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Preventing Postpartum Depression in African American Home Visiting Clients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175603
First Posted: August 5, 2010
Last Update Posted: April 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abell Foundation
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Baseline ]
  • Depressive symptoms [ Time Frame: 1 week post intervention ]
  • Depressive Symptoms [ Time Frame: 3 months post-intervention ]
  • Depressive symptoms [ Time Frame: 6 months post-intervention ]

Secondary Outcome Measures:
  • Depressive episodes [ Time Frame: 3 months post-intervention ]
  • Depressive Episodes [ Time Frame: 6 Months Post-Intervention ]

Enrollment: 82
Study Start Date: October 2009
Study Completion Date: October 2010
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175603


Locations
United States, Maryland
People's Community Health Center
Baltimore, Maryland, United States, 20001
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
Sponsors and Collaborators
Johns Hopkins University
Abell Foundation
Investigators
Principal Investigator: Shiv D Tandon, PhD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01175603     History of Changes
Other Study ID Numbers: JHMI ICTR 2009
ICTR 2009 ( Other Identifier: Johns Hopkins University ICTR )
First Submitted: August 3, 2010
First Posted: August 5, 2010
Last Update Posted: April 7, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders