Actively Recruiting

Age: 3Months - 12Months
All Genders
Healthy Volunteers
ID05815095

Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services A Randomized Pragmatic, Cluster, Stepped-wedge Trial

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-06-13

10400

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two methods of early screening to identify infants at risk for Autism Spectrum Disorder and Neurodevelopmental Disorders. It targets infants under 12 months of age to provide early access to care, hoping to improve outcomes by detecting developmental delays compared to typical age expectations. The study is conducted at multiple Maternal and Child Protection Services in France and follows infants up to 48 months of age. Two screening approaches are evaluated during routine visits for vaccinations or developmental exams at 4 and 9 months. One method involves a health professional assessing neurodevelopment through routine observations of motor skills, vocalizations, babbling, and social interactions. The other method uses the PREAUT grid, a specific screening tool for autism spectrum disorders. Infants showing abnormal results are referred promptly to specialized centers for further advice and treatment when needed. Participants will have follow-ups at 12, 24, and 36 months including developmental assessments like the Modified Checklist for Autism in Toddlers and the Child Development Inventory. Additional diagnostic tools are used if initial tests indicate concerns. The study also collects data on treatments received, parental psychological state, quality of life, and family impact. Health insurance data will track care pathways up to 48 months. The main outcome is the proportion of children diagnosed and receiving care before age one.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Months - 12Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants between 4 and 9 months of age followed up in participating Maternal and Child Protection Services for the fourth and ninth-month vaccinations
  • Availability of a personal telephone for at least one parent
  • Parents informed about data collection and active follow-up until 36 months and provide consent
  • Affiliated with a social security system or eligible for Medical assistance of the state
  • Ability to understand French or presence of a French-speaking relative
Not Eligible

You will not qualify if you...

  • Infant with a severe neurological pathology such as encephalopathy
  • Refusal to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during routine medical follow-up

Diagnostic Evaluation

Duration - At 4 and 9 months of age

Participants undergo neurodevelopmental assessments using either routine practice evaluations or the PREAUT grid to detect early signs of developmental gaps or autism spectrum disorder.

2 visits aligned with routine vaccination and developmental examinations

Long-term Monitoring

Duration - Up to 36 months

Participants are followed up at 12, 24, and 36 months to assess development, including screenings with M-CHAT-R/F and IDE tests, and additional diagnostic assessments if results are abnormal.

Visits at 12, 24, and 36 months with additional assessments as needed

Care Pathway Observation

Duration - Up to 48 months

Participants' care pathways are monitored using health insurance claims data to evaluate treatments and interventions received up to 48 months of age.

No additional visits; data collected through health records

Trial Site Locations

Total: 1 location

1

PMI Stalingrad

Champigny-sur-Marne, France, 94500

Actively Recruiting

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Research Team

C

Catherine DELMAS, MD

C

Camille JUNG, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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).

Catherine Delmas, Xavier Xu Wang, Anne-Sylvie Pelloux...

https://pubmed.ncbi.nlm.nih.gov/40759525