An interventional study of The M.E.R. program in Child Psychiatry, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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).
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:
The second secondary objective was to study variables that could impact the effect of the intervention, including
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's planned enrollment of 132 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregnant women followed by the center in the period before the intervention is implemented (the start of which is determined by randomization)
Pregnant women followed by the center during the period after the intervention is implemented (the start of which is determined by randomization)
Other: 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 at home.
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
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.
Time frame: 5 months after delivery
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
To evaluate the effect of the MER program on maternal anxiety related to pregnancy
Time frame: between 11 weeks and 26 weeks of gestation
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
To evaluate the effect of the MER program on maternal anxiety related to pregnancy
Time frame: at 3 months after intervention
Appraisal of Life Events Scale (ALES)
Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale)
Time frame: between 11 weeks and 26 weeks of gestation
Appraisal of Life Events Scale (ALES)
Perceived pregnancy-related stress in the mother.scale with a list of adjectives, rated on a five-point Likert scale
Time frame: at 3 months after intervention
Edimburgh Postnatal Depression Scale (EPDS)
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.
Time frame: 10 months after birth
quality of life score-Bref (WhoQol-Bref)
WHOQOL-BREF includes 26 items that measure the following broad domains: physical health, psychological health, social relationships and environment.
Time frame: 10 months after birth
parental anxiety score (HAM)
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)
Time frame: 10 months after birth
mother's intelligence quotient
measured by Raven's Progressive Matrices
Time frame: between 11 weeks and 26 weeks of gestation
Social Responsiveness Scale (SRS)
to refine the evaluation of social difficulties in a dimensional way
Time frame: between 11 weeks and 26 weeks of gestation
Wechsler Mullen scale
developmental level of the ASD child
Time frame: between 11 weeks and 26 weeks of gestation
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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