Trial Outcomes & Findings for Gaming for Autism to Mold Executive Skills Project (NCT NCT02361762)
NCT ID: NCT02361762
Last Updated: 2021-07-28
Results Overview
Conflict Processing-Behavior (Post-testing controlling for Baseline) Children indicate the location of a picture by pressing the left and right arrow buttons for 75% of the trials (i.e., the dominant task). For the remaining 25% of trials, a stop signal appears and a Change response (i.e., space bar) was required. Stop signals occurred equally at 50, 200, 350, and 500 ms before the anticipated response based on the child's reaction time. The SSRT estimates the latency of inhibitory responding to the stop signal. Lower scores indicate more rapid inhibition.
COMPLETED
NA
70 participants
Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
2021-07-28
Participant Flow
Prior to randomization, 106 potential participants were screened. 31 were ineligible; 5 others declined to participate. 70 children were randomized. 35 were assigned to training. 35 were assigned to waitlist.
Participant milestones
| Measure |
Training
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Training
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Gaming for Autism to Mold Executive Skills Project
Baseline characteristics by cohort
| Measure |
Training
n=35 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=35 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.80 years
STANDARD_DEVIATION 1.39 • n=39 Participants
|
8.69 years
STANDARD_DEVIATION 1.41 • n=41 Participants
|
8.704 years
STANDARD_DEVIATION 1.39 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=39 Participants
|
35 participants
n=41 Participants
|
70 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children randomized who returned for post testing, data were available for 61 across both time points; one participant was unable to map the correct buttons at baseline, two participants refused the task at post testing, and computer failure occurred for four participants (3 at baseline, 1 at post testing).
Conflict Processing-Behavior (Post-testing controlling for Baseline) Children indicate the location of a picture by pressing the left and right arrow buttons for 75% of the trials (i.e., the dominant task). For the remaining 25% of trials, a stop signal appears and a Change response (i.e., space bar) was required. Stop signals occurred equally at 50, 200, 350, and 500 ms before the anticipated response based on the child's reaction time. The SSRT estimates the latency of inhibitory responding to the stop signal. Lower scores indicate more rapid inhibition.
Outcome measures
| Measure |
Training
n=31 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=30 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Change Task - Stop Signal Reaction Time
Baseline
|
233.8 miliseconds
Standard Deviation 87.8
|
238.3 miliseconds
Standard Deviation 94.3
|
|
Change Task - Stop Signal Reaction Time
Post-training/Waitlisted phase
|
213.6 miliseconds
Standard Deviation 78.5
|
234.7 miliseconds
Standard Deviation 98.1
|
PRIMARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Data were available for 63 children; five children were unable to complete the task or refused to play (3 baseline, 2 at post).
Conflict Processing-Behavior (Post-testing controlling for Baseline) Trials were presented in three conditions: (1) congruent trials (25%); (2) incongruent trials (25%); and (3) neutral trials (50%). The difference between percent correct for congruent and incongruent conditions was the dependent variable, such that larger differences indicated more difficulty with conflicting information. Lower scores at Post-testing indicate improved ability to suppress interfering/conflicting information.
Outcome measures
| Measure |
Training
n=34 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=29 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)
Baseline
|
3.8 difference in % of correct responses
Standard Deviation 8
|
6.0 difference in % of correct responses
Standard Deviation 12
|
|
Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)
Post-Training/Wait-listed phase
|
2.9 difference in % of correct responses
Standard Deviation 13
|
3.8 difference in % of correct responses
Standard Deviation 9
|
PRIMARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Conflict Processing-Event Related Potential (ERP) Brain Response (N2 mean amplitude) Data were compared for congruent and incongruent conditions at each time point (baseline and post testing). Each trial of the task began with a beep for 150ms paired with a fixation cross for 450ms at the center of the screen. Then, a target and flankers were presented for 2000ms. Congruent trials (50%) consisted of a central target animal flanked by two animals on each side with the same orientation and size as the target. Incongruent trials (50%) were identical except that the target and flankers faced opposite directions. Children pressed a button indicating the direction the target animal faced (50% left, 50% right) and received visual and auditory feedback upon responding.
Outcome measures
| Measure |
Training
n=24 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=22 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Event-related Potentials Assessed During Child Attention Network Flanker Task
Congruent - Pre
|
-.20 microvolts
Standard Deviation 3.2
|
-2.5 microvolts
Standard Deviation 3.3
|
|
Event-related Potentials Assessed During Child Attention Network Flanker Task
Incongruent - Pre
|
.83 microvolts
Standard Deviation 3.3
|
-3.8 microvolts
Standard Deviation 4.8
|
|
Event-related Potentials Assessed During Child Attention Network Flanker Task
Congruent - Post
|
-1.0 microvolts
Standard Deviation 3.6
|
-3.7 microvolts
Standard Deviation 4.1
|
|
Event-related Potentials Assessed During Child Attention Network Flanker Task
Incongruent - Post
|
-1.8 microvolts
Standard Deviation 3.7
|
-3.3 microvolts
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: 63 parents completed the questionnaire at both time points.
