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NCT Number: NCT06329245

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

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.

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Key information

Conditions

Autism or Autistic Traits Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Healthy Mental Disorders Neurodevelopmental Disorders

Age range

0 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Xiu Xu, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Do not take any interventions

Other

Do not take any interventions

Primary outcomes

  1. clinical diagnosis

    Time frame: At 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.

  2. neurodevelopmental outcome

    Time frame: At 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.

  3. Prosocial behaviors

    Time frame: At 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.

  4. nuclear magnetic resonance imaging(MRI)

    Time frame: 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.

  5. Event related potentials (ERPs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingrui Zhou, doctor

CONTACT

[email protected]

13701989113

Chunchun Hu, master

CONTACT

[email protected]

15800850080

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • ShanghaiTech University

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 25, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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