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NCT00465556 Clinical Trial

Domestic Violence Enhanced Home Visitation Program (DOVE)

Domestic Violence Clinical Trial

Official title:
Domestic Violence Enhanced Home Visitation Program - DOVE

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00465556
Other study ID # NR009093
Secondary ID 1R01NR009093-01A
Status Completed
Phase Phase 2
First received April 23, 2007
Last updated March 31, 2015
Start date February 2006
Est. completion date November 2011

Study information
Verified date March 2015
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.

Description:

Outcomes will provide intervention efficacy data about a public health nurse home visit intervention aimed at reducing and preventing intimate partner violence and children's exposure to IVP as well as prospective information about patterns of intimate partner violence.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date November 2011
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English

Study Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Public Health Nurse Home Visit
The perinatal public health nurse home visit intervention also includes a trifold brochure, printed on 8X10 inch paper, with 6 panels, that can be read with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Participants will receive three prenatal and three postpartum sessions. The first prenatal sessions will be given during the first (enrollment), second, and third trimesters, with at least three weeks between sessions. Women entering the study after the first trimester will receive the initial session at enrollment, with two subsequent sessions spread out over the remainder of the scheduled prenatal home visitation program sessions.
• Intimate Partner Violence (IPV) Protocol
The current protocol in use by the participating health departments when a women screens positive for intimate partner violence (IPV), current or history within the last year.

Locations
Country Name City State
United States Baltimore City Health Department Baltimore Maryland
United States Missouri Department of Health and Senior Services; Missouri Community Based Home Visiting Program and Lutheran and Family Children's Services in Columbia and Springfield Columbia Missouri

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reducing children's exposure to Intimate Partner Violence Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth. Yes
Primary Patterns of Intimate Partner Violence Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth. Yes
Primary Reducing Intimate Partner Violence Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth. Yes
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