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

NCT06329245 | Recruiting DMC

• 1 other identifier: brainpro2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Autism or Autistic Traits

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

high-risk group

Subjects in the case group have one or more older siblings with ASD.

Other: Do not take any interventions

low-risk group

Subjects in the controlled group do not have older siblings with ASD.

Other: Do not take any interventions

Interventions

Do not take any interventions OTHER

Do not take any interventions

high-risk group; low-risk group

Eligibility Criteria

• Age: 0 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShanghaiTech University: collaborator
• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu, doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingrui Zhou, doctor

CONTACT

13701989113; zbr1800@163.com

Chunchun Hu, master

CONTACT

15800850080; 172113062@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)