<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/NCT02236663</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00054334</org_study_id>
    <secondary_id>1R01HD076881-01A1</secondary_id>
    <nct_id>NCT02236663</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends</brief_title>
  <official_title>Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intimate partner violence (IPV), including violence in dating relationships (dating violence,&#xD;
      DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1%&#xD;
      report their first abusive relationship occurred at college age (age 18-24). Similarly, in&#xD;
      national surveys, adults respondents 18-24 years of age report the highest rate of stalking&#xD;
      victimization, most commonly by a former intimate partner. Safety planning is the most widely&#xD;
      used intervention to prevent and respond to IPV, yet the vast majority of abused women never&#xD;
      access safety planning services. Our challenge is to increase college women's access to&#xD;
      safety planning, with the opportunity to consider their unique safety priorities and level of&#xD;
      danger during and when ending an abusive relationship. In addition, while &quot;bystander&quot;&#xD;
      interventions that train peers to safely intervene have been shown to be effective in sexual&#xD;
      assault prevention on campus, and college women in abusive relationships most frequently&#xD;
      disclose IPV to a friend, no similar interventions have been tested with friends for IPV&#xD;
      response on campuses. Therefore, the objective of the study is to evaluate the:&#xD;
&#xD;
        1. effectiveness of an interactive, personalized smart phone and web based safety&#xD;
           application (&quot;App&quot;) intervention in Maryland and Oregon with: 1) college women (age&#xD;
           18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The&#xD;
           safety decision App allows the user to enter information on: a) relationship health; b)&#xD;
           safety priorities; and c) severity of violence/danger in relationship. The App then uses&#xD;
           the information to provide the user with a personalized safety planning information and&#xD;
           resources; and&#xD;
&#xD;
        2. dissemination of the App nationally to determine the reach, adoption, implementation and&#xD;
           maintenance of App use among university/college students.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in survivors' use of safety strategies on Safety Behavior Checklist at 12 months</measure>
    <time_frame>Baseline, 12 Months</time_frame>
    <description>Adapted from Intimate Partner Violence Strategies Index to assess for survivors the range of strategies used to halt, escape, or resist violence, and the helpfulness of each strategy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in survivors' and friends' decisional conflict on Decisional Conflict Scale (DCS) immediately post intervention.</measure>
    <time_frame>Baseline, immediately post intervention</time_frame>
    <description>The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process). Will be used to assess decisional conflict with survivors and friends.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in friends' efficacy to intervene on adapted Self-efficacy to Deal with Violence Scale at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>19 times scale adapted to assess friends of survivors' confidence to intervene.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in friends' supportive behaviors on Supportive Behaviors Checklist at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Assesses supportive behaviors used to assist a friend experiencing intimate partner violence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in survivors' drug and alcohol use on adapted Monitoring the Future Drug and Alcohol Questionnaire at 12 months.</measure>
    <time_frame>Baseline, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The CAS is a 30 item validated comprehensive intimate partner violence screening measure with</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo</measure>
    <time_frame>Baseline, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>A 20-item self report measure, designed to screen for depressive symptoms in community samples and assess the probability that an individual meets the criteria for major depressive disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in friends' attitudes on the Intimate Partner Violence on the Acceptance of Dating Violence Scale at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>5 item scale used to measures norms that support violence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">649</enrollment>
  <condition>Intimate Partner Violence</condition>
  <arm_group>
    <arm_group_label>App Based Safety Decision Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Personalized App-Based Safety Decision Aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Care Safety Plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Safety Planing App</intervention_name>
    <description>The control group App will provide women and friends with basic safety planning information and a brief resource list of IPV resources. The resources will be targeted to college students age 18-24 years. The control group App safety plan is not personalized to woman/friend's safety priorities and danger in the relationship.</description>
    <arm_group_label>Control App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized App-Based Safety Decision Aid</intervention_name>
    <description>Setting of priorities for safety: participants will establish priorities by making pairwise comparisons of importance between 5 factors.&#xD;
Danger Assessment: asks participants to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger and safety planning information and resources based on their level of danger.&#xD;
Personalized action plan: Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented tailored to their level of danger and priority settings. The participant is given the option to print results and the personalized plan.</description>
    <arm_group_label>App Based Safety Decision Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females who report current physical violence, sexual violence, psychological abuse or&#xD;
             stalking by a dating/intimate/ex-intimate partner, or who have a female friend&#xD;
             currently experiencing abuse from dating/intimate/ex-intimate partner.&#xD;
&#xD;
          -  Males who have a female friend currently experiencing physical violence, sexual&#xD;
             violence, psychological abuse or stalking by a dating/intimate/ex-intimate partner&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Between the ages of 18-24 years old&#xD;
&#xD;
          -  Attend a college in Maryland or Oregon&#xD;
&#xD;
          -  Enrolled in college or university (at least part time)&#xD;
&#xD;
