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

NCT06772701 | Recruiting

• 1 other identifier: 2024-A00242-45
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• Mini International Neuropsychiatric Interview

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

  at inclusion

Secondary Outcomes (1)

• socio-demographic questionnaire

  at inclusion and 6 to 8 weeks after the birth of their child

Study Arms (2)

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.

Diagnostic Test: Mini International Neuropsychiatric Interview; Other: EPDS book

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.

Other: EPDS book

Interventions

Mini International Neuropsychiatric Interview DIAGNOSTIC_TEST

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

Fathers included at the maternity hospital or through their wife

EPDS book OTHER

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

Fathers included at the maternity hospital or through their wife; fathers includes through the awareness campaign

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All fathers whose baby is 10 days old or less

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (2)

Antoine-Béclère hospital AP-HP

Clamart, 92140, France

ENROLLING BY INVITATION

Le Havre hospital - site Jacques Monod

Montivilliers, 76290, France

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Angélique PICARD, project coordinator

CONTACT

+33232734856; angelique.picard@ch-havre.fr

Christophe FRUIT, CRA

CONTACT

+33232734857; cellule.rechercheclinique@ch-havre.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fathers included at the maternity hospital or through the mother take the Mini International Neuropsychiatric Interview and complete the PH-Q9, EPDS and socio-demographic questionnaires. Fathers included through the awareness campaign have only the PH-Q9, EPDS and socio-demographic questionnaires.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: July 11, 2024
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)