Evaluation of a Therapeutic Education Program for Pregnant Women with a First Child Diagnosed with an Autism Spectrum Disorder

Study acronym: AUTMER
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated September 19, 2024 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Notable Start date: Sep 2024 to Nov 2024
    • Study description revised
    • Site details revised
    v5
  3. Notable Start date: Feb 2023 to Sep 2024
    • Enrollment target: 160 to 132
    v4
  4. Notable Start date: Oct 2022 to Feb 2023
    • Primary and study completion dates: Apr 2026 to Aug 2026
    v3
  5. Notable Primary and study completion dates: Aug 2025 to Apr 2026
    • Start date: Feb 2022 to Oct 2022
    v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Autism Spectrum Disorder (ASD) is a heterogeneous set of severe developmental abnormalities of the nervous system characterized by deficits affecting social interactions and verbal and non-verbal communication, as well as the presence of restricted interests, repetitive behaviors, and atypical sensory manifestations . ASD affects approximately 1% of the general population (Elsabbagh et al., 2012). Studies of siblings of individuals with ASD show that ASD is present in 7-20% of the offspring in families where a child has had a diagnosis of ASD and this prevalence increases if there are two diagnosed children. Several studies show the benefits of interventions targeting parents\' interaction strategies in the early phases of development of infants at high risk for ASDs, in reducing the risk itself or its severity. Very early intervention, due to the presence of significant brain plasticity at these stages, may be particularly effective in changing these emerging trajectories, from a \"preventive intervention\" perspective that would aim to mitigate developmental risk and alter prodromal symptom trajectories, rather than eliminate a condition. Our hypothesis is that the implementation of a specific therapeutic education program during a new pregnancy in the mother of a child with a diagnosis of ASD (MER Program) could improve the mother\'s well-being, increase parenting communication skills, and thereby improve interaction with the newborn at high risk for ASD. If the infant is affected, it may also reduce the symptoms of the disorder. Indirectly, it could also improve the well-being of the other parent involved in the interaction. The M.E.R (Mères Ecoute Ressources) programme is a therapeutic education intervention aimed at mothers of children with ASD during a new pregnancy. This programme, which is being piloted in France and Europe, involves a number of dimensions, both educational and behavioural (strategies for stimulating the baby, use of specific communication and interaction tools) and psychological (reduction of stress, anxiety, etc. in the mother). The programme comprises 8 one-to-one sessions lasting 1.5 hours every 15 days. The first and last of these are for assessment purposes, with the 6 intermediate sessions constituting the support. The structure of the programme and the sessions is based on what is recommended in therapeutic education. The sessions can take place on the hospital site or by teleconsultation (remote consultation used in the context of healthcare).
Trial Details
NCT Number NCT05104112
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Child Psychiatry
Related terms Autism Spectrum Disorder
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov