Therapeutic Education for Pregnant Women Having a First Child with Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial with a stepped-wedge design compares an innovative therapeutic education program for expectant mothers to standard care. Participants are pregnant women who already have a child diagnosed with autism and their newborns at risk for ASD, followed from pregnancy through 10 months after birth. The study measures the impact on mother–infant interaction, using the MACI caregiver non-directiveness score as the primary endpoint. Randomization determines when centers begin the MER program, allowing all centers to eventually train and use the intervention while providing a structured control period. Follow-up collects data during pregnancy and after birth to assess whether early parental education can influence developmental trajectories.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Mothers of children with a diagnosis of ASD, in pregnancy (before the 26th week of amenorrhea);
* The diagnosis of ASD of the older child has been made, according to the DSM IV-TR or DSM 5 criteria, formalized by a diagnostic evaluation including if possible: the Autism Diagnostic Observation Schedule ADOS, and/or ADI
* Informed consent from mother and sec

Exclusion Criteria:

* Presence of a clearly identified and unstabilized severe psychiatric disorder in the mother (confirmed by medical interview and DIGS questionnaire conducted at the time of the inclusion visit) and/or intellectual disability;
* Engagement in another form of individual therapeutic intervention.
* Refusal of either parent (for child assessment, primary criterion)
* Parents not proficient in French language
* Persons (mother or second parent) under legal protection, guardianship or trusteeship, persons deprived of liberty, under court protection, under psychiatric care, under constraint, admitted to a health or social institution for purposes other than research
* Persons with cognitive disorders or intellectual disabilities

Where it's running

• Hôpital Robert Debré
  Paris, France Recruiting

Study contacts

• Principal investigator: Anita Beggiato, PHD — Aphp
• Study coordinator: Anita Beggiato, PHD
• Email: anita.beggiato@aphp.fr
• Phone: 0033140032000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.