NCT06698107

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

March 12, 2025

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 15, 2024

Last Update Submit

March 11, 2025

Conditions

Keywords

Postpartum depressionTeenage mothersInterventionChildbirth education

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks postpartum

Secondary Outcomes (9)

  • Edinburgh Postnatal Depression Scale

    12 weeks postpartum

  • Sense of Coherence Scale

    6 weeks postpartum

  • Sense of Coherence Scale

    12 weeks postpartum

  • Parenting Self-Efficacy Scale

    6 weeks postpartum

  • Parenting Self-Efficacy Scale

    12 weeks postpartum

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Childbirth education programme

Control group:

ACTIVE COMPARATOR
Other: Usual Care

Interventions

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.

Intervention group

The control group will receive the usual maternity care.

Control group:

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Addis Alem Hospital

Bahir Dar, Amhara, Ethiopia

COMPLETED

Felege Hiwot Specialized Hospital

Bahir Dar, Amhara, Ethiopia

RECRUITING

Tibebe Gion Hospital

Bahir Dar, Amhara, Ethiopia

COMPLETED

Dessie Specialized Hospital

Dessie, Amhara, Ethiopia

COMPLETED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Lebeza Alemu Tenaw

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 20, 2024

Study Start

December 5, 2024

Primary Completion

May 30, 2025

Study Completion

July 15, 2025

Last Updated

March 12, 2025

Record last verified: 2024-11

Locations