Viewing Study NCT06523660



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06523660
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-17

Brief Title: Improving Executive Function in Korean Children With Autism
Sponsor: None
Organization: None

Study Overview

Official Title: A Randomized Control Trial of Executive Function Training for Korean Kindergartners With Autism Spectrum Disorder
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None