<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02258841</url>
  </required_header>
  <id_info>
    <org_study_id>HSREB 105436</org_study_id>
    <nct_id>NCT02258841</nct_id>
  </id_info>
  <brief_title>Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence</brief_title>
  <official_title>Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Brunswick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of an interactive, online safety&#xD;
      decision aid among diverse Canadian women who are experiencing intimate partner violence&#xD;
      (IPV). The investigators will also explore how the online intervention works, and whether it&#xD;
      has different effects for different groups of women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1 in 3 Canadian women experience IPV in their lifetimes. Over time, chronic stress of living&#xD;
      in an abusive relationship has been shown to contribute to depression, anxiety and PTSD.&#xD;
      Safety planning to reduce the risk of physical and emotional harm in abusive situations is&#xD;
      one of the most widely recommended interventions for women in abusive relationship. However,&#xD;
      fewer than 1 in 5 Canadian women access support from violence services to assist them in&#xD;
      safety planning. Rural, Aboriginal, racialized, immigrant, sexual minority women and women&#xD;
      who prioritize their privacy face particular barriers to accessing information and support&#xD;
      for safety planning.&#xD;
&#xD;
      We adapted an interactive, online safety decision aid (SDA) recently developed and tested in&#xD;
      the U.S. (Glass and colleagues, 2010) so that it applies to diverse groups of Canadian women,&#xD;
      and extends the focus on emotional safety. The tool was revised based on a pilot testing for&#xD;
      content and usability with 30 women (15 women who had experienced IPV and 15 service&#xD;
      providers/experts). In this study, we test the effectiveness of this new tool, called &quot;I CAN&#xD;
      Plan 4 Safety&quot; in a sample of 450 women from 3 provinces (ON, BC, New Brunswick). Women will&#xD;
      be randomly assigned to complete either the personalized online safety decision aid&#xD;
      (intervention) or an online tool which contains general risk and safety information (usual&#xD;
      care control). Both tools are located on a confidential, password protected website. After&#xD;
      initial completion of the online tools, they will be asked to login to the websites 3, 6 and&#xD;
      12 months later to complete standard outcome assessments. Women may access the information&#xD;
      and resources in the online tools at any time for a 12 month period after they enrol in the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale</measure>
    <time_frame>baseline, immediately post-intervention</time_frame>
    <description>The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in use of safety strategies on a Safety Behavior Checklist</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in use of safety strategies on a Safety Behavior Checklist</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mastery on Pearlin's Mastery Scale</measure>
    <time_frame>baseline, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in self-efficacy for safety planning on investigator developed scales</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in self-efficacy for safety planning on investigator developed scales</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Severity of violence on the Composite Abuse Scale</measure>
    <time_frame>baseline, 6, 12 months</time_frame>
    <description>30 item validated measure of severity of intimate partner violence</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support on the Medical Outcomes Study Social Support Survey</measure>
    <time_frame>baseline, 3, 6, 12 months</time_frame>
    <description>5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Helpfulness of the online tool to decision making on the Preparation for Decision making scale</measure>
    <time_frame>immediately post-intervention, 6, 12 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Coercive control on the Women's Experiences of Battering Scale (WEB)</measure>
    <time_frame>baseline, 3, 6, 12 months</time_frame>
    <description>10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">462</enrollment>
  <condition>Domestic Violence</condition>
  <arm_group>
    <arm_group_label>Personalized online Safety Decision Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Setting priorities for safety; Danger Assessment; Personalized Action Plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General Online Risk/Safety Information</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General Risk and Safety Information; Basic Emergency Safety Plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Setting Priorities for Safety</intervention_name>
    <description>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.</description>
    <arm_group_label>Personalized online Safety Decision Aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Danger Assessment</intervention_name>
    <description>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.</description>
    <arm_group_label>Personalized online Safety Decision Aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized Action Plan</intervention_name>
    <description>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.</description>
    <arm_group_label>Personalized online Safety Decision Aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General risk and safety information</intervention_name>
    <description>Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.</description>
