Creation and Evaluation of a Mobile Intervention Team in Perinatal Psychiatry (0-3 Years) in Meurthe-et-Moselle Sud

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2028-08-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The research system is a Mobile Perinatal Psychiatry Team (EMPPer), for children aged 0 to 3 and their parents. it facilitates access to psychiatric care by going to families who need it and who are in difficulty to ensure this process.

This device, already deployed in a dozen French cities for several years, convinced the teams of its interest, without demonstrating its effectiveness by evaluation conducted according to research standards. The deployment of a Mobile Perinatal Psychiatry Team in a region not yet equipped (Meurthe-et-Moselle Sud) would therefore offer the opportunity to assess its effectiveness,

The main objective of the research is to evaluate the effect of the EMPPer on the prevalence of abnormalities in the psychomotor development of children at the age of 2 years, in comparison with similar territories that do not benefit from it, and in comparison with the period preceding the establishment of the EMPPer in the targeted territory.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)

NCT06640907

Perinatal Depression Perinatal Anxiety

RECRUITING NA

Description of the Psychiatric Care Pathway of Pregnant Women After the Early Prenatal Interview

NCT04574986

Psychiatric Disorder

COMPLETED

Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders

NCT02150681

Major Depressive Disorder Bipolar Disorder

COMPLETED PHASE1

Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App

NCT06301087

Development, Child Postnatal Depression

COMPLETED

Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes

NCT07008183

Perinatal Mental Health

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Context:

The inflation of psycho-social vulnerability and precariousness situations, of parents or isolated mothers with their young child, who do not have easy access to perinatal psychiatry care structures, incites us to develop a modality of home interventions. This is part of a therapeutic perspective of the parenting process and parent-child interactions and a preventive perspective of the child's development. This system is a Mobile Perinatal Psychiatry Team and is also designed for professionals working in early childhood (such as the homes that take in parents). They are in demand for direct interventions with patients, but also indirect interventions, for assistance in the detection of early disorders in children and for referral to psychiatric care.

The main objective of the research is to evaluate the effect of the EMPPer on the prevalence of abnormalities in the psychomotor development of children at the age of 2 years , in comparison with similar territories that do not benefit from it, and in comparison with the period before the EMPPer was implemented in the targeted territory.

The secondary objectives are:

* to evaluate the long-term effect of the EMPPer on the prevalence of child language delay at age 4, compared with similar territories without the EMPPer and compared with the period before the EMPPer was implemented in the target territory
* to evaluate the EMPPer implementation process, in terms of context, interventions implemented, implementation, and impact mechanisms
* to evaluate the medico-economic impact at 2 years of the implementation of the EMPPer.

Methodology:

EMPER is a quasi-experimental study combining a before-and-after EMPPer implementation design with a here-and-now design. A concomitant process evaluation will also be conducted to assess the actual implementation of the intervention, the impact mechanisms of the intervention on the judgment criteria, and to understand precisely the context of implementation in order to better identify the transferability and sustainability of the intervention.

the study will include all the children of the EMPPer sector as well as those of the Reims and Strasbourg hospital sectors. Data from their 24th month and 3-4 years examinations will be collected .

Process evaluation will be based on mixed methods.It will be based on standardized data collection using an observation book and validated measurement instruments such as the satisfaction and therapeutic alliance questionnaire. It will include all users and professionals involved in the implementation of the EMPPer and willing to participate.

The qualitative approach will make it possible, through field observations and semi-structured interviews with professionals and volunteer users, to specify certain elements relating to the intervention itself, such as the organizations within the EMPPer, but also its implementation (possible adaptations of the intervention) or its impact mechanisms.

Expected results are that the deployment of an EMPPer will allow:

* To promote early detection of interaction disorders in order to limit theirs consequences on somatic, cognitive and psychomotor development
* To promote early detection of neurodevelopmental disorders
* To promote early intervention, in connection with early childhood partners
* To facilitate the care pathway of the young patient and his family by allowing easier access to care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abnormality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

For the primary objective, i.e., analysis of the effect of the intervention at age 2 (and the first SO, i.e., analysis of the effect of the intervention at age 4), a difference-in-differences analysis will be performed. That is, the difference in the prevalence of abnormal psychomotor development at age 2 (and at age 4) before and after the implementation of the EMPPer in the target territory will be compared to the difference in the prevalence of abnormal psychomotor development at age 2 (and at age 4) between the periods corresponding to the implementation of the EMPPer in the territories that did not benefit from it, using a mixed linear regression model with psychomotor developmental abnormalities as the variable to be explained, year (pre vs. post intervention) and region (with vs. without intervention) as explanatory variables, and which will include the year\*region interaction. The assumption of equivalence of temporal developmental trends here and elsewhere will be tested

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With EMPPer

All children (0 to 3 years old) in the areas Meurthe-et-Moselle South will benefit from the intervention of the Mobile Perinatal Psychiatry Team (EMPPer)

Group Type EXPERIMENTAL

Mobile Intervention Team in Perinatal Psychiatry (EMPPer)

Intervention Type OTHER

The Mobile Intervention Team in Perinatal Psychiatry consists in going towards the most excluded patients, changing the organization of care compared to the current practice and facilitating access to care for the most vulnerable populations

without EMPPer

All children (0 to 3 years) from Strasbourg and Reims will not benefit from the Mobile Intervention Team in Perinatal Psychiatry

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobile Intervention Team in Perinatal Psychiatry (EMPPer)

The Mobile Intervention Team in Perinatal Psychiatry consists in going towards the most excluded patients, changing the organization of care compared to the current practice and facilitating access to care for the most vulnerable populations

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children benefiting from EMPPer intervention
* Children affiliated or entitled to a social security system
* Children for whom the holder of parental authority has received informed information about the study and has co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria

* Children whose parents are visiting the region ( vacations, family visits ...)
* Children for whom the 2 holders of parental authority do not speak french
* Children for whom both parents do not know how to read

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No