Improving Executive Function in Korean Children With Autism
NCT Number: NCT06523660
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: BEHAVIORAL: CHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKills|BEHAVIORAL: Parent Psychoeducation
Sponsor: Korea University
Collaborators: National Research Foundation of Korea
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2025-09-30

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.

Primary Outcome Measures: Executive Function (EF) Touch, 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)., 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), 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)., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|Stroop Color and Word Test Children's Version (Stroop), 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., 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-Boston Naming Test-Children's Version (K-BNT-C), 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., 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), 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., 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 Behavior Rating Inventory of Executive Function (BRIEF), 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., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|Emotion Dysregulation Inventory (EDI), 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., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|EF Training Program Feasibility Survey, 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., post-intervention (1 week after the completion of the intervention)|EF Training Program Acceptability Survey, 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., post-intervention (1 week after the completion of the intervention)
Secondary Outcome Measures: Vineland Adaptive Behavior Scale (VABS), The VABS is a standardized parent report to measure children's social skills, communication, and adaptive behavior. Higher scores on each subscale indicate better adaptive function., 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), The PIPPS is a play behavior assessment developed to understand children's interactions with peers. It consists of three subscales: play interaction, play disruption, play disconnection. 1) Play Interaction is an indication of children's play strengths and includes such behaviors as comforting and helping other children, showing creativity in play, and encouraging others to join play. 2) Play Disruption describes aggressive, antisocial behaviors that interfere with on-going peer play interactions. 3) Play Disconnection reflects withdrawn behavior and non-participation in peer play., 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), The CBCL is a standardized behavior rating scale informed by parents and / or teachers for assessing child behavior. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often) and higher scales indicate greater problems., 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), The BASC is a standardized parent-report of emotional behavior for toddlers and young children., 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), The BOSCC is a behavioral observation tool originally developed to measure pre- and post-intervention treatment effects in children with autism., 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), The Zoo Game will be used as a go/no-go EEG task to measure error-related theta oscillations and error-related negativity (ERN) using EEG tasks., 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), The National Institute for Special Education (NISE) tests will assess basic learning skills, such as reading and math, for students (ages 5 to 14). Higher scores indicate better performance., 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), The Korean-Parent Stress Index-Short Form is a parent self-report measuring parenting stressors. Higher scores indicate higher levels of parenting stress., 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 Outcome Measures: Barkley Deficits in Executive Functioning Scale (BDEFS), In this study, the Korean version of Barkley Deficits in Executive Functioning Scale (BDEFS) will be used to assess the presence of executive function and attention deficit hyperactivity disorder symptoms in daily lives of caregivers of children with autism., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|Kims Frontal Executive Neuropsychology Test (K-FENT), The K-FENT assesses attention, language, visuospatial and memory skills in adults. In this study, the K-FENT will be used to measure EF function of parents., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|Emotion Regulation Questionnaire (ERQ), The ERQ will be used to measure how parents experience and express their emotions. Higher scores indicate greater use of that particular emotion regulation strategy., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|Loneliness and Social Isolation Scale (LSIS), The LSIS is an instrument that encompasses both objectively measurable "social network" and an individual's subjective perceptions of "social support" and "loneliness" to estimate the complex concept of "social isolation"., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)|UCLA (University of California, Los Angeles) Loneliness Scale, The Korean version of the UCLA Loneliness Scale will be used to assess loneliness as 'a state of extreme distress due to relational deficiency'. Higher scores indicate greater levels of loneliness., pre-intervention, post-intervention (1 week after the completion of the intervention), 3-month follow-up (3 months after the completion of the intervention)