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Search / Trial NCT06329245

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

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Mar 19, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how infants and toddlers develop social behaviors—like sharing and helping—while also looking at their brain activity. The researchers want to see how these behaviors and brain connections differ between children who are at high risk for autism (those with an older sibling diagnosed with autism) and those at low risk (those without an older sibling with autism and no family history of it). By observing these children, the study hopes to better understand how autism might affect social development over time.

To participate, children ages 0 to 4 years old may be eligible if they fit into one of the two risk groups mentioned. Participants will undergo various assessments to evaluate their development and social communication, as well as non-invasive brain scans while they sleep. It's important to note that children with certain medical conditions or a family history of specific disorders will not be included in the study. This research is currently in the recruiting stage, and it aims to contribute valuable insights into early development related to autism.

Gender

ALL

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.

About Children's Hospital Of Fudan University

The Children's Hospital of Fudan University is a leading pediatric healthcare institution in China, renowned for its commitment to advancing child health through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital focuses on conducting high-quality, ethically-driven studies that aim to improve pediatric care and treatment outcomes. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital leverages its robust infrastructure and expertise to facilitate groundbreaking clinical trials, ensuring the safety and well-being of child participants while contributing valuable insights to the global medical community.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Xiu Xu, doctor

Principal Investigator

Children's Hospital of Fudan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported