跳至主要内容
临床试验/NCT05512637
NCT05512637招募中不适用

Screening for Neurodevelopmental Disorders in Siblings of Children with Autism Diagnosed in Tertiary Centers

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2023年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
384
试验地点
1
主要终点
Percentage of family participation

研究概览

简要总结

In this study, a selective and multi-stages screening for neurodevelopmental disorders (NDD) in siblings of children with a confirmed ASD is done. The main aims are to estimate the prevalence of NDD among siblings and to evaluate the feasibility and acceptability of a standardized screening procedure.

详细描述

Although NDD are frequent among siblings of children with ASD, their developmental screening is not yet sufficiently organized in routine practice. The needs and the characteristics of these siblings have yet to be better understood in order to define their developmental surveillance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Step 1: Brothers or sisters (including stepsisters and brothers); aged between 2 and 16 years; living in Occitanie; informed and express consent of parents ; affiliated to social security.
  • Step 2: step 1 positive screening or parental concerns for child's development ; parental signed informed consent.

排除标准

  • Parents (or child) refusal to participate; adopted brother or sister. Do not speak French

结局指标

主要结局

Percentage of family participation

时间窗: 12 months

Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.

次要结局

  • Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure(12 months)
  • Percentage of satisfied parents(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Véronique GONNIER

child psychiatrist

University Hospital, Montpellier

研究点 (1)

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