Preventing Postpartum Depression in African American Home Visiting Clients

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)

• 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

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral intervention	Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)	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.

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)

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

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

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

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