Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Do not take any interventions.
- Who it may be relevant to
- Registry conditions: Autism or Autistic Traits, Healthy. Basic parameters: 0 months — 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The longitude observational study will be performed 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). We will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. Clinical diagnosis will be made on 24-month-old or after, with the DSM-5 as the diagnostic criterion.
Interventions
- Other Do not take any interventions
Do not take any interventions
Primary outcome measures
- clinical diagnosis [Time frame: At about 2.5 to 3 year-old.]
- neurodevelopmental outcome [Time frame: At 6, 12, 18, 24, and 36-month-old.]
- Prosocial behaviors [Time frame: At 6, 12, 18, 24, and 36-month-old.]
- nuclear magnetic resonance imaging(MRI) [Time frame: At 6, 12, 18, 24, and 36-month-old.]
- Event related potentials (ERPs) [Time frame: At 6, 12, 18, 24, and 36-month-old.]
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
- 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);
- 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);
- contraindication for MRI (e.g., metal implants);
- a family history of intellectual disability, psychosis, schizophrenia or bipolar disorder in a first-degree relative.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT06329245 · brainpro2022