scale
Standard Error 0.14
|
|
Selective Eating Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.76 score on a scale
Standard Error 0.18
|
1.37 score on a scale
Standard Error 0.15
|
1.58 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.81 score on a scale
Standard Error 0.11
|
1.68 score on a scale
Standard Error 0.10
|
1.62 score on a scale
Standard Error 0.10
|
|
Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.43 score on a scale
Standard Error 0.13
|
1.61 score on a scale
Standard Error 0.11
|
1.43 score on a scale
Standard Error 0.10
|
|
Tactile Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.54 score on a scale
Standard Error 0.14
|
1.41 score on a scale
Standard Error 0.12
|
1.46 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Measures sensory vulnerabilities of auditory processing, visual processing, tactile processing, and eating and feeding behaviors. Scoring Range: 0-40; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At Baseline
|
1.41 score on a scale
Standard Error 0.10
|
1.09 score on a scale
Standard Error 0.09
|
1.46 score on a scale
Standard Error 0.09
|
|
Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 16 Weeks
|
1.43 score on a scale
Standard Error 0.13
|
1.16 score on a scale
Standard Error 0.10
|
1.38 score on a scale
Standard Error 0.09
|
|
Visual Hypersensitivity Score for Brain-Body Center Sensory Scales (BBCSS)
At 32 Weeks
|
1.46 score on a scale
Standard Error 0.13
|
1.31 score on a scale
Standard Error 0.11
|
1.42 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-60; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At Baseline
|
37.01 score on a scale
Standard Error 3.36
|
34.20 score on a scale
Standard Error 2.97
|
29.12 score on a scale
Standard Error 3.04
|
|
Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At 16 Weeks
|
34.82 score on a scale
Standard Error 3.96
|
32.74 score on a scale
Standard Error 3.28
|
38.40 score on a scale
Standard Error 3.10
|
|
Competing Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At 32 Weeks
|
35.72 score on a scale
Standard Error 4.23
|
36.14 score on a scale
Standard Error 3.51
|
37.10 score on a scale
Standard Error 3.17
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Screening for auditory processing difficulties; Subtests: Competing Words (dichotic listening tasks) and Filtered Words (speech processing when the signal is distorted or compromised by a poor acoustic environment). Scoring Range: 0-40; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At Baseline
|
27.76 score on a scale
Standard Error 1.67
|
28.47 score on a scale
Standard Error 1.48
|
30.12 score on a scale
Standard Error 1.52
|
|
Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At 16 Weeks
|
28.37 score on a scale
Standard Error 2.01
|
29.54 score on a scale
Standard Error 1.65
|
30.67 score on a scale
Standard Error 1.55
|
|
Filtered Total Score for SCAN-3:A Tests for Auditory Processing Disorders
At 32 Weeks
|
30.06 score on a scale
Standard Error 2.13
|
30.77 score on a scale
Standard Error 1.76
|
35.17 score on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-138; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Social Skills Scale Score for Social Skills Improvement System (SSIS)
At Baseline
|
79.78 score on a scale
Standard Error 3.12
|
80.48 score on a scale
Standard Error 2.76
|
76.10 score on a scale
Standard Error 2.93
|
|
Social Skills Scale Score for Social Skills Improvement System (SSIS)
At 16 Weeks
|
80.05 score on a scale
Standard Error 3.82
|
86.31 score on a scale
Standard Error 2.96
|
82.23 score on a scale
Standard Error 3.14
|
|
Social Skills Scale Score for Social Skills Improvement System (SSIS)
At 32 Weeks
|
82.62 score on a scale
Standard Error 4.02
|
88.06 score on a scale
Standard Error 3.11
|
87.69 score on a scale
Standard Error 2.96
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-45; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS)
At Baseline
|
19.10 score on a scale
Standard Error 1.03
|
17.87 score on a scale
Standard Error 0.91
|
20.25 score on a scale
Standard Error 0.98
|
|
Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS)
At 16 Weeks
|
18.13 score on a scale
Standard Error 1.39
|
15.24 score on a scale
Standard Error 1.02
|
17.41 score on a scale
Standard Error 1.12
|
|
Autism Spectrum Subscale Score for Social Skills Improvement System (SSIS)
At 32 Weeks
|
15.69 score on a scale
Standard Error 1.40
|
14.94 score on a scale
Standard Error 1.07
|
15.41 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Assesses social skills, problem behaviors, and academic competence. Scoring Range: 0-99; lower score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Problem Behavior Subscale Score for Social Skills Improvement System (SSIS)
At 16 Weeks
|
39.24 score on a scale
Standard Error 2.92
|
30.64 score on a scale
Standard Error 2.28
|
35.35 score on a scale
Standard Error 2.42
|
|
Problem Behavior Subscale Score for Social Skills Improvement System (SSIS)
At 32 Weeks
|
33.90 score on a scale
Standard Error 3.05
|
29.22 score on a scale
Standard Error 2.39
|
29.19 score on a scale
Standard Error 2.27
|
|
Problem Behavior Subscale Score for Social Skills Improvement System (SSIS)
At Baseline
|
41.13 score on a scale
Standard Error 2.39
|
35.49 score on a scale
Standard Error 2.11
|
35.16 score on a scale
Standard Error 2.25
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks and 32 weeksPopulation: At 16 weeks: For Arm A, 8 participants were lost to follow-up; for Arm B, 4 participants were lost to follow-up and one participant withdrew consent; for Arm C, 1 participant was lost to follow-up. At 32 weeks: For Arm A, 1 participant was lost to follow-up; for Arm B, 2 participants were lost to follow-up.
