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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02258841
Other study ID # HSREB 105436
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date March 2017

Study information

Verified date April 2019
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 462
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.
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)

Locations

Country Name City State
Canada University of New Brunswick Fredericton New Brunswick
Canada Western University London Ontario
Canada University of British Columbia Vancouver British Columbia

Sponsors (7)

Lead Sponsor Collaborator
Western University, Canada Canadian Institutes of Health Research (CIHR), Johns Hopkins University, Kaiser Permanente, McMaster University, University of British Columbia, University of New Brunswick

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Severity of violence on the Composite Abuse Scale 30 item validated measure of severity of intimate partner violence baseline, 6, 12 months
Other Social support on the Medical Outcomes Study Social Support Survey 5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale baseline, 3, 6, 12 months
Other Helpfulness of the online tool to decision making on the Preparation for Decision making scale 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. immediately post-intervention, 6, 12 months
Other Coercive control on the Women's Experiences of Battering Scale (WEB) 10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control baseline, 3, 6, 12 months
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Change in Mastery on Pearlin's Mastery Scale baseline, 12 months
Secondary 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
Secondary 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
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