Delmas Catherine, Wang Xavier Xu, Pelloux Anne-Sylvie, Caeymaex Laurence, Bouaziz Nora, Aegerter Philippe, Jung Camille
Department of Child Psychiatry, secteur 94I01, Centre Hospitalier Intercommunal de Créteil, Creteil, France.
Department of Clinical Research, Centre Hospitalier Intercommunal de Creteil, Creteil, France
BMJ Open. 2025 Aug 4;15(8):e094729. doi: 10.1136/bmjopen-2024-094729.
Autism and neurodevelopmental disorders (NDDs) are complex conditions that manifest as significant impairments in social communication and behaviour. Early detection and intervention play a pivotal role in improving outcomes, largely due to the high brain plasticity in infants. The PRECO-TSA study aims to validate the effectiveness of systematic use of the Prévention de l'Autisme (PREAUT) grid for early screening and referral strategies for autism and NDDs in infants, focusing on a coordinated approach that integrates maternal and child protection centre with medical-psychological centres. The goal is to evaluate a streamlined referral system to improve early detection and facilitate effective interventions for children at higher risk of autism.
The PRECO-TSA study is a prospective, pragmatic, multicentre, cluster-randomised controlled trial using an incomplete stepped-wedge design, which maximises external validity. The study includes a 6-month baseline phase, a 3-month semiobservation phase and a 6-month follow-up phase. The 36-month patient inclusion period is followed by a 48-month passive follow-up through the National Health Data System, data collection includes demographic and clinical information, with hierarchical mixed models used to analyse the impact of early screening and referral for autism and NDDs.
This study was funded by the French Ministry of Health (PREPS-20-0186) and was approved by Ile de France I Ethics Committee CPP (number CPPIDF1-2023-DI29-Cat2). The results will be submitted for publication in peer-reviewed journals.
NCT05815095.
自闭症和神经发育障碍（NDDs）是复杂的病症，表现为社交沟通和行为方面的显著损害。早期发现和干预对改善预后起着关键作用，这主要归因于婴儿大脑的高可塑性。PRECO-TSA研究旨在验证系统使用自闭症预防（PREAUT）网格对婴儿自闭症和NDDs进行早期筛查和转诊策略的有效性，重点是将母婴保护中心与医学心理中心相结合的协调方法。目标是评估一个简化的转诊系统，以改善早期发现并促进对自闭症高危儿童的有效干预。
PRECO-TSA研究是一项前瞻性、实用性、多中心、整群随机对照试验，采用不完全阶梯楔形设计，以最大限度地提高外部有效性。该研究包括一个6个月的基线期、一个3个月的半观察期和一个6个月的随访期。在36个月的患者纳入期之后，通过国家卫生数据系统进行48个月的被动随访，数据收集包括人口统计学和临床信息，使用分层混合模型分析早期筛查和转诊对自闭症和NDDs的影响。
本研究由法国卫生部资助（PREPS-20-0186），并获得法兰西岛I伦理委员会CPP批准（编号CPPIDF1-2023-DI29-Cat2）。研究结果将提交至同行评审期刊发表。
NCT05815095。