          -  Have access to a safe smart-phone or computer with internet and are comfortable&#xD;
             downloading an app or using the internet&#xD;
&#xD;
          -  Have a safe email address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Older than 24 years of age&#xD;
&#xD;
          -  Cannot read/speak English&#xD;
&#xD;
          -  Live outside targeted states&#xD;
&#xD;
          -  No access to safe smart phone or computer with internet&#xD;
&#xD;
          -  Uncomfortable with downloading an app&#xD;
&#xD;
          -  No access to a safe email address&#xD;
&#xD;
          -  Does not report current violence from an intimate partner or having a female friend&#xD;
             that has experienced intimate partner violence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Glass, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University School of Nursing</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intimate Partner Violence</keyword>
  <keyword>Dating Violence</keyword>
  <keyword>Relationships</keyword>
  <keyword>Safety Planning</keyword>
  <keyword>College</keyword>
  <keyword>Student</keyword>
  <keyword>App</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/NCT02236663
org study id: NA_00054334
secondary id: 1R01HD076881-01A1
nct id: NCT02236663
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Intimate partner violence (IPV), including violence in dating relationships (dating violence,
      DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1%
      report their first abusive relationship occurred at college age (age 18-24). Similarly, in
      national surveys, adults respondents 18-24 years of age report the highest rate of stalking
      victimization, most commonly by a former intimate partner. Safety planning is the most widely
      used intervention to prevent and respond to IPV, yet the vast majority of abused women never
      access safety planning services. Our challenge is to increase college women's access to
      safety planning, with the opportunity to consider their unique safety priorities and level of
      danger during and when ending an abusive relationship. In addition, while "bystander"
      interventions that train peers to safely intervene have been shown to be effective in sexual
      assault prevention on campus, and college women in abusive relationships most frequently
      disclose IPV to a friend, no similar interventions have been tested with friends for IPV
      response on campuses. Therefore, the objective of the study is to evaluate the:

        1. effectiveness of an interactive, personalized smart phone and web based safety
           application ("App") intervention in Maryland and Oregon with: 1) college women (age
           18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The
           safety decision App allows the user to enter information on: a) relationship health; b)
           safety priorities; and c) severity of violence/danger in relationship. The App then uses
           the information to provide the user with a personalized safety planning information and
           resources; and

        2. dissemination of the App nationally to determine the reach, adoption, implementation and
           maintenance of App use among university/college students.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change from baseline in survivors' use of safety strategies on Safety Behavior Checklist at 12 months
time frame: Baseline, 12 Months
description: Adapted from Intimate Partner Violence Strategies Index to assess for survivors the range of strategies used to halt, escape, or resist violence, and the helpfulness of each strategy.
measure: Change from baseline in survivors' and friends' decisional conflict on Decisional Conflict Scale (DCS) immediately post intervention.
time frame: Baseline, immediately post intervention
description: The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process). Will be used to assess decisional conflict with survivors and friends.
measure: Change from baseline in friends' efficacy to intervene on adapted Self-efficacy to Deal with Violence Scale at 12 months
time frame: Baseline, 12 months
description: 19 times scale adapted to assess friends of survivors' confidence to intervene.
measure: Changes from baseline in friends' supportive behaviors on Supportive Behaviors Checklist at 12 months
time frame: Baseline, 12 months
description: Assesses supportive behaviors used to assist a friend experiencing intimate partner violence.
measure: Change from baseline in survivors' drug and alcohol use on adapted Monitoring the Future Drug and Alcohol Questionnaire at 12 months.
time frame: Baseline, 12 months
measure: Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months
time frame: Baseline, 12 months
description: The CAS is a 30 item validated comprehensive intimate partner violence screening measure with
measure: Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo
time frame: Baseline, 12 month
measure: Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months
time frame: Baseline, 12 months
description: A 20-item self report measure, designed to screen for depressive symptoms in community samples and assess the probability that an individual meets the criteria for major depressive disorder.
measure: Changes from baseline in friends' attitudes on the Intimate Partner Violence on the Acceptance of Dating Violence Scale at 12 months
time frame: Baseline, 12 months
description: 5 item scale used to measures norms that support violence.
arm group label: App Based Safety Decision Aid
arm group type: Experimental
description: Personalized App-Based Safety Decision Aid
arm group label: Control App
arm group type: Active Comparator
description: Usual Care Safety Plan
intervention type: Behavioral
intervention name: Usual Care Safety Planing App
description: The control group App will provide women and friends with basic safety planning information and a brief resource list of IPV resources. The resources will be targeted to college students age 18-24 years. The control group App safety plan is not personalized to woman/friend's safety priorities and danger in the relationship.
arm group label: Control App
intervention type: Behavioral
intervention name: Personalized App-Based Safety Decision Aid
description: Setting of priorities for safety: participants will establish priorities by making pairwise comparisons of importance between 5 factors.
Danger Assessment: asks participants to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger and safety planning information and resources based on their level of danger.
Personalized action plan: Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented tailored to their level of danger and priority settings. The participant is given the option to print results and the personalized plan.
arm group label: App Based Safety Decision Aid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Glass, PhD
role: Principal Investigator
affiliation: Johns Hopkins University School of Nursing
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor