Executive Function Training Program for Children With ASD
A Randomized Controlled Trial for the Development and Validation of an Executive Function Training Program for Elementary School Students
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this clinical trial is to learn whether a structured executive function training program can improve executive function, adaptive behavior, and self-regulation in elementary school students with autism spectrum disorder (ASD). The main questions it aims to answer are: Does the program improve participants' executive function skills and their ability to use these skills in daily life? Does the program improve participants' adaptive behavior and self-regulation? Researchers will compare participants who receive the executive function training program with participants in a waitlist control group to determine whether the program is effective. Participants will be randomly assigned to either the intervention group or the waitlist control group and will complete assessments before and after the intervention. The intervention consists of a structured, group-based program provided once a week for 12 weeks. Children participate in sessions designed to teach and practice executive function strategies, while their parents participate in parent education and review of home practice to support the use of these skills in daily life. The program focuses on skills such as planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Participants practice applying these strategies to situations encountered at home, at school, and in everyday life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2026
CompletedFirst Submitted
Initial submission to the registry
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
September 3, 2026
April 1, 2026
10 months
August 31, 2026
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
The BRIEF-2 is a parent-report questionnaire that assesses executive function behaviors in children's everyday life. The Global Executive Composite (GEC), index scores, and individual clinical scale scores will be analyzed to evaluate changes in different aspects of executive functioning. Higher T-scores indicate greater difficulties with executive functioning, whereas lower T-scores indicate fewer difficulties.
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Secondary Outcomes (4)
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Emotion Regulation as Assessed by the Emotion Regulation Checklist (ERC)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Academic Self-Regulation as Assessed by the Academic Self-Regulation Questionnaire (SRQ-A)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Prosocial Self-Regulation as Assessed by the Prosocial Self-Regulation Questionnaire (SRQ-P)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Other Outcomes (8)
Inhibitory Control as Assessed by the Stroop Test
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Cognitive Flexibility as Assessed by the Children's Color Trails Test (CCTT)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
Cognitive Flexibility as Assessed by the Wisconsin Card Sorting Test (WCST)
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
- +5 more other outcomes
Study Arms (2)
Executive Function Training Group
EXPERIMENTALParticipants receive a structured, group-based executive function training program once a week for 12 weeks. The program includes an 80-minute child session and a 65-minute parent session each week. Parents receive education on the same executive function topics taught to their children and review home practice to support the application and generalization of these skills in daily life.
Waitlist Control Group
NO INTERVENTIONParticipants do not receive the executive function training program during the initial 12-week intervention period. After completion of the post-intervention assessment, participants in the waitlist control group are offered the same executive function training program.
Interventions
A 12-week, structured, group-based executive function training program delivered once weekly to elementary school students aged 9-12 years with autism spectrum disorder (ASD) and their parents. Each weekly session includes an 80-minute child session and a 65-minute parent session. The child sessions use explicit instruction, modeling, guided practice, role-play, feedback, and home practice to teach and practice executive function strategies related to planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. In parallel, parents receive education on the same executive function topics taught to their children and review their child's home practice. Parent involvement is designed to help children apply and generalize the executive function strategies learned in the program to daily life at home, at school, and in other everyday situations.
Eligibility Criteria
You may qualify if:
- Children aged 9 to 12 years who are attending elementary school
- Diagnosis of autism spectrum disorder (ASD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Full-scale intelligence quotient (IQ) of 70 or higher
- Ability to understand the study procedures and participate in the intervention program
- Availability of a parent or legal guardian who is able to participate in the parent sessions and study assessments
You may not qualify if:
- Presence of a severe neurological or medical condition that may interfere with participation in the study
- Presence of a severe psychiatric or behavioral condition that may interfere with participation in the group-based intervention
- Significant sensory or physical impairment that would prevent participation in the intervention or assessments
- Concurrent participation in another structured intervention program targeting executive function during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Jeong Yoo, MD., Ph.D.
Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2026
First Posted
September 3, 2026
Study Start
March 12, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
September 3, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share