Preventing Postpartum Depression in African American Home Visiting Clients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 82
- Locations
- 4
- Primary Endpoint
- Depressive Symptoms
Study Overview
Brief Summary
The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.
Detailed Description
This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child < 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •pregnant or has child < 6 months of age
- •enrolled in home visiting program
- •exhibiting elevated depressive symptoms and/or personal history of clinical depression
Exclusion Criteria
- •no current clinical depression at time of enrollment
Arms & Interventions
Cognitive behavioral intervention
Women in the intervention condition will receive 6 two-hour intervention sessions delivered weekly in a group format by the Study Clinician. Each session contains didactic instruction on core content, as well as activities and group discussion. One of the strengths of embedding the MB Course within home visiting is our ability to have home visitors reinforce the material presented by the Study Clinician. The 6-week curriculum is divided into three modules: (a) pleasant activities, (b) thoughts, and (c) relationships with others. Each module has two sessions. These sessions map onto core cognitive-behavioral concepts.
Intervention: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs) (Behavioral)
Usual home visiting
Women in the control group will receive usual home visiting services and information on postpartum depression.
Outcomes
Primary Outcomes
Depressive Symptoms
Time Frame: 3 months post-intervention
Depressive symptoms
Time Frame: 6 months post-intervention
Depressive symptoms
Time Frame: Baseline
Depressive symptoms
Time Frame: 1 week post intervention
Secondary Outcomes
- Depressive Episodes(6 Months Post-Intervention)
- Depressive episodes(3 months post-intervention)