Social Cognition in Children and Adolescents With Autism Spectrum Disorder (NCT07692022) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Social Cognition in Children and Adolescents With Autism Spectrum Disorder
China1,000 participantsStarted 2025-01-05
Plain-language 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.
Who can participate
Age range
30 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.