Domestic ViolencePhase 2NCT00465556
Domestic Violence Enhanced Home Visitation Program (DOVE)
A Phase 2 study testing Public Health Nurse Home Visit and Intimate Partner Violence (IPV) Protocol in people with Domestic Violence, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Public Health Nurse Home Visit and Intimate Partner Violence (IPV) Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore City Health Department
Baltimore, Maryland, 21205
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, 65211
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Domestic Violence
- Being tested
- Public Health Nurse Home Visit, Intimate Partner Violence (IPV) Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public Health Nurse Home VisitBehavioural
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) ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dove Intervention Receives: Behavioral: Public Health Nurse Home Visit |
| 2 | Active comparator | Intimate Partner Violence (IPV) Protocol Receives: Behavioral: Intimate Partner Violence (IPV) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing children's exposure to Intimate Partner Violence
Measured: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
Patterns of Intimate Partner Violence
Measured: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
Reducing Intimate Partner Violence
Measured: Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startFeb 2006
- Primary completionNov 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Phyllis Sharps, Johns Hopkins University
- Investigators
- Phyllis Sharps, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465556
- Sponsor's protocol ID
- NR009093
- Other IDs
- 1R01NR009093-01A2
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2007
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34057734Sharps 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.
PubMed 27206047Sharps 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.
PubMed 24187115
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domestic Violence Enhanced Home Visitation Program - DOVE
- ClinicalTrials.gov ID
- NCT00465556
- Acronym / sponsor ID
- NR009093
- Conditions
- Domestic Violence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Public Health Nurse Home VisitDove Intervention |
| 2 | Active comparator | Behavioral: Intimate Partner Violence (IPV) ProtocolIntimate Partner Violence (IPV) Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public Health Nurse Home VisitThe 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. | Behavioural | 1 |
| Intimate Partner Violence (IPV) ProtocolThe 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. | Behavioural | 2 |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 34057734Kalra 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.
- Derived from this study: PubMed 27206047Sharps 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.
- Derived from this study: PubMed 24187115Sharps 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis Sharps, PhD, RN principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Public Health Nurse Home Visit and Intimate Partner Violence (IPV) Protocol in people with Domestic Violence, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00465556, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.