Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol)
Introduction 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 PREC...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/8/e094729.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849768365106659328 |
|---|---|
| author | Camille Jung Laurence Caeymaex Philippe Aegerter Catherine Delmas Xavier Xu Wang Anne-Sylvie Pelloux Nora Bouaziz |
| author_facet | Camille Jung Laurence Caeymaex Philippe Aegerter Catherine Delmas Xavier Xu Wang Anne-Sylvie Pelloux Nora Bouaziz |
| author_sort | Camille Jung |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05815095. |
| format | Article |
| id | doaj-art-bd2d92c5c0c54bd9bad9117a28de2799 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-bd2d92c5c0c54bd9bad9117a28de27992025-08-20T03:03:50ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2024-094729Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol)Camille Jung0Laurence Caeymaex1Philippe Aegerter2Catherine Delmas3Xavier Xu Wang4Anne-Sylvie Pelloux5Nora Bouaziz6Department of Clinical Research, Centre Hospitalier Intercommunal de Creteil, Creteil, FranceNeonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Créteil, Creteil, FranceUnité de Recherche Clinique et Département de Santé Publique, Groupement Inter-Régional de Recherche Clinique et d’Innovation, Paris, FranceDepartment of Child Psychiatry, secteur 94I01, Centre Hospitalier Intercommunal de Créteil, Creteil, FranceDepartment of Clinical Research, Centre Hospitalier Intercommunal de Creteil, Creteil, FranceDepartment of Child Psychiatry, Hôpitaux Paris Est Val-de-Marne, Saint-Maurice, FranceDepartment of Child Psychiatry (Area 5), Centre Hospitalier Intercommunal de Creteil, Creteil, FranceIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05815095.https://bmjopen.bmj.com/content/15/8/e094729.full |
| spellingShingle | Camille Jung Laurence Caeymaex Philippe Aegerter Catherine Delmas Xavier Xu Wang Anne-Sylvie Pelloux Nora Bouaziz Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) BMJ Open |
| title | Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) |
| title_full | Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) |
| title_fullStr | Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) |
| title_full_unstemmed | Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) |
| title_short | Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol) |
| title_sort | effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre a french randomised pragmatic trial in a stepped wedge trial preco tsa protocol |
| url | https://bmjopen.bmj.com/content/15/8/e094729.full |
| work_keys_str_mv | AT camillejung effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT laurencecaeymaex effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT philippeaegerter effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT catherinedelmas effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT xavierxuwang effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT annesylviepelloux effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol AT norabouaziz effectivenessofearlydetectionandcoordinatedreferralofinfantsbefore1yearatriskforautismspectrumandneurodevelopmentaldisordersinmaternalandchildprotectioncentreafrenchrandomisedpragmatictrialinasteppedwedgetrialprecotsaprotocol |