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

NCT ID: NCT06329245

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2029-07-01

Brief 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.

Conditions

Autism or Autistic Traits; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

high-risk group

Subjects in the case group have one or more older siblings with ASD.

Do not take any interventions

Intervention Type: OTHER

Do not take any interventions

low-risk group

Subjects in the controlled group do not have older siblings with ASD.

Do not take any interventions

Intervention Type: OTHER

Do not take any interventions

Interventions

Do not take any interventions

Do not take any interventions

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ShanghaiTech University

OTHER

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiu Xu, doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Bingrui Zhou, doctor

Role: CONTACT

zbr1800@163.com

13701989113

Chunchun Hu, master

Role: CONTACT

172113062@qq.com

15800850080

Facility Contacts

Xiu Xu, PhD

Role: primary

Other Identifiers

brainpro2022

Identifier Type: -

Identifier Source: org_study_id