Improving Executive Function in Korean Children With Autism

Korea University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: CHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKills; Behavioral: Parent Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06523660

IRB-2024-0026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous medical diagnosis of ASD, confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
• Non-verbal IQ (NVIQ) equal to or above 85
• Verbal children (with flexible phrases or complex sentences)

Exclusion criteria

• NVIQ below 85
• Presence of medical disorders or injuries with implications for the central nervous system or that require medications that alter EEG processes such as anticonvulsants
• Presence of significant sensory or motor impairment
• Presence of major physical anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Children will receive the EF training intervention, which will be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks), targeting core EF components including inhibitory control, attention shifting, and working memory. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

Treatment:

Behavioral: CHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKills

Control Group

Active Comparator group

Description:

Group-based parent psychoeducation will be provided to the control group. This program will also be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks) and will cover a broad range of information relevant to ASD.

Treatment:

Behavioral: Parent Psychoeducation