Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Melhorando a função executiva em crianças coreanas com autismo

20 de setembro de 2026 atualizado por: So Hyun Kim, Korea University

Um ensaio randomizado e de controle de treinamento de funções executivas para alunos do jardim de infância coreanos com transtorno do espectro do autismo

The purpose of this randomized controlled study is to evaluate the acceptability, feasibility, and preliminary efficacy of an executive function (EF) training intervention for 5- to 7-year-old autistic children in South Korea. This study will have three aims: (1) to assess the acceptability and feasibility of the EF intervention with children with ASD; (2) to examine clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) to determine whether the effects are generalized to everyday EF skills in real-world settings using parent-ratings.

Visão geral do estudo

Descrição detalhada

The ability to self-monitor and flexibly adapt behavior in response to internal or external changes refers to neurocognitive processes known as executive function (EF). EF impairments, such as inflexible problem-solving, attention-shifting difficulties, and challenges in goal-directed behavior planning, are consistently identified as core cognitive deficits in autism spectrum disorder (ASD). Early life EF deficits can lead to negative social and academic outcomes, including poor school performance, externalizing behaviors, antisocial conduct, and adverse adult outcomes. Therefore, EF has become a significant focus for interventions, yet few studies have investigated EF interventions in ASD. Evidence-based interventions targeting EF are critically needed.

The purpose of this randomized controlled study is to evaluate the effectiveness of an online EF training intervention for 5- to 7-year-old children with ASD in South Korea, where intervention services, especially during school transition periods, are extremely limited. The project has three scientific goals: (1) assess the acceptability and feasibility of the EF intervention for children with ASD; (2) examine the clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) determine whether the effects generalize to everyday EF skills in real-world settings using parent-ratings.

The investigators will recruit 40 Korean children with ASD during school transition (20 randomly assigned to the intervention, 20 to the control). Children in the intervention group will participate in a 10-week online training program and will be administered outcome measures, including physiological measures, lab-based behavior, and parent-reports of clinical functioning, at three time points (i.e., pre-intervention, 1-week after the completion of the intervention, and 3-months after the completion of the intervention). Parent coaching will be provided to enhance the generalization of EF skills. The control group will receive group-based parent psychoeducation. This work has the potential to significantly improve EF skills and functional outcomes for autistic children, addressing the urgent need for targeted interventions for the underserved population in South Korea.

Tipo de estudo

Intervencional

Inscrição (Real)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

5 anos a 7 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Previous medical diagnosis of ASD, confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
  • Non-verbal IQ (NVIQ) equal to or above 85
  • Verbal children (with flexible phrases or complex sentences)

Exclusion Criteria:

  • NVIQ below 85
  • Presence of medical disorders or injuries with implications for the central nervous system or that require medications that alter EEG processes such as anticonvulsants
  • Presence of significant sensory or motor impairment
  • Presence of major physical anomalies

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention Group

Children will receive the EF training intervention, which will be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks), targeting core EF components including inhibitory control, attention shifting, and working memory. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

The intervention will consist of an online EF training that will be delivered across 10 sessions (one 1 hour session per week for ten weeks). It will target core EF components including inhibitory control, attention shifting, and working memory in children with Autism Spectrum Disorder aged 5 to 7 years. It will also provide strategies (e.g., behavioral principles, compliance training) for promoting behavioral regulation and emotion regulation in these children. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

Comparador Ativo: Control Group

Group-based parent psychoeducation will be provided to the control group. This program will also be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks) and will cover a broad range of information relevant to ASD.

Group-based parent psychoeducation, which consists of 10 sessions, 1-hour weekly program delivered via telehealth, will be provided to the control group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Executive Function (EF) Touch
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

Executive Function (EF) Touch is a child-friendly computerized assessment of executive function skills, administered on a touch-screen tablet. The use of Executive Function Touch will allow the investigators to target fine-grained, multiple EF domains, including inhibitory control ("Spatial Conflict Arrows"), working memory ("Pick the Picture"), and attention shifting ("Something's the Same). The investigators will use a proportion of correct trials from each task as the outcome measure, with higher scores indicating a better performance on the task (minimum = 0, maximum = 1).

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Head-Toes-Knees-Shoulders (HTKS)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

Head-Toes-Knees-Shoulders (HTKS) is a behavioral task that measures self-regulation in children and consists of short tasks suitable for children 4-8 years of age, with higher scores indicating a better performance (minimum = 0, maximum = 118).

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Stroop Color and Word Test Children's Version (Stroop)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Stroop test is a neuropsychological measure for assessing the efficiency of inhibitory control. Participants are asked to read 1) the Word page where names of colors are printed in black 2) the Color page where patches labeled as 'XXXX' are printed in different colors 3) the Color-Word page where names of colors are printed in inconsistent colors (ex. the word "red" is printed in blue, and participants need to read out the color "blue" instead of the word "red".). The number of items correctly read within 45 seconds for each page is recorded.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Korean-Boston Naming Test-Children's Version (K-BNT-C)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Korean-Boston Naming Test-Children's Version assesses not only the "word processing", but also the "visuospatial perception" of the pictures. Participants are shown black-and-white pictures of objects and asked to name them.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Children's Color Trail Making Test (CCTT)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

