← Back to all trials
Active Not Recruiting
NCT07692022
Social Cognition in Children and Adolescents With Autism Spectrum Disorder
Conditions: Autism
Sex: All
Ages: 30 Months – 16 Years
Healthy volunteers: Yes
Enrollment: 1000
Sponsor: Children's Hospital of Fudan University
Location: Children's Hospital of Fudan University Shanghai Shanghai Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07692022). StuddyBuddy aggregates publicly available trial information.