Evaluation of a Therapeutic Education Program for Pregnant Women with a First Child Diagnosed with an Autism Spectrum Disorder
NCT05104112 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2024-09-19
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
Interventions
- 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.
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Anita Beggiato, PHD · APHP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-30
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- France
Study Locations
More Related Trials
-
Testing a Novel Parenting Intervention for Children With Autism
NCT04574206 ·Status: UNKNOWN ·Phase: NA
-
Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
NCT05176808 ·Status: RECRUITING ·Phase: NA
-
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
NCT05741840 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Validation Study of the Performance of the French Version of the Autism Mental Status Examination Scale as a Tool for Identifying Autism Spectrum Disorder in Adults
NCT06549179 ·Status: RECRUITING
-
REGulatory T Cells in Autism Induced by Maternal Immune Activation
NCT06169111 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Evaluating a Web Delivered Behavioral Parent Training Intervention for Rural Parents of Children With Autism Spectrum Disorder
NCT05554198 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
NCT04369417 ·Status: COMPLETED ·Phase: NA
-
Efficacy of IMPACT in Infant Siblings of Children With ASD
NCT03274622 ·Status: COMPLETED ·Phase: NA
-
Parents of Newly Diagnosed Preschool Children With Autism Spectrum Disorder:
NCT03005431 ·Status: UNKNOWN ·Phase: NA
-
Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
NCT03020277 ·Status: COMPLETED ·Phase: NA
-
The Effectiveness of a Parent Training Program for Children With Autism Spectrum Disorder and High-Risk Infants: A Case-Control Study
NCT07075614 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Telehealth Intervention for Autism Spectrum Disorder
NCT04832152 ·Status: RECRUITING ·Phase: NA
-
Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
NCT05215028 ·Status: COMPLETED
-
Parent Telehealth Intervention for Children With Autism
NCT04501588 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
NCT06443320 ·Status: RECRUITING ·Phase: NA
-
Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
NCT02707939 ·Status: UNKNOWN
-
Improving the Part C Early Intervention Service Delivery System for Children With ASD
NCT05114538 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Efficacy of Training Programme to Reduce Stress
NCT02384486 ·Status: COMPLETED ·Phase: NA
-
Parenting with an Autism Spectrum Disorder
NCT06502054 ·Status: RECRUITING
-
Examining an Adaptive Telehealth Intervention
NCT03840642 ·Status: COMPLETED ·Phase: NA
-
Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care
NCT04820998 ·Status: COMPLETED
-
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
NCT03592654 ·Status: COMPLETED ·Phase: NA
-
Telehealth Rapid Intervention for Externalizing Behaviors in ASD
NCT05056922 ·Status: COMPLETED ·Phase: NA
-
REward SYSTem in Autism Spectrum Disorder and Addictive Disorder
NCT05391113 ·Status: RECRUITING ·Phase: NA
-
Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder
NCT05810675 ·Status: UNKNOWN ·Phase: NA