<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/NCT03037866</url>
  </required_header>
  <id_info>
    <org_study_id>R44DA039602-01</org_study_id>
    <nct_id>NCT03037866</nct_id>
  </id_info>
  <brief_title>Primary Prevention of Sexual Violence Among College Students</brief_title>
  <official_title>Primary Prevention of Sexual Violence Among College Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Health Promotion Associates, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Health Promotion Associates, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is designed to address the urgent need for an effective primary prevention&#xD;
      approach to the problem of sexual violence among college students. The project involves&#xD;
      developing, feasibility testing, and testing for effectiveness an innovative new approach to&#xD;
      the primary prevention of sexual violence, alcohol, and drug abuse among college students&#xD;
      utilizing both online e-learning and small group facilitator-led intervention modalities. The&#xD;
      intervention is an adaptation of the successful evidence-based substance abuse and violence&#xD;
      prevention approach called Life Skills Training (LST). The adapted intervention is designed&#xD;
      to address the relationship between sexual violence and substance abuse; positively change&#xD;
      social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify&#xD;
      and appropriately respond to problematic situations; and build social, self-regulation, and&#xD;
      relationship skills through interactive learning and behavioral rehearsal scenarios. At the&#xD;
      conclusion of the study, the investigators expect to be able to widely disseminate and market&#xD;
      a new evidence-based primary prevention intervention for sexual violence for use in a variety&#xD;
      of higher educational settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal is designed to address the urgent need for an effective primary prevention&#xD;
      approach to the problem of sexual violence among college students. It is estimated that 1 in&#xD;
      every 5 college women has been sexually assaulted while in college. There is a dearth of&#xD;
      primary prevention strategies that have demonstrated significant reductions in sexual&#xD;
      violence in college students as part of a rigorously designed evaluation. Research shows that&#xD;
      many victims of sexual assault are abused while drunk, under the influence of drugs, or&#xD;
      otherwise incapacitated, and that incidents of sexual violence typically occur in college&#xD;
      party settings where the victim knows the perpetrator and the perpetrator has been drinking&#xD;
      or using drugs. In Phase I of this study, the investigators established the feasibility,&#xD;
      relevance, and appeal of the new primary prevention program for sexual violence, alcohol, and&#xD;
      drug abuse for incoming college students. The program is an adaptation of a successful&#xD;
      evidence-based substance abuse and violence prevention approach called Life Skills Training&#xD;
      (LST). The LST approach is designed to build personal self-management skills, social skills,&#xD;
      and other life skills needed to reduce substance abuse and violence, increase resilience, and&#xD;
      successfully navigate developmental tasks. In Phase I, the investigators developed the full&#xD;
      scope and sequence of the program which outlines the learning objectives and activities of&#xD;
      the of the online e-learning modules and small group facilitator-led sessions; developed&#xD;
      relevant prototype materials to represent a subset of the full program; conducted formative&#xD;
      research to establish the feasibility, relevance, and appeal of the intervention through a&#xD;
      series of focus groups with college students and key informant interviews with college&#xD;
      prevention staff; and recruited over 40 colleges and universities to participate in Phase II&