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

Not Applicable

Recruiting

• Conditions: Abnormality

• Registration Number: NCT05636878
• Lead Sponsor: Centre Psychothérapique de Nancy

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-11-24
• Study First Posted: 2022-12-05
• Study Start: 2023-08-18
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2027-12-01
• Study Completion: 2028-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with anomaly of the child's psychomotor development at age 2 years	up to 24 months	It defined by the fact of having at least one box ticked "no" in the psychomotor development section of the medical part of the third health certificate , carried out after a systematic examination at the age of 24 months of the child

Secondary Outcome Measures

Name	Time	Method
Therapeutic alliance score	up to 4 years	Therapeutic alliance score (parents of the child) on the Working Alliance Inventory questionnaire (Bottemine, 2017; Horvath 1989)
Number of Children with Language Delay at age 4	up to 4 years	It evaluated during a health examination systematically carried out at the age of 4 years for the child attending school
User satisfaction score	up to 4 years	using the questionnaire offered to parents of children in care by the Nancy Psychotherapy Center as part of its quality approach
the cost of care for children with a psychomotor development problem	2 years	it makes it possible to carry out a medico-economic analysis, and to estimate the difference in costs between the two strategies of care (with and without EMPPer)

Trial Locations

Locations (1)

Centre Psychothérapique de Nancy; 🇫🇷 Laxou, France