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Not Yet RecruitingNCT07376356

Executive Function Intervention for Children With ASD Combining a Digital App and Parent Coaching

A Randomized Controlled Trial of Executive Function Intervention for Children With Autism Spectrum Disorder(ASD) Combining Digital Application and Parent Coaching

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Korea University · Academic / Other
Sex
All
Age
5 Years – 8 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALChuckChuck StepOur intervention will consist of a daily(Mon-Fri), six-week, digital application based intervention (15 minutes per day) for children and six-week telehealth based group intervention (60 minutes per week) to support both children with ASD (5- to 8-year-olds) and their parents regarding executive function hardships. This program provides training for inhibition, working memory, planning and organizing, cognitive flexibility, and emotion regulation. Children will practice these aspects of executive function while playing child-friendly games with the storyline being based on everyday school related themes. Games will consist of go-nogo tasks, following arrows, memory games etc. Parents will learn about these aspects of executive function through real-time telehealth and will be provided with strategies to further promote growth of executive function abilities in their children. The parent mediated intervention curriculum moves beyond didactic instruction by combining psychoeducation with
BEHAVIORALChuckChuck Step (Shortened Parent Coaching)Children in the waitlist control group will receive the same intervention as the intervention group after the waitlist period. Parents in the waitlist control group will receive an abbreviated version(three-week) of the parent mediated intervention with the same contents as the intervention group.

Timeline

Start date
2026-02-01
Primary completion
2026-08-01
Completion
2027-08-01
First posted
2026-01-29
Last updated
2026-01-30

Source: ClinicalTrials.gov record NCT07376356. Inclusion in this directory is not an endorsement.