NCT07801833

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress70%
Mar 2026Jan 2027

Study Start

First participant enrolled

March 12, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

September 3, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Executive Function, Executive Function Training, Adaptive Behavior, Self-Regulation, Parent-Mediated Intervention

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

EXPERIMENTAL

Participants 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.

Behavioral: Executive Function Training Program

Waitlist Control Group

NO INTERVENTION

Participants 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.

Executive Function Training Group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Autism Spectrum DisorderSelf-Control

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Hee Jeong Yoo, MD., Ph.D.

    Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

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

Locations