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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| Johns Hopkins Center for Communication Programs | UNKNOWN |
| Camber Collective | OTHER |
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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.
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. This study builds on evidence from a previous study (Principal Investigator: Hendrickson, Institutional Review Board (IRB) #: 16604) demonstrating the feasibility and acceptability of using Mother's Time to address mild to moderate depressive and anxiety symptoms and associated behavioral and social barriers to family planning in Ethiopia. The study also builds on previous human-centered design work (Principal Investigator: Hendrickson, IRB #: 21414) to obtain further design input on the Mother's Time intervention. The investigators have adapted the intervention based on data and findings from the pilot study and the Human Centered Design workshop. The specific aims of this study are to:
1) Quantitatively examine the impact of participating in Mother's Time on symptoms of stress, depression, and anxiety among postpartum women ages 16-24 years of age who have given birth within the last year.
1a) Assess the immediate (post intervention) and longer term (3-month post-intervention) impact of participation in Mother's Time on symptoms of stress, depression, and anxiety.
2) Quantitatively assess the impact of participating in Mother's Time on use of a modern contraceptive method among postpartum women ages 16-24 years of age who have given birth within the last year.
2a) Assess the immediate (post intervention) and longer term (3-month post-intervention) impact of participation in Mother's Time on use of a modern contraceptive method among postpartum women.
2b) Quantitatively assess the impact of participating in Mother's Time on perceived benefits and self-efficacy to engage in healthy thinking patterns and modify behaviors related to family planning.
3) Explore feasibility and acceptability of implementing Mothers Time from the perspective of health extension workers (HEWs) and HEW supervisors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother's Time Intervention | Experimental | Working with local research partners, the research team will train HEWs in the intervention clusters in the Amhara region of Ethiopia to deliver four intervention sessions in a group setting of approximately six to eight women (average: 7). These sessions will take place over a period of approximately one month. Participants in the intervention group will receive four sessions of Mother's Time, delivered by an HEW. |
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| Standard of care | No Intervention | Participants in the control group will receive the standard of care that postpartum mothers in Ethiopia receive. Standard of care for postpartum mothers related to family planning and mental health in Ethiopia includes multiple touch points that correspond with postpartum care as well as routine immunization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mother's Time | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postpartum depression | Symptoms of depression using Patient Health Questionnaire-9 (PHQ-9). This is a 9-item questionnaire with scores for each question ranging from 0 (not at all) to 3 (nearly every day). Scores are summed for an overall score range of 0-27, with higher scores meaning more greater depression severity. | Baseline, Endline up to 1 month post-intervention, 3-month follow-up |
| Change in postpartum anxiety | Symptoms of anxiety using General Anxiety Disorder-7 (GAD-7). This is a 7-item questionnaire with scores for each question ranging from 0 (not at all) to 3 (nearly every day). Scores are summed for an overall score range of 0-21, with higher scores meaning more greater anxiety severity. | Baseline, Endline up to 1 month post-intervention, 3-month follow-up |
| Change in postpartum family planning | Current use of modern contraception method postpartum (yes vs. no) | Baseline, Endline up to 1 month post-intervention, 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Stella Babalola, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health centers/clusters in selected woredas | West Gojjam | Amhara | Ethiopia |
The investigators plan to share summary reports and presentations about this research project and results in presentations to the investigators' funder, USAID, local partners, the Ethiopian Ministry of Health and other stakeholders working in family planning, mental health, or maternal health. All shared information will be at the summary level and not provide any identifiable information. The investigators also plan to publish peer-reviewed articles and international comments which will not include any identifiable information. If journal reviewers request data, the investigators will provide high-level, aggregated descriptive statistics on our participants from the quantitative data, but will not share full datasets or transcripts outside the study team. As these data are related to a potentially sensitive topic, they will not be made publicly available. Due to the relatively small sample size, making data publicly available could create risks around confidentiality.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D001008 | Anxiety Disorders |
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| DeepDive Consulting |
| UNKNOWN |
This is a cluster-randomized parallel intervention study model.
Following random assignment of clusters to either the intervention or control arm and subsequent recruitment of participants, individuals will be enrolled in the study.
Intervention arm: Mother's Time intervention Control arm: Standard of care
Clusters will be randomly assigned using a random number generator to either the intervention arm or the control arm. Then, all individuals recruited within a given cluster will be assigned to the same intervention condition.
Anticipating that the Mother's Time intervention will be superior to the standard care with respect to reducing symptoms of stress, depression, and anxiety and increasing modern contraceptive use, women in the control group will have opportunity to receive the full intervention upon completion of the intervention to the intervention group.
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Participants will not be fully blinded to whether participants are in an intervention or control cluster. However, the use of a cluster-randomized approach reduces the risk of contamination among women from different clusters because it reduces the risk of communication between individuals in intervention and control arms. As HEWs will be responsible for assisting with recruitment of participants, HEWs will be aware of these eligibility criteria and who has been recruited for the study in both the control and intervention arms. As a result, HEWs will not be fully blinded to the study. Outcome assessors and statisticians will be blinded.
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D043762 | Reproductive Behavior |
| D001519 | Behavior |