Clinical trial NCT02258841: Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
Official title: Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Keywords: domestic violence
mental health
safety planning
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of British Columbia
name: University of New Brunswick
name: McMaster University
name: Johns Hopkins University
name: Kaiser Permanente
First posted: 2014-10-08
Enrollment: 462
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effectiveness of an interactive, online safety decision aid among diverse Canadian women who are experiencing intimate partner violence (IPV). The investigators will also explore how the online intervention works, and whether it has different effects for different groups of women.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women
* 19 years and older,
* English-speaking,
* Living in Ontario, New Brunswick, or British Columbia,
* Reports current physical, sexual or emotional abuse in the context of coercive control from a current or former partner (boyfriend, girlfriend, husband, wife, or intimate/sexual partner)
* Expresses comfort with and access to a safe computer with internet
* Access to safe email and mailing address

Exclusion Criteria:

* Men
* Under 19 years of age
* Cannot read/speak English
* Living outside of the 3 study sites
* Uncomfortable using a computer or internet
* No access to a safe computer with internet
* No access to safe email and mailing address
* Does not report current violence from an intimate partner

Primary outcomes:
measure: Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
timeFrame: baseline, 12 months
measure: Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
timeFrame: baseline, immediately post-intervention
measure: Changes in use of safety strategies on a Safety Behavior Checklist
timeFrame: baseline, 6 months
measure: Changes in use of safety strategies on a Safety Behavior Checklist
timeFrame: baseline, 12 months
measure: Change in Mastery on Pearlin's Mastery Scale
timeFrame: baseline, 12 months
measure: changes in self-efficacy for safety planning on investigator developed scales
timeFrame: baseline, 6 months
measure: changes in self-efficacy for safety planning on investigator developed scales
timeFrame: baseline, 12 months
Other outcomes:
measure: Severity of violence on the Composite Abuse Scale
timeFrame: baseline, 6, 12 months
measure: Social support on the Medical Outcomes Study Social Support Survey
timeFrame: baseline, 3, 6, 12 months
measure: Helpfulness of the online tool to decision making on the Preparation for Decision making scale
timeFrame: immediately post-intervention, 6, 12 months
measure: Coercive control on the Women's Experiences of Battering Scale (WEB)
timeFrame: baseline, 3, 6, 12 months
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Marilyn Ford-Gilboe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ford-Gilboe M, Varcoe C, Scott-Storey K, Perrin N, Wuest J, Wathen CN, Case J, Glass N. Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial. BMC Public Health. 2020 Feb 26;20(1):260. doi: 10.1186/s12889-020-8152-8.
citation: Ford-Gilboe M, Varcoe C, Scott-Storey K, Wuest J, Case J, Currie LM, Glass N, Hodgins M, MacMillan H, Perrin N, Wathen CN. A tailored online safety and health intervention for women experiencing intimate partner violence: the iCAN Plan 4 Safety randomized controlled trial protocol. BMC Public Health. 2017 Mar 21;17(1):273. doi: 10.1186/s12889-017-4143-9.