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).

This is a study protocol (research plan) for a large French trial testing whether systematic screening for autism signs in babies under 1 year old improves early detection and referral to services. The screening uses a tool called the PREAUT grid in maternal and child health centres. The goal is to help identify children who might benefit from early intervention while their brains are still very adaptable. No results are available yet as this is just the research plan.

PRECO-TSA is a French pragmatic randomised controlled trial protocol designed to evaluate the effectiveness of systematic early screening for autism and neurodevelopmental disorders in infants before 1 year of age. The study uses the PREAUT grid screening tool within maternal and child protection centres, with coordinated referral to medical-psychological centres. The trial employs a stepped-wedge design across 36 months of patient inclusion, followed by 48 months of passive follow-up through national health data systems. The study aims to validate streamlined referral systems to improve early detection and facilitate effective interventions for high-risk children, capitalising on infant brain plasticity.

If successful, this trial could validate systematic early screening approaches for autism and neurodevelopmental disorders before 12 months of age. The coordinated referral system between maternal-child health centres and medical-psychological centres may provide a model for improving early detection and intervention access, though results are pending.

This is a protocol paper describing the study design only. No actual results or findings are reported. The effectiveness of the screening approach and referral system has not yet been demonstrated through this trial.

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.