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NCT Number: NCT07692022

Social Cognition in Children and Adolescents With Autism Spectrum Disorder

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

30 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Study Sites Data will be collected at the primary site and potentially at international collaborating institutions. All sites will follow a harmonized protocol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correct on total score of Theory of Mind Task

    Time frame: Baseline

    Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks

Secondary outcomes

  1. Proportion of Fixation Time on Facial Regions of Interest (%)

    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)

  2. Age-Stratified Mean Score on Theory of Mind Tasks (TD Normative Sample)

    Time frame: Baseline

    Age-stratified mean score of Theory of Mind tasks in the typically developing normative sample

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

A Study of Social Cognition in Children With Autism Spectrum Disorder: Behavioral and Cognitive Assessments With Typically Developing Controls

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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