Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
French-PAPA
Psychometric properties (acceptability, internal validity, validity of structure against external criteria) of the French version of the PAPA questionnaire
Time frame
0 day2
Change of French-PAPA from baseline at 10 days
Test-retest reliability of the French version of the PAPA questionnaire
Time frame
0 day, 10 daysSecondary outcomes
1
Hospital Anxiety and Depression Scale (HADS)
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.
Time frame
0 day2
Perceived Stress Scale - 10 items (PSS-10)
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.
Time frame
0 day3
General Health Questionnaire - 12 items (GHQ-12)
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.
Time frame
0 day4
Dyadic Adjustment Scale - 4 items (DAS-4)
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.
Time frame
0 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov