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
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.
연구 개요
상세 설명
Executive function refers to a set of skills that support goal-directed behavior and independent functioning, including planning, organization, task initiation, time management, emotional and impulse control, flexible thinking, working memory, and self-monitoring. Difficulties in executive function may affect how children with autism spectrum disorder (ASD) manage everyday demands at home, at school, and in social situations. These difficulties may also be related to adaptive functioning and self-regulation.
This study evaluates a structured executive function training program developed for elementary school students with ASD. The program is designed to help children understand executive function strategies, practice them in structured activities, and apply them to situations encountered in everyday life. Rather than focusing only on performance on cognitive tasks, the intervention emphasizes the practical use of executive function skills for daily activities, school routines, emotional and behavioral regulation, and interactions with others.
The program is delivered in a group format over 12 weekly sessions. Intervention sessions use explicit instruction, therapist modeling, guided practice, role-play and other activities, feedback, and home practice. The major areas addressed include planning and prioritizing, organization, time management and task initiation, emotional and impulse control, and flexible thinking. Visual materials and age-appropriate activities are used to help children understand and practice the strategies.
Parents participate in a parallel parent component. They review the skills taught to their children, receive guidance on supporting the use of these strategies, and review the child's home practice with the intervention team. Parent involvement is intended to promote generalization of skills learned during the sessions to everyday settings.
Participants are randomly assigned to an intervention group or a waitlist control group. After the initial intervention period and post-intervention assessment, participants in the waitlist control group are also offered the program. The study examines whether participation in the program is associated with improvement in executive function and its use in daily life, as well as adaptive behavior, self-regulation, and related psychosocial functioning.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Executive Function Training Group
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.
|
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.
|
|
간섭 없음: Waitlist Control Group
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The Vineland-3 is a standardized measure of adaptive functioning in everyday life.
The Adaptive Behavior Composite (ABC) score will be used as the primary outcome measure.
Domain scores for Communication, Daily Living Skills, and Socialization will also be analyzed.
Higher scores indicate better adaptive functioning.
|
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)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The Emotion Regulation Checklist (ERC) is a 24-item questionnaire that assesses children's emotional regulation and emotional lability/negativity.
Items are rated on a 4-point scale from 1 (Never) to 4 (Always).
Scores for the Emotion Regulation and Lability/Negativity subscales will be analyzed, with higher Emotion Regulation scores indicating better emotion regulation and higher Lability/Negativity scores indicating greater emotional dysregulation.
|
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)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The Academic Self-Regulation Questionnaire (SRQ-A) is a child-report measure that assesses children's reasons for engaging in school-related behaviors.
It includes four regulatory styles: external regulation, introjected regulation, identified regulation, and intrinsic motivation.
Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style.
Subscale scores and the Relative Autonomy Index (RAI) will be analyzed, with higher RAI scores indicating more autonomous or self-determined regulation.
|
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)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The Prosocial Self-Regulation Questionnaire (SRQ-P) is a child-report measure that assesses children's reasons for engaging in prosocial behaviors.
It includes three regulatory styles: external regulation, introjected regulation, and identified regulation.
Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style.
Subscale scores will be analyzed to assess changes in the regulation of prosocial behavior.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Inhibitory Control as Assessed by the Stroop Test
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The Stroop Test is a performance-based measure used to assess inhibitory control and cognitive interference.
Performance indices derived from the Stroop task will be analyzed, with better performance reflecting greater inhibitory control and ability to manage cognitive interference.
|
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)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The CCTT is a performance-based measure of attention, sequencing, and cognitive flexibility in children.
Performance indices from the CCTT will be analyzed to assess changes in attentional control and cognitive flexibility, including the ability to shift between task demands.
|
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)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The WCST is a performance-based measure of executive functioning that assesses cognitive flexibility, concept formation, and the ability to shift cognitive sets in response to changing feedback.
Performance indices from the WCST will be analyzed to assess changes in cognitive flexibility.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
|
Autism-Related Social Functioning as Assessed by the Social Responsiveness Scale, Second Edition (SRS-2)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The SRS-2 is a questionnaire that assesses social functioning and autism-related social difficulties.
Total and subscale scores will be analyzed.
Higher scores indicate greater difficulties in social functioning and greater severity of autism-related social characteristics.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
|
Emotional and Behavioral Problems as Assessed by the Child Behavior Checklist (CBCL)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
Description: range of emotional and behavioral problems in children.
Composite and syndrome scale scores will be analyzed.
Higher scores indicate greater emotional and behavioral difficulties.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
|
Depressive Symptoms as Assessed by the Children's Depression Inventory (CDI)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The CDI is a child-report questionnaire used to assess depressive symptoms in children.
The total score will be analyzed, with higher scores indicating greater depressive symptoms.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
|
Anxiety Symptoms as Assessed by the State-Trait Anxiety Inventory for Children (STAIC)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The STAIC is a child-report questionnaire that assesses state anxiety and trait anxiety in children.
State Anxiety and Trait Anxiety scores will be analyzed separately, with higher scores indicating greater anxiety.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
|
Parenting Stress as Assessed by the Korean Parenting Stress Index, Fourth Edition, Short Form (K-PSI-4-SF)
기간: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
The K-PSI-4-SF is a parent-report questionnaire that assesses parenting stress.
The Total Stress score and subscale scores will be analyzed, with higher scores indicating greater levels of parenting stress.
|
Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hee Jeong Yoo, MD., Ph.D., Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B-2512-1015-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .