Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594263
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Validation of the French Version of the Perinatal Assessment of Paternal Affectivity PAPA
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
French-Papa
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
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 irritabilityanger 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 babys 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
The PAPA consists of 8 items assessing in the last two weeks anxiety depression perceived stress irritabilityanger 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 babys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None