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Preventing Postpartum Depression in African American Home Visiting Clients

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring depression, African American, home visiting, prevention

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • People's Community Health Center
  • DRUM Healthy Families
  • Maternal and Infant Nursing Program
  • Sinai Hospital Perinatal Depression Outreach Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive behavioral intervention

Usual home visiting

Arm Description

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.

Women in the control group will receive usual home visiting services and information on postpartum depression.

Outcomes

Primary Outcome Measures

Depressive symptoms
Depressive symptoms
Depressive Symptoms
Depressive symptoms

Secondary Outcome Measures

Depressive episodes
Depressive Episodes

Full Information

First Posted
August 3, 2010
Last Updated
April 5, 2016
Sponsor
Johns Hopkins University
Collaborators
Abell Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01175603
Brief Title
Preventing Postpartum Depression in African American Home Visiting Clients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Abell Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, African American, home visiting, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual home visiting
Arm Type
No Intervention
Arm Description
Women in the control group will receive usual home visiting services and information on postpartum depression.
Intervention Type
Behavioral
Intervention Name(s)
Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
Intervention Description
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Baseline
Title
Depressive symptoms
Time Frame
1 week post intervention
Title
Depressive Symptoms
Time Frame
3 months post-intervention
Title
Depressive symptoms
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Depressive episodes
Time Frame
3 months post-intervention
Title
Depressive Episodes
Time Frame
6 Months Post-Intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv D Tandon, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Community Health Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20001
Country
United States
Facility Name
DRUM Healthy Families
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Maternal and Infant Nursing Program
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Sinai Hospital Perinatal Depression Outreach Program
City
Baltimore
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

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Preventing Postpartum Depression in African American Home Visiting Clients

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