Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women

NCT ID: NCT01312103

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Domestic Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Internet Based Safety Decision Aid

Group Type EXPERIMENTAL

Internet-based safety decision aid

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Usual Care Safety Plan

Intervention Type BEHAVIORAL

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nancy Glass

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nancy Glass, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona State University

Phoenix, Arizona, United States

Site Status

Johns Hopkins University School of Nursing

Baltimore, Maryland, United States

Site Status

University of Missouri

Columbia, Missouri, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20040709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25637195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25547929 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH085641

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH085641

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.