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NCT Number: NCT06908174

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

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).

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Healthy Mental Disorders Neurodevelopmental Disorders

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Xiu Xu, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Case group:

Inclusion criteria

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

Exclusion criteria

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

Control group:

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ADOS-2

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingrui Zhou

CONTACT

[email protected]

13701989113

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • ShanghaiTech University

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 3, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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