Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Evaluatie van een therapeutisch onderwijsprogramma voor zwangere vrouwen met een eerste kind met de diagnose autismespectrumstoornis (AUTMER)

4 november 2026 bijgewerkt door: Assistance Publique - Hôpitaux de Paris

Evaluatie van een therapeutisch onderwijsprogramma voor zwangere vrouwen met een eerste kind met de diagnose autismespectrumstoornis (ASS)

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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Randomized controlled trial with deferred start, French multicenter stepped-wedge type.

The start date of the intervention in each center will be done by randomization, defining 2 periods: a control period located before the start of the intervention, and an experimental period located after the start of the intervention.

This design allows the principal investigating team to train the centers associated in turn with the intervention, and to have a control group with structured follow-up but without intervention.

All subjects will be included before 26 ADT and assigned to the control or experimental group, depending on the time of inclusion and the randomization of the center to which they belong.

The follow-up will be conducted in 2 phases: 1. during pregnancy and 2. After the birth of the child.

Subjects included were pregnant women who already had a child with an ASD diagnosis, the second parent if present, and the newborn at risk for an ASD diagnosis.

The primary objective of this study is to evaluate the effect of an innovative therapeutic education program (the MER program) versus control in pregnant women with a first child followed for ASD on the quality of interaction strategies of the mother-infant dyad at 10 months postpartum.

The primary endpoint was the caregiver non-directiveness subscore of the Manchester Assessment of Caregiver-infant Interaction (MACI) scale at 10 months postpartum. This subscore is both the most sensitive to intervention and predictive of ASD diagnosis.

The first secondary objective is the evaluation of the effect of the MER versus control program on:

  • maternal pregnancy-related anxiety (PRAQ-R2 score) ;
  • Anxious and depressive symptomatology and quality of life (WhoQoL-Bref score) in the mother and the second parent during pregnancy (EPDS score) and up to 20 months of age of the newborn (HAM-Anxiety and HAM-Depression scores);
  • perceived stress related to pregnancy (ALES score)
  • mother-infant interaction at 10 and 20 months (MACI score and subscore);
  • autistic signs in at-risk infants at 20 months (ADOS Toddler score);

The second secondary objective was to study variables that could impact the effect of the intervention, including

  • adherence: compliance with sessions, satisfaction of participants (PEI-Parent score) ;
  • other variables that could modulate the effect of the intervention: sociodemographic variables (socioeconomic level, family configuration, number of children); clinical profile of the mother (intellectual efficiency (Raven's PM score), psychiatric comorbidities (DIGS, SRS score)); clinical profile of the child already diagnosed (ADI-R and ADOS score; developmental level); clinical profile of the infant at risk (gestational age, MSEL, IBQ-R and ECBQ scores).

The third secondary objective was to describe the barriers and levers to the implementation of the intervention.

Characteristics related to the implementation of the intervention (recruitment, uptake, fidelity, and implementation) will be collected, as well as the profile of mothers who did not participate in the project.

Studietype

Ingrijpend

Inschrijving (Geschat)

165

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
      • Paris, Frankrijk, 75019
        • Werving
        • Hôpital Robert Debré
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: control group

Pregnant women followed by the center in the period before the intervention is implemented (the start of which is determined by randomization)
Experimenteel: experimental group

Pregnant women followed by the center during the period after the intervention is implemented (the start of which is determined by randomization)
Ander: The M.E.R. program

The M.E.R program is a therapeutic education intervention for mothers of children with ASD during a new pregnancy. This program, which is a pilot in France and in Europe, involves several dimensions, both pedagogical and behavioral (strategies for stimulating the baby, use of specific communication and interaction tools) and psychological (reduction of stress, anxiety, etc. in the mother).

It includes 8 individual interviews of 1h30 every 15 days. The first and the last one are for evaluation purposes, the 6 intermediate sessions constitute the accompaniment. The structure of the program and the sessions are based on what is recommended in therapeutic education. The sessions can take place on the hospital site or teleconsultation (remote consultation used in the context of healthcare).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
Tijdsspanne: 5 months after delivery

mother-baby interaction in the experimental group versus the control group at 5 months postpartum.

This subscore is the most sensitive to intervention and predictive of ASD diagnosis.
5 months after delivery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
Tijdsspanne: between 11 weeks and 26 weeks of gestation

To evaluate the effect of the MER program on maternal anxiety related to pregnancy
between 11 weeks and 26 weeks of gestation
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
Tijdsspanne: at 3 months after intervention

To evaluate the effect of the MER program on maternal anxiety related to pregnancy
at 3 months after intervention
Appraisal of Life Events Scale (ALES)
Tijdsspanne: between 11 weeks and 26 weeks of gestation

Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale)
between 11 weeks and 26 weeks of gestation
Appraisal of Life Events Scale (ALES)
Tijdsspanne: at 3 months after intervention

Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale
at 3 months after intervention
Edimburgh Postnatal Depression Scale (EPDS)
Tijdsspanne: 10 months after birth

used to assess the risk of postnatal depression and is useful for identifying the presence of anxiety symptoms.The threshold retained for the French validation is 10.5, above which a depression is possible and below which the risk is very low.
10 months after birth
quality of life score-Bref (WhoQol-Bref)
Tijdsspanne: 10 months after birth

WHOQOL-BREF includes 26 items that measure the following broad domains: physical health, psychological health, social relationships and environment.
10 months after birth
parental anxiety score (HAM)
Tijdsspanne: 10 months after birth

hetero-questionnaire with 14 items, measuring both the psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) expression of anxiety. Each item is rated on a Likert scale from 0 to 4 (total range 0-56, where <17= mild anxiety; 18-24= mild to moderate; 25-30 moderate to severe)
10 months after birth
mother's intelligence quotient
Tijdsspanne: between 11 weeks and 26 weeks of gestation

measured by Raven's Progressive Matrices
between 11 weeks and 26 weeks of gestation
Social Responsiveness Scale (SRS)
Tijdsspanne: between 11 weeks and 26 weeks of gestation

to refine the evaluation of social difficulties in a dimensional way
between 11 weeks and 26 weeks of gestation
Wechsler Mullen scale
Tijdsspanne: between 11 weeks and 26 weeks of gestation

developmental level of the ASD child
between 11 weeks and 26 weeks of gestation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Onderzoekers

  • Hoofdonderzoeker: Anita Beggiato, PHD, APHP

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 mei 2025

Primaire voltooiing (Geschat)

13 maart 2029

Studie voltooiing (Geschat)

13 augustus 2029

Studieregistratiedata

Eerst ingediend

11 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2021

Eerst geplaatst (Werkelijk)

2 november 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APHP191096

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren