Comparing prosocial behaviors and brain networks in infants at risk for autism
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
This study looks at how babies and toddlers who are at high or low risk for autism develop social behaviors and brain connections as they grow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Months to 18 Months |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06329245 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the developmental trajectories of prosocial behaviors and brain network connections in infants and toddlers identified as high or low risk for autism spectrum disorder (ASD). Participants will undergo a series of developmental and social communication assessments, as well as resting-state EEG and MRI while in a natural sleeping state. The study will follow subjects at multiple age milestones from 3 to 36 months to observe differences in behavior and brain connectivity. Clinical diagnoses will be made at 24 months or older using DSM-5 criteria.
Who should consider this trial
Good fit: Ideal candidates include infants and toddlers with an older sibling diagnosed with ASD (high-risk) or those with no family history of ASD (low-risk).
Not a fit: Patients with significant medical or neurological conditions, genetic syndromes, or sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early identification and understanding of autism risk factors in infants, leading to better-targeted interventions.
How similar studies have performed: Other studies have explored developmental trajectories in autism risk, but this specific approach focusing on prosocial behaviors and brain networks is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Children's Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiu Xu, doctor — Children's Hospital of Fudan University
- Study coordinator: Bingrui Zhou, doctor
- Email: zbr1800@163.com
- Phone: 13701989113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.