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

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Autism Spectrum Disorder; Neurodevelopmental Disorders

Treatments: Other: PREAUT grid

Study type: Observational

Funder types: Other

Identifiers

NCT05815095

PRECO TSA

Details and patient eligibility

About

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

Full 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.

Enrollment: 10,400 estimated patients

Sex: All

Ages: 3 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

10,400 participants in 2 patient groups

Routine practice (control)

Description:

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

Use of PREAUT Grid (intervention)

Description:

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

Treatment:

Other: PREAUT grid