Social Cognition in Children and Adolescents With Autism Spectrum Disorder

NCT07692022 | Active Not Recruiting

• 2 other identifiers: MOSC ASD2022ZD0205100
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

autism; social cognition

Outcome Measures

Primary Outcomes (1)

• Correct on total score of Theory of Mind Task

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

  Baseline

Secondary Outcomes (2)

• Proportion of Fixation Time on Facial Regions of Interest (%)

  Baseline

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

  Baseline

Study Arms (2)

autism

Subjects in the case group are diagnosed with autism spectrum disorder according to DSM-V and clinical observation.

non-autism

Subjects in the control group are healthy children without serious chronic or congenital diseases.

Eligibility Criteria

• Age: 30 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of two groups of children aged 2.5 to 11 years: a clinical group and a typically developing (TD) control group. The clinical group includes children with a confirmed clinical diagnosis of Autism Spectrum Disorder (ASD), validated by a specialist using DSM-5 criteria. The TD control group comprises age-matched individuals with no history of ASD, other neurodevelopmental conditions, or psychiatric disorders. All participants must have an IQ or Developmental Quotient (DQ) equal to or greater than 70, with no co-occurring intellectual disability, and possess normal or corrected-to-normal vision and hearing. Children with known genetic syndromes, severe neurological disorders (e.g., epilepsy, brain injury), or major trauma within the past 3 months are excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 9, 2026
• Study Start: January 5, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CN (1)