Clinical trial NCT06523660: Improving Executive Function in Korean Children With Autism
Official title: A Randomized, Control Trial of Executive Function Training for Korean Kindergartners With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2024-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Executive Function (EF) Touch
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Head-Toes-Knees-Shoulders (HTKS)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Stroop Color and Word Test Children's Version (Stroop)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Korean-Boston Naming Test-Children's Version (K-BNT-C)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Children's Color Trail Making Test (CCTT)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: The Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Emotion Dysregulation Inventory (EDI)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: EF Training Program Feasibility Survey
timeFrame: post-intervention (1 week after the completion of the intervention)
measure: EF Training Program Acceptability Survey
timeFrame: post-intervention (1 week after the completion of the intervention)
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale (VABS)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Penn Interactive Peer Play Scale (PIPPS)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Children's Behavior Checklist (CBCL)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Behavior Assessment System for Children (BASC)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Brief Observation of Social Communication Change (BOSCC)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Electroencephalogram (EEG)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: National Institute for Special Education-Basic Academic Competence Tests (NISE-B ACT)
timeFrame: pre-intervention,post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Korean-Parent Stress Index-Short Form (K-PSI-SF)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Other outcomes:
measure: Barkley Deficits in Executive Functioning Scale (BDEFS)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Kims Frontal Executive Neuropsychology Test (K-FENT)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: Loneliness and Social Isolation Scale (LSIS)
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
measure: UCLA (University of California, Los Angeles) Loneliness Scale
timeFrame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University
Study officials:
affiliation: Korea University
name: So Hyun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Boin Choi, PhD
role: STUDY_DIRECTOR
References: