Child PsychiatryAUTMERNCT05104112
Evaluation of a Therapeutic Education Program for Pregnant Women with a First Child Diagnosed with an Autism Spectrum Disorder
A study testing The M.E.R. program in people with Child Psychiatry, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Child Psychiatry
- What is being tested?
- The M.E.R. program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Robert Debré
Paris, Paris, 75019
Anita Beggiato, PHD, 01 40 03 20 00, anita.beggiato@aphp.fr
About this study
Official title: Evaluation of a Therapeutic Education Program for Pregnant Women with a First Child Diagnosed with an Autism Spectrum Disorder (ASD)
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.
Read more
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).
Read the detailed 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.
- Conditions
- Child Psychiatry
- Being tested
- The M.E.R. program
- Keywords
- autism spectrum disorder, therapeutic education, prevention, pregnancy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The M.E.R. programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: The M.E.R. program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months after delivery
Secondary outcomes (10)
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
To evaluate the effect of the MER program on maternal anxiety related to pregnancy
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 10 months after birth
mother's intelligence quotient
measured by Raven's Progressive Matrices
Measured: between 11 weeks and 26 weeks of gestation
Social Responsiveness Scale (SRS)
to refine the evaluation of social difficulties in a dimensional way
Measured: between 11 weeks and 26 weeks of gestation
Wechsler Mullen scale
developmental level of the ASD child
Measured: between 11 weeks and 26 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study startNov 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child PsychiatryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, multicenter, randomized, delayed-onset, stepped-wedge cluster study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Beggiato, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104112
- Sponsor's protocol ID
- APHP191096
- Acronym
- AUTMER
- Status last verified
- Sep 2024
- First submitted
- 11 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Education Program for Pregnant Women with a First Child Diagnosed with an Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT05104112
- Acronym / sponsor ID
- AUTMER / APHP191096
- Conditions
- Child Psychiatry
- Keywords
- autism spectrum disorder, therapeutic education, prevention, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic, multicenter, randomized, delayed-onset, stepped-wedge cluster study.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: The M.E.R. programPregnant women followed by the center during the period after the intervention is implemented (the start of which is determined by randomization) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The M.E.R. programThe 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. | Other | experimental group |
Primary outcome
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore
Time frame: 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.
10 secondary outcomes
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
Time frame: between 11 weeks and 26 weeks of gestation
Pregnancy-Related Anxiety Questionnaire-Revised2 (PRAQ-R2) subscore
Time frame: at 3 months after intervention
Appraisal of Life Events Scale (ALES)
Time frame: between 11 weeks and 26 weeks of gestation
Appraisal of Life Events Scale (ALES)
Time frame: at 3 months after intervention
Edimburgh Postnatal Depression Scale (EPDS)
Time frame: 10 months after birth
quality of life score-Bref (WhoQol-Bref)
Time frame: 10 months after birth
parental anxiety score (HAM)
Time frame: 10 months after birth
mother's intelligence quotient
Time frame: between 11 weeks and 26 weeks of gestation
Social Responsiveness Scale (SRS)
Time frame: between 11 weeks and 26 weeks of gestation
Wechsler Mullen scale
Time frame: between 11 weeks and 26 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Beggiato, PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The M.E.R. program in people with Child Psychiatry, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita Beggiato, PHD (0033140032000, anita.beggiato@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester Assessment of Caregiver-infant Interaction (MACI) "caregiver non-directiveness" subscore (time frame: 5 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.