Domestic ViolenceNCT01312103
Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women
A study testing Internet-based safety decision aid in people with Domestic Violence, run by Johns Hopkins University at 4 sites in United States.
Trial summary
The purpose for this trial is to test the effectiveness of the first interactive internet-based safety decision aid on abused women's exposure to repeat intimate partner violence (IPV) and mental health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Internet-based safety decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Feb 2016
- 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 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 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
Who cannot join
- Male
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
University of Missouri
Columbia, Missouri, 65233
Arizona State University
Phoenix, Arizona, 85004
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
The purpose for this trial is to test the effectiveness of the first interactive internet-based safety decision aid on abused women's exposure to repeat intimate partner violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g., knowing the advantages and disadvantages of the relationship, having enough information to make a decision) will increase safety-seeking behaviors which in turn will decrease exposure to repeat IPV and improve mental health outcomes. Findings from the development and initial test of our computerized safety decision aid suggests that it offered abused women privacy to consider personalized safety options, informed them about danger in their relationship and would be used again if they had access to it through a safe internet site.
The investigators are conducting a five year experimental trial in four states (Oregon, Maryland, Missouri, and Arizona) to address the following aims:
Read more
- 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.
- 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.
- 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.
Read the detailed description
Intimate partner violence (IPV) is well established as a widespread problem with important negative physical and mental health, social and cost consequences for victims, their families and the community. Beyond the physical conditions associated with IPV, research has consistently demonstrated a strong association between experiencing IPV and increased rates of anxiety, depression, low-self esteem, substance abuse and suicidality. Increasing abused women's safety and reducing ongoing exposure to violence is key to minimizing such consequences.
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
- Domestic Violence
- Being tested
- Internet-based safety decision aid, Usual Care Safety Plan
- Keywords
- Safety Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based safety decision aidBehavioural
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 PlanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet Based Safety Decision Aid | Experimental | Not described Receives: Behavioral: Internet-based safety decision aid |
| Control Website | Active comparator | Not described Receives: Behavioral: Usual Care Safety Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Violence Against Women
This 46-item scale has been widely used with ethnically diverse women. It is designed to address types and severity of physical and sexual violence, including the threat of violence. The frequency of violence is based on a four-point scale (1=never to 4=many times) and the participants rank the severity of violence from mild to serious.
Measured: 6 months
Women's Experience with Battering
The WEB is a 10-item scale designed to capture a wide variety of abuse behaviors women experience from an intimate partner, including emotional abuse.
Measured: 6 months
Safety Behavior Checklist
This includes a checklist of safety steps abused women may use (asking for help, removing gun from home, hiding important papers) and utilization of community resources. Questions will be asked about women's access and use of criminal justice, health, and social resources and how helpful the safety steps are in coping with abuse.
Measured: 6 months
Decisional Conflict Scale
The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process).
Measured: 6 months
Secondary outcomes (2)
Center for Epidemiologic Studies Depression Scale, Revised
A 20-item self report measure, designed to screen for depressive symptoms in community samples and assess the probability that an individual meets the criteria for major depressive disorder.
Measured: 6 months
PTSD Checklist
A self-report measure of PTSD symptoms, designed for use in community samples to measure symptoms and assess the probability that an individual meets DSM-IV criteria for PTSD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionFeb 2016
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Arizona State University, University of Missouri-Columbia, Oregon Health and Science University, Kaiser Permanente
- Responsible party
- Principal investigator, Nancy Glass, Johns Hopkins University
- Investigators
- Nancy Glass, PhD, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312103
- Sponsor's protocol ID
- 1R01MH085641
- Other IDs
- R01MH085641
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20040709Koziol-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.
PubMed 25637195Eden 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.
PubMed 25547929
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women
- ClinicalTrials.gov ID
- NCT01312103
- Acronym / sponsor ID
- 1R01MH085641
- Conditions
- Domestic Violence
- Keywords
- Safety Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Arizona State University, University of Missouri-Columbia, Oregon Health and Science University, Kaiser Permanente
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Mar 2011 (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.
The purpose for this trial is to test the effectiveness of the first interactive internet-based safety decision aid on abused women's exposure to repeat intimate partner violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g., knowing the advantages and disadvantages of the relationship, having enough information to make a decision) will increase safety-seeking behaviors which in turn will decrease exposure to repeat IPV and improve mental health outcomes. Findings from the development and initial test of our computerized safety decision aid suggests that it offered abused women privacy to consider personalized safety options, informed them about danger in their relationship and would be used again if they had access to it through a safe internet site.
The investigators are conducting a five year experimental trial in four states (Oregon, Maryland, Missouri, and Arizona) to address the following aims:
- 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.
- 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.
- 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.
Detailed description
Intimate partner violence (IPV) is well established as a widespread problem with important negative physical and mental health, social and cost consequences for victims, their families and the community. Beyond the physical conditions associated with IPV, research has consistently demonstrated a strong association between experiencing IPV and increased rates of anxiety, depression, low-self esteem, substance abuse and suicidality. Increasing abused women's safety and reducing ongoing exposure to violence is key to minimizing such consequences.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Based Safety Decision Aid | Experimental | Behavioral: Internet-based safety decision aid |
| Control Website | Active comparator | Behavioral: Usual Care Safety Plan |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- 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)
Key exclusion criteria (8 listed)
- Male
- Younger than 18 years of age
- Older than 64 years of age
- Cannot read/speak English/Spanish
- Live outside targeted 4 states
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 |
|---|---|---|
| Internet-based safety decision aidParticipants 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. | Behavioural | Internet Based Safety Decision Aid |
| Usual Care Safety PlanParticipants 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. | Behavioural | Control Website |
Primary outcome
Severity of Violence Against Women
Time frame: 6 months
This 46-item scale has been widely used with ethnically diverse women. It is designed to address types and severity of physical and sexual violence, including the threat of violence. The frequency of violence is based on a four-point scale (1=never to 4=many times) and the participants rank the severity of violence from mild to serious.
Women's Experience with Battering
Time frame: 6 months
The WEB is a 10-item scale designed to capture a wide variety of abuse behaviors women experience from an intimate partner, including emotional abuse.
Safety Behavior Checklist
Time frame: 6 months
This includes a checklist of safety steps abused women may use (asking for help, removing gun from home, hiding important papers) and utilization of community resources. Questions will be asked about women's access and use of criminal justice, health, and social resources and how helpful the safety steps are in coping with abuse.
Decisional Conflict Scale
Time frame: 6 months
The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process).
2 secondary outcomes
Center for Epidemiologic Studies Depression Scale, Revised
Time frame: 6 months
PTSD Checklist
Time frame: 6 months
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 Mar 2017.
- Background: PubMed 20040709Glass 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.
- Derived from this study: PubMed 25637195Koziol-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.
- Derived from this study: PubMed 25547929Eden 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.
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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.
Nancy Glass, PhD principal investigator
Johns Hopkins University School of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based safety decision aid in people with Domestic Violence, run by Johns Hopkins University at 4 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 6 inclusion and 8 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Severity of Violence Against Women (time frame: 6 months). The study lists 4 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 NCT01312103, 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 Mar 2017.