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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06329245
Enrollment
100
Registered
2024-03-25
Start date
2024-04-01
Completion date
2029-07-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism or Autistic Traits, Healthy

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.

Interventions

Do not take any interventions

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER
ShanghaiTech University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Months to 18 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical diagnosisAt about 2.5 to 3 year-old.Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.
neurodevelopmental outcomeAt 6, 12, 18, 24, and 36-month-old.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.
Prosocial behaviorsAt 6, 12, 18, 24, and 36-month-old.The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.
nuclear magnetic resonance imaging(MRI)At 6, 12, 18, 24, and 36-month-old.Cranial MRI data will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Event related potentials (ERPs)At 6, 12, 18, 24, and 36-month-old.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.

Countries

China

Contacts

CONTACTBingrui Zhou, doctor
zbr1800@163.com13701989113
CONTACTChunchun Hu, master
172113062@qq.com15800850080
PRINCIPAL_INVESTIGATORXiu Xu, doctor

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026