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改善韩国自闭症儿童的执行功能

2026年9月20日 更新者:So Hyun Kim、Korea University

韩国自闭症谱系障碍幼儿园儿童执行功能训练的随机对照试验

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Seoul、韩国
        • Korea University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 7年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Executive Function (EF) Touch
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Vineland Adaptive Behavior Scale (VABS)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)

其他结果措施

结果测量
措施说明
大体时间
Barkley Deficits in Executive Functioning Scale (BDEFS)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:So Hyun Kim, PhD、Korea University
  • 研究主任:Boin Choi, PhD、Korea University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月11日

初级完成 (实际的)

2026年3月15日

研究完成 (实际的)

2026年3月15日

研究注册日期

首次提交

2024年7月17日

首先提交符合 QC 标准的

2024年7月23日

首次发布 (实际的)

2024年7月26日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月20日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB-2024-0026
  • 00209635 (其他赠款/资助编号:National Research Foundation of Korea)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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