Trial Outcomes & Findings for Translating Neuroprediction Into Precision Medicine Via Brain Priming (NCT NCT03370510)
NCT ID: NCT03370510
Last Updated: 2022-08-09
Results Overview
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
TERMINATED
PHASE2
5 participants
Change from Baseline to post-treatment, 16 weeks
2022-08-09
Participant Flow
Participant milestones
| Measure |
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Oxytocin: Oxytocin nasal spray.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
|
Pivotal Response Treatment (PRT)/Placebo Nasal Spray
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Placebo: Placebo nasal spray.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Oxytocin: Oxytocin nasal spray.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
|
Pivotal Response Treatment (PRT)/Placebo Nasal Spray
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Placebo: Placebo nasal spray.
|
|---|---|---|
|
Overall Study
COVID-19
|
2
|
0
|
Baseline Characteristics
Translating Neuroprediction Into Precision Medicine Via Brain Priming
Baseline characteristics by cohort
| Measure |
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray
n=3 Participants
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Oxytocin: Oxytocin nasal spray.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
|
Pivotal Response Treatment (PRT)/Placebo Nasal Spray
n=2 Participants
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Placebo: Placebo nasal spray.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 Months
n=99 Participants
|
82 Months
n=107 Participants
|
76 Months
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Only 1/3 participants completed treatment in the oxytocin group. Therefore, the mean raw score for the oxytocin group is based off of that subject's data only.
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.
Outcome measures
| Measure |
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray
n=1 Participants
Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.
Oxytocin: Oxytocin nasal spray.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
|
Pivotal Response Treatment (PRT)/Placebo Nasal Spray
n=2 Participants
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.
Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
Placebo: Placebo nasal spray.
|
|---|---|---|
|
Social Responsiveness Scale, 2nd Edition (SRS-2)
|
39 score on a scale
Interval 39.0 to 39.0
|
-16 score on a scale
Interval -21.0 to -11.0
|
SECONDARY outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The CBCL is a parent report measure of problem behaviors. The form for children ages 1.5-5 has 100 items, and the form for children ages 6-18 has 113 items.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The CASI-5 is a behavior inventory measuring symptoms of several mental health problems among children. The CASI-5 is a 173-item parent report measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The ABC is a 58-item parent report behavior rating scale.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The BRIEF is an 86-item parent report measure of executive function.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
Neural activity while viewing videos of biological motion will be measured using fMRI.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to post-treatment, 16 weeksPopulation: Data were not collected due to COVID-19 related termination of study.
The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents.
Outcome measures
Outcome data not reported
Adverse Events
Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray
Pivotal Response Treatment (PRT)/Placebo Nasal Spray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place