Preventing Postpartum Depression in African American Home Visiting Clients

Phase 2

Completed

• Conditions: Depression

• Registration Number: NCT01175603
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	3 months post-intervention
Depressive symptoms	6 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Depressive Episodes	6 Months Post-Intervention
Depressive episodes	3 months post-intervention

Trial Locations

Locations (4)

People's Community Health Center; 🇺🇸 Baltimore, Maryland, United States

DRUM Healthy Families; 🇺🇸 Baltimore, Maryland, United States

Maternal and Infant Nursing Program; 🇺🇸 Baltimore, Maryland, United States

Sinai Hospital Perinatal Depression Outreach Program; 🇺🇸 Baltimore, Maryland, United States