Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
NCT Number: NCT07692022
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.
This study is active but is not currently recruiting participants.
Notify Me30 month–16 year
All sexes
Observational
Shanghai, Shanghai Municipality, 201102, China
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
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.
Study Sites Data will be collected at the primary site and potentially at international collaborating institutions. All sites will follow a harmonized protocol.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks
Time frame: Baseline
Percentage of total fixation time directed to pre-defined facial regions of interest (eyes, mouth) during social scene stimuli; measured via remote eye-tracker (e.g., Tobii Pro or equivalent)
Time frame: Baseline
Age-stratified mean score of Theory of Mind tasks in the typically developing normative sample
Children's Hospital of Fudan University
Other
A Study of Social Cognition in Children With Autism Spectrum Disorder: Behavioral and Cognitive Assessments With Typically Developing Controls
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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