Domestic ViolenceNCT01688427
Perinatal Nurse Home Visiting Enhanced With mHealth Technology
A study testing Standard IPV Assessment and Standard DOVE Intervention in people with Domestic Violence and Intimate Partner Violence, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Intimate Partner Violence
- What is being tested?
- Standard IPV Assessment and Standard DOVE Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 30 Sep 2018
- Phase
- Interventional
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women in Baltimore, Virginia, and Missouri if needed.
- Speak English or Spanish
- Eligible for home visitation.
Who cannot join
- Women who begin participation in a perinatal home visiting program after the baby is born.
- Women who do not speak English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, School of Nursing
Baltimore, Maryland, 21205
About this study
This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.
Read the detailed description
This study addresses PA-11-104 calling for Reducing Health Disparities among Minority and Underserved Children. The Institute of Medicine, World Health Organization and Centers for Disease Control and Prevention recognize that prenatal home visitation, which improves the well-being of mother and children, presents an opportunity to provide early intervention to reduce intimate partner violence (IPV) and the impact the exposure has on the children. Major challenges for nurses and other home visitors (HV) are to accurately identify abused women and facilitate their accessing resources needed to change their situation. HVs often find it difficult to assess and intervene for IPV in the intimacy of home settings. The use of mHealth technology may increase the sensitivity of screening instruments and reduce communication barriers between HVs and clients regarding IPV, as well as enhance implementation of IPV interventions and allow for a more standard delivery of an intervention. Building on the successful trial testing the DOVE IPV intervention in prenatal home visiting programs (NR009093), the investigators propose to test mHealth technology using an open-source application, eMOCHA, to improve assessment of IPV and to deliver the DOVE intervention. The proposed eMOCHA DOVE study will first (Specific Aim/Phase 1) compare sensitivity and specificity of two different approaches for IPV assessment; paper and pencil versus the eMOCHA mHealth technology. Phase 2 (Aim 2) will compare effectiveness of the DOVE intervention delivered in standard form (paper brochure) versus mHealth eMOCHA DOVE application. In Phase 1 women enrolled in a perinatal home visiting program and consenting to the study, will be randomized to one of the two assessment groups and assessed for IPV at enrollment, birth and 2 months post birth. Women who are IPV positive (IPV+) at any of the assessment times will be re-randomized to receive the DOVE intervention by one of the two approaches. 1600 Medicaid eligible pregnant women in a perinatal home visiting program (800 from urban Baltimore and 800 from rural Virginia) will be recruited for Phase I and 400 IPV+ women (200 from each site) for Phase II. Women participating in Phase 2 will receive 6 home visit interventions over 6 months. Maternal outcomes related to IPV and mental health and selected infant outcomes will be collected at enrollment, 3, 6, 12, and 18 months after entry into Phase 2. Specific Aim 1 will use logistic and linear regression models to examine the proportion of women experiencing IPV through mHealth technology versus paper and pencil on the same validated assessments. Specific Aim 2 (comparing effectiveness of two intervention administrations) will be assessed with logistic and linear regression models for categorical (proportion abused and premature infants) and continuous outcome variables (e.g. depression, frequency and severity of physical, psychological, sexual IPV, use of community resources) respectively. Study findings will assist nurse home visitation programs to use best approaches for routine assessment of IPV and implement empowerment interventions to reduce IPV and improve maternal infant health outcomes.
- Conditions
- Domestic Violence, Intimate Partner Violence
- Being tested
- Standard IPV Assessment, Standard DOVE Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IPV AssessmentBehavioural
Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth.
