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Executive Function Training Program for Children With ASD

31. august 2026 opdateret af: Seoul National University Bundang Hospital

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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
40

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.
Adfærdsmæssigt: Executive Function Training Program
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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inhibitory Control as Assessed by the Stroop Test
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Seoul National University Bundang Hospital

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Hee Jeong Yoo, MD., Ph.D., Seoul National University College of Medicine, Child and Adolescent Psychiatry Clinic Seoul National University Bundang Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
12. marts 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. januar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
31. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
3. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
3. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • B-2512-1015-001

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