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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06339359
Enrollment
200
Registered
2024-04-01
Start date
2024-03-01
Completion date
2025-03-31
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASD

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.

Interventions

OTHERExmainations 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-Ⅲ), , Beery-Buktenica Visual-Motor Integration, Sixth Edition (VMI-6) and clinical measurement. motor analysis and eye tracking

Sponsors

Bundang CHA Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
K-BSID-ⅢBetween March 2024 and March 2025Measurement 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 2025Measurement 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 2025Measurement 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.
ADOS-2Between March 2024 and March 2025Measurement 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.
K-WPPSI-ⅣBetween March 2024 and March 2025Measurement 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.
K-CARS-2Between March 2024 and March 2025Measurement 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.
CBCLBetween March 2024 and March 2025Measurement 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 2025Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.
GMFMBetween March 2024 and March 2025Measurement of GMFM is a standardized observational evaluation tool with validity that measures changes in gross motor function over time in children with cerebral palsy.
HFTBetween March 2024 and March 2025Measurement 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.
BOT-2Between March 2024 and March 2025Measurement of BOT-2 is a testing tool used for movement training evaluation and development.
VMI-6Between March 2024 and March 2025Measurement 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.
SPBetween March 2024 and March 2025Measurement 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.
Eye TrackingBetween March 2024 and March 2025While the subject watches the video material being played, gaze and behavioral data are recorded.
Motion AnalysisBetween March 2024 and March 2025Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC.

Countries

South Korea

Contacts

Primary ContactKim MinYoung
kmin@cha.ac.kr82-31-780-6281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026