A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CBCL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
CBCL
时间窗: Between 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.
SCQ
时间窗: Between March 2024 and March 2025
Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.
BOT-2
时间窗: Between March 2024 and March 2025
Measurement of BOT-2 is a testing tool used for movement training evaluation and development.
Motion Analysis
时间窗: Between 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-2
时间窗: Between 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.
HFT
时间窗: Between 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.
SP
时间窗: Between 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-Ⅲ
时间窗: Between 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-R
时间窗: Between 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-CHAT
时间窗: Between 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-2
时间窗: Between 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-Ⅳ
时间窗: Between 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.
GMFM
时间窗: Between 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-6
时间窗: Between 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 Tracking
时间窗: Between March 2024 and March 2025
While the subject watches the video material being played, gaze and behavioral data are recorded.
次要结局
未报告次要终点
研究者
MinYoung Kim, MD, PhD
Principle investigator
Bundang CHA Hospital