Early detection and referral for autism and developmental disorders in infants at maternal and child clinics
Official title: 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
Run by Centre Hospitalier Intercommunal Creteil · NCT05815095 · Data updated 2026-11-12
This study tests two ways of screening babies during routine clinic visits to see if they find infants under one year at risk for autism or other developmental disorders so they can be referred earlier.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months to 12 Months |
| Sex | All |
| Enrollment | 10400 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 1 site (Champigny-sur-Marne) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | April 14, 2030 |
| Study ends | April 14, 2032 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT05815095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 4 to 9 months attending participating Maternal and Child Protection Services for routine vaccinations whose parents can provide consent and a contact telephone are ideal candidates.
✕Probably not a fit
Infants with severe established neurological conditions or those already under specialized neurodevelopmental care are unlikely to benefit from this early screening approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort study enrolls infants seen at several Maternal and Child Protection Services in France to compare two early screening strategies for neurodevelopmental risk. Infants aged 4 to 9 months are screened during routine visits using either standard clinical observations of motor, vocal, and social behaviors or the PREAUT grid. Infants with abnormal results are referred to specialized centers within a month and treatments received by 12 months are recorded. All participants are followed to 36 months with standardized developmental assessments at 24 and 36 months to document outcomes.
Why it matters
Potential benefit: If successful, the approach could lead to earlier referrals and faster access to interventions, increasing the chance of improved developmental outcomes.
How similar studies have gone: Previous studies using the PREAUT grid and similar early screening tools have shown promise in detecting early risk signs, but results have been mixed and are not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:in * Infants between 4 and 9 months of age followed up in the participating Maternal and Child Protection Services for the fourth and ninth-month mandatory vaccinations * Availability of a personnel telephone for at least one parent * Information to the parents for data collection and the active follow-up of the child until 36 months and express consent to participate in the research * Affiliation to a social security system or benefiting from the Medical assistance of the state * Mastery of a minimum of French according to the principal investigator or the presence of a French-speaking relative Exclusion Criteria: * Infant with a severe neurological pathology such as encephalopathy * Refusal to participate in the study
Where it's running
-
PMI Stalingrad
Champigny-sur-Marne, France Recruiting
Study contacts
- Study coordinator: Catherine DELMAS, MD
- Email: catherine.delmas@chicreteil.fr
- Phone: 01 47 06 49 25
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.