Standard DOVE InterventionBehavioural
Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Standard IPV Assessment | Experimental | Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper. Receives: Behavioral: Standard IPV Assessment |
| Standard DOVE intervention | Experimental | The standard DOVE intervention has already been developed and tested (NR009093). The standard DOVE intervention is a brochure based 10 minute intervention that the home visitor reviews with the women. It consists of information about IPV, its effects on pregnancy and infant health, community resources and a plan for individual safety options. For the eMOCHA DOVE intervention, the DOVE 10 minute brochure intervention will be converted from the paper format to a visually colorful interactive presentation loaded into the home visitor device using the eMOCHA application. The format will be completely activated and implemented by the women. She uses small ear buds and a touch screen, so how she responds and interacts with the media enhanced eMOCHA DOVE intervention is private. Receives: Behavioral: Standard IPV Assessment; Behavioral: Standard DOVE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IPV assessments
Instances of intimate partner violence (IPV).
Measured: Screening and at 2 months post-birth.
Secondary outcomes (2)
Change in use of safety behaviors
Record the number of pregnant/parenting women using safety behaviors (including mental health and other community resources).
Measured: Baseline and end of study (approximately 18 months post-birth)
Change in number of safety behaviors
Record the aggregate number of services (including mental health and other community resources).
Measured: Baseline and end of study (approximately 18 months post-birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startOct 2012
- Primary completion30 Sep 2016
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Phyllis W Sharps, PhD, Principal investigator, Johns Hopkins University, School of NursingLinda Bullock, PhD, RN, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688427
- Sponsor's protocol ID
- NA_00051481
- Other IDs
- 1R01HD071771-01
- Status last verified
- Mar 2019
- First submitted
- 10 Sep 2012
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharps P, Bullock L, Perrin N, Campbell J, Hill K, Kanu I, Norling M, Russell NG. Comparison of different methods of screening to identify intimate partner violence: A randomized controlled trial. Public Health Nurs. 2024 Mar-Apr;41(2):328-337. doi: 10.1111/phn.13279. Epub 2024 Jan 24.
PubMed 38265246Bacchus LJ, Bullock L, Sharps P, Burnett C, Schminkey DL, Buller AM, Campbell J. Infusing Technology Into Perinatal Home Visitation in the United States for Women Experiencing Intimate Partner Violence: Exploring the Interpretive Flexibility of an mHealth Intervention. J Med Internet Res. 2016 Nov 17;18(11):e302. doi: 10.2196/jmir.6251.
PubMed 27856405
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Nurse Home Visiting Enhanced With mHealth Technology
- ClinicalTrials.gov ID
- NCT01688427
- Acronym / sponsor ID
- NA_00051481
- Conditions
- Domestic Violence, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2012
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Sep 2012 (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.
This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.
Detailed description
This study addresses PA-11-104 calling for Reducing Health Disparities among Minority and Underserved Children. The Institute of Medicine, World Health Organization and Centers for Disease Control and Prevention recognize that prenatal home visitation, which improves the well-being of mother and children, presents an opportunity to provide early intervention to reduce intimate partner violence (IPV) and the impact the exposure has on the children. Major challenges for nurses and other home visitors (HV) are to accurately identify abused women and facilitate their accessing resources needed to change their situation. HVs often find it difficult to assess and intervene for IPV in the intimacy of home settings. The use of mHealth technology may increase the sensitivity of screening instruments and reduce communication barriers between HVs and clients regarding IPV, as well as enhance implementation of IPV interventions and allow for a more standard delivery of an intervention. Building on the successful trial testing the DOVE IPV intervention in prenatal home visiting programs (NR009093), the investigators propose to test mHealth technology using an open-source application, eMOCHA, to improve assessment of IPV and to deliver the DOVE intervention. The proposed eMOCHA DOVE study will first (Specific Aim/Phase 1) compare sensitivity and specificity of two different approaches for IPV assessment; paper and pencil versus the eMOCHA mHealth technology. Phase 2 (Aim 2) will compare effectiveness of the DOVE intervention delivered in standard form (paper brochure) versus mHealth eMOCHA DOVE application. In Phase 1 women enrolled in a perinatal home visiting program and consenting to the study, will be randomized to one of the two assessment groups and assessed for IPV at enrollment, birth and 2 months post birth. Women who are IPV positive (IPV+) at any of the assessment times will be re-randomized to receive the DOVE intervention by one of the two approaches. 