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

Abnormality Clinical Trial

— EMPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636878
• Other study ID #: RIPH 2021-06
• Secondary ID: 2021-A02678-33
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: August 18, 2028

Study information

• Verified date: December 2023
• Source: Centre Psychothérapique de Nancy
• Contact: Fabienne LIGIER, Pr.
• Phone: 03 83 15 45 53
• Email: fabienne.ligier[@]cpn-laxou.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4260
• Est. completion date: August 18, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormality
• Congenital Abnormalities

Intervention

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

Locations

Country	Name	City	State
France	Centre Psychothérapique de Nancy	Laxou

Sponsors (2)

Lead Sponsor	Collaborator
Centre Psychothérapique de Nancy	Centre Hospitalier Régional et Universitaire de Nancy

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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/ — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Therapeutic alliance score	Therapeutic alliance score (parents of the child) on the Working Alliance Inventory questionnaire (Bottemine, 2017; Horvath 1989)	up to 4 years
Secondary	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
Secondary	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