Centre de Ressource Autisme Languedoc-Roussillon et Centre d'excellence sur l'autisme et les troubles neurodeveloppementaux, CHU Montpellier, Montpellier, France
Université Paris-Saclay, UVSQ, Inserm, CESP, Team DevPsy, 94807 Villejuif, France.
BMJ Open. 2023 Jan 30;13(1):e066520. doi: 10.1136/bmjopen-2022-066520.
The elevated rates of neurodevelopmental disorders (NDDs) among siblings of children with autism spectrum disorder (ASD) raise concerns about their developmental monitoring and development. The main aim of this study is to assess the feasibility and acceptability of a standardised screening process on a large sample of siblings.
This prospective study will assess the feasibility of a selective and multi-stage screening process for NDD performed on 384 siblings of children with confirmed ASD. Stage 1 will consist of the screening of NDD performed using online parental questionnaires (Social Responsiveness Scale, IdentiDys scale, DCDQ, parental concerns) through a web platform. In cases of a positive result, the second stage, consisting of a clinical semi-structured interview with a psychologist, will be proposed to the sibling before referral for diagnosis and treatment, if necessary. Approximately 12 months after stage 2, parents will be contacted by telephone to collect the diagnosis established following the referrals and their level of satisfaction concerning the screening process. Based on an expected participation rate of 50%, to estimate this rate with an accuracy of 5%, it is necessary to screen 384 subjects.
The Ethics Committee on the Research of Human Subjects of Paris (Ile de France VII) approved this study in March 2022 (number: 2021-A02241-40). Express consent is required from all participants. Findings from the cohort study will be disseminated by publication of peer-reviewed manuscripts, presentations at scientific meetings and conferences with associated teams.
NCT05512637.
自闭症谱系障碍（ASD）患儿的兄弟姐妹中神经发育障碍（NDD）的发生率较高，这引起了人们对他们发育监测和发育的关注。本研究的主要目的是评估在大量 ASD 患儿兄弟姐妹中进行标准化筛查的可行性和可接受性。
本前瞻性研究将评估对 384 名确诊 ASD 患儿的兄弟姐妹进行 NDD 选择性多阶段筛查过程的可行性。第 1 阶段将包括通过网络平台使用在线父母问卷（社会反应量表、IdentiDys 量表、DCDQ、父母关注）进行 NDD 筛查。如果结果呈阳性，将向兄弟姐妹提出第 2 阶段，即与心理学家进行临床半结构化访谈，如果需要，将转诊进行诊断和治疗。在第 2 阶段结束后大约 12 个月，将通过电话联系父母，收集转诊后的诊断结果及其对筛查过程的满意度。基于预期的参与率为 50%，为了以 5%的精度估计这个比率，需要对 384 名受试者进行筛查。
巴黎（法兰西岛七区）人类研究伦理委员会于 2022 年 3 月批准了这项研究（编号：2021-A02241-40）。所有参与者都需要表达同意。将通过发表同行评议的论文、在科学会议和相关团队的会议上展示来传播队列研究的结果。
NCT05512637。
