AutismNCT07692022
Social Cognition in Children and Adolescents With Autism Spectrum Disorder
An observational study of Autism, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Study of Social Cognition in Children With Autism Spectrum Disorder: Behavioral and Cognitive Assessments With Typically Developing Controls
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Autism
- Keywords
- autism, social cognition
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct on total score of Theory of Mind Task
Proportion of correct responses on researcher-designed Theory of Mind behavioral experimental tasks
Measured: Baseline
Secondary outcomes (2)
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)
Measured: Baseline
Age-Stratified Mean Score on Theory of Mind Tasks (TD Normative Sample)
Age-stratified mean score of Theory of Mind tasks in the typically developing normative sample
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start5 Jan 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692022
- Sponsor's protocol ID
- MOSC ASD
- Other IDs
- 2022ZD0205100
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Social Cognition in Children With Autism Spectrum Disorder: Behavioral and Cognitive Assessments With Typically Developing Controls
- ClinicalTrials.gov ID
- NCT07692022
- Acronym / sponsor ID
- MOSC ASD
- Conditions
- Autism
- Keywords
- autism, social cognition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Proportion of Fixation Time on Facial Regions of Interest (%)
Time frame: Baseline
Age-Stratified Mean Score on Theory of Mind Tasks (TD Normative Sample)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiu Xu principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct on total score of Theory of Mind Task (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.