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

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.

Study Overview

• Status: Recruiting
• Conditions: Abnormality
• Intervention / Treatment: Other: Mobile Intervention Team in Perinatal Psychiatry (EMPPer)

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 Type: Interventional
• Enrollment (Estimated): 4260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabienne LIGIER, Pr.; Phone Number: 0033 03 83 15 45 53; Email: fabienne.ligier@cpn-laxou.com
• Study Contact Backup: Name: Naoual MELLOUKI BENDIM'RED, PhD; Phone Number: 0033 03 83 92 52 67; Email: unic@cpn-laxou.com

Study Locations

• France
  • Laxou, France
    • Recruiting
    • Centre Psychothérapique de Nancy
    • Contact: Naoual MELLOUKI BENDIMRED; Email: unic@cpn-laxou.com
    • Principal Investigator: fabienne LIGIER, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 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
No Intervention: without EMPPer; All children (0 to 3 years) from Strasbourg and Reims will not benefit from the Mobile Intervention Team in Perinatal Psychiatry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with anomaly of the child's psychomotor development at age 2 years	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	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Children with Language Delay at age 4	It evaluated during a health examination systematically carried out at the age of 4 years for the child attending school	up to 4 years
Therapeutic alliance score	Therapeutic alliance score (parents of the child) on the Working Alliance Inventory questionnaire (Bottemine, 2017; Horvath 1989)	up to 4 years
User satisfaction score	using the questionnaire offered to parents of children in care by the Nancy Psychotherapy Center as part of its quality approach	up to 4 years
the cost of care for children with a psychomotor development problem	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)	2 years

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Collaborators: Centre Hospitalier Régional et Universitaire de Nancy
• Investigators: Principal Investigator: Fabienne LIGIER, Pr., Centre Psychothérapique de Nancy

Publications and helpful links

General Publications

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
• Antenatal and postnatal mental health: clinical management and service guidance. London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/
• Alla F, Guillemin F, Colombo MC, Roy B, Maeder C. [Diagnostic value of ERTL4: a screening test of language disorders in 4-year-old children]. Arch Pediatr. 1998 Oct;5(10):1082-8. doi: 10.1016/s0929-693x(99)80004-9. French.
• Dupont C, Touzet S, Ploin D, Croidieu C, Balsan M, Mazas AS, Rudigoz RC. [Evaluation of the perinatal network professionals' integration: study about 653 professionals of AURORE network]. J Gynecol Obstet Biol Reprod (Paris). 2007 Jun;36(4):375-83. doi: 10.1016/j.jgyn.2007.01.003. Epub 2007 Feb 20. French.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 18, 2028

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: children; Psychiatry; Perinatal; psychomoteur
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: RIPH 2021-06; 2021-A02678-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No