Postpartum Depression (PPD)NCT06698107
Salutogenesis and Self-efficacy-based Childbirth Education Programme for Preventing Postpartum Depression
A study testing Childbirth education programme in people with Postpartum Depression (PPD), run by The Hong Kong Polytechnic University at 4 sites in Ethiopia.
Trial summary
Although the transition to motherhood is often a joyful experience, there is evidence that teenage motherhood can present many stressful challenges, potentially leading to the development of postpartum depression. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Childbirth education programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesEthiopia
- Study dates
- 5 Dec 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia4 sites, 1 recruiting
- Completed
Addis Alem Hospital
Bahir Dar, Amhara
- Recruiting
Felege Hiwot Specialized Hospital
Bahir Dar, Amhara
Temesgen Mekonnen, 0913512832, temesgenm@gmail.com
- Completed
Tibebe Gion Hospital
Bahir Dar, Amhara
- Completed
Dessie Specialized Hospital
Dessie, Amhara
About this study
Official title: Effectiveness of Childbirth Education Based on Salutogenic Perspective and Self-Efficacy Theory in Preventing Postpartum Depression Among Ethiopian Teenage Mothers: a Pilot RCT Study
Although the transition to motherhood is often a joyful experience, there is evidence that teenage motherhood can present many stressful challenges, potentially leading to the development of postpartum depression. Postpartum depression (PPD) remains a public health issue with negative consequences for both mothers and their babies. The aim of this study is to assess the feasibility of implementing childbirth education underpinned by salutogenic and self-efficacy perspectives among teenage mothers in low-income settings. The study also aims to provide preliminary findings on the intervention's effectiveness in preventing postpartum depression among Ethiopian teenage mothers. The theoretical based childbirth education approach can enhance the psychosocial well-being of first-time teenage mothers. The intervention consists of six sessions: three during the antenatal period and three in the postpartum period. These sessions contain two individual face-to-face educations (each lasting 60-90 minutes), two phone calls (each lasting 30 minutes), and two group discussion (each lasting 90-120 minutes), as supported by the existing evidence. The study expected to support the feasibility of the study design. Preliminary findings are anticipated to show a significant difference in postpartum depression scores between the intervention and control groups, with teenage mothers in the intervention group having a lower risk of postpartum depression compared to those in the control group. Integrating sense of coherence and self-efficacy theories into maternity care services could provide empirical support for preventive efforts against postpartum depression. The findings of this study may address research gaps regarding the psychosocial wellbeing of teenage mothers, serving as baseline evidence for large scale interventional studies that consider the sociocultural and economic contexts of low-income countries.
Read the 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.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- Childbirth education programme, Usual Care
- Keywords
- Postpartum depression, Teenage mothers, Intervention, Childbirth education
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childbirth education programmeBehavioural
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.
Usual CareOther
The control group will receive the usual maternity care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Childbirth education programme |
| Control group: | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
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.
Measured: 6 weeks postpartum
Secondary outcomes (9)
Edinburgh Postnatal Depression Scale
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.
Measured: 12 weeks postpartum
Sense of Coherence Scale
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.
Measured: 6 weeks postpartum
Sense of Coherence Scale
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.
Measured: 12 weeks postpartum
Parenting Self-Efficacy Scale
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.
Measured: 6 weeks postpartum
Parenting Self-Efficacy Scale
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.
Measured: 12 weeks postpartum
Social Support Questionnaire (modified version)
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.
Measured: 6 weeks postpartum
Social Support Questionnaire (modified version)
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.
Measured: 12 weeks postpartum
Perceived Stress Scale
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.
Measured: 6 weeks postpartum
Perceived Stress Scale
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.
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start5 Dec 2024
- Primary completion30 May 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Fei Wan, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698107
- Sponsor's protocol ID
- HSEARS20240907003
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Childbirth Education Based on Salutogenic Perspective and Self-Efficacy Theory in Preventing Postpartum Depression Among Ethiopian Teenage Mothers: a Pilot RCT Study
- ClinicalTrials.gov ID
- NCT06698107
- Acronym / sponsor ID
- HSEARS20240907003
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Postpartum depression, Teenage mothers, Intervention, Childbirth education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 20 Nov 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.
Although the transition to motherhood is often a joyful experience, there is evidence that teenage motherhood can present many stressful challenges, potentially leading to the development of postpartum depression. Postpartum depression (PPD) remains a public health issue with negative consequences for both mothers and their babies. The aim of this study is to assess the feasibility of implementing childbirth education underpinned by salutogenic and self-efficacy perspectives among teenage mothers in low-income settings. The study also aims to provide preliminary findings on the intervention's effectiveness in preventing postpartum depression among Ethiopian teenage mothers. The theoretical based childbirth education approach can enhance the psychosocial well-being of first-time teenage mothers. The intervention consists of six sessions: three during the antenatal period and three in the postpartum period. These sessions contain two individual face-to-face educations (each lasting 60-90 minutes), two phone calls (each lasting 30 minutes), and two group discussion (each lasting 90-120 minutes), as supported by the existing evidence. The study expected to support the feasibility of the study design. Preliminary findings are anticipated to show a significant difference in postpartum depression scores between the intervention and control groups, with teenage mothers in the intervention group having a lower risk of postpartum depression compared to those in the control group. Integrating sense of coherence and self-efficacy theories into maternity care services could provide empirical support for preventive efforts against postpartum depression. The findings of this study may address research gaps regarding the psychosocial wellbeing of teenage mothers, serving as baseline evidence for large scale interventional studies that consider the sociocultural and economic contexts of low-income countries.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Childbirth education programme |
| Control group: | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Childbirth education programmeThe 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. | Behavioural | Intervention group |
| Usual CareThe control group will receive the usual maternity care. | Other | Control group: |
Primary outcome
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.
9 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 12 weeks postpartum
Sense of Coherence Scale
Time frame: 6 weeks postpartum
Sense of Coherence Scale
Time frame: 12 weeks postpartum
Parenting Self-Efficacy Scale
Time frame: 6 weeks postpartum
Parenting Self-Efficacy Scale
Time frame: 12 weeks postpartum
Social Support Questionnaire (modified version)
Time frame: 6 weeks postpartum
Social Support Questionnaire (modified version)
Time frame: 12 weeks postpartum
Perceived Stress Scale
Time frame: 6 weeks postpartum
Perceived Stress Scale
Time frame: 12 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Depression (PPD)
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Not yet recruiting
Postpartum Care in the NICU Multi-Site
Postpartum, Postpartum Depression (PPD)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Childbirth education programme in people with Postpartum Depression (PPD), run by The Hong Kong Polytechnic University at 4 sites in Ethiopia.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ethiopia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lebeza Alemu Tenaw (52242797 ext. 852, lebeza.tenaw@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: 6 weeks postpartum). 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 12 Mar 2025.