- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06698107
Salutogenesis and Self-efficacy-based Childbirth Education Programme for Preventing Postpartum Depression
Effectiveness of Childbirth Education Based on Salutogenic Perspective and Self-Efficacy Theory in Preventing Postpartum Depression Among Ethiopian Teenage Mothers: a Pilot RCT Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postpartum depression (PPD) is a common mental health disorder that occur following childbirth. It typically develops within the first 12 weeks of the postpartum period, although researchers and public health experts consider PPD to be prevalent up to one year after giving birth. Although postpartum depression remains a global public health concern, it is often overlooked in the maternal healthcare system, particularly in low-and middle-income countries. The existing maternity care service often prioritizes addressing obstetrical issues while neglecting the mental well-being of labouring mothers. In Ethiopia, the prevalence of PPD among teenage mothers has reached 37%, which is much higher than the global average of 18%. Consequently, depression following childbirth continues to pose a significant risk to the overall well-being of both mothers and newborns. This study is significant in providing evidence to policymakers and health stakeholders, urging them to integrate mental health and health promotion interventions in maternity care services without imposing an additional financial burden on the healthcare system.
The role of maternity care provision during the antenatal and postnatal period is to enhance mothers' birth preparedness and complication readiness to achieve optimal maternal and infant health. However, it is crucial to practically evaluate the effectiveness of childbirth education underpinned by salutogenesis and self-efficacy perspectives in preventing PPD by enhancing mothers' sense of coherence, parenting self-efficacy, and perception of social support throughout the transition to motherhood. The findings of this study provide significant evidence for the integrating of the current disease prevention-focused approach of maternal care services with health-protective salutogenic interventions to maintain mothers' psychosocial well-being during childbirth and the parenting experience. Furthermore, the evidence may encourage countries, including Ethiopia, to implement childbirth classes that are not yet conducting in maternity care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lebeza Alemu Tenaw
- Phone Number: 852 52242797
- Email: lebeza.tenaw@connect.polyu.hk
Study Locations
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Amhara
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Bahir Dar, Amhara, Ethiopia
- Completed
- Addis Alem Hospital
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Bahir Dar, Amhara, Ethiopia
- Recruiting
- Felege Hiwot Specialized Hospital
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Contact:
- Temesgen Mekonnen
- Phone Number: 0913512832
- Email: temesgenm@gmail.com
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Bahir Dar, Amhara, Ethiopia
- Completed
- Tibebe Gion Hospital
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Dessie, Amhara, Ethiopia
- Completed
- Dessie Specialized Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- married first-time teenage mothers aged 13-19 years attending antenatal follow-up in the selected hospitals
- a single pregnancy with 28-30 weeks of gestational age
- no pregnancy complications contraindicating vaginal delivery
- plan to have institutional delivery and postnatal visits at the selected health hospitals and who reside for a minimum of 12 weeks postdelivery around the selected hospitals
Exclusion Criteria:
- have self-reported history or current mental health problems
- participated in similar interventional programmes
- have serious medical and obstetrics problems
- having foetus with diagnosed congenital anomalies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
The intervention framework is underpinned by a converging of salutogenic and self-efficacy perspectives, aiming to enhance mothers' ability to adapt to new motherhood life despite stressors, and to address the question, "How do teenage mothers stay well despite stressful events of transition to motherhood?"
The intervention consists of six sessions: three of which will be provided in the antenatal period and the other three in the postpartum period.
The sessions contain two individual face-to-face educations (each lasting 60-90 minutes), two phone calls (each lasting 30 minutes), and two group discussion sessions (each lasting 90-120 minutes), as supported by the existing evidence.
|
|
Active Comparator: Control group:
|
The control group will receive the usual maternity care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edinburgh Postnatal Depression Scale
Time Frame: 6 weeks postpartum
|
Edinburgh Postnatal Depression Scale is a 10-item self-report scale assessing the presence of depressive symptoms in the postnatal period.
