Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)
- Conditions
- Perinatal DepressionAffective DisorderFathers
- Registration Number
- NCT06594263
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method French-PAPA 0 day Psychometric properties (acceptability, internal validity, validity of structure against external criteria) of the French version of the PAPA questionnaire
Change of French-PAPA from baseline at 10 days 0 day, 10 days Test-retest reliability of the French version of the PAPA questionnaire
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) 0 day The HADS is a valid and reliable self-report questionnaire that assesses anxiety and depression symptoms. It consists of 14 items, 7 for the anxiety subscale and 7 for the depression subscale. A total score ranging from 0 to 21 is calculated for both subscales, with higher scores representing a higher level of symptoms.
Perceived Stress Scale - 10 items (PSS-10) 0 day The PPS-10 is a widely used self-report questionnaire that evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month. It consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). A total score is calculated by reverse-scoring questions 4, 5, 7 and 8 and then adding scores of all 10 items together. The total score range from 0 to 10 with higher scores indicating higher perceived stress.
General Health Questionnaire - 12 items (GHQ-12) 0 day The GHQ-12 is a screening self-report instrument to detect psychiatric disorders in community settings and non-psychiatric clinical settings. The scores typically used for items are the binary scale (0-0-1-1) and the 4-point Likert-type scale (0-1-2-3). Responses to all items are summed up to a total score ranging from 0 to 12 (binary scale) or 0 to 36 (Likert scale), with higher scores indicating more severe impairment.
Dyadic Adjustment Scale - 4 items (DAS-4) 0 day The DAS-4 is a self-report questionnaire consisting of 4 items and measuring relationship quality in married or cohabiting couples. Each item is rated on 6-point Likert scale. A total score is obtained by summing all the item scores and ranges from 0 to 20, with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress.
Socio-demographic and medical characteristics of male partners 0 day Age, educational level, professional status, number of children, experience of miscarriage, death in utero or death within 28 days of birth with a current or former partner, use of toxic substances (tobacco, alcohol, cannabis, other substances), health problems, psychological or psychiatric support (during life, currently), tranquillisers, antidepressants, anxiolytics treatments (during life, currently), problems or conflicts at work in the last 6 months, stressful life events in the last 6 months.
Socio-demographic and medical characteristics of female partners 0 day Age, marital status, educational level, professional status, parity, number of embryos at the start of pregnancy, diseases related to pregnancy, hospitalisation during pregnancy.
Only for couples included in the postnatal period, data on childbirth and the postnatal period : gestational age at delivery, onset of labor, anaesthesia before and after birth, mode of delivery, length of labor, postpartum hemorrhage, transfer of the mother, postnatal pathology, length of mother's stay in the maternity unit.
Only for couples included in the postnatal period, data on the newborn: weight, gender, reanimation in the delivery room, neonatal transfer, neonatal pathology, length of newborn's stay in the maternity unit, breastfeeding on discharge.
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France