Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women
NCT ID: NCT01312103
Last Updated: 2017-03-03
Study Results
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Basic Information
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COMPLETED
NA
720 participants
INTERVENTIONAL
2011-03-31
2016-02-29
Brief Summary
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The investigators are conducting a five year experimental trial in four states (Oregon, Maryland, Missouri, and Arizona) to address the following aims:
1. Test the effectiveness of an interactive internet-based safety decision aid on abused women's safety seeking behaviors and exposure to violence compared to women assigned to control websites. The investigators hypothesize that at three, six, and 12 months post-baseline the intervention group will have increased safety seeking behaviors and reduced IPV exposure in comparison to the control group.
2. Test the effectiveness of an interactive internet-based safety decision aid on abused women's mental health compared to women assigned to control websites. The investigators hypothesize that at three, six, and 12 months post-baseline the intervention group will have improved mental health in comparison to the control group.
3. Test if the effect of an interactive internet-based safety decision aid on abused women's mental health and exposure to violence is mediated by the safety decision making process and safety-seeking behaviors. The investigators hypothesize that the intervention group will have a better decision making process and have greater safety seeking behavior over the year in comparison to the control group, and that this better decision process and increased safety seeking behavior will mediate improvement in mental health and exposure to violence at 12 months post baseline.
This study will provide much needed new information about safety planning's impact on making difficult safety decisions, exposure to violence, and mental health effects.
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Detailed Description
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Building from the empowerment framework, safety planning interventions focus on protecting women from exposure to repeat violence. However, despite the significant evidence of the negative outcomes of IPV and the complex individual and community factors that influence safety, little is known about what interventions improve the safety and mental health outcomes of abused women. While experimental trials are beginning, to date there has not been a trial to examine the effectiveness of safety planning, a cornerstone of IPV interventions, on exposure to repeat violence, safety, and mental health outcomes for women. An internet-based safety decision aid may assist abused women in weighing risks and benefits of safety options, assessing danger, and identifying the factors that are most important in their safety decisions. Further, it provides personalized links with community mental health and domestic violence resources, which are invaluable in assisting women in planning for safety, thereby reducing the immediate and long terms risk of negative mental health consequences of violence.
Women who consent to participate in this study and who have access to a safe computer (e.g. at home, work, community agency, friend/family) will be randomized to the intervention or control group. If a woman is randomized into the intervention group, she will complete the internet-based safety decision aid program. The decision aid program will be located on a confidential password protected and secured study website and will take approximately 60 minutes to complete. Participants will first be asked demographic and relationship questions as well as questions about their ability to make decisions about safety in their relationship. Next, participants will be asked to make a series of comparisons to determine the importance of specific factors such as: keeping the abuse private, safety of self, family and children, feelings for partner, resources such as housing and employment and maintaining norms within family, to safety decisions. Participants will then be asked questions specific to risk factors for violence and safety seeking behaviors in their relationship. After completion, the safety decision aid generates results to provide an individualized safety plan to the participant. Women randomized into the control group will access the confidential and password protected control website which includes a brief assessment of risk factors and their history of violence, and will provide a list of local resources, but not an individualized safety plan. Both intervention and control group participants will then complete a series of instruments to measure intimate partner violence, mental health outcomes, and safety seeking behaviors. Each participant will have a skilled and trained research assistant available by phone or email to assist them in understanding questions, interpreting the results, developing strategies for safety and providing referrals for community-based services.
Follow up sessions on the study website will be conducted at 3, 6, and 12 months post-baseline. Participants will be encouraged by the RA through phone or email contact to access the password-protected website to complete the internet session and follow-up assessment questions. Post-baseline questions will be the same as the baseline, but will focus on outcomes since the previous internet session.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Internet Based Safety Decision Aid
Internet-based safety decision aid
Participants will log into the the intervention website at baseline, 3 months, 6 months, and 12 months post baseline and receive:
* Setting of priorities for safety; a "sliding bar" allows participants to establish priorities by making pairwise comparisons of importance between factors.
* Danger Assessment; asks women to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger.
* Personalized action plan. Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented to her. The participant is given the option to print her results and the personalized plan.
Control Website
Usual Care Safety Plan
Participants will log into a control website at baseline, 3 months, 6 months and 12 months post baseline. Website will include the "usual services" provided to IPV survivors looking for safety planning resources on the internet. Participants will receive:
* Danger Assessment, will see risk factors associated with lethal violence, but will not receive a score or feedback.
* A brief emergency safety plan with links to national and state domestic violence resources as well as a suicide resource.
Interventions
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Internet-based safety decision aid
Participants will log into the the intervention website at baseline, 3 months, 6 months, and 12 months post baseline and receive:
* Setting of priorities for safety; a "sliding bar" allows participants to establish priorities by making pairwise comparisons of importance between factors.
* Danger Assessment; asks women to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger.
* Personalized action plan. Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented to her. The participant is given the option to print her results and the personalized plan.
Usual Care Safety Plan
Participants will log into a control website at baseline, 3 months, 6 months and 12 months post baseline. Website will include the "usual services" provided to IPV survivors looking for safety planning resources on the internet. Participants will receive:
* Danger Assessment, will see risk factors associated with lethal violence, but will not receive a score or feedback.
* A brief emergency safety plan with links to national and state domestic violence resources as well as a suicide resource.
Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking
* 18-64 years of age
* Report current physical, or sexual intimate partner violence or emotional abuse within the context of threats of physical or sexual intimate partner violence
* Live in one of the target states (Oregon, Arizona, Missouri, or Maryland)
* Express comfort with and access to a safe computer with internet
Exclusion Criteria
* Younger than 18 years of age
* Older than 64 years of age
* Cannot read/speak English/Spanish
* Live outside targeted 4 states
* No access to safe computer with internet
* Uncomfortable with computers
* Does not report past year violence from an intimate partner
18 Years
64 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Arizona State University
OTHER
University of Missouri-Columbia
OTHER
Oregon Health and Science University
OTHER
Kaiser Permanente
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Nancy Glass
Associate Professor
Principal Investigators
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Nancy Glass, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University School of Nursing
Locations
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Arizona State University
Phoenix, Arizona, United States
Johns Hopkins University School of Nursing
Baltimore, Maryland, United States
University of Missouri
Columbia, Missouri, United States
Oregon Health Sciences University
Portland, Oregon, United States
Countries
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References
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Glass N, Eden KB, Bloom T, Perrin N. Computerized aid improves safety decision process for survivors of intimate partner violence. J Interpers Violence. 2010 Nov;25(11):1947-64. doi: 10.1177/0886260509354508. Epub 2009 Dec 29.
Koziol-McLain J, Vandal AC, Nada-Raja S, Wilson D, Glass NE, Eden KB, McLean C, Dobbs T, Case J. A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol. BMC Public Health. 2015 Jan 31;15:56. doi: 10.1186/s12889-015-1395-0.
Eden KB, Perrin NA, Hanson GC, Messing JT, Bloom TL, Campbell JC, Gielen AC, Clough AS, Barnes-Hoyt JS, Glass NE. Use of online safety decision aid by abused women: effect on decisional conflict in a randomized controlled trial. Am J Prev Med. 2015 Apr;48(4):372-83. doi: 10.1016/j.amepre.2014.09.027. Epub 2014 Dec 26.
Other Identifiers
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