A Randomized Controlled Trial of Executive Function Intervention for Children With Autism Spectrum Disorder(ASD) Combining Digital Application and Parent Coaching
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- EF Touch
研究概览
简要总结
The purpose of this randomized controlled study is to develop and evaluate a digital cognitive control intervention that integrates a digital application-based child training program with an online parent coaching program for early school-aged children aged 5-8 with autism spectrum disorder (ASD) and their caregivers in South Korea. This intervention is designed to enhance clinical applicability, sustainability, and generalization to daily life of executive skills through active parental involvement. This study has three primary aims: (1) to examine the feasibility, acceptability, and implementation fidelity of the integrated child-parent digital intervention, (2) to investigate the effects of the intervention on children's cognitive control and executive function using behavioral assessments and neurophysiological measures (e.g., EEG), as well as on parents' use of cognitive control-supportive strategies in daily contexts, and (3) to assess whether intervention related changes generalize to real-world functioning, including children's adaptive behavior, academic readiness, and social functioning, as reported by parents, and whether these effects are maintained over time.
详细描述
Early school-aged children with autism spectrum disorder (ASD) frequently experience difficulties in executive functioning, including challenges in inhibitory control, working memory, cognitive flexibility, planning, and emotion regulation. These skills are essential for successful adaptation to school environments, peer relationships, and daily routines, and early deficits have been shown to predict long-term outcomes related to academic achievement, social participation, independent living, and mental health. Despite their clinical importance, there remains a lack of developmentally appropriate, evidence-based executive functioning interventions tailored for early school-aged children with ASD.
Parent-mediated interventions have demonstrated effectiveness in improving children's cognitive control and reducing problem behaviors, particularly due to their strength in promoting generalization of skills to everyday contexts such as home and school. However, these interventions are often limited by caregiver burden, parenting stress, and difficulties maintaining consistency and long-term adherence. In contrast, child-focused digital interventions provide structured, engaging, and algorithm-based training but frequently show limited generalization beyond the intervention setting. Integrating child-centered digital cognitive control training with structured parent coaching may therefore address the limitations of each approach and yield a more effective and sustainable intervention model.
The purpose of this randomized controlled study is to develop and evaluate a digital cognitive control intervention that integrates a digital application-based, game-oriented child training program with an online parent group coaching program for children aged 5 to 8 years with ASD and their caregivers in South Korea. The intervention targets core components of executive functioning within everyday school-related contexts and aims to enhance caregivers' understanding of executive functioning, their capacity to scaffold and reinforce skills in daily life, and the generalization of intervention gains beyond the digital environment, particularly for high-functioning children with ASD who have limited access to specialized services.
A total of 40 children with ASD (aged 5 years 0 months to 8 years 11 months) and their primary caregivers will be recruited in South Korea. Eligible children must meet DSM-5 or Autism Diagnostic Observation Schedule criteria, demonstrate phrase-level expressive language (ADOS modules 2 or 3), and have a nonverbal IQ of 70 or above. Participants will be randomly assigned to either an intervention group (n=20) or an active control group (n=20) using stratified block randomization based on age, sex, and nonverbal IQ. Children in both groups will complete a six-week home-based digital application cognitive control training program conducted five days per week for approximately 15 minutes per session. In addition, caregivers in the intervention group will participate in a six-week online parent group coaching program with weekly 60-minute sessions, while caregivers in the active control group will receive a shortened parent coaching program after their assessment period. Outcomes will be assessed at three time points using behavioral tasks, parent-report measures, and electroencephalography (EEG) to provide a comprehensive evaluation of intervention efficacy and underlying mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in South Korea aged 5-8
- •Children with previous medical diagnosis of ASD or children categorized as "Autism" or "Autism Spectrum" after administering ADOS-2
- •Children with language abilities that meet the eligibility for ADOS-2 Module 2 or 3
- •Children with cognitive functioning assessed using the Wechsler Preschool and Primary Scale of Intelligence and a nonverbal IQ of 70 or above
排除标准
- •Children with significant intellectual disability
- •Children with significant language delay
研究组 & 干预措施
ChuckChuck Step Intervention
Children will participate in an executive function training intervention delivered via a digital application provided by Neudive. The intervention consists of daily(Mon-Fri) child-friendly and school-context games that lasts approximately 15 minutes for six weeks. Meanwhile, parents will participate in a parent mediated executive function intervention delivered via telehealth over six weekly 60 minute group sessions. Sessions will include psychoeducation, delivering of executive function related strategies, and interactive activities to promote engagement and skill practice. This program is designed to train children with Autism Spectrum Disorder in executive function and support parents of those children through parent mediated intervention.
干预措施: ChuckChuck Step (Behavioral)
Waitlist Control
After collecting data for all timepoints, children in the waitlist control group will participate in the same EF(Executive Function) training intervention delivered via a digital application provided by Neudive. Meanwhile, parents will participate in an abbreviated parent mediated EF intervention delivered via telehealth over three weekly 60 minute group sessions. Sessions will consist of the same contents as the intervention group, including psychoeducation, delivering of EF related strategies, and interactive activities to promote engagement and skill practice.
