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Recruiting NCT06772701

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

No phase Interventional Depression, Postpartum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mini International Neuropsychiatric Interview, EPDS book.
Who it may be relevant to
Registry conditions: Depression, Postpartum. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test Mini International Neuropsychiatric Interview
    Fathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression
  • Other EPDS book
    PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.

Primary outcome measures

  • Mini International Neuropsychiatric Interview [Time frame: at inclusion]
Secondary outcome measures (1)
  • socio-demographic questionnaire [Time frame: at inclusion and 6 to 8 weeks after the birth of their child]

Eligibility criteria

Inclusion criteria

  • All fathers whose baby is 10 days old or less

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 2 centers
  • Antoine-Béclère hospital AP-HP — Clamart
  • Le Havre hospital - site Jacques Monod — Montivilliers

Identifiers

NCT: NCT06772701 · 2024-A00242-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