Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father (EPDS-PERE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angélique PICARD, project coordinator
- Phone Number: +33232734856
- Email: angelique.picard@ch-havre.fr
Study Contact Backup
- Name: Christophe FRUIT, CRA
- Phone Number: +33232734857
- Email: cellule.rechercheclinique@ch-havre.fr
Study Locations
-
-
-
Clamart, France, 92140
- Enrolling by invitation
- Antoine-Béclère hospital AP-HP
-
Montivilliers, France, 76290
- Recruiting
- Le Havre hospital - site Jacques Monod
-
Contact:
- PICARD Angélique
- Phone Number: 0232734856
-
Principal Investigator:
- Gisèle APTER, Professor - child psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
Fathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression
PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.
|
|
Experimental: 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.
|
PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini International Neuropsychiatric Interview
Time Frame: at inclusion
|
This short structured clinical interview is used to diagnose psychiatric disorders and is currently the gold standard for diagnosing depression.
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
socio-demographic questionnaire
Time Frame: at inclusion and 6 to 8 weeks after the birth of their child
|
Socio-demographic data will be a secondary evaluation criterion.
It will be used to study risk and protective factors, both those already known in the literature and those that have been little studied, and to identify profiles that are more at risk, with a view to taking preventive action in the field.
|
at inclusion and 6 to 8 weeks after the birth of their child
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A00242-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.