跳至主要内容
临床试验/NCT05636878
NCT05636878招募中不适用

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

Centre Psychothérapique de Nancy1 个研究点 分布在 1 个国家目标入组 4,260 人开始时间: 2023年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,260
试验地点
1
主要终点
Number of participants with anomaly of the child's psychomotor development at age 2 years

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of participants with anomaly of the child's psychomotor development at age 2 years

时间窗: 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

次要结局

  • Therapeutic alliance score(up to 4 years)
  • Number of Children with Language Delay at age 4(up to 4 years)
  • User satisfaction score(up to 4 years)
  • the cost of care for children with a psychomotor development problem(2 years)

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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