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Completed

NCT Number: NCT01175603

Preventing Postpartum Depression in African American Home Visiting Clients

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

DRUM Healthy Families, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)

Behavioral

6 weekly 2-hour cognitive-behavioral intervention sessions held in group format

Primary outcomes

  1. Depressive symptoms

    Time frame: Baseline

  2. Depressive symptoms

    Time frame: 1 week post intervention

  3. Depressive Symptoms

    Time frame: 3 months post-intervention

  4. Depressive symptoms

    Time frame: 6 months post-intervention

Secondary outcomes

  1. Depressive episodes

    Time frame: 3 months post-intervention

  2. Depressive Episodes

    Time frame: 6 Months Post-Intervention

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Abell Foundation

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 5, 2010
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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