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

Primary Purpose

Abnormality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Intervention Team in Perinatal Psychiatry (EMPPer)
Sponsored by
Centre Psychothérapique de Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Abnormality focused on measuring Perinatal, Psychiatry, psychomoteur, children

Eligibility Criteria

1 Day - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    With EMPPer

    without EMPPer

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Therapeutic alliance score
    Therapeutic alliance score (parents of the child) on the Working Alliance Inventory questionnaire (Bottemine, 2017; Horvath 1989)
    User satisfaction score
    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
    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)

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    August 2, 2023
    Sponsor
    Centre Psychothérapique de Nancy
    Collaborators
    Centre Hospitalier Régional et Universitaire de Nancy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05636878
    Brief Title
    Creation and Evaluation of a Mobile Intervention Team in Perinatal Psychiatry (0-3 Years) in Meurthe-et-Moselle Sud
    Acronym
    EMPER
    Official Title
    Creation and Evaluation of a Mobile Intervention Team in Perinatal Psychiatry (0-3 Years) in Meurthe-et-Moselle Sud
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2027 (Anticipated)
    Study Completion Date
    December 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Psychothérapique de Nancy
    Collaborators
    Centre Hospitalier Régional et Universitaire de Nancy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abnormality
    Keywords
    Perinatal, Psychiatry, psychomoteur, children

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    4260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With EMPPer
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    without EMPPer
    Arm Type
    No Intervention
    Arm Description
    All children (0 to 3 years) from Strasbourg and Reims will not benefit from the Mobile Intervention Team in Perinatal Psychiatry
    Intervention Type
    Other
    Intervention Name(s)
    Mobile Intervention Team in Perinatal Psychiatry (EMPPer)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Number of participants with anomaly of the child's psychomotor development at age 2 years
    Description
    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
    Time Frame
    up to 24 months
    Secondary Outcome Measure Information:
    Title
    Number of Children with Language Delay at age 4
    Description
    It evaluated during a health examination systematically carried out at the age of 4 years for the child attending school
    Time Frame
    up to 4 years
    Title
    Therapeutic alliance score
    Description
    Therapeutic alliance score (parents of the child) on the Working Alliance Inventory questionnaire (Bottemine, 2017; Horvath 1989)
    Time Frame
    up to 4 years
    Title
    User satisfaction score
    Description
    using the questionnaire offered to parents of children in care by the Nancy Psychotherapy Center as part of its quality approach
    Time Frame
    up to 4 years
    Title
    the cost of care for children with a psychomotor development problem
    Description
    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)
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabienne LIGIER, Pr.
    Phone
    03 83 15 45 53
    Ext
    0033
    Email
    fabienne.ligier@cpn-laxou.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naoual MELLOUKI BENDIM'RED, PhD
    Phone
    03 83 92 52 67
    Ext
    0033
    Email
    unic@cpn-laxou.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabienne LIGIER, Pr.
    Organizational Affiliation
    Centre Psychothérapique de Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31990493
    Citation
    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/
    Results Reference
    background
    PubMed Identifier
    9809150
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18824488
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17317036
    Citation
    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.
    Results Reference
    background

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

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