Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
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|ClinicalTrials.gov Identifier: NCT02258841|
Recruitment Status : Unknown
Verified December 2015 by Marilyn Ford-Gilboe, Western University, Canada.
Recruitment status was: Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Domestic Violence||Behavioral: Setting Priorities for Safety Behavioral: Danger Assessment Behavioral: Personalized Action Plan Behavioral: General risk and safety information Behavioral: Basic Emergency Safety Plan||Not Applicable|
1 in 3 Canadian women experience IPV in their lifetimes. Over time, chronic stress of living in an abusive relationship has been shown to contribute to depression, anxiety and PTSD. Safety planning to reduce the risk of physical and emotional harm in abusive situations is one of the most widely recommended interventions for women in abusive relationship. However, fewer than 1 in 5 Canadian women access support from violence services to assist them in safety planning. Rural, Aboriginal, racialized, immigrant, sexual minority women and women who prioritize their privacy face particular barriers to accessing information and support for safety planning.
We adapted an interactive, online safety decision aid (SDA) recently developed and tested in the U.S. (Glass and colleagues, 2010) so that it applies to diverse groups of Canadian women, and extends the focus on emotional safety. The tool was revised based on a pilot testing for content and usability with 30 women (15 women who had experienced IPV and 15 service providers/experts). In this study, we test the effectiveness of this new tool, called "I CAN Plan 4 Safety" in a sample of 450 women from 3 provinces (ON, BC, New Brunswick). Women will be randomly assigned to complete either the personalized online safety decision aid (intervention) or an online tool which contains general risk and safety information (usual care control). Both tools are located on a confidential, password protected website. After initial completion of the online tools, they will be asked to login to the websites 3, 6 and 12 months later to complete standard outcome assessments. Women may access the information and resources in the online tools at any time for a 12 month period after they enrol in the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: Personalized online Safety Decision Aid
Setting priorities for safety; Danger Assessment; Personalized Action Plan
Behavioral: Setting Priorities for Safety
Participants rate the importance of 5 priorities to decision-making about their unsafe relationship by comparing the relative importance of each pair of priorities. Weights for each priority are computed and provided to the woman, along with examples of safety strategies that fit with her top ranked priority.
Behavioral: Danger Assessment
Participants complete a calendar to show episodes of physical and/or sexual violence they have experienced in the past 12, along with 20 questions assessing risk of serious or lethal violence. A standardized weighted score is provided, along with a brief explanation about her level of danger and appropriate actions she may take.
Behavioral: Personalized Action Plan
Women create a tailored action plan for themselves by selecting strategies from 8 different groups, including those which are recommended to them based on their responses to previous questions.
Active Comparator: General Online Risk/Safety Information
General Risk and Safety Information; Basic Emergency Safety Plan
Behavioral: General risk and safety information
Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
Behavioral: Basic Emergency Safety Plan
Participants are provided with a basic emergency plan including information about local DV resources. The information is not personalized but is consistent with online information which women could find on their own (usual care)
- Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised [ Time Frame: baseline, 12 months ]20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder
- Changes in PTSD symptomology on the PTSD Checklist (Civilian Version) [ Time Frame: baseline, 12 months ]17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting DSM-IV diagnostic criterial for PTSD
- Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale [ Time Frame: baseline, immediately post-intervention ]The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.
- Changes in use of safety strategies on a Safety Behavior Checklist [ Time Frame: baseline, 6 months ]self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
- Changes in use of safety strategies on a Safety Behavior Checklist [ Time Frame: baseline, 12 months ]self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
- Change in Mastery on Pearlin's Mastery Scale [ Time Frame: baseline, 12 months ]
- changes in self-efficacy for safety planning on investigator developed scales [ Time Frame: baseline, 6 months ]2 self-report items which assess self-efficacy in making a safety plan for self and for children on a 100 mm visual analogue scale (range 0-100).
- changes in self-efficacy for safety planning on investigator developed scales [ Time Frame: baseline, 12 months ]2 self-report items which assess self-efficacy in making a safety plan for self and for children on a 100 mm visual analogue scale (range 0-100).
- Severity of violence on the Composite Abuse Scale [ Time Frame: baseline, 6, 12 months ]30 item validated measure of severity of intimate partner violence
- Social support on the Medical Outcomes Study Social Support Survey [ Time Frame: baseline, 3, 6, 12 months ]5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale
- Helpfulness of the online tool to decision making on the Preparation for Decision making scale [ Time Frame: immediately post-intervention, 6, 12 months ]10 item self-report measure of helpfulness of the online tool, adapted to IPV context by Glass et al (2010) from the standardized measure developed by the Ottawa Patient Decision Aids Research Group.
- Coercive control on the Women's Experiences of Battering Scale (WEB) [ Time Frame: baseline, 3, 6, 12 months ]10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258841
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Canada, New Brunswick|
|University of New Brunswick|
|Fredericton, New Brunswick, Canada, N5X 1V5|
|London, Ontario, Canada, N6A 3C1|
|Principal Investigator:||Marilyn Ford-Gilboe, PhD||Western University|