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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Autism or Autistic Traits
• Intervention / Treatment: Other: Do not take any interventions

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bingrui Zhou, doctor; Phone Number: 13701989113; Email: zbr1800@163.com
• Study Contact Backup: Name: Chunchun Hu, master; Phone Number: 15800850080; Email: 172113062@qq.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Children's Hospital of Fudan University
    • Contact: Xiu Xu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The longitude study will be performed in high-risk infants of ASD who have at least one older sibling with a clinical diagnosis of ASD. The low-risk group will also be recruited from healthy infants as control group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high-risk group; Subjects in the case group have one or more older siblings with ASD.	Other: Do not take any interventions; Do not take any interventions
low-risk group; Subjects in the controlled group do not have older siblings with ASD.	Other: Do not take any interventions; Do not take any interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical diagnosis	Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.	At about 2.5 to 3 year-old.
neurodevelopmental outcome	The neurodevelopmental outcome will be measured by Griffiths Mental Developemental Scales. The developmental ages (DA) are referred from the norms and developmental quotients (DQs) are calculated by DA/CA (chronological age)*100. Higher DQ indicates better development. The normal range of the DQ is above 70.	At 6, 12, 18, 24, and 36-month-old.
Prosocial behaviors	The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.	At 6, 12, 18, 24, and 36-month-old.
nuclear magnetic resonance imaging(MRI)	Cranial MRI data will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.	At 6, 12, 18, 24, and 36-month-old.
Event related potentials (ERPs)	ERPs will be tested using eego™ mylab of ANT Neuro company. Mu suppression、N1/N2、P3/LPP will be compared between children with ASD and typical development.	At 6, 12, 18, 24, and 36-month-old.

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: ShanghaiTech University
• Investigators: Principal Investigator: Xiu Xu, doctor, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder
• Other Study ID Numbers: brainpro2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No