Clinical Trial

Social Cognition in Children and Adolescents With Autism Spectrum Disorder

Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07692022
Lead Sponsor Children's Hospital of Fudan University
Conditions Autism
Enrollment 1,000 participants
Start Date 2025-01-05
Primary Completion 2028-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-09