Comparing prosocial behaviors and brain networks in infants at risk for autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.