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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ShanghaiTech University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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