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Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD | Clinical Trials | Clareo Health

RECRUITING

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

NCT06329245•Children's Hospital of Fudan University

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

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 or cognition (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 compounds reported 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 bipolar disorder in a first-degree relative.

Locations (1)

Children's Hospital of Fudan University

Shanghai, China

Key Dates

Start Date

April 1, 2024

Primary Completion Date

January 1, 2029

Completion Date

July 1, 2029

Last Updated

March 16, 2026

Enrollment

100

ESTIMATED participants

Conditions

Autism or Autistic TraitsHealthy

Interventions

Do not take any interventions

OTHER

Contacts

Bingrui Zhou, doctor

CONTACT

13701989113 zbr1800@163.com

Chunchun Hu, master

CONTACT

15800850080 172113062@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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