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

NCT07376356 | Not Yet Recruiting

• 2 other identifiers: IRB-2025-028600209635
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (7)

• EF Touch

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• HTKS

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• Stroop

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• ACE

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• BRIEF

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• EDI

  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.

  baseline, immediately after the intervention, 6-weeks follow-up

• Intervention feasibility and acceptability survey

  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").

  immediately after the intervention

Secondary Outcomes (15)

• 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

Study Arms (2)

ChuckChuck Step Intervention

EXPERIMENTAL

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.

Behavioral: ChuckChuck Step

Waitlist Control

ACTIVE COMPARATOR

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.

Behavioral: ChuckChuck Step (Shortened Parent Coaching)

Interventions

ChuckChuck Step BEHAVIORAL

Our 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

ChuckChuck Step Intervention

ChuckChuck Step (Shortened Parent Coaching) BEHAVIORAL

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.

Waitlist Control

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University: lead
• National Research Foundation of Korea: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Waitlist Control Group Design

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01