Efficacy of Mother's Time in Ethiopia

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Contraceptive Usage; Depression, Postpartum; Anxiety, Postpartum

Treatments: Behavioral: Mother's Time

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05806463

23020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 328 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 2 patient groups

Mother's Time Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mother's Time

Standard of care

No Intervention group

Description:

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.