Executive Control at home/school-Generalization (Post-testing controlling for Baseline) Global Executive Composite (GEC) scores are available for parents. The GEC is comprised of two sub-scales: Metacognition and Behavioral Regulation. T-scores are reported for the GEC (range = 30-100). Higher scores reflect more difficulty with executive function. At Post, lower scores represent a better outcome. Note: Teacher BRIEF was originally planned as an outcome measure, but due to low teacher response (10 teachers provided data for each group at both time points) the results were not analyzed.
Outcome measures
| Measure |
Training
n=33 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=30 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
BRIEF Parent Survey (Global Executive Composite)
Global Executive Composite-Pre
|
66.55 scores on a scale
Standard Deviation 11.51
|
68.40 scores on a scale
Standard Deviation 8.61
|
|
BRIEF Parent Survey (Global Executive Composite)
Global Executive Composite-Post
|
65.85 scores on a scale
Standard Deviation 9.96
|
67.77 scores on a scale
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who completed post testing, 63 provided data at both time points.
Working Memory Behavior (Post-testing controlling for Baseline) A control task - not specifically targeted by intervention. Scaled score for Backward Digit Span (higher scores represent better memory). Scaled scores are reported (range = 1-19). Higher scores reflect better working memory (an aspect of executive function). At Post, higher scores represent a better outcome.
Outcome measures
| Measure |
Training
n=33 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=30 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Backward Digit Span (Scaled Score)
Post-training/Waitlisted phase
|
10.15 scores on a scale
Standard Deviation 3.17
|
9.55 scores on a scale
Standard Deviation 3.55
|
|
Backward Digit Span (Scaled Score)
Baseline
|
10.42 scores on a scale
Standard Deviation 3.45
|
9.83 scores on a scale
Standard Deviation 3.55
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who returned for post testing, 45 children had sufficient time during visits at both time points for this task.
Theory of Mind Behavior (Post-testing controlling for Baseline) A measure of generalization.
Outcome measures
| Measure |
Training
n=24 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=21 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Social Attribution Task (SAT) - Problem Solving Scale
Baseline
|
34.6 percent correct on SAT problem solving
Standard Deviation 16.4
|
33.8 percent correct on SAT problem solving
Standard Deviation 16.9
|
|
Social Attribution Task (SAT) - Problem Solving Scale
Post-Training
|
32.9 percent correct on SAT problem solving
Standard Deviation 16.3
|
31.0 percent correct on SAT problem solving
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who returned for post testing, 60 children had sufficient time during visits at both time points to complete these video tasks.
Theory of Mind (TOM) Behavior (Post-testing controlling for Baseline) A measure of generalization Composite score by computing the percent correct (range = 0-100% correct) across three video tasks measuring cognitive aspects of theory of mind (i.e., the Perception Knowledge Task, Location Change False Belief Task, and Unexpected-contents False Belief Task). Higher scores represent better performance (i.e., more correct responses). Higher scores at post testing represent better outcomes.
Outcome measures
| Measure |
Training
n=31 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=29 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief
Baseline
|
75 percentage of correct responses
Standard Deviation 25
|
71 percentage of correct responses
Standard Deviation 29
|
|
Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief
Post-training/Waitlisted phase
|
90 percentage of correct responses
Standard Deviation 20
|
84 percentage of correct responses
Standard Deviation 26
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who returned for post testing, 67 had sufficient time to complete the TOM Test at both time points.
Theory of Mind Behavior (Post-testing controlling for Baseline). A measure of generalization. Overall percent correct across the three sub-scales (i.e., percent correct calculated across all items of Level 1-Precursors, Level 2-First Order False Belief, and Level 3-Advanced) is reported. The percent correct ranges from 0-100% correct. Higher scores represent better theory of mind (affective and first/second order false belief).
Outcome measures
| Measure |
Training
n=34 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=33 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
TOM Test (Theory of Mind Test)
Post-Training/Wait-listed phase
|
71 percentage of correct responses
Standard Deviation 12
|
65 percentage of correct responses
Standard Deviation 10
|
|
TOM Test (Theory of Mind Test)
Baseline
|
66 percentage of correct responses
Standard Deviation 14
|
63 percentage of correct responses
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who returned for post testing, 62 parents completed the SSIS questionnaire at both time points.
