NCT06329245 Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
| NCT ID | NCT06329245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Autism or Autistic Traits |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-04-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Xiu Xu, doctor
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06329245 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 18 Months, studying Autism or Autistic Traits. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06329245 currently recruiting?
Yes, NCT06329245 is actively recruiting participants. Contact the research team at zbr1800@163.com for enrollment information.
Where is the NCT06329245 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06329245 clinical trial?
NCT06329245 is sponsored by Children's Hospital of Fudan University. The principal investigator is Xiu Xu, doctor at Children's Hospital of Fudan University. The trial plans to enroll 100 participants.