MedPath

A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders

Recruiting
Conditions
ASD
Registration Number
NCT06339359
Lead Sponsor
Bundang CHA Hospital
Brief Summary

This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.

Detailed Description

This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Children and adolescents under the age of 19 at the time of registration
  • A person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it
Exclusion Criteria
  • Those with abnormalities in hearing and vision
  • Those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator
  • If the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CBCLBetween March 2024 and March 2025

Measurement of CBCL is a useful clinical tool used in many countries around the world to evaluate social adaptation and emotional behavior problems in children and adolescents.

SCQBetween March 2024 and March 2025

Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.

BOT-2Between March 2024 and March 2025

Measurement of BOT-2 is a testing tool used for movement training evaluation and development.

Motion AnalysisBetween March 2024 and March 2025

Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC.

ADOS-2Between March 2024 and March 2025

Measurement of ADOS-2 is a standardized assessment tool that evaluates social interaction and stereotyped and repetitive behavior in people suspected of having autism spectrum disorder.

HFTBetween March 2024 and March 2025

Measurement of HFT is a tool to evaluate the degree of development of hand function according to age, forward arm reaching, various grasping abilities, coordination ability between both hands, and object handling ability.

SPBetween March 2024 and March 2025

Measurement of SP is a standardized tool for assessing children's sensory processing patterns in the context of everyday life, providing unique information about how sensory processing supports or hinders participation.

K-BSID-ⅢBetween March 2024 and March 2025

Measurement of K-BSID-Ⅲ is a developmental test administered to infants from 16 days old to 42 months old, and consists of 16 subtests measuring a total of 5 development areas (cognitive, language, motor, social-emotional, and adaptive behavior).

ADI-RBetween March 2024 and March 2025

Measurement of ADI-R is a test conducted to screen autism spectrum disorder from other developmental disabilities in children with a mental age of 2 years or older, and is conducted through a structured interview with the primary caregiver.

M-CHATBetween March 2024 and March 2025

Measurement of M-CHAT is a tool to screen the risk level of autism spectrum disorder in children aged 16 to 30 months and is evaluated based on the primary caregiver's report.

K-CARS-2Between March 2024 and March 2025

Measurement of K-CARS-2 is an one of the most widely used tools for the purpose of distinguishing autism from other developmental disabilities and the degree of autism.

K-WPPSI-ⅣBetween March 2024 and March 2025

Measurement of K-WPPSI-Ⅳ is an intelligence test to evaluate cognitive function in children aged 2 years and 6 months to 7 years and 7 months.

GMFMBetween March 2024 and March 2025

Measurement of GMFM is a standardized observational evaluation tool with validity that measures changes in gross motor function over time in children with cerebral palsy.

VMI-6Between March 2024 and March 2025

Measurement of VMI-6 is a test that validly measures the visual-motor integration ability, visual perception ability, and motor coordination ability of various age groups from infants to adults.

Eye TrackingBetween March 2024 and March 2025

While the subject watches the video material being played, gaze and behavioral data are recorded.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHA Bundang Medical Center, CHA University

🇰🇷

Seongnam-si, Gyeonggi-do, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath