Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

Last updated: March 13, 2026
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Autism Spectrum Disorder (Asd)

Treatment

Do not take any interventions

Clinical Study ID

NCT06329245
brainpro2022
  • Ages < 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects were enrolled as high-risk if they had an older sibling with a clinicaldiagnosis of ASD confirmed on the Autism Diagnostic Observation Schedule, secondedition (ADOS-2) or Autism Diagnostic Interview (ADI-R).

  • Subjects were enrolled in the low-risk group if they had an older sibling withoutevidence of ASD and no family history of a first or second-degree relative with ASD.

Exclusion

Exclusion Criteria:

  1. diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;

  2. a significant medical or neurological condition affecting growth, development orcognition (e.g., CNS infection, seizure disorder, congenital heart disease);

  3. sensory impairment such as vision or hearing loss;

  4. low birth weight (<2000 grams) or prematurity (<37 weeks gestation);

  5. possible perinatal brain injury from exposure to in-utero exogenous compoundsreported to likely affect the brain adversely in at least some individuals (e.g.,alcohol, selected prescription medications);

  6. contraindication for MRI (e.g., metal implants);

  7. a family history of intellectual disability, psychosis, schizophrenia or bipolardisorder in a first-degree relative.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Do not take any interventions
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
July 01, 2029

Study Description

The longitude observational study will be performed to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). We will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. Clinical diagnosis will be made on 24-month-old or after, with the DSM-5 as the diagnostic criterion.

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.