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

Child Psychiatry Clinical Trial

— AUTMER  

Official title:

Evaluation of a Therapeutic Education Program for Pregnant Women With a First Child Diagnosed With an Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05104112
• Other study ID #: APHP191096
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anita Beggiato, PHD
• Phone: 0033140032000
• Email: anita.beggiato[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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: 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

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Psychiatry

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore	To evaluate the effect of the MER program on maternal anxiety related to pregnancy	between 11 weeks and 26 weeks of gestation
Secondary	Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore	To evaluate the effect of the MER program on maternal anxiety related to pregnancy	at 3 months after intervention
Secondary	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)	between 11 weeks and 26 weeks of gestation
Secondary	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	at 3 months after intervention
Secondary	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.	10 months after birth
Secondary	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.	10 months after birth
Secondary	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)	10 months after birth
Secondary	mother's intelligence quotient	measured by Raven's Progressive Matrices	between 11 weeks and 26 weeks of gestation
Secondary	Social Responsiveness Scale (SRS)	to refine the evaluation of social difficulties in a dimensional way	between 11 weeks and 26 weeks of gestation
Secondary	Wechsler Mullen scale	developmental level of the ASD child	between 11 weeks and 26 weeks of gestation