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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopmental Disorders; Autism Spectrum Disorder
• Intervention / Treatment: Other: PREAUT grid

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.

• Study Type: Observational
• Enrollment (Estimated): 10400

Contacts and Locations

• Study Contact: Name: Catherine DELMAS, MD; Phone Number: 01 47 06 49 25; Email: catherine.delmas@chicreteil.fr
• Study Contact Backup: Name: Camille JUNG, MD; Phone Number: 01 57 02 22 68; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • 1er secteur de psychopathologie de l'enfant et de l'adolescent du Val de Marne
    • Contact: Catherine DELMAS, MD; Phone Number: 0147064925
    • Contact: Laetitia ZUGAJ, MD; Phone Number: 0147064143; Email: laetitia.zugajbensaou@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants aged at least 4 months at study inclusion and followed in Maternal and Child Protection Services

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
Use of PREAUT Grid (intervention); In this group, a health professional will assess the infant's neurodevelopmental characteristics using the PREAUT grid	Other: PREAUT grid; Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one	At 2 years of age

Secondary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of two screening strategies on the occurrence severity of Autism Spectrum Disorders (ASD) and Neurodevelopmental Disorders (NDD)	At 2 and 3 years of age
Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis	At 2 and 3 years of age
Association between ASD-NDD diagnosis and neonatal or familial risk factors	At 2 and 3 years of age of child's referral to the Medical psychological center
Quality of life assessed by the QUALIN score	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	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	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	Through study completion, an average of 4 years
Evaluation of the implementation of infant care in the Medical-psychological center	Through study completion, an average of 4 years
Qualitative study of the incentives and obstacles of the screening and early referral strategy with the Maternal and Child Protection Service's workers	Through study completion, an average of 4 years
Qualitative study of the screening and early referral strategy with parents	Through study completion, an average of 4 years
Description of the practice of identification by the Maternal and Child Protection Services and referral to the Medical-psychological center	At the inclusion, at the end of inclusion and at the late visit
Description of the care pathway in the two groups	At 4 years of the child

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infant; Prospective Study; Autism Spectrum Disorder / diagnosis; Neurodevelopmental Disorders /diagnosis
• Additional Relevant MeSH Terms: Mental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder; Neurodevelopmental Disorders
• Other Study ID Numbers: PRECO TSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No