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

NCT ID: NCT05815095

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2032-04-14

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Routine practice (control)

In this group, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions

No interventions assigned to this group

Use of PREAUT Grid (intervention)

In this group, a health professional will assess the infant's neurodevelopmental characteristics using the PREAUT grid

PREAUT grid

Intervention Type: OTHER

Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary

Interventions

PREAUT grid

Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PMI Stalingrad

Champigny-sur-Marne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine DELMAS, MD

Role: CONTACT

catherine.delmas@chicreteil.fr

01 47 06 49 25

Camille JUNG, MD

Role: CONTACT

camille.jung@chicreteil.fr

01 57 02 22 68

Facility Contacts

Catherine DELMAS, MD

Role: primary

0147064925

References

Delmas C, Wang XX, Pelloux AS, Caeymaex L, Bouaziz N, Aegerter P, Jung C. 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. 2025 Aug 4;15(8):e094729. doi: 10.1136/bmjopen-2024-094729.

Reference Type: DERIVED

PMID: 40759525 (View on PubMed)

Other Identifiers

PRECO TSA

Identifier Type: -

Identifier Source: org_study_id