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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorKorea University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Children with significant intellectual disability

Children with significant language delay

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 (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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ChuckChuck Step InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
2

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.

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
3

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.

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
4

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.

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

Secondary outcomes

1

Vineland

The Vineland Adaptive Behavior Scale is a standardized parent report to measure children's social skills, communication, and adaptive behavior. It can be administered on children 0 to 90 years of age and consists of 433 items, each scored on a 0, 1, or 2-point scale. It provides measures of overall adaptive behavioral functioning and subdomains of adaptive behavior (communication, life skills, social, and motor skills).

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
2

K-WFA

The Korean Wechsler Fundamentals: Academic Skills is a brief, standardized achievement assessment adapted and normed from the original Wechsler Fundamentals: Academic Skills (WFA) to evaluate core academic skills essential for learning in educational settings. In the present study, the K-WFA will be used to assess children's academic skill levels and changes associated with intervention effects. The measure evaluates fundamental domains including word reading, reading comprehension, writing, and numerical calculation. The K-WFA consists of parallel forms (Form A and Form B), allowing for pre- and post-intervention assessment, and enables rapid evaluation of functional academic skills as well as monitoring of learning-related changes over time.

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
3

PIPPS

The Penn Interactive Peer Play Scale is a play behavior assessment developed to understand children's interactions with peers and to be consistently rated by parents or teachers across settings during early childhood. Our study will utilize the parent report to assess children's play in home and neighborhood environments. The parent report records the level of frequency at which each behavior was observed during the child's free play over a 2-month period. It consists of 32 4-point Likert scales and results include the following domains: play disruption, play interaction, and play disengagement.

Time frame
baseline, immediately after the intervention, 6-weeks follow-up
4

CBCL

The Child Behavior Checklist is a standardized parent-report measure used to assess children's emotional and behavioral problems, with age-specific versions to ensure developmental appropriateness. In this study, it will be administered based on the child's age: the CBCL 1.5-5 will be used for children aged 18 months to 5 years, and the Korean Child Behavior Checklist for Ages 6-18 (K-CBCL 6-18) will be used for children aged 6 to 18 years. The Korean CBCL 1.5-5, published in 2008, includes a Problem Behavior Scale and a Language Development Scale, with the problem behavior items assessing internalizing and externalizing difficulties as well as DSM-oriented symptom domains using a 3-point Likert scale. The K-CBCL 6-18, released in 2010 following nationwide standardization, consists of a 113-item, 3-point Likert-scale Problem Behavior Scale that captures a broad range of emotional and behavioral functioning based on parent report.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Korea University

Lead sponsor

National Research Foundation of Korea

Collaborator

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