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

NCT ID: NCT06772701

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2027-03-12

Brief Summary

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.

Conditions

Depression, Postpartum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Fathers included at the maternity hospital or through their wife

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.

Group Type: ACTIVE_COMPARATOR

Mini International Neuropsychiatric Interview

Intervention Type: DIAGNOSTIC_TEST

Fathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression

EPDS book

Intervention Type: OTHER

PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.

fathers includes through the awareness campaign

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.

Group Type: EXPERIMENTAL

EPDS book

Intervention Type: OTHER

PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.

Interventions

Mini International Neuropsychiatric Interview

Fathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression

Intervention Type: DIAGNOSTIC_TEST

EPDS book

PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Groupe Hospitalier du Havre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antoine-Béclère hospital AP-HP

Clamart, , France

Site Status: ENROLLING_BY_INVITATION

Le Havre hospital - site Jacques Monod

Montivilliers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Angélique PICARD, project coordinator

Role: CONTACT

angelique.picard@ch-havre.fr

+33232734856

Christophe FRUIT, CRA

Role: CONTACT

cellule.rechercheclinique@ch-havre.fr

+33232734857

Facility Contacts

PICARD Angélique

Role: primary

0232734856

Other Identifiers

2024-A00242-45

Identifier Type: -

Identifier Source: org_study_id