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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Seoul National University Bundang Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Emotion Regulation as Assessed by the Emotion Regulation Checklist (ERC)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Academic Self-Regulation as Assessed by the Academic Self-Regulation Questionnaire (SRQ-A)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Prosocial Self-Regulation as Assessed by the Prosocial Self-Regulation Questionnaire (SRQ-P)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inhibitory Control as Assessed by the Stroop Test
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Cognitive Flexibility as Assessed by the Children's Color Trails Test (CCTT)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Cognitive Flexibility as Assessed by the Wisconsin Card Sorting Test (WCST)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Autism-Related Social Functioning as Assessed by the Social Responsiveness Scale, Second Edition (SRS-2)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Emotional and Behavioral Problems as Assessed by the Child Behavior Checklist (CBCL)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Depressive Symptoms as Assessed by the Children's Depression Inventory (CDI)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Anxiety Symptoms as Assessed by the State-Trait Anxiety Inventory for Children (STAIC)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Parenting Stress as Assessed by the Korean Parenting Stress Index, Fourth Edition, Short Form (K-PSI-4-SF)
Periodo de tiempo: Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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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.
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Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hee Jeong Yoo, MD., Ph.D., Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B-2512-1015-001
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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