Preventing Postpartum Depression in African American Home Visiting Clients

NCT01175603 | Completed Phase 2

• 2 other identifiers: JHMI ICTR 2009ICTR 2009
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

depression, African American, home visiting, prevention

Outcome Measures

Primary Outcomes (4)

• Depressive symptoms

  Baseline

• Depressive symptoms

  1 week post intervention

• Depressive Symptoms

  3 months post-intervention

• Depressive symptoms

  6 months post-intervention

Secondary Outcomes (2)

• Depressive episodes

  3 months post-intervention

• Depressive Episodes

  6 Months Post-Intervention

Study Arms (2)

Cognitive behavioral intervention

EXPERIMENTAL

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)

Usual home visiting

NO INTERVENTION

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

Interventions

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

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

Cognitive behavioral intervention

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pregnant or has child \< 6 months of age
• enrolled in home visiting program
• exhibiting elevated depressive symptoms and/or personal history of clinical depression

You may not qualify if:

• no current clinical depression at time of enrollment

Sponsors & Collaborators

• Johns Hopkins University: lead
• Abell Foundation: collaborator

Study Sites (4)

People's Community Health Center

Baltimore, Maryland, 20001, United States

Location

DRUM Healthy Families

Baltimore, Maryland, United States

Location

Maternal and Infant Nursing Program

Baltimore, Maryland, United States

Location

Sinai Hospital Perinatal Depression Outreach Program

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Shiv D Tandon, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

US (4)