Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorChildren's Hospital of Fudan University
About this trial
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
Qualifiers
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.
Disqualifiers
diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;
a significant medical or neurological condition affecting growth, development or cognition (e.g., CNS infection, seizure disorder, congenital heart disease);
sensory impairment such as vision or hearing loss;
low birth weight (<2000 grams) or prematurity (<37 weeks gestation);
Trial design
Treatments tested in this trial
- Do not take any interventions
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Fudan University
Lead sponsor
ShanghaiTech University
Collaborator
Source ClinicalTrials.gov