    <arm_group_label>General Online Risk/Safety Information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Basic Emergency Safety Plan</intervention_name>
    <description>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)</description>
    <arm_group_label>General Online Risk/Safety Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  19 years and older,&#xD;
&#xD;
          -  English-speaking,&#xD;
&#xD;
          -  Living in Ontario, New Brunswick, or British Columbia,&#xD;
&#xD;
          -  Reports current physical, sexual or emotional abuse in the context of coercive control&#xD;
             from a current or former partner (boyfriend, girlfriend, husband, wife, or&#xD;
             intimate/sexual partner)&#xD;
&#xD;
          -  Expresses comfort with and access to a safe computer with internet&#xD;
&#xD;
          -  Access to safe email and mailing address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Under 19 years of age&#xD;
&#xD;
          -  Cannot read/speak English&#xD;
&#xD;
          -  Living outside of the 3 study sites&#xD;
&#xD;
          -  Uncomfortable using a computer or internet&#xD;
&#xD;
          -  No access to a safe computer with internet&#xD;
&#xD;
          -  No access to safe email and mailing address&#xD;
&#xD;
          -  Does not report current violence from an intimate partner&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marilyn Ford-Gilboe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Brunswick</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>N5X 1V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Marilyn Ford-Gilboe</investigator_full_name>
    <investigator_title>Professor and Women's Health Research Chair in Rural Health</investigator_title>
  </responsible_party>
  <keyword>domestic violence</keyword>
  <keyword>mental health</keyword>
  <keyword>safety planning</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258841
org study id: HSREB 105436
nct id: NCT02258841
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
time frame: baseline, 12 months
description: 20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder
measure: Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)
time frame: baseline, 12 months
description: 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
measure: Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
time frame: baseline, immediately post-intervention
description: The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.
measure: Changes in use of safety strategies on a Safety Behavior Checklist
time frame: baseline, 6 months
description: self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
measure: Changes in use of safety strategies on a Safety Behavior Checklist
time frame: baseline, 12 months
description: self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
measure: Change in Mastery on Pearlin's Mastery Scale
time frame: baseline, 12 months
measure: changes in self-efficacy for safety planning on investigator developed scales
time frame: baseline, 6 months
description: 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).
measure: changes in self-efficacy for safety planning on investigator developed scales
time frame: baseline, 12 months
description: 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).
measure: Severity of violence on the Composite Abuse Scale
time frame: baseline, 6, 12 months
description: 30 item validated measure of severity of intimate partner violence
measure: Social support on the Medical Outcomes Study Social Support Survey
time frame: baseline, 3, 6, 12 months
description: 5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale
measure: Helpfulness of the online tool to decision making on the Preparation for Decision making scale
time frame: immediately post-intervention, 6, 12 months
description: 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.
measure: Coercive control on the Women's Experiences of Battering Scale (WEB)
time frame: baseline, 3, 6, 12 months
description: 10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control
arm group label: Personalized online Safety Decision Aid
arm group type: Experimental
description: Setting priorities for safety; Danger Assessment; Personalized Action Plan
arm group label: General Online Risk/Safety Information
arm group type: Active Comparator
description: General Risk and Safety Information; Basic Emergency Safety Plan
intervention type: Behavioral
intervention name: Setting Priorities for Safety
description: 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.
arm group label: Personalized online Safety Decision Aid
intervention type: Behavioral
intervention name: Danger Assessment
description: 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.
arm group label: Personalized online Safety Decision Aid
intervention type: Behavioral
intervention name: Personalized Action Plan
description: 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.
arm group label: Personalized online Safety Decision Aid
intervention type: Behavioral
intervention name: General risk and safety information
description: Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
arm group label: General Online Risk/Safety Information
intervention type: Behavioral
intervention name: Basic Emergency Safety Plan
description: 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)
arm group label: General Online Risk/Safety Information
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marilyn Ford-Gilboe, PhD
role: Principal Investigator
affiliation: Western University
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Marilyn Ford-Gilboe
investigator title: Professor and Women's Health Research Chair in Rural Health