Social function home (Post-testing controlling for Baseline). A measure of generalization. Scores were available from parents. The SSIS Social Scale organizes prosocial behaviors into seven areas or subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-Control. Scores range from 40-160. Higher scores reflect more prosocial skills (i.e., better social ability). At Post, higher scores represent a better outcome. Note: Teacher SSIS was originally planned as an outcome measure, but due to low teacher response the results were not analyzed.
Outcome measures
| Measure |
Training
n=32 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=30 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Social Skills Improvement System-Parent (SSIS) - Social Standard Score
Baseline
|
81.63 scores on a scale
Standard Deviation 12.5
|
80.47 scores on a scale
Standard Deviation 15.7
|
|
Social Skills Improvement System-Parent (SSIS) - Social Standard Score
Post-training/Waitlisted phase
|
81.69 scores on a scale
Standard Deviation 10.6
|
79.33 scores on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Data were not collected.
Social Communication Ability Behavior (Post-testing controlling for Baseline). A measure of generalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who completed post-testing, 64 completed the task at both time points.
Conflict Processing (Reward) Behavior (Post-testing controlling for Baseline). Children selected from four doors with varying reward and loss ratios. Two doors have lower rewards but an overall net gain (safe) and two doors have higher rewards but an overall net loss (risky). Scores represent the ratio of safe to risky selections in the final two blocks (of five total blocks administered).
Outcome measures
| Measure |
Training
n=33 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=31 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections
Baseline
|
1.39 ratio of safe to risky selections
Standard Deviation 10.85
|
0.16 ratio of safe to risky selections
Standard Deviation 10.28
|
|
Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections
Post-training/Waitlisted phase
|
0.33 ratio of safe to risky selections
Standard Deviation 11.7
|
1.74 ratio of safe to risky selections
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: This task was always administered after the Child ANT Flanker Task, resulting in fewer children who completed it at both time points. Of the 68 children who returned for post-testing, 31 provided usable, artifact free data at both time points.
Conflict Processing-ERP Brain Response (N2 mean amplitude) Data were compared for Go and Nogo conditions at each time point (baseline and post testing). The task included 200 test trials. During 'go' trials (70% of trials), children were instructed to press a single button on a keypad each time a letter appeared on the screen. During 'nogo' trials (30% of trials), children were instructed to withhold their response when a specific letter appeared on the screen. To account for the confound of frequency with condition, two letters were used for go trials - an infrequent go (30% of trials) and a frequent go (40% of trials). Go responses were analyzed only for the infrequent go trials. Each trial was preceded by a fixation cross presented on the screen for 500 ms. Test trials were then presented for 700 ms. Only ERPs for correct trials that followed a correct 'go' response were analyzed in order to ensure consistent motor response on the previous trial.
Outcome measures
| Measure |
Training
n=16 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
|
Waitlist
n=15 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
|
|---|---|---|
|
Event-related Potentials Assessed During Cued Go/Nogo Task
Go - Pre
|
-2.4 microvolts
Standard Deviation 2.8
|
-2.9 microvolts
Standard Deviation 4.0
|
|
Event-related Potentials Assessed During Cued Go/Nogo Task
Nogo - Pre
|
-1.6 microvolts
Standard Deviation 3.4
|
-3.0 microvolts
Standard Deviation 4.3
|
|
Event-related Potentials Assessed During Cued Go/Nogo Task
Go - Post
|
-1.1 microvolts
Standard Deviation 2.1
|
-2.3 microvolts
Standard Deviation 3.0
|
|
Event-related Potentials Assessed During Cued Go/Nogo Task
Nogo - Post
|
-2.8 microvolts
Standard Deviation 3.6
|
-2.6 microvolts
Standard Deviation 4.5
|
POST_HOC outcome
Timeframe: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)Population: Of the 68 children who returned for post-testing, data were available for 60 participants.
Parent report of restricted and repetitive symptoms at home-Generalization (Post-testing controlling for Baseline) Total RBS-R scores are analyzed. The RBS-R includes information about stereotyped behavior, self-injurious behavior, compulsive behavior, ritualistic behavior, sameness behavior, and restricted behavior. The range of scores is (range = 0-176). Higher scores reflect more restricted and repetitive behavior symptoms. At Post, lower scores represent a better outcome.
Outcome measures
| Measure |
Training
n=31 Participants
Computerized executive control training
Computerized executive control training: Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.
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Waitlist
n=29 Participants
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.
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|---|---|---|
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Repetitive Behavior Scale-Revised (RBS-R) - Total Score
Baseline
|
16.61 score on a scale
Standard Deviation 10.75
|
24.11 score on a scale
Standard Deviation 14.06
|
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Repetitive Behavior Scale-Revised (RBS-R) - Total Score
Post-training/Waitlisted phase
|
13.61 score on a scale
Standard Deviation 9.04
|
27.03 score on a scale
Standard Deviation 17.90
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Adverse Events
Training
Waitlist
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