Preventing Postpartum Depression in African American Home Visiting Clients

NCT ID: NCT01175603

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Usual home visiting

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abell Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiv D Tandon, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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People's Community Health Center

Baltimore, Maryland, United States

Site Status

DRUM Healthy Families

Baltimore, Maryland, United States

Site Status

Maternal and Infant Nursing Program

Baltimore, Maryland, United States

Site Status

Sinai Hospital Perinatal Depression Outreach Program

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ICTR 2009

Identifier Type: OTHER

Identifier Source: secondary_id

JHMI ICTR 2009

Identifier Type: -

Identifier Source: org_study_id

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