Validation of a French tool to assess fathers' mental health during the perinatal period
Cross-cultural Adaptation and Validation of the French Version of the PAPA (Perinatal Assessment of Paternal Affectivity) Self-questionnaire Assessing the Psychological Experience of Fathers Pre- and Post-natal
This study is testing a new French tool to help check on the mental health of fathers during pregnancy and after their baby is born.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06594263 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the French version of the Perinatal Assessment of Paternal Affectivity (PAPA), a tool designed to assess mental health issues in fathers during the perinatal period. The PAPA consists of 8 items that evaluate symptoms such as anxiety, depression, and stress, specifically tailored to the experiences of fathers. Couples will be recruited during prenatal consultations or postnatal hospital stays, and both partners must provide informed consent to participate. The study will help ensure that the tool is culturally appropriate and effective for French-speaking fathers.
Who should consider this trial
Good fit: Ideal candidates include couples where the woman is pregnant or has recently given birth, and both partners can understand and communicate in French.
Not a fit: Patients who do not have a male partner or those who are unable to participate due to medical or legal reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could improve the identification and support of fathers experiencing mental health issues during the perinatal period.
How similar studies have performed: While there is limited research specifically on the PAPA tool in French, similar studies have shown the importance of gender-specific assessments for perinatal mental health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman and its male partner aged 18 years old and older * Couple understanding, speaking and reading French * Couple giving their informed consent to participate voluntarily Exclusion Criteria: * Woman without male partner * Woman admitted to intensive care after giving birth * Couple whose newborn died peripartum * Couple who have had a medical abortion or fetal death in utero for the current pregnancy * Woman and/or male partner refusing to participate in the study * Woman and/or male partner not speaking French * Woman and/or male partner in the incapacity to answer the questionnaires * Woman and/or male partner under guardianship or conservatorship, deprived of liberty, or in the custody of correctional authorities
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Françoise Vendittelli, PhD — Clermont-Ferrand University Hospital Centre
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33 4 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.