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

Recruiting now

Conditions studied: Autism or Autistic Traits, Healthy

In brief

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.

Key facts

Study ID

NCT06329245

Run by

Children's Hospital of Fudan University

People needed

100

Starts

2024-04-01

Expected to finish

2029-07-01

Last updated by the study team

2026-03-16

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects were enrolled as high-risk if they had an older sibling with a clinical diagnosis of ASD confirmed on the Autism Diagnostic Observation Schedule, second edition (ADOS-2) or Autism Diagnostic Interview (ADI-R).
• Subjects were enrolled in the low-risk group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.

You may not qualify if…

• diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;
• a significant medical or neurological condition affecting growth, development or cognition (e.g., CNS infection, seizure disorder, congenital heart disease);
• sensory impairment such as vision or hearing loss;
• low birth weight (<2000 grams) or prematurity (<37 weeks gestation);
• possible perinatal brain injury from exposure to in-utero exogenous compounds reported to likely affect the brain adversely in at least some individuals (e.g., alcohol, selected prescription medications);
• contraindication for MRI (e.g., metal implants);
• a family history of intellectual disability, psychosis, schizophrenia or bipolar disorder in a first-degree relative.

Where it is running

• Children's Hospital of Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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