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Clinical Trials in China / NCT07692022
Active, not recruiting Observational

Social Cognition in Children and Adolescents With Autism Spectrum Disorder

NCT07692022 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Observational
Started
2025-01-05
Last updated
2026-07-09

Condition(s) studied

Autism

Study summary

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.

Eligibility

Sex
ALL
Min age
30 Months
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * Intellectual/Developmental assessment score (IQ/DQ) less than 70. * 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.

Primary outcome measure(s)

  • Correct on total score of Theory of Mind Task — Baseline
    Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07692022 on ClinicalTrials.gov ↗ ← All trials in China