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

NCT05636878 | Recruiting

• 2 other identifiers: RIPH 2021-062021-A02678-33
• Study Type: interventional
• Target: 4,260
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormality

Keywords

Perinatal; Psychiatry; psychomoteur; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Children with Language Delay at age 4

  up to 4 years

• Therapeutic alliance score

  up to 4 years

• User satisfaction score

  up to 4 years

• the cost of care for children with a psychomotor development problem

  2 years

Study Arms (2)

With EMPPer

EXPERIMENTAL

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)

without EMPPer

NO INTERVENTION

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

Interventions

Mobile Intervention Team in Perinatal Psychiatry (EMPPer) 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

With EMPPer

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead
• Central Hospital, Nancy, France: collaborator

Study Sites (1)

Centre Psychothérapique de Nancy

Laxou, France

RECRUITING

Related Publications (4)

• 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/

  PMID: 31990493 BACKGROUND

• 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.

  PMID: 9809150 BACKGROUND

• 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.

  PMID: 18824488 BACKGROUND

• 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.

  PMID: 17317036 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fabienne LIGIER, Pr.

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne LIGIER, Pr.

CONTACT

03 83 15 45 53; fabienne.ligier@cpn-laxou.com

Naoual MELLOUKI BENDIM'RED, PhD

CONTACT

03 83 92 52 67; unic@cpn-laxou.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: December 5, 2022
• Study Start: August 18, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 18, 2028
• Last Updated: February 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)