Clinical trial NCT05806463: Efficacy of Mother's Time in Ethiopia
Official title: Efficacy of a Simplified Cognitive Behavioral Therapy Approach to Support Postpartum Mental Health and Address Social and Behavioral Barriers to Postpartum Family Planning in Ethiopia: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Anxiety, Postpartum
Contraceptive Usage
Keywords: Postpartum depression
Postpartum anxiety
Postpartum family planning
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Johns Hopkins Center for Communication Programs
name: Camber Collective
name: DeepDive Consulting
First posted: 2023-04-10
Enrollment: 328
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in postpartum depression
timeFrame: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
measure: Change in postpartum anxiety
timeFrame: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
measure: Change in postpartum family planning
timeFrame: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: West Gojjam
country: Ethiopia
facility: Health centers/clusters in selected woredas
state: Amhara
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Stella Babalola, PhD
role: PRINCIPAL_INVESTIGATOR
References: