RecruitingNot Applicable

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

France10,400 participantsStarted 2025-04-14

Plain-language 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

Who can participate

Age range

3 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At 2 years of age

Trial details

NCT IDNCT05815095

SponsorCentre Hospitalier Intercommunal Creteil

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-04-14

Contact for this trial

Catherine DELMAS, MD

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

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Who can participate

Age range

3 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.