A Study of Social Cognition in Children With Autism Spectrum Disorder: Behavioral and Cognitive Assessments With Typically Developing Controls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Correct on total score of Theory of Mind Task
研究概览
简要总结
This study aims to (1) characterize the multi-domain social cognitive profile and developmental trajectory of children with autism spectrum disorder (ASD) aged 2.5 to 14 years relative to typically developing peers; (2) establish age-referenced normative data for the social cognition assessment battery in a large sample of typically developing children.
In the observational component, children with ASD and typically developing controls will undergo a comprehensive assessment battery spanning five domains of social cognition: emotion recognition, theory of mind (ToM), face processing, social communication, and broader social cognitive abilities. Assessments include standardized clinical instruments (ADOS-2, Wechsler intelligence scales), eye-tracking paradigms, and a range of behavioral experimental tasks targeting ToM, empathy, and self-perception.
In the normative component, a large sample of typically developing children (target n = 880) will complete the same social cognition assessment battery to establish age-stratified normative reference data.
This study is conducted across multiple sites, potentially including international collaborating institutions. Findings will advance the understanding of social cognitive development in ASD and inform the design of scalable, family-implemented interventions.
详细描述
Background Social cognition - encompassing emotion recognition, theory of mind, face processing, social communication, and related abilities - is a core domain of impairment in ASD. Despite growing interest, the developmental trajectory of social cognition across early childhood and adolescence in ASD remains incompletely characterized, and evidence-based normative benchmarks and scalable family-implemented interventions targeting these abilities are limited.
Objectives
- To comprehensively characterize the multi-domain social cognitive profile and developmental trajectory of children with ASD (aged 2.5-14 years) relative to typically developing peers.
- To establish age-referenced normative data for the multi-domain social cognition assessment battery in a large sample of typically developing children (n ≈ 880).
Observational Component All enrolled participants (ASD and TD groups) will complete a multi-modal assessment battery including: ADOS-2 (ASD group only); Wechsler intelligence scales; eye-tracking paradigms probing face processing and social attention; and a series of behavioral experimental tasks assessing ToM, empathy, and self-perception.
Normative Component A large sample of typically developing children (target n = 880) will complete the full social cognition assessment battery. Age-stratified means, standard deviations, and percentile norms will be calculated across the battery to serve as reference data for clinical and research use.
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
- 30 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 2 years 6 months and 11 years 11 months, with normative data focusing on 3.0 to 10.0 years.
- •Native Mandarin Chinese speaker, capable of understanding and cooperating with the assessment.
- •Normal development, with no diagnosed neurodevelopmental disorders.
- •Guardian has provided written informed consent.
排除标准
- •Intellectual/Developmental assessment score (IQ/DQ) less than
- •Diagnosed with Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), language impairment, cerebral palsy, or other neurodevelopmental conditions.
- •Severe hearing or visual impairment that prevents completion of the assessment.
- •History of major psychological or physical trauma within the past 3 months, or significant lack of cooperation.
结局指标
主要结局
Correct on total score of Theory of Mind Task
时间窗: Baseline
Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks
次要结局
- Proportion of Fixation Time on Facial Regions of Interest (%)(Baseline)
- Age-Stratified Mean Score on Theory of Mind Tasks (TD Normative Sample)(Baseline)