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Recruiting NCT06908174

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

— Observational Autism Spectrum Disorder Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADOS-2.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Healthy. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

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

Primary outcome measures

  • clinical diagnosis [Time frame: Baseline (during 2 to 17 years old).]
  • Latencies in event related potentials(ERPs) [Time frame: Baseline (during 2 to 17 years old).]
  • Amplitudes in ERPs [Time frame: Baseline (during 2 to 17 years old).]
  • nuclear magnetic resonance imaging(MRI) [Time frame: 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Children's Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT06908174 · brainpro2022-cross-sectional

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