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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339359
Other study ID # 2024-02-014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date March 31, 2025

Study information

Verified date March 2024
Source Bundang CHA Hospital
Contact Kim MinYoung
Phone 82-31-780-6281
Email kmin@cha.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 19 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments
Collection of clinical data including K-Bayley Scales of Infant and Toddler Development Third Edition (K-BSID-?), , Beery-Buktenica Visual-Motor Integration, Sixth Edition (VMI-6) and clinical measurement. motor analysis and eye tracking

Locations

Country Name City State
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary K-BSID-? Measurement of K-BSID-? 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). Between March 2024 and March 2025
Primary ADI-R 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. Between March 2024 and March 2025
Primary M-CHAT 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. Between March 2024 and March 2025
Primary ADOS-2 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. Between March 2024 and March 2025
Primary K-WPPSI-? Measurement of K-WPPSI-? is an intelligence test to evaluate cognitive function in children aged 2 years and 6 months to 7 years and 7 months. Between March 2024 and March 2025
Primary K-CARS-2 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. Between March 2024 and March 2025
Primary CBCL 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. Between March 2024 and March 2025
Primary SCQ Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report. Between March 2024 and March 2025
Primary GMFM 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. Between March 2024 and March 2025
Primary HFT 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. Between March 2024 and March 2025
Primary BOT-2 Measurement of BOT-2 is a testing tool used for movement training evaluation and development. Between March 2024 and March 2025
Primary VMI-6 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. Between March 2024 and March 2025
Primary SP 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. Between March 2024 and March 2025
Primary Eye Tracking While the subject watches the video material being played, gaze and behavioral data are recorded. Between March 2024 and March 2025
Primary Motion Analysis Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC. Between March 2024 and March 2025
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