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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Do not take any interventions
  Do not take any interventions

Первичные конечные точки

• clinical diagnosis [Срок оценки: At about 2.5 to 3 year-old.]
• neurodevelopmental outcome [Срок оценки: At 6, 12, 18, 24, and 36-month-old.]
• Prosocial behaviors [Срок оценки: At 6, 12, 18, 24, and 36-month-old.]
• nuclear magnetic resonance imaging(MRI) [Срок оценки: At 6, 12, 18, 24, and 36-month-old.]
• Event related potentials (ERPs) [Срок оценки: At 6, 12, 18, 24, and 36-month-old.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06329245 · brainpro2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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