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

NCT05104112 | Not Yet Recruiting

• 1 other identifier: APHP191096
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Child Psychiatry

Keywords

autism spectrum disorder; therapeutic education; prevention; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months after delivery

Secondary Outcomes (10)

• Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore

  between 11 weeks and 26 weeks of gestation

• Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore

  at 3 months after intervention

• Appraisal of Life Events Scale (ALES)

  between 11 weeks and 26 weeks of gestation

• Appraisal of Life Events Scale (ALES)

  at 3 months after intervention

• Edimburgh Postnatal Depression Scale (EPDS)

  10 months after birth

Study Arms (2)

control group

NO INTERVENTION

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

experimental group

EXPERIMENTAL

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

Interventions

The M.E.R. program OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: the Autism Diagnostic Observation Schedule ADOS, the Autism Diagnostic Interview - Revised version (ADI-R) accompanied by a cognitive evaluation of the child (Wechsler/Mullen Scales of Early Learning/Raven's Progressive Matrices);
• Informed consent from mother and sec

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert Debré

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anita Beggiato, PHD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Beggiato, PHD

CONTACT

0033140032000; anita.beggiato@aphp.fr

Richard Delorme, PHD

CONTACT

0033140034130; richard.delorme@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure blinding, the primary endpoint, assessed on video, will be measured at the end of the study by a blinded investigator from the randomization group and from a different center than the inclusion center.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic, multicenter, randomized, delayed-onset, stepped-wedge cluster study.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 2, 2021
• Study Start: November 1, 2024
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)