A Randomized, Control Trial of Executive Function Training for Korean Kindergartners With Autism Spectrum Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Korea University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Head-Toes-Knees-Shoulders (HTKS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Head-Toes-Knees-Shoulders (HTKS)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Head-Toes-Knees-Shoulders (HTKS) is a behavioral task that measures self-regulation in children and consists of short tasks suitable for children 4-8 years of age, with higher scores indicating a better performance (minimum = 0, maximum = 118).
Stroop Color and Word Test Children's Version (Stroop)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
The Stroop test is a neuropsychological measure for assessing the efficiency of inhibitory control. Participants are asked to read 1) the Word page where names of colors are printed in black 2) the Color page where patches labeled as 'XXXX' are printed in different colors 3) the Color-Word page where names of colors are printed in inconsistent colors (ex. the word "red" is printed in blue, and participants need to read out the color "blue" instead of the word "red".). The number of items correctly read within 45 seconds for each page is recorded.
Executive Function (EF) Touch
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Executive Function (EF) Touch is a child-friendly computerized assessment of executive function skills, administered on a touch-screen tablet. The use of Executive Function Touch will allow the investigators 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 investigators will use a proportion of correct trials from each task as the outcome measure, with higher scores indicating a better performance on the task (minimum = 0, maximum = 1).
Korean-Boston Naming Test-Children's Version (K-BNT-C)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
The Korean-Boston Naming Test-Children's Version assesses not only the "word processing", but also the "visuospatial perception" of the pictures. Participants are shown black-and-white pictures of objects and asked to name them.
EF Training Program Feasibility Survey
Time Frame: post-intervention (1 week after the completion of the intervention)
This will be completed by the parents at the end of the intervention program to assess whether the intervention was feasible for the participants. It will include items related to practicality of the program such as 'zoom was easy to operate' and 'I was able to find time to do homework with my child', and parents will provide answers on a likert scale.
Children's Color Trail Making Test (CCTT)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
Children's Color Trail Making Test (CCTT) consists of two subscales: CCTT-1, which requires perceptual tracking, sustained attention, and fine motor skills, and CCTT-2, which requires divided attention, sequential processing, and inhibition/disinhibition in addition to the first three skills. Participants are asked to connect circles with numbers and colors in order, and the time spent to complete each task is recorded.
EF Training Program Acceptability Survey
Time Frame: post-intervention (1 week after the completion of the intervention)
This will be completed by the parents at the end of the intervention program to assess whether the intervention was acceptable and satisfying to the participants. It will include items such as 'I benefit from intervention sessions with the interventionist' and parents will provide answers on a likert scale.
The Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
The BRIEF is a standardized parent report measure where parents rate the frequency of their child's EF challenges within everyday contexts, such as home and other community settings. The BRIEF results in scores that reflect the child's level of EF dysfunction, with higher scores indicating more EF challenges. The BRIEF consists of 63 items, with each item rated on a 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). In this study, the investigators will use T-scores from clinical scales (e.g., Inhibit, Shift, Working Memory) of the BRIEF (M=50, SD=10), as well as Global Executive Composite, an overall summary score that incorporates all the clinical scales of the BRIEF.
Emotion Dysregulation Inventory (EDI)
Time Frame: pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)
The Emotion Dysregulation Inventory (EDI) is a parent-report questionnaire that assesses emotion regulation difficulties of children, rated on a five-point scale from "not at all" to "very severe." The EDI results in scores that reflect the child's level of emotion regulation dysfunction, with higher scores representing more emotion regulation challenges. The investigators will use a 30-item full version of the EDI, which consists of 24 items related to Reactivity and 6 items related to Dysphoria. Raw scores of the Reactivity scale range from 0 to 96. Raw scores of the Dysphoria range from 0 to 24.
Secondary Outcomes
- Vineland Adaptive Behavior Scale (VABS)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Electroencephalogram (EEG)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- National Institute for Special Education-Basic Academic Competence Tests (NISE-B ACT)(pre-intervention,post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Behavior Assessment System for Children (BASC)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Brief Observation of Social Communication Change (BOSCC)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Korean-Parent Stress Index-Short Form (K-PSI-SF)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Penn Interactive Peer Play Scale (PIPPS)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
- Children's Behavior Checklist (CBCL)(pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention))
Investigators
So Hyun Kim
Associate Professor
Korea University