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Preventing Postpartum Depression in African American Home Visiting Clients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abell Foundation
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01175603
First received: August 3, 2010
Last updated: August 4, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
 Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 1 week post intervention ] [ Designated as safety issue: No ]
  • Depressive Symptoms [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive episodes [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
  • Depressive Episodes [ Time Frame: 6 Months Post-Intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 91
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format

Detailed Description:

This study will conduct a 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 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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175603

Locations
United States, Maryland
Maternal and Infant Nursing Program
Baltimore, Maryland, United States
DRUM Healthy Families
Baltimore, Maryland, United States
Sinai Hospital Perinatal Depression Outreach Program
Baltimore, Maryland, United States
People's Community Health Center
Baltimore, Maryland, United States, 20001
Sponsors and Collaborators
Johns Hopkins University
Abell Foundation
Investigators
Principal Investigator: Shiv D Tandon, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Shiv Darius Tandon, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01175603     History of Changes
Other Study ID Numbers: JHMI ICTR 2009, ICTR 2009
Study First Received: August 3, 2010
Last Updated: August 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
depression, African American, home visiting, prevention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 19, 2013