1600 Medicaid eligible pregnant women in a perinatal home visiting program (800 from urban Baltimore and 800 from rural Virginia) will be recruited for Phase I and 400 IPV+ women (200 from each site) for Phase II. Women participating in Phase 2 will receive 6 home visit interventions over 6 months. Maternal outcomes related to IPV and mental health and selected infant outcomes will be collected at enrollment, 3, 6, 12, and 18 months after entry into Phase 2. Specific Aim 1 will use logistic and linear regression models to examine the proportion of women experiencing IPV through mHealth technology versus paper and pencil on the same validated assessments. Specific Aim 2 (comparing effectiveness of two intervention administrations) will be assessed with logistic and linear regression models for categorical (proportion abused and premature infants) and continuous outcome variables (e.g. depression, frequency and severity of physical, psychological, sexual IPV, use of community resources) respectively. Study findings will assist nurse home visitation programs to use best approaches for routine assessment of IPV and implement empowerment interventions to reduce IPV and improve maternal infant health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard IPV Assessment | Experimental | Behavioral: Standard IPV AssessmentTest the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper. |
| Standard DOVE intervention | Experimental | Behavioral: Standard IPV Assessment, Behavioral: Standard DOVE InterventionThe standard DOVE intervention has already been developed and tested (NR009093). The standard DOVE intervention is a brochure based 10 minute intervention that the home visitor reviews with the women. It consists of information about IPV, its effects on pregnancy and infant health, community resources and a plan for individual safety options. For the eMOCHA DOVE intervention, the DOVE 10 minute brochure intervention will be converted from the paper format to a visually colorful interactive presentation loaded into the home visitor device using the eMOCHA application. The format will be completely activated and implemented by the women. She uses small ear buds and a touch screen, so how she responds and interacts with the media enhanced eMOCHA DOVE intervention is private. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women in Baltimore, Virginia, and Missouri if needed.
- Speak English or Spanish
- Eligible for home visitation.
Key exclusion criteria (2 listed)
- Women who begin participation in a perinatal home visiting program after the baby is born.
- Women who do not speak English or Spanish.
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 |
|---|---|---|
| Standard IPV AssessmentTest the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth. | Behavioural | Standard DOVE intervention, Standard IPV Assessment |
| Standard DOVE InterventionIntervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months. | Behavioural | Standard DOVE intervention |
Primary outcome
Change in IPV assessments
Time frame: Screening and at 2 months post-birth.
Instances of intimate partner violence (IPV).
2 secondary outcomes
Change in use of safety behaviors
Time frame: Baseline and end of study (approximately 18 months post-birth)
Change in number of safety behaviors
Time frame: Baseline and end of study (approximately 18 months post-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 6 Mar 2019.
- Derived from this study: PubMed 38265246Sharps P, Bullock L, Perrin N, Campbell J, Hill K, Kanu I, Norling M, Russell NG. Comparison of different methods of screening to identify intimate partner violence: A randomized controlled trial. Public Health Nurs. 2024 Mar-Apr;41(2):328-337. doi: 10.1111/phn.13279. Epub 2024 Jan 24.
- Derived from this study: PubMed 27856405Bacchus LJ, Bullock L, Sharps P, Burnett C, Schminkey DL, Buller AM, Campbell J. Infusing Technology Into Perinatal Home Visitation in the United States for Women Experiencing Intimate Partner Violence: Exploring the Interpretive Flexibility of an mHealth Intervention. J Med Internet Res. 2016 Nov 17;18(11):e302. doi: 10.2196/jmir.6251.
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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 W Sharps, PhD principal investigator
Johns Hopkins University, School of Nursing
Linda Bullock, PhD, RN principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard IPV Assessment and Standard DOVE Intervention in people with Domestic Violence and Intimate Partner Violence, run by Johns Hopkins University at 1 site 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 3 inclusion and 2 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Change in IPV assessments (time frame: Screening and at 2 months post-birth.). 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 NCT01688427, which also lists 2 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 6 Mar 2019.