Efficacy of Mother's Time in Ethiopia (NCT05806463) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Mother's Time in Ethiopia
Ethiopia328 participantsStarted 2023-05-04
Plain-language summary
Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to support postpartum women experiencing mild to moderate symptoms of stress, depression or anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs) and includes CBT exercises and discussion on topics relating to family planning, such as planning for the future, speaking to the husband, and considering potential side effects.
The primary objective of this research is to test the efficacy of Mother's Time, on mild to moderate symptoms of postpartum stress, anxiety, and depression as well as associated behavioral and social barriers to postpartum family planning, specifically among women under 25 who have given birth within the last year.
Who can participate
Age range
16 Years – 24 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has given birth within the last year to an infant who is still living
* Not currently using a method of modern family planning (Women who are breastfeeding but not following the Lactation Amenorrhea Method (LAM) criteria will be considered "not using")
* Married (traditional, religious or legal)
* Aged 16-24 (participants under 18 will be considered emancipated minors as these individuals will be married)
* Scores between 5 and 14 on the PHQ-9 questionnaire and/or between 5 and 14 on the GAD-7 questionnaire
* In screener, does not indicate she has "death ideation" ("no" response on question 14) Consents to participate in study
Exclusion Criteria:
* Unmarried women
* Women under age 16 or over age 24
* Women who have lost their infants since birth
* Scores under 5 on both the PHQ-9 and GAD-7 questionnaire
* Scores over 14 on both the PHQ-9 and GAD-7 questionnaire
* In screener, indicates she has "death ideation" ("yes" response on question 14)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in postpartum depression
Timeframe: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
2
Change in postpartum anxiety
Timeframe: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
3
Change in postpartum family planning
Timeframe: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Trial details
NCT IDNCT05806463
SponsorJohns Hopkins Bloomberg School of Public Health