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

Centre Hospitalier Intercommunal Creteil10,400 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

10,400

Conditions

Autism Spectrum Disorder Neurodevelopmental Disorders

Interventions

PREAUT gridOTHER

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PMI Stalingrad

Champigny-sur-Marne, France

RECRUITING

Outcomes

Primary Outcomes

Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one

Time frame: At 2 years of age

Secondary Outcomes

Effectiveness of two screening strategies on the occurrence severity of Autism Spectrum Disorders (ASD) and Neurodevelopmental Disorders (NDD)

Time frame: At 2 and 3 years of age

Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis

Time frame: At 2 and 3 years of age

Association between ASD-NDD diagnosis and neonatal or familial risk factors

Time frame: At 2 and 3 years of age of child's referral to the Medical psychological center

Quality of life assessed by the QUALIN score

Time frame: At inclusion in Maternal and Child Protection Services or at Medical-psychological center and at 2 and 3 years of age

Measurement of the parents' psychological state at the time of the child's referral to the Medical psychological center

Time frame: At a Medical-psychological center and at 2 and 3 years of age

Impact on the family life (IOFS) of a child diagnosed with risk of Autism Spectrum and Neurodevelopmental Disorders

Time frame: At 2 and 3 years of age

Evaluation of the implementation of the new model of systematic screening of infants in Maternal and Child Protection Services and systematic referral to the Medical-psychological center

Time frame: Through study completion, an average of 4 years

Central Contacts

Catherine DELMAS, MD

CONTACT

01 47 06 49 25 catherine.delmas@chicreteil.fr

Camille JUNG, MD

CONTACT

01 57 02 22 68 camille.jung@chicreteil.fr

Data from ClinicalTrials.gov

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