Clinical trial NCT06329245: Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Official title: Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism or Autistic Traits
Healthy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: ShanghaiTech University
First posted: 2024-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

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.

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.

Primary outcomes:
measure: clinical diagnosis
timeFrame: At about 2.5 to 3 year-old.
measure: neurodevelopmental outcome
timeFrame: At 6, 12, 18, 24, and 36-month-old.
measure: Prosocial behaviors
timeFrame: At 6, 12, 18, 24, and 36-month-old.
measure: nuclear magnetic resonance imaging(MRI)
timeFrame: At 6, 12, 18, 24, and 36-month-old.
measure: Event related potentials (ERPs)
timeFrame: At 6, 12, 18, 24, and 36-month-old.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiu Xu, doctor
role: PRINCIPAL_INVESTIGATOR
References: