Gaming for Autism to Mold Executive Skills Project
NCT02361762, Not applicable, Completed, Boston Children's Hospital; results first posted 2019-02-20
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Gaming for Autism to Mold Executive Skills Project | ClinicalTrials.gov |
| NCT number | NCT02361762 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 70 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Boston Children's Hospital | ClinicalTrials.gov |
| Conditions | Autism Spectrum Disorders | ClinicalTrials.gov |
| Interventions | Computerized executive control training | ClinicalTrials.gov |
| First posted | 2015-02-12 | ClinicalTrials.gov |
| Last updated | 2021-07-28 | ClinicalTrials.gov |
| Results first posted | 2019-02-20 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change Task - Stop Signal Reaction Time | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Primary | Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Primary | Event-related Potentials Assessed During Child Attention Network Flanker Task | 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. | ClinicalTrials.gov |
| Primary | BRIEF Parent Survey (Global Executive Composite) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Secondary | Backward Digit Span (Scaled Score) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Secondary | Social Attribution Task (SAT) - Problem Solving Scale | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Theory of Mind Behavior (Post-testing controlling for Baseline) A measure of generalization. | ClinicalTrials.gov |
| Secondary | Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Secondary | TOM Test (Theory of Mind Test) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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). | ClinicalTrials.gov |
| Secondary | Social Skills Improvement System-Parent (SSIS) - Social Standard Score | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
| Secondary | Narrative Language Task | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Social Communication Ability Behavior (Post-testing controlling for Baseline). A measure of generalization. | ClinicalTrials.gov |
| Secondary | Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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). | ClinicalTrials.gov |
| Secondary | Event-related Potentials Assessed During Cued Go/Nogo Task | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | ClinicalTrials.gov |
Outcomes 13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change Task - Stop Signal Reaction Time | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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). | miliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Data were available for 63 children; five children were unable to complete the task or refused to play (3 baseline, 2 at post). | difference in % of correct responses | MEAN | ClinicalTrials.gov |
| PRIMARY | Event-related Potentials Assessed During Child Attention Network Flanker Task | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | microvolts | MEAN | ClinicalTrials.gov | |
| PRIMARY | BRIEF Parent Survey (Global Executive Composite) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 63 parents completed the questionnaire at both time points. | scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Backward Digit Span (Scaled Score) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who completed post testing, 63 provided data at both time points. | scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Social Attribution Task (SAT) - Problem Solving Scale | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who returned for post testing, 45 children had sufficient time during visits at both time points for this task. | percent correct on SAT problem solving | MEAN | ClinicalTrials.gov |
| SECONDARY | Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | percentage of correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | TOM Test (Theory of Mind Test) | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who returned for post testing, 67 had sufficient time to complete the TOM Test at both time points. | percentage of correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | Social Skills Improvement System-Parent (SSIS) - Social Standard Score | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who returned for post testing, 62 parents completed the SSIS questionnaire at both time points. | scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Narrative Language Task | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Data were not collected. | ClinicalTrials.gov | ||
| SECONDARY | Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who completed post-testing, 64 completed the task at both time points. | ratio of safe to risky selections | MEAN | ClinicalTrials.gov |
| SECONDARY | Event-related Potentials Assessed During Cued Go/Nogo Task | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | 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. | microvolts | MEAN | ClinicalTrials.gov |
| POST_HOC | Repetitive Behavior Scale-Revised (RBS-R) - Total Score | Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase) | Of the 68 children who returned for post-testing, data were available for 60 participants. | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change Task - Stop Signal Reaction Time | Training | Baseline | 233.8 | Standard Deviation 87.8 | miliseconds | ClinicalTrials.gov |
| Change Task - Stop Signal Reaction Time | Waitlist | Baseline | 238.3 | Standard Deviation 94.3 | miliseconds | ClinicalTrials.gov |
| Change Task - Stop Signal Reaction Time | Training | Post-training/Waitlisted phase | 213.6 | Standard Deviation 78.5 | miliseconds | ClinicalTrials.gov |
| Change Task - Stop Signal Reaction Time | Waitlist | Post-training/Waitlisted phase | 234.7 | Standard Deviation 98.1 | miliseconds | ClinicalTrials.gov |
| Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Training | Baseline | 3.8 | Standard Deviation 8 | difference in % of correct responses | ClinicalTrials.gov |
| Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Waitlist | Baseline | 6.0 | Standard Deviation 12 | difference in % of correct responses | ClinicalTrials.gov |
| Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Training | Post-Training/Wait-listed phase | 2.9 | Standard Deviation 13 | difference in % of correct responses | ClinicalTrials.gov |
| Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) | Waitlist | Post-Training/Wait-listed phase | 3.8 | Standard Deviation 9 | difference in % of correct responses | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Training | Congruent - Pre | -.20 | Standard Deviation 3.2 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Waitlist | Congruent - Pre | -2.5 | Standard Deviation 3.3 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Training | Incongruent - Pre | .83 | Standard Deviation 3.3 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Waitlist | Incongruent - Pre | -3.8 | Standard Deviation 4.8 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Training | Congruent - Post | -1.0 | Standard Deviation 3.6 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Waitlist | Congruent - Post | -3.7 | Standard Deviation 4.1 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Training | Incongruent - Post | -1.8 | Standard Deviation 3.7 | microvolts | ClinicalTrials.gov |
| Event-related Potentials Assessed During Child Attention Network Flanker Task | Waitlist | Incongruent - Post | -3.3 | Standard Deviation 4.5 | microvolts | ClinicalTrials.gov |
| BRIEF Parent Survey (Global Executive Composite) | Training | Global Executive Composite-Pre | 66.55 | Standard Deviation 11.51 | scores on a scale | ClinicalTrials.gov |
| BRIEF Parent Survey (Global Executive Composite) | Waitlist | Global Executive Composite-Pre | 68.40 | Standard Deviation 8.61 | scores on a scale | ClinicalTrials.gov |
| BRIEF Parent Survey (Global Executive Composite) | Training | Global Executive Composite-Post | 65.85 | Standard Deviation 9.96 | scores on a scale | ClinicalTrials.gov |
| BRIEF Parent Survey (Global Executive Composite) | Waitlist | Global Executive Composite-Post | 67.77 | Standard Deviation 10.42 | scores on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Training | 35 | ClinicalTrials.gov | |
| Overall Study | STARTED | Waitlist | 35 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Training | 35 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Waitlist | 33 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Training | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Waitlist | 2 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Training | 0 | 35 | ClinicalTrials.gov |
| Total, all-cause mortality | Waitlist | 0 | 35 | ClinicalTrials.gov |
| Total, other adverse events | Training | 0 | 35 | ClinicalTrials.gov |
| Total, other adverse events | Waitlist | 0 | 35 | ClinicalTrials.gov |
| Total, serious adverse events | Training | 0 | 35 | ClinicalTrials.gov |
| Total, serious adverse events | Waitlist | 0 | 35 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 35481725 | DERIVED | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R00HD071966 | Electrophysiological Response to Executive Control Training in Autism | FAJA, SUSAN | BOSTON CHILDREN'S HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2014 to 2016 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Training vs Waitlist: deaths from any cause | Trial comparisons |
| Training vs Waitlist: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| False Belief Stories | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)