Clinical trial NCT06594263: Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perinatal Depression
Affective Disorder
Fathers
Keywords: Fathers
Perinatal
Cross-cultural adaptation
Validation
Depression
Affective disorders
Screening
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: The cross-cultural adaptation of the pre- and postnatal versions of the PAPA in French will be conduct according to international guidelines.

The PAPA consists of 8 items assessing in the last two weeks anxiety, depression, perceived stress, irritability/anger, relationship problems, abnormal illness behavior, physiological problems, and addictions and other risky behaviors. The severity of the symptoms and behaviors is rated on a 4-point Likert scale from 0 (not at all) to 3 (a lot). A total score is calculated by summing the 8 items' scores. Three additional items consist of: perceiving the symptoms as related to fatherhood, feeling happy with being or becoming a father, reporting additional aspects to better describe feelings.

The study will be offered to all eligible couples. Recruitment will take place in two different ways, depending on whether it is prenatal or postnatal. Women in the prenatal period will be included during one of the third trimester pregnancy monitoring consultations or during one of the third trimester ultrasounds or during a third trimester parenthood preparation course. If the woman is alone at the consultation, she will be asked if she can bring her partner to the next consultation. Postnatal enrolment will take place in the maternity unit, after the woman has given birth.

The couple will give written informed consent if they agree to participate in the study. The women will not be asked to complete any questionnaires. Only some of their socio-demographic and medical data, and that of their child, will be collected from their electronic medical file. For the prenatal study period, the male partners will complete the study questionnaires online after the consultation in the third trimester of pregnancy, and before the baby is born. For the postnatal study period, the male partners will complete the study questionnaires online eight weeks after the baby's birth.

To assess the test-retest reliability of the French-PAPA, the male partners will receive an e-mail to complete the French-PAPA questionnaire a second time online 10 days after the first completion.

Eligibility 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

Primary outcomes:
measure: French-PAPA
timeFrame: 0 day
measure: Change of French-PAPA from baseline at 10 days
timeFrame: 0 day, 10 days
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 day
measure: Perceived Stress Scale - 10 items (PSS-10)
timeFrame: 0 day
measure: General Health Questionnaire - 12 items (GHQ-12)
timeFrame: 0 day
measure: Dyadic Adjustment Scale - 4 items (DAS-4)
timeFrame: 0 day
measure: Socio-demographic and medical characteristics of male partners
timeFrame: 0 day
measure: Socio-demographic and medical characteristics of female partners
timeFrame: 0 day
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: Clermont-Ferrand University Hospital Centre
name: Françoise Vendittelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: