Preventing Postpartum Depression in African American Home Visiting Clients

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01175603

Collaborator

Abell Foundation (Other)

Enrollment

Locations

Arms

Duration (Months)

20.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Depressive symptoms [Baseline]
Depressive symptoms [1 week post intervention]
Depressive Symptoms [3 months post-intervention]
Depressive symptoms [6 months post-intervention]

Secondary Outcome Measures

Depressive episodes [3 months post-intervention]
Depressive Episodes [6 Months Post-Intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	People's Community Health Center	Baltimore	Maryland	United States	20001
2	DRUM Healthy Families	Baltimore	Maryland	United States
3	Maternal and Infant Nursing Program	Baltimore	Maryland	United States
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01175603

Other Study ID Numbers:

JHMI ICTR 2009
ICTR 2009

First Posted:

Aug 5, 2010

Last Update Posted:

Apr 7, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Johns Hopkins University

depression, African American, home visiting, prevention

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Apr 7, 2016