跳至主要内容
临床试验/NCT06772701
NCT06772701招募中不适用

Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father

Groupe Hospitalier du Havre4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
4
主要终点
Mini International Neuropsychiatric Interview

研究概览

简要总结

In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period.

The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers.

They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.

详细描述

Fathers complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •All fathers whose baby is 10 days old or less

排除标准

  • •People with a poor understanding of spoken or written French
  • •Persons under court protection, guardianship or curatorship

研究组 & 干预措施

Fathers included at the maternity hospital or through their wife

Active Comparator

At inclusion, fathers included at the maternity hospital or through their wife take the Mini International Neuropsychiatric Interview and complete the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire). 6 to 8 weeks after the birth of their child, they complete only EPDS book.

干预措施: Mini International Neuropsychiatric Interview (Diagnostic Test)

Fathers included at the maternity hospital or through their wife

Active Comparator

At inclusion, fathers included at the maternity hospital or through their wife take the Mini International Neuropsychiatric Interview and complete the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire). 6 to 8 weeks after the birth of their child, they complete only EPDS book.

干预措施: EPDS book (Other)

fathers includes through the awareness campaign

Experimental

At inclusion, fathers included through the awareness campaign have only the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire) at inclusion. 6 to 8 weeks after the birth of their child, they complete the same EPDS book.

干预措施: EPDS book (Other)

结局指标

主要结局

Mini International Neuropsychiatric Interview

时间窗: at inclusion

This short structured clinical interview is used to diagnose psychiatric disorders and is currently the gold standard for diagnosing depression.

次要结局

  • socio-demographic questionnaire(at inclusion and 6 to 8 weeks after the birth of their child)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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