Each item is scored on a 4-point scale with total scores ranging from 0 to 30.
Higher score indicates greater depressive symptoms, i.e. worse outcome.
|
6 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edinburgh Postnatal Depression Scale
Time Frame: 12 weeks postpartum
|
Edinburgh Postnatal Depression Scale is a 10-item self-report scale assessing the presence of depressive symptoms in the postnatal period.
Each item is scored on a 4-point scale with total scores ranging from 0 to 30.
A higher score indicates greater depressive symptoms, i.e. worse outcome.
|
12 weeks postpartum
|
|
Sense of Coherence Scale
Time Frame: 6 weeks postpartum
|
Sense of Coherence Scale is a 13-item scale assessing the extent to which teenage mothers perceive the transition to motherhood as meaningful, comprehensible and manageable.
Each item is scored on a 7-point scale, with total scores ranging from 7 to 91.
Higher scores indicate a stronger perception of life coherence, i.e. better outcome.
|
6 weeks postpartum
|
|
Sense of Coherence Scale
Time Frame: 12 weeks postpartum
|
Sense of Coherence Scale is a 13-item scale assessing the extent to which teenage mothers perceive the transition to motherhood as meaningful, comprehensible and manageable.
Each item is scored on a 7-point scale, with total scores ranging from 7 to 91.
Higher scores indicate a stronger perception of life coherence, i.e. better outcome.
|
12 weeks postpartum
|
|
Parenting Self-Efficacy Scale
Time Frame: 6 weeks postpartum
|
Parenting self-efficacy scale has 20 items, scored on a 4-point Likert scale, assessing teenage mothers' beliefs about their abilities to handle a set of stressful situations during the childbearing period.
Higher scores indicate a stronger parenting self-efficacy, i.e. better outcome.
|
6 weeks postpartum
|
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Parenting Self-Efficacy Scale
Time Frame: 12 weeks postpartum
|
Parenting self-efficacy scale has 20 items, scored on a 4-point Likert scale, assessing teenage mothers' beliefs about their abilities to handle a set of stressful situations during the childbearing period.
Higher scores indicate a stronger parenting self-efficacy, i.e. better outcome.
|
12 weeks postpartum
|
|
Social Support Questionnaire (modified version)
Time Frame: 6 weeks postpartum
|
The modified version of social support questionnaire (SSQ) assessing the perceived social support during transition to motherhood, which has 6 items with 6 Likert scale points with total scores ranging from 6 to 36.
Higher scores indicate a stronger perception of social support, i.e. better outcome.
|
6 weeks postpartum
|
|
Social Support Questionnaire (modified version)
Time Frame: 12 weeks postpartum
|
The modified version of social support questionnaire (SSQ) assessing the perceived social support during transition to motherhood, which has 6 items with 6 Likert scale points with total scores ranging from 6 to 36.
Higher scores indicate a stronger perception of social support, i.e. better outcome.
|
12 weeks postpartum
|
|
Perceived Stress Scale
Time Frame: 6 weeks postpartum
|
Perceived stress scale (PSS) is a 10 items scale with 5-point Likert scoring from 0 to 4 to assess one's perceived stress level during transition to motherhood.
Out of 10 items, six are negative questions (1, 2, 3, 6, 9, 10) and four are positive (4, 5, 7, 8), indicating 'perceived distress' and 'perceived coping', respectively.
A higher score indicates greater perception of stress level, i.e. worse outcome.
|
6 weeks postpartum
|
|
Perceived Stress Scale
Time Frame: 12 weeks postpartum
|
Perceived stress scale (PSS) is a 10 items scale with 5-point Likert scoring from 0 to 4 to assess one's perceived stress level during transition to motherhood.
Out of 10 items, six are negative questions (1, 2, 3, 6, 9, 10) and four are positive (4, 5, 7, 8), indicating 'perceived distress' and 'perceived coping', respectively.
A higher score indicates greater perception of stress level, i.e. worse outcome.
|
12 weeks postpartum
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20240907003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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