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| ID | Type | Description | Link |
|---|---|---|---|
| 2022ZD0205100 | Other Grant/Funding Number | National Science and Technology Major Project |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correct on total score of Theory of Mind Task | Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Fixation Time on Facial Regions of Interest (%) | 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) | Baseline |
| Age-Stratified Mean Score on Theory of Mind Tasks (TD Normative Sample) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Xiu Xu | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
o protect participant privacy and compliance with the informed consent process, individual participant data (IPD) will not be shared outside of the investigating institution, as participants did not consent to the public sharing of their raw data.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Age-stratified mean score of Theory of Mind tasks in the typically developing normative sample |
| Baseline |