Paternal Involvement in Breastfeeding

Depression Clinical Trial

Official title:

The Impact of Paternal Involvement on Breastfeeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064982
• Other study ID #: 09.2021.845
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: October 2023

Study information

• Verified date: September 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Paternal involvement in breastfeeding has been identified as a significant predictor in maternal breastfeeding outcomes. The main aim of this study is to examine the relationship between reported paternal breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. The hypothesis is that paternal involvement in breastfeeding increase exclusive breastfeeding rates, total breastfeeding duration and strengthen paternal-infant attachment.

Description:

Initiation, duration and exclusivity of breastfeeding are greatly influenced by paternal involvement in breastfeeding. Previous studies showed that fathers who are involved in the breastfeeding process have stronger attachments with their babies. However, research on fathers' involvement in their partners' breastfeeding is lacking and there are no comprehensive studies conducted on the effects of the paternal involvement and infant attachment on exclusive breastfeeding (EB) and total breastfeeding duration. Therefore, the aim of the study is to examine the relationship between fathers reported breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration. Data will be collected from a tertiary university hospital. The study will be conducted in two phases. In the first phase, the researcher will approach healthy, term, one month old babies and their fathers who fulfilled the eligibility criteria and will invite them to participate in the study. Informed consent will be obtained from participating fathers. The Partner Breastfeeding Influence scale will be used to measure fathers' involvement in their partner's breastfeeding, Paternal-infant attachment, paternal depression, and marital adjustment will be measured with Paternal-Infant Attachment Questionnaire, Edinburgh Postpartum Depression Scale and Marital Adjustment Scale respectively. Four sets of questionnaires will be administered at two time points for the study. The first set will be administered at postpartum first month. The second set of data will be collected at postpartum six months. In the second phase, fathers participating in the study will be interviewed for breastfeeding duration and factors associated with cessation will be explored at postpartum 12 and 24 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Fathers of

• one-month-old,
• healthy,
• breastfed infants

Exclusion Criteria:

• Infants with a birth weight less than 2500 grams
• Infants who are less than 37 weeks gestation
• Infants with prenatally suspected or diagnosed congenital defects
• Parents with major depression
• Divorced or separated couples

Related Conditions & MeSH terms

• Breastfeeding
• Depression
• Paternal Behavior

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding duration	Exclusive breastfeeding duration will be asked with a single question at six months	at 6 months
Primary	Total breastfeeding duration	Total breastfeeding duration will be asked with a single question at 12 months	at 12 months
Primary	Total breastfeeding duration	Total breastfeeding duration will be asked with a single question at 12 months	at 24 months
Secondary	Change in perceived paternal breastfeeding support	The Partner Breastfeeding Influence Scale (PBIS) will be used to measure perceived breastfeeding support and will be assessed using five dimensions of partner breastfeeding support. These are Savvy, helping, appreciation, breastfeeding presence, and responsiveness. Mean scores are calculated from all questions, from 1 (extremely not supportive) to 5 (extremely supportive) for each breastfeeding support component. High scores show that breastfeeding support of father is notable.	Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary	Change in Paternal-Infant Attachment	The Paternal-Infant Attachment Scale (PIAS) will be used to measure the strength of the bond between the father and infant. The PIAS is a scale consisting of 19 items, with every item graded between 1 and 5 points. High scores show that the attachment is strong. The gathered score average from PIAS is near the score of 19 (minimum value) show a weak attachment; however, when it is near the score of 95 (the maximum value), show a strong attachment.	Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary	Change in paternal depression	The Edinburgh Postpartum Depression Scale (EPDS) will be used to detect depression as a screening tool. The EPDS is a ten item self-report questionnaire. Items 1 and 2 assess anhedonia; item 3: self-blame; item 4: anxiety; item 5: fear or panic; item 6: inability to cope; item 7: difficulty sleeping; item 8: sadness; item 9: tearfulness and item 10: self-harm ideas. Responses are scored as 0, 1, 2 and 3 according to the increasing severity of the symptoms. Total score is calculated by adding each score of each 10 items. The value of score can range from 0 to 30. The traditional cut-off score for the Edinburgh Postpartum Depression Scale when assessing women is 13 or greater however, a lower cut-off score is recommended for fathers as men express emotions differently from women, mainly that they are less expressive with their negative emotions. For this study a cut-off score of 10 or above will be used to assess Paternal Postpartum Depression.	Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Secondary	Change in Marital Adjustment	The Marital Adjustment Scale (MAS) consists of 15 items that evaluate general adjustment, conflict resolution, attachment, and communication. High scores from this scale indicates high marital adjustment. The value of score can range 0 to 60. A score of less than a 43 or below reflects marital distress in marital adjustment scale.	Baseline (postpartum 1st month) and 5 months after (at 6th Month)