NCT05815095

Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services

Randomized Pragmatic, Cluster, Stepped-wedge Trial of Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services for Care Before 1 Year of Follow-up

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,400 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 3 Months – 12 Months
• Healthy volunteers: Accepted

Summary

This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome

Detailed description

This prospective cohort study is performed at several Maternal and Child Protection Services in France. It aims to early detect infants under 12 months of age with a developmental gap compared to that expected for their age. The first consultation will occur at the same time as the infant's usual medical follow-up at the Maternal and Child Protection Service (usually vaccination in the fourth month and developmental examination at nine months). Two strategies will be evaluated during this visit to assess the infant's neurodevelopmental characteristics. In the first one, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions. In the second one, the PREAUT grid will be used for screening of screening for autism spectrum disorder. Patients with abnormal results in these evaluations would be referred to a specialized center early for advice and treatment if necessary. We will consider an early referral as the referral of infants to an adapted consultation within the month following the first consultation. Also, these patients will be assessed using the State-Trait Anxiety Inventory-Form Y and T and the QUALIN score. After 12 months of follow-up, data regarding the received treatments of patients who were addressed to a specialized center will be performed. At 24 and 36 months of follow-up, all the included patients will be assessed with the Modified Checklist for Autism in Toddlers, Revised with Follow-up instrument (M-CHAT-R/F) ,and the IDE ( the French version of the Child Development Inventory). In case of an abnormal result of the M-CHAT-R/F, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) will be administered. In case of an abnormal result of the IDE, the Brunet-Lézine scale will be administered. Finally, the French health insurance claims databases will be used to evaluate the care pathway of all included patients up to 48 months of the child.

Conditions

• Autism Spectrum Disorder
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
OTHER	PREAUT grid	Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary

Timeline

• Start date: 2025-04-14
• Primary completion: 2030-04-14
• Completion: 2032-04-14
• First posted: 2023-04-18
• Last updated: 2025-06-13

Locations

1 site across 1 country: France