Assesses treatment changes in adolescents' knowledge of social skills taught during PEERS. Scoring Range: 0-30; higher score means a better outcome.
Outcome measures
| Measure |
CICADAS Only (Arm A)
n=19 Participants
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 Participants
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 Participants
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Total Score for Test of Adolescent Social Skills Knowledge (TASSK)
At 32 Weeks
|
16.98 score on a scale
Standard Error 1.11
|
21.02 score on a scale
Standard Error 0.93
|
23.11 score on a scale
Standard Error 0.83
|
|
Total Score for Test of Adolescent Social Skills Knowledge (TASSK)
At Baseline
|
16.74 score on a scale
Standard Error 0.86
|
15.12 score on a scale
Standard Error 0.80
|
17.66 score on a scale
Standard Error 0.82
|
|
Total Score for Test of Adolescent Social Skills Knowledge (TASSK)
At 16 Weeks
|
16.60 score on a scale
Standard Error 0.98
|
20.53 score on a scale
Standard Error 0.85
|
22.73 score on a scale
Standard Error 0.81
|
Adverse Events
CICADAS Only (Arm A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PEERS + CICADAS (Arm B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PEERS + Active Control (Arm C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CICADAS Only (Arm A)
n=19 participants at risk
Participants assigned to Arm A will engage in CICADAS app only for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
CICADAS only: Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. The NB-TCT exercises are adaptive with the task difficulty adjusting on a trial-to-trial and session-by-session basis to the abilities of each individual. A second set of computerized assessments was administered following the intervention period. Participants had to log in to access these assessments and exercises using a study provided username that contained no personally identifiable information.
|
PEERS + CICADAS (Arm B)
n=22 participants at risk
Participants assigned to Arm B will engage in PEERS + CICADAS for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + CICADAS and then no-contact: Participants will complete both PEERS and CICADAS study activities. Participants completed baseline assessments and neuroplasticity-based targeted cognitive training (NB-TCT) exercises on a digital device for up to 40 hours through BrainHQ (Posit Science Corporation, San Francisco). The CICADAS app captures user-specific sensory and cognitive processing metrics through 10 brief computerized assessments; these data are used to guide and personalize the delivery of 13 NB-TCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
PEERS + Active Control (Arm C)
n=21 participants at risk
Participants assigned to Arm C will engage in PEERS + Active Comparator for the first 16 weeks of the intervention period. After the completion of the first intervention period and the mid-intervention assessment (V3) visit, these participants will then be assigned to No-Contact (no active intervention) for the second 16 weeks of the intervention period.
PEERS + Active Comparator and then no-contact: Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
|
|---|---|---|---|
|
Psychiatric disorders
Exacerbation of psychiatric symptoms
|
5.3%
1/19 • Number of events 1 • Adverse event data are collected throughout the study duration (a total of 32 weeks).
Adverse events are assessed at each assessment visit at Baseline, Post-Intervention (16-week), and Follow-up (32-week) visits and throughout the intervention period.
|
4.5%
1/22 • Number of events 1 • Adverse event data are collected throughout the study duration (a total of 32 weeks).
Adverse events are assessed at each assessment visit at Baseline, Post-Intervention (16-week), and Follow-up (32-week) visits and throughout the intervention period.
|
0.00%
0/21 • Adverse event data are collected throughout the study duration (a total of 32 weeks).
Adverse events are assessed at each assessment visit at Baseline, Post-Intervention (16-week), and Follow-up (32-week) visits and throughout the intervention period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60