Actively Recruiting
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Led by Children's Hospital of Fudan University · Updated on 2026-03-16
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Fudan University
Lead Sponsor
S
ShanghaiTech University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the development of prosocial behaviors and brain network connections in infants and toddlers who are at high or low risk for autism spectrum disorder (ASD). This observational study aims to understand how these behaviors and brain functions differ between children with and without a family history of ASD. The study follows participants from infancy through toddlerhood to observe developmental changes over time. Participants are divided into two groups: those with older siblings diagnosed with ASD (high-risk group) and those without such siblings or family history (low-risk group). The study does not involve any treatments or interventions. Instead, it monitors natural development and brain activity at multiple time points: 3, 6, 9, 12, 18, 24, 30, and 36 months of age. Clinical diagnosis for ASD is made at 24 months or later using established criteria. During the study, infants and toddlers undergo a series of developmental and social communication assessments, including the Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, and the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist. Brain activity is measured using resting-state EEG and MRI scans performed while the child is naturally asleep. Researchers will review clinical diagnosis, neurodevelopmental outcomes, prosocial behaviors, MRI results, and event-related potentials at specified ages to understand developmental trajectories. Participation may last up to three years with regular assessments throughout this period.
CONDITIONS
Brief Title
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are enrolled as high-risk if they have an older sibling with a confirmed clinical diagnosis of autism spectrum disorder.
- Subjects are enrolled in the low-risk group if they have an older sibling without evidence of autism and no family history of autism in first or second-degree relatives.
You will not qualify if you...
- Diagnosis or physical signs strongly suggestive of a genetic condition or syndrome associated with autism spectrum disorders.
- Significant medical or neurological condition affecting growth, development, or cognition.
- Sensory impairment such as vision or hearing loss.
- Low birth weight (less than 2000 grams) or premature birth (less than 37 weeks gestation).
- Possible perinatal brain injury from exposure to substances likely to affect the brain.
- Contraindications for MRI, such as metal implants.
- Family history of intellectual disability, psychosis, schizophrenia, or bipolar disorder in a first-degree relative.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth up to 36 months old
Participants are observed to compare developmental trajectories of prosocial behaviors and brain network connections over time.
Visits at 3, 6, 9, 12, 18, 24, 30, and 36 months old
Duration - At about 2.5 to 3 years old
Clinical diagnosis for autism spectrum disorder is performed using DSM-5 criteria at or after 24 months old.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
B
Bingrui Zhou, doctor
C
Chunchun Hu, master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here