- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465556
Domestic Violence Enhanced Home Visitation Program (DOVE)
Domestic Violence Enhanced Home Visitation Program - DOVE
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Baltimore City Health Department
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Missouri
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Columbia, Missouri, United States, 65211
- Missouri Department of Health and Senior Services; Missouri Community Based Home Visiting Program and Lutheran and Family Children's Services in Columbia and Springfield
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Dove Intervention
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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.
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Active Comparator: 2
Intimate Partner Violence (IPV) Protocol
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Reducing children's exposure to Intimate Partner Violence
Time Frame: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Patterns of Intimate Partner Violence
Time Frame: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Reducing Intimate Partner Violence
Time Frame: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Phyllis Sharps, PhD, RN, Johns Hopkins University
Publications and helpful links
General Publications
- Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
- Sharps PW, Bullock LF, Campbell JC, Alhusen JL, Ghazarian SR, Bhandari SS, Schminkey DL. Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial. J Womens Health (Larchmt). 2016 Nov;25(11):1129-1138. doi: 10.1089/jwh.2015.5547. Epub 2016 May 20.
- Sharps P, Alhusen JL, Bullock L, Bhandari S, Ghazarian S, Udo IE, Campbell J. Engaging and retaining abused women in perinatal home visitation programs. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S134-9. doi: 10.1542/peds.2013-1021L.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NR009093
- 1R01NR009093-01A2 (U.S. NIH Grant/Contract)
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