Efficacy of Mother's Time in Ethiopia
Condition: Depression, Postpartum; Anxiety, Postpartum; Contraceptive Usage
MeSH terms: Depression, Postpartum; Depression
Study type: Interventional

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.
    

Intervention name(s): Mother's Time
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Postpartum depression; Postpartum anxiety; Postpartum family planning