Preventing Postpartum Depression in African American Home Visiting Clients

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175603
• Other study ID #: JHMI ICTR 2009
• Secondary ID: ICTR 2009
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2010
• Last updated: April 5, 2016
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format

Locations

Country	Name	City	State
United States	DRUM Healthy Families	Baltimore	Maryland
United States	Maternal and Infant Nursing Program	Baltimore	Maryland
United States	People's Community Health Center	Baltimore	Maryland
United States	Sinai Hospital Perinatal Depression Outreach Program	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Abell Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		Baseline	No
Primary	Depressive symptoms		1 week post intervention	No
Primary	Depressive Symptoms		3 months post-intervention	No
Primary	Depressive symptoms		6 months post-intervention	No
Secondary	Depressive episodes		3 months post-intervention	No
Secondary	Depressive Episodes		6 Months Post-Intervention	No