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

May 28, 2025 updated by: Children's Hospital of Fudan University
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:
          • Xiu Xu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The observation study will be performed in children with ASD and healthy, typically developing children.

Description

Case group:

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.

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:

Inclusion Criteria:

  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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Subjects in the case group are diagnosed with autism spectrum disorder according to DSM-V and clinical observation.
Diagnostic test: ADOS-2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latencies in event related potentials(ERPs)
Time Frame: Baseline (during 2 to 17 years old).
The investigators will explore the differences of N1/N2, P3/LPP and N400 in event related potentials (ERPs) between case and control groups (children with ASD and typical development) in responses to special prosocial stimulus, and also in false belief tasks. Event related potentials (ERPs) will be tested using eego™ mylab of ANT Neuro company.
Baseline (during 2 to 17 years old).
Amplitudes in ERPs
Time Frame: Baseline (during 2 to 17 years old).
Amplitudes of N1/N2, P3/LPP and N400 will be compared between children with autism spectrum disorder and typical development.
Baseline (during 2 to 17 years old).
nuclear magnetic resonance imaging(MRI)
Time Frame: Baseline (during 2 to 17 years old).
Cranial MRI data, including sMRI and fMRI, will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Baseline (during 2 to 17 years old).
Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions
Time Frame: Baseline (during 2 to 17 years old).
The investigators will explore inter-group differences of children with ASD and typical development in the concentrations of HbO and HbR during social communication scenes between participants and investigators.
Baseline (during 2 to 17 years old).
clinical diagnosis
Time Frame: Baseline (during 2 to 17 years old).
Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2. The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Baseline (during 2 to 17 years old).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

ShanghaiTech University

Investigators

  • Principal Investigator: Xiu Xu, Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • brainpro2022-cross-sectional

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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