Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 139 for:    (domestic or partner) AND (violence OR abuse)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of British Columbia
University of New Brunswick
McMaster University
Johns Hopkins University
Kaiser Permanente
Information provided by (Responsible Party):
Marilyn Ford-Gilboe, Western University, Canada

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.

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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Change in Mastery on Pearlin's Mastery Scale [ Time Frame: baseline, 12 months ]
  5. 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).

  6. 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).


Other Outcome Measures:
  1. Severity of violence on the Composite Abuse Scale [ Time Frame: baseline, 6, 12 months ]
    30 item validated measure of severity of intimate partner violence

  2. 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

  3. 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.

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, New Brunswick
University of New Brunswick
Fredericton, New Brunswick, Canada, N5X 1V5
Canada, Ontario
Western University
London, Ontario, Canada, N6A 3C1
Sponsors and Collaborators
Western University, Canada
Canadian Institutes of Health Research (CIHR)
University of British Columbia
University of New Brunswick
McMaster University
Johns Hopkins University
Kaiser Permanente
Investigators
Layout table for investigator information
Principal Investigator: Marilyn Ford-Gilboe, PhD Western University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marilyn Ford-Gilboe, Professor and Women's Health Research Chair in Rural Health, Western University, Canada
ClinicalTrials.gov Identifier: NCT02258841     History of Changes
Other Study ID Numbers: HSREB 105436
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Marilyn Ford-Gilboe, Western University, Canada:
domestic violence
mental health
safety planning