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

Korea University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: ChuckChuck Step; Behavioral: ChuckChuck Step (Shortened Parent Coaching)

Study type: Interventional

Funder types: Other

Identifiers

NCT07376356

00209635 (Other Grant/Funding Number)

IRB-2025-0286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Children with significant intellectual disability
• Children with significant language delay

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

ChuckChuck Step Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: ChuckChuck Step

Waitlist Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: ChuckChuck Step (Shortened Parent Coaching)