Preventing Postpartum Depression in African American Home Visiting Clients

April 5, 2016 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 20001
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
No Intervention: Usual home visiting
Women in the control group will receive usual home visiting services and information on postpartum depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms
Time Frame: Baseline
Baseline
Depressive symptoms
Time Frame: 1 week post intervention
1 week post intervention
Depressive Symptoms
Time Frame: 3 months post-intervention
3 months post-intervention
Depressive symptoms
Time Frame: 6 months post-intervention
6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Depressive episodes
Time Frame: 3 months post-intervention
3 months post-intervention
Depressive Episodes
Time Frame: 6 Months Post-Intervention
6 Months Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Abell Foundation

Investigators

  • Principal Investigator: Shiv D Tandon, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHMI ICTR 2009
  • ICTR 2009 (Other Identifier: Johns Hopkins University ICTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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