Gaming for Autism to Mold Executive Skills Project

NCT02361762 | Completed Results

• 2 other identifiers: P00014188R00HD071966
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorders

Keywords

Executive Function; Theory of Mind; Individual Differences; Social Skills; Executive Control

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

Secondary Outcomes (8)

• Backward Digit Span (Scaled Score)

  Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

• Social Attribution Task (SAT) - Problem Solving Scale

  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

  Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

• TOM Test (Theory of Mind Test)

  Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

• Social Skills Improvement System-Parent (SSIS) - Social Standard Score

  Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)

Study Arms (2)

Training

EXPERIMENTAL

Computerized executive control training

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.

Interventions

Computerized executive control training BEHAVIORAL

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.

Training

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

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

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 35481725 DERIVED

Related Links

• Faja Lab Website

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Susan Faja
• Organization: Boston Children's Hospital

susan.faja@childrens.harvard.edu

617-919-4108

Study Officials

• Susan Faja, Ph.D.

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 28, 2021
• Results First Posted: February 20, 2019

Record last verified: 2021-07

Locations

US (1)