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

NCT06908174 | Recruiting

• 1 other identifier: brainpro2022-cross-sectional
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Autism Spectrum Disorder; Healthy

Keywords

autism

Outcome Measures

Primary Outcomes (5)

• clinical diagnosis

  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).

• Latencies in event related potentials(ERPs)

  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

  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)

  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

  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).

Study Arms (2)

Case group

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

Diagnostic Test: ADOS-2

Control group

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

Interventions

ADOS-2 DIAGNOSTIC_TEST

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

Case group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• ShanghaiTech University: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingrui Zhou

CONTACT

13701989113; zbr1800@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: April 3, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)