Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development

NCT ID: NCT06908174

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-07

Study Completion Date

2029-07-01

Brief Summary

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The goal of this observational study is to compare the brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).

Detailed Description

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The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.

Conditions

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Autism Spectrum Disorder Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case group

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

ADOS-2

Intervention Type DIAGNOSTIC_TEST

The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis.

Control group

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

No interventions assigned to this group

Interventions

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ADOS-2

The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
2. Ages 2-17 years;
3. Parents/caregivers understand the content of the study and agree to participate in.


1. Healthy children age between 2 to 17 years.
2. Children without the family history of ASD or other neurodevelopmental/mental diseases.
3. Parents/caregivers understand the content of the study and agree to participate in.

Exclusion Criteria

1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
2. Children with brain injuries, specific chronic or congenital diseases.
3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
4. Children cannot receive the head MRI examination.

Control group:


1. Children with brain injuries, specific chronic or congenital diseases.
2. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
3. Children cannot receive the head MRI examination.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ShanghaiTech University

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiu Xu

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingrui Zhou

Role: CONTACT

13701989113

Facility Contacts

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Xiu Xu, PhD

Role: primary

Other Identifiers

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brainpro2022-cross-sectional

Identifier Type: -

Identifier Source: org_study_id

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