Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence

Study Overview
=================
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.

Official Title
-----------------
Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: Setting Priorities for Safety
* Behavioral: Danger Assessment
* Behavioral: Personalized Action Plan
* Behavioral: General risk and safety information
* Behavioral: Basic Emergency Safety Plan


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized online Safety Decision Aid<br>Setting priorities for safety; Danger Assessment; Personalized Action Plan | Behavioral: Setting Priorities for Safety<br>* 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.<br>Behavioral: Danger Assessment<br>* 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.<br>Behavioral: Personalized Action Plan<br>* 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.<br>|
| Active Comparator: General Online Risk/Safety Information<br>General Risk and Safety Information; Basic Emergency Safety Plan | Behavioral: General risk and safety information<br>* Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.<br>Behavioral: Basic Emergency Safety Plan<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised | 20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder | baseline, 12 months | 
| Changes in PTSD symptomology on the PTSD Checklist (Civilian Version) | 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 | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale | The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group. | baseline, immediately post-intervention | 
| Changes in use of safety strategies on a Safety Behavior Checklist | self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index | baseline, 6 months | 
| Changes in use of safety strategies on a Safety Behavior Checklist | self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index | baseline, 12 months | 
| Change in Mastery on Pearlin's Mastery Scale |  | baseline, 12 months | 
| changes in self-efficacy for safety planning on investigator developed scales | 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). | baseline, 6 months | 
| changes in self-efficacy for safety planning on investigator developed scales | 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). | baseline, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
domestic violence, mental health, safety planning