干预措施: ChuckChuck Step (Shortened Parent Coaching) (Behavioral)
结局指标
主要结局
EF Touch
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
EF Touch is a child-friendly computerized EF task, administered on a touch-screen tablet. The use of EF Touch will allow us 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 proportion of correct trials for each domain will be used as an outcome.
HTKS
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
HTKS is a tool that measures behavioral self-regulation in children and consists of short tasks suitable for children 4-8 years of age. The game consists of up to four behavioral rules, and the examiner elicits a natural response from the child, such as "touch your head" or "touch your knee," and then switches the rules in a "reverse" fashion (e.g., "Now touch your toes when I tell you to touch your head"). This should take about 5 minutes.
Stroop
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
The Stroop Color and Word Test Children's Version is a tool for measuring the efficiency of inhibitory control, and the Korean version of the test was standardized for reliability and validity in 2006. During the test, words that do not match in color and letter are presented, and the subject must respond to the color instead of the letter, which is an automatic response. It is a neuropsychological test suitable for ages 5-14 and takes about 5-10 minutes.
ACE
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
The ADHD Comprehensive Evaluation (ACE) is a standardized, multi-component assessment tool designed to provide a comprehensive evaluation of ADHD-related functional impairments as well as core components of cognitive control. The ACE includes the Korean Attention Test (KAT), the Korean ADHD Rating Scale-5 (K-ARS-5), a Working Memory Test (WMT), and an Executive Function Test (Computerized Trail Making Test; C-TMT). It is a neuropsychological assessment battery suitable for children aged 5 to 15 years and assesses key domains of attention, working memory, and executive functioning relevant to cognitive control. WMT and C-TMT will be utilized in this study and each component requires approximately 5 to 15 minutes to administer.
BRIEF
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
The Korean Behavior Rating Inventory of Executive Function is a standardized parent report to observe children's cognitive control. It assesses behavior in executive functioning and is used to assess children with learning disabilities and attention disorders, as well as neurological, psychiatric, and medical conditions. It includes 86 items measuring various aspects of each executive function, which are categorized into eight clinical scales and two validity scales to provide a balanced view of the child's behavior. The test is intended for children ages 5-18 and takes approximately 15 minutes to complete.
EDI
时间窗: baseline, immediately after the intervention, 6-weeks follow-up
The Emotion Dysregulation Inventory is an informant questionnaire that assesses emotion regulation difficulties. It consists of 30 items, and informants (parents/caregivers) rate each item (e.g., "has sudden outbursts of emotion," "doesn't seem to enjoy anything") on a 5-point Likert scale ranging from "not at all" to "very severe" based on their observations of the child's functioning over the past 7 days.
Intervention feasibility and acceptability survey
时间窗: immediately after the intervention
Intervention feasibility and acceptability survey will be systematically evaluated using multiple indicators relevant to clinical trial implementation. Intervention feasibility will be assessed by tracking enrollment and retention rates across key demographic characteristics, the proportion of participants deemed ineligible based on screening procedures and clinical assessments, and data acquisition rates for cognitive control-related tasks administered before and after the intervention. Intervention acceptability will be evaluated using Likert-scale ratings and open-ended questions to capture participants' experiences and perceptions of the program (e.g., "Please describe the strengths of the intervention program," "Please describe any difficulties you experienced while participating in the intervention").
次要结局
- Vineland(baseline, immediately after the intervention, 6-weeks follow-up)
- K-WFA(baseline, immediately after the intervention, 6-weeks follow-up)
- PIPPS(baseline, immediately after the intervention, 6-weeks follow-up)
- CBCL(baseline, immediately after the intervention, 6-weeks follow-up)
- BOSCC(baseline, immediately after the intervention, 6-weeks follow-up)
- EEG(baseline, immediately after the intervention, 6-weeks follow-up)
- K-PSI(baseline, immediately after the intervention, 6-weeks follow-up)
- BDEFS(baseline, immediately after the intervention, 6-weeks follow-up)
- ERQ(baseline, immediately after the intervention, 6-weeks follow-up)
- Loneliness and Social Isolation Scale(baseline, immediately after the intervention, 6-weeks follow-up)
- UCLA Loneliness Scale(baseline, immediately after the intervention, 6-weeks follow-up)
- Parenting Sense of Competence (PSOC)(baseline, immediately after the intervention, 6-weeks follow-up)
- Parent Satisfaction Scale (PSS)(baseline, immediately after the intervention, 6-weeks follow-up)
- Autism Stigma and Knowledge Questionnaire (ASK-Q-2)(baseline, immediately after the intervention, 6-weeks follow-up)
- National Institute for Special Education-Basic Academic Competence Tests(baseline, immediately after the intervention, 6-weeks follow-up)
研究者
So Hyun Kim
Associate Professor
Korea University