Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT06523660

Improving Executive Function in Korean Children With Autism

A Randomized, Control Trial of Executive Function Training for Korean Kindergartners With Autism Spectrum Disorder

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Korea University · Academic / Other
Sex
All
Age
5 Years – 7 Years
Healthy volunteers
Not accepted

Summary

The purpose of this randomized controlled study is to evaluate the acceptability, feasibility, and preliminary efficacy of an executive function (EF) training intervention for 5- to 7-year-old autistic children in South Korea. This study will have three aims: (1) to assess the acceptability and feasibility of the EF intervention with children with ASD; (2) to examine clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) to determine whether the effects are generalized to everyday EF skills in real-world settings using parent-ratings.

Detailed description

The ability to self-monitor and flexibly adapt behavior in response to internal or external changes refers to neurocognitive processes known as executive function (EF). EF impairments, such as inflexible problem-solving, attention-shifting difficulties, and challenges in goal-directed behavior planning, are consistently identified as core cognitive deficits in autism spectrum disorder (ASD). Early life EF deficits can lead to negative social and academic outcomes, including poor school performance, externalizing behaviors, antisocial conduct, and adverse adult outcomes. Therefore, EF has become a significant focus for interventions, yet few studies have investigated EF interventions in ASD. Evidence-based interventions targeting EF are critically needed. The purpose of this randomized controlled study is to evaluate the effectiveness of an online EF training intervention for 5- to 7-year-old children with ASD in South Korea, where intervention services, especially during school transition periods, are extremely limited. The project has three scientific goals: (1) assess the acceptability and feasibility of the EF intervention for children with ASD; (2) examine the clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) determine whether the effects generalize to everyday EF skills in real-world settings using parent-ratings. The investigators will recruit 40 Korean children with ASD during school transition (20 randomly assigned to the intervention, 20 to the control). Children in the intervention group will participate in a 10-week online training program and will be administered outcome measures, including physiological measures, lab-based behavior, and parent-reports of clinical functioning, at three time points (i.e., pre-intervention, 1-week after the completion of the intervention, and 3-months after the completion of the intervention). Parent coaching will be provided to enhance the generalization of EF skills. The control group will receive group-based parent psychoeducation. This work has the potential to significantly improve EF skills and functional outcomes for autistic children, addressing the urgent need for targeted interventions for the underserved population in South Korea.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKillsThe intervention will consist of an online EF training that will be delivered across 10 sessions (one 1 hour session per week for ten weeks). It will target core EF components including inhibitory control, attention shifting, and working memory in children with Autism Spectrum Disorder aged 5 to 7 years. It will also provide strategies (e.g., behavioral principles, compliance training) for promoting behavioral regulation and emotion regulation in these children. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.
BEHAVIORALParent PsychoeducationGroup-based parent psychoeducation, which consists of 10 sessions, 1-hour weekly program delivered via telehealth, will be provided to the control group.

Timeline

Start date
2024-09-11
Primary completion
2026-03-15
Completion
2026-06-30
First posted
2024-07-26
Last updated
2025-12-24

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06523660. Inclusion in this directory is not an endorsement.