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

ASD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339359
• Other study ID #: 2024-02-014
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• ASD
• Autism Spectrum Disorder

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