Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

Healthy Clinical Trial

Official title:

Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329245
• Other study ID #: brainpro2022
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: July 1, 2029

Study information

• Verified date: March 2024
• Source: Children's Hospital of Fudan University
• Contact: Bingrui Zhou, doctor
• Phone: 13701989113
• Email: zbr1800[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autistic Disorder
• Healthy

Intervention

Other:
• Do not take any interventions
Do not take any interventions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	ShanghaiTech University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical diagnosis	Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.	At about 2.5 to 3 year-old.
Primary	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.	At 6, 12, 18, 24, and 36-month-old.
Primary	Prosocial behaviors	The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.	At 6, 12, 18, 24, and 36-month-old.
Primary	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.	At 6, 12, 18, 24, and 36-month-old.
Primary	Event related potentials (ERPs)	ERPs will be tested using eego™ mylab of ANT Neuro company. Mu suppression?N1/N2?P3/LPP will be compared between children with ASD and typical development.	At 6, 12, 18, 24, and 36-month-old.