Autism Spectrum DisordersGAMESNCT02361762

Gaming for Autism to Mold Executive Skills Project

A study of Autism Spectrum Disorders, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 11 years
Conditions the study is for: Autism Spectrum Disorders
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children should be 7 to 11 years of age
Children must have a parent/guardian who is available and willing to provide informed consent and to respond to screening phone calls
Children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria
Children must have general cognitive ability in the average range or above (above 80 using the Wechsler Abbreviated Scale of Intelligence-2 Full Scale IQ)
Caregivers and children must be fluent in English

Who cannot join

Children must not have a seizure disorder or be taking medication that alters EEG processes (e.g. anti-seizure medications)
Children must not have medical disorders or injuries affecting the brain or spinal cord
Children may not have experienced significant prenatal exposure to substances such as tobacco, alcohol or street drugs
Children may not have significant sensory or motor impairment that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital: Labs of Cognitive Neuroscience- Faja Lab
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Electrophysiological Response to Executive Control Training

The goal of the project is to better understand executive control-how children manage complex or conflicting information in the service of a goal. This skill has been linked to social and academic functioning in typically developing children. Executive control is often reduced in children with autism spectrum disorder (ASD), but it has not been a focus of treatment. This project will have the goal of determining whether computer-training tasks developed to enhance the executive control skills of preschoolers and school-aged children without autism are appropriate for children with ASD. The investigators do not yet know if this training is beneficial for children with ASD. In addition, because executive control has been found to relate to social knowledge and problem solving, the investigators will collect information with this type of task to measure possible effects of training.

Read the detailed description

Participation will include two phone calls to determine if the study is a good fit and collect some preliminary information, five visits to Boston Children's Hospital (3 before training and 2 about 6-8 weeks later), caregiver questionnaires, and an optional teacher questionnaire packet. The visits will include activities designed to assess verbal and nonverbal thinking ability; social skills and general interests; and specific tasks related to cognitive and social problem solving. In addition, EEG measurement of brain function will be made. EEG is a non-invasive recording of brain activity. Children will be randomly assigned (i.e., like flipping a coin) to receive training or to a non-training group. The training group will complete tasks designed to improve executive control presented over the course of 5-10 1-hour sessions. All tasks are game-like and are presented on a computer with child friendly graphics. A staff member will work with each child as he/she completes the training activities. Children assigned to the non-training group will be invited to participate in training at the end of the study if it is shown to improve executive control.

Conditions: Autism Spectrum Disorders
Being tested: Computerized executive control training
Keywords: Executive Function, Theory of Mind, Individual Differences, Social Skills, Executive Control
Medical subject headings: Autism Spectrum Disorder, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computerized executive control trainingBehavioural
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.

Study groups in NCT02361762
Study group	Role	What they receive
Training	Experimental	Computerized executive control training Receives: Behavioral: Computerized executive control training
Waitlist	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change Task - Stop Signal Reaction Time
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Event-related Potentials Assessed During Child Attention Network Flanker Task
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
BRIEF Parent Survey (Global Executive Composite)
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

Secondary outcomes (8)

Backward Digit Span (Scaled Score)
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Social Attribution Task (SAT) - Problem Solving Scale
Theory of Mind Behavior (Post-testing controlling for Baseline) A measure of generalization.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
TOM Test (Theory of Mind Test)
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).
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Social Skills Improvement System-Parent (SSIS) - Social Standard Score
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Narrative Language Task
Social Communication Ability Behavior (Post-testing controlling for Baseline). A measure of generalization.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections
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).
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Event-related Potentials Assessed During Cued Go/Nogo Task
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.
Measured: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Nov 2017

First posted12 Feb 2015 (estimated)
Study startFeb 2015
Primary completionNov 2017
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02361762
Sponsor's protocol ID: P00014188
Other IDs: R00HD071966
Acronym: GAMES
Status last verified: Jul 2021
First submitted: 4 Feb 2015
Last updated: 28 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Edmunds SR, MacNaughton GA, Rueda MR, Combita LM, Faja S. Beyond group differences: Exploring the preliminary signals of target engagement of an executive function training for autistic children. Autism Res. 2022 Jul;15(7):1261-1273. doi: 10.1002/aur.2735. Epub 2022 Apr 28.
PubMed 35481725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electrophysiological Response to Executive Control Training
ClinicalTrials.gov ID: NCT02361762
Acronym / sponsor ID: GAMES / P00014188
Conditions: Autism Spectrum Disorders
Keywords: Executive Function, Theory of Mind, Individual Differences, Social Skills, Executive Control
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Feb 2015
Primary completion: Nov 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 12 Feb 2015 (estimated)
Results: Posted 20 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Training	Experimental	Behavioral: Computerized executive control trainingComputerized executive control training
Waitlist	No intervention	–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.

Who may qualify

Ages: 7 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children should be 7 to 11 years of age
Children must have a parent/guardian who is available and willing to provide informed consent and to respond to screening phone calls
Children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria
Children must have general cognitive ability in the average range or above (above 80 using the Wechsler Abbreviated Scale of Intelligence-2 Full Scale IQ)
Caregivers and children must be fluent in English

Key exclusion criteria (4 listed)

Children must not have a seizure disorder or be taking medication that alters EEG processes (e.g. anti-seizure medications)
Children must not have medical disorders or injuries affecting the brain or spinal cord
Children may not have experienced significant prenatal exposure to substances such as tobacco, alcohol or street drugs
Children may not have significant sensory or motor impairment that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computerized executive control trainingChildren 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.	Behavioural	Training

Primary outcome

Change Task - Stop Signal Reaction Time
Time frame: 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.
Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)
Time frame: 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.
Event-related Potentials Assessed During Child Attention Network Flanker Task
Time frame: 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.
BRIEF Parent Survey (Global Executive Composite)
Time frame: 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.

8 secondary outcomes

Backward Digit Span (Scaled Score)
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Social Attribution Task (SAT) - Problem Solving Scale
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
TOM Test (Theory of Mind Test)
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Social Skills Improvement System-Parent (SSIS) - Social Standard Score
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Narrative Language Task
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Event-related Potentials Assessed During Cued Go/Nogo Task
Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

Results and safety

Results posted to the registry on 20 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Training	35	35
Waitlist	35	33

Primary outcome: Change Task - Stop Signal Reaction Time

Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase). Mean (Standard Deviation). Unit: miliseconds

Measure	Training n = 31	Waitlist n = 30
Baseline	233.8 (87.8)	238.3 (94.3)
Post-training/Waitlisted phase	213.6 (78.5)	234.7 (98.1)

Training vs Waitlist: p = 0.36, ANCOVA

Population analysed: 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).

Primary outcome: Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)

Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase). Mean (Standard Deviation). Unit: difference in % of correct responses

Measure	Training n = 34	Waitlist n = 29
Baseline	3.8 (8)	6.0 (12)
Post-Training/Wait-listed phase	2.9 (13)	3.8 (9)

Training vs Waitlist: p = 0.79, ANCOVA

Population analysed: Data were available for 63 children; five children were unable to complete the task or refused to play (3 baseline, 2 at post).

Primary outcome: Event-related Potentials Assessed During Child Attention Network Flanker Task

Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase). Mean (Standard Deviation). Unit: microvolts

Measure	Training n = 24	Waitlist n = 22
Congruent - Pre	-.20 (3.2)	-2.5 (3.3)
Incongruent - Pre	.83 (3.3)	-3.8 (4.8)
Congruent - Post	-1.0 (3.6)	-3.7 (4.1)
Incongruent - Post	-1.8 (3.7)	-3.3 (4.5)

Training vs Waitlist: p = 0.009, ANOVA

Primary outcome: BRIEF Parent Survey (Global Executive Composite)

Time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase). Mean (Standard Deviation). Unit: scores on a scale

Measure	Training n = 33	Waitlist n = 30
Global Executive Composite-Pre	66.55 (11.51)	68.40 (8.61)
Global Executive Composite-Post	65.85 (9.96)	67.77 (10.42)

Training vs Waitlist: p = .79, ANCOVA

Population analysed: 63 parents completed the questionnaire at both time points.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Given that this was a behavioral study, adverse event data were not formally collected but participants were encouraged to report any concerns about participation to study staff throughout the study period, which was approximately 6 months (baseline + 3 month intervention window + post testing). At each assessment visit, families were also given a debriefing form to determine whether the child's behavior was expected during the visit and whether any stressors occurred since the previous visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Training	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Waitlist	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35481725Edmunds SR, MacNaughton GA, Rueda MR, Combita LM, Faja S. Beyond group differences: Exploring the preliminary signals of target engagement of an executive function training for autistic children. Autism Res. 2022 Jul;15(7):1261-1273. doi: 10.1002/aur.2735. Epub 2022 Apr 28.
Faja Lab WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Faja, Ph.D. principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Autism Spectrum Disorders, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Task - Stop Signal Reaction Time (time frame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.