Perinatal DepressionFrench-PapaNCT06594263
Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)
An observational study of Perinatal Depression and Affective Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Affective Disorder, Fathers
- How many people
- 343 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2024to 23 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Perinatal Depression, Affective Disorder, Fathers
- Keywords
- Fathers, Perinatal, Cross-cultural adaptation, Validation, Depression, Affective disorders, Screening
- Medical subject headings
- Mood Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
French-PAPA
Psychometric properties (acceptability, internal validity, validity of structure against external criteria) of the French version of the PAPA questionnaire
Measured: 0 day
Change of French-PAPA from baseline at 10 days
Test-retest reliability of the French version of the PAPA questionnaire
Measured: 0 day, 10 days
Secondary outcomes (6)
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.
Measured: 0 day
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.
Measured: 0 day
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.
Measured: 0 day
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.
Measured: 0 day
Socio-demographic and medical characteristics of male partners
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.
Measured: 0 day
Socio-demographic and medical characteristics of female partners
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.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Oct 2024
- Primary completion11 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise Vendittelli, PhD, Principal investigator, Clermont-Ferrand University Hospital Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594263
- Sponsor's protocol ID
- RNI 2024 VENDITTELLI 2
- Acronym
- French-Papa
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06594263
- Acronym / sponsor ID
- French-Papa / RNI 2024 VENDITTELLI 2
- Conditions
- Perinatal Depression, Affective Disorder, Fathers
- Keywords
- Fathers, Perinatal, Cross-cultural adaptation, Validation, Depression, Affective disorders, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
French-PAPA
Time frame: 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
Time frame: 0 day, 10 days
Test-retest reliability of the French version of the PAPA questionnaire
6 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0 day
Perceived Stress Scale - 10 items (PSS-10)
Time frame: 0 day
General Health Questionnaire - 12 items (GHQ-12)
Time frame: 0 day
Dyadic Adjustment Scale - 4 items (DAS-4)
Time frame: 0 day
Socio-demographic and medical characteristics of male partners
Time frame: 0 day
Socio-demographic and medical characteristics of female partners
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Fathers and Babies (FAB) Research Study
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Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise Vendittelli, PhD principal investigator
Clermont-Ferrand University Hospital Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Depression and Affective Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
French-PAPA (time frame: 0 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.