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
This trial accepts healthy volunteersQualifiers
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 population
The longitude study will be performed in high-risk infants of ASD who have at least one older sibling with a clinical diagnosis of ASD. The low-risk group will also be recruited from healthy infants as control group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Do not take any interventions
Other interventionDo not take any interventions
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: high-risk group1 intervention
Group B: low-risk group1 intervention
Trial outcomes
Primary outcomes
1
clinical diagnosis
Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.
Time frame
At about 2.5 to 3 year-old.2
neurodevelopmental outcome
The neurodevelopmental outcome will be measured by Griffiths Mental Developemental Scales. The developmental ages (DA) are referred from the norms and developmental quotients (DQs) are calculated by DA/CA (chronological age)\*100. Higher DQ indicates better development. The normal range of the DQ is above 70.
Time frame
At 6, 12, 18, 24, and 36-month-old.3
Prosocial behaviors
The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.
Time frame
At 6, 12, 18, 24, and 36-month-old.4
nuclear magnetic resonance imaging(MRI)
Cranial MRI data will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Time frame
At 6, 12, 18, 24, and 36-month-old.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
ShanghaiTech University
Collaborator
Source ClinicalTrials.gov