Efficacy of Mother's Time in Ethiopia

NCT05806463 | Completed

• 1 other identifier: 23020
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Postpartum; Anxiety, Postpartum; Contraceptive Usage

Keywords

Postpartum depression; Postpartum anxiety; Postpartum family planning

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Mother's Time

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.

Interventions

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.

Mother's Time Intervention

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• United States Agency for International Development (USAID): collaborator
• Johns Hopkins Center for Communication Programs: collaborator
• Camber Collective: collaborator
• DeepDive Consulting: collaborator

Study Sites (1)

Health centers/clusters in selected woredas

West Gojjam, Amhara, Ethiopia

Location

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Contraception Behavior

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Reproductive Behavior; Behavior

Study Officials

• Stella Babalola, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: May 4, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)