Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)

NCT06594263 | Recruiting

• 1 other identifier: RNI 2024 VENDITTELLI 2
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

The transition to parenthood is a critical period for both the woman and her partner, and this can affect the mental health of the parents. Like mothers, fathers are at risk of stress, anxiety, depression and post-traumatic stress disorder during the perinatal period. Existing screening or diagnostic tools have been developed on the basis of traditional depressive symptoms expressed by women. However, the manifestations of perinatal mental disorders appear to be different in men. It is therefore essential to develop tools that are sensitive and specific to both gender and the perinatal period in order to increase the sensitivity and specificity of screening for fathers. In France, to the best of the knowledge of the investigators, there is no validated tool in French to assess paternal psychological disorders, either prenatally or postnatally. Baldoni et al. had validated a brief self-report questionnaire, the " Perinatal Assessment of Paternal Affectivity " (PAPA), to screen for perinatal signs and symptoms of paternal affective disorder, using a gender-sensitive approach. The aim of this study is to cross-cultural adapt the PAPA in French and to evaluate its psychometric properties. This validation of the French-PAPA would provide a simple tool, easy to use in everyday practice, to detect any signs or symptoms of paternal psychopathological distress in the pre- and postnatal period.

Conditions

Perinatal Depression; Affective Disorder; Fathers

Keywords

Fathers; Perinatal; Cross-cultural adaptation; Validation; Depression; Affective disorders; Screening

Outcome Measures

Primary Outcomes (2)

• French-PAPA

  Psychometric properties (acceptability, internal validity, validity of structure against external criteria) of the French version of the PAPA questionnaire

  0 day

• Change of French-PAPA from baseline at 10 days

  Test-retest reliability of the French version of the PAPA questionnaire

  0 day, 10 days

Secondary Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS)

  0 day

• Perceived Stress Scale - 10 items (PSS-10)

  0 day

• General Health Questionnaire - 12 items (GHQ-12)

  0 day

• Dyadic Adjustment Scale - 4 items (DAS-4)

  0 day

• Socio-demographic and medical characteristics of male partners

  0 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women and their male partners whose wives have been consulted during the third trimester of pregnancy at the Clermont-Ferrand University Hospital Centre (France) or at one of the three private practices participating in the study and who wish to give birth at the Clermont-Ferrand University Hospital Centre and/or couples whose wives have given birth at the maternity unit of the Clermont-Ferrand University Hospital Centre.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Françoise Vendittelli, PhD

  Clermont-Ferrand University Hospital Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 19, 2024
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: August 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)