Children's Color Trail Making Test (CCTT) consists of two subscales: CCTT-1, which requires perceptual tracking, sustained attention, and fine motor skills, and CCTT-2, which requires divided attention, sequential processing, and inhibition/disinhibition in addition to the first three skills. Participants are asked to connect circles with numbers and colors in order, and the time spent to complete each task is recorded.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
The Behavior Rating Inventory of Executive Function (BRIEF)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The BRIEF is a standardized parent report measure where parents rate the frequency of their child's EF challenges within everyday contexts, such as home and other community settings. The BRIEF results in scores that reflect the child's level of EF dysfunction, with higher scores indicating more EF challenges. The BRIEF consists of 63 items, with each item rated on a 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). In this study, the investigators will use T-scores from clinical scales (e.g., Inhibit, Shift, Working Memory) of the BRIEF (M=50, SD=10), as well as Global Executive Composite, an overall summary score that incorporates all the clinical scales of the BRIEF.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Emotion Dysregulation Inventory (EDI)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Emotion Dysregulation Inventory (EDI) is a parent-report questionnaire that assesses emotion regulation difficulties of children, rated on a five-point scale from "not at all" to "very severe." The EDI results in scores that reflect the child's level of emotion regulation dysfunction, with higher scores representing more emotion regulation challenges. The investigators will use a 30-item full version of the EDI, which consists of 24 items related to Reactivity and 6 items related to Dysphoria. Raw scores of the Reactivity scale range from 0 to 96. Raw scores of the Dysphoria range from 0 to 24.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
EF Training Program Feasibility Survey
Prazo: post-intervention (1 week after the completion of the intervention)

This will be completed by the parents at the end of the intervention program to assess whether the intervention was feasible for the participants. It will include items related to practicality of the program such as 'zoom was easy to operate' and 'I was able to find time to do homework with my child', and parents will provide answers on a likert scale.

post-intervention (1 week after the completion of the intervention)
EF Training Program Acceptability Survey
Prazo: post-intervention (1 week after the completion of the intervention)

This will be completed by the parents at the end of the intervention program to assess whether the intervention was acceptable and satisfying to the participants. It will include items such as 'I benefit from intervention sessions with the interventionist' and parents will provide answers on a likert scale.

post-intervention (1 week after the completion of the intervention)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Vineland Adaptive Behavior Scale (VABS)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The VABS is a standardized parent report to measure children's social skills, communication, and adaptive behavior. Higher scores on each subscale indicate better adaptive function.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Penn Interactive Peer Play Scale (PIPPS)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The PIPPS is a play behavior assessment developed to understand children's interactions with peers. It consists of three subscales: play interaction, play disruption, play disconnection. 1) Play Interaction is an indication of children's play strengths and includes such behaviors as comforting and helping other children, showing creativity in play, and encouraging others to join play. 2) Play Disruption describes aggressive, antisocial behaviors that interfere with on-going peer play interactions. 3) Play Disconnection reflects withdrawn behavior and non-participation in peer play.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Children's Behavior Checklist (CBCL)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The CBCL is a standardized behavior rating scale informed by parents and / or teachers for assessing child behavior. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often) and higher scales indicate greater problems.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Behavior Assessment System for Children (BASC)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The BASC is a standardized parent-report of emotional behavior for toddlers and young children.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Brief Observation of Social Communication Change (BOSCC)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The BOSCC is a behavioral observation tool originally developed to measure pre- and post-intervention treatment effects in children with autism.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Electroencephalogram (EEG)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Zoo Game will be used as a go/no-go EEG task to measure error-related theta oscillations and error-related negativity (ERN) using EEG tasks.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
National Institute for Special Education-Basic Academic Competence Tests (NISE-B ACT)
Prazo: pre-intervention,post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The National Institute for Special Education (NISE) tests will assess basic learning skills, such as reading and math, for students (ages 5 to 14). Higher scores indicate better performance.

pre-intervention,post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Korean-Parent Stress Index-Short Form (K-PSI-SF)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Korean-Parent Stress Index-Short Form is a parent self-report measuring parenting stressors. Higher scores indicate higher levels of parenting stress.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Barkley Deficits in Executive Functioning Scale (BDEFS)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

In this study, the Korean version of Barkley Deficits in Executive Functioning Scale (BDEFS) will be used to assess the presence of executive function and attention deficit hyperactivity disorder symptoms in daily lives of caregivers of children with autism.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Kims Frontal Executive Neuropsychology Test (K-FENT)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The K-FENT assesses attention, language, visuospatial and memory skills in adults. In this study, the K-FENT will be used to measure EF function of parents.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Emotion Regulation Questionnaire (ERQ)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The ERQ will be used to measure how parents experience and express their emotions. Higher scores indicate greater use of that particular emotion regulation strategy.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Loneliness and Social Isolation Scale (LSIS)
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The LSIS is an instrument that encompasses both objectively measurable "social network" and an individual's subjective perceptions of "social support" and "loneliness" to estimate the complex concept of "social isolation".

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
UCLA (University of California, Los Angeles) Loneliness Scale
Prazo: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

The Korean version of the UCLA Loneliness Scale will be used to assess loneliness as 'a state of extreme distress due to relational deficiency'. Higher scores indicate greater levels of loneliness.

pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: So Hyun Kim, PhD, Korea University
  • Diretor de estudo: Boin Choi, PhD, Korea University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de setembro de 2024

Conclusão Primária (Real)

15 de março de 2026

Conclusão do estudo (Real)

15 de março de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de julho de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2024

Primeira postagem (Real)

26 de julho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB-2024-0026
  • 00209635 (Número de outro subsídio/financiamento: National Research Foundation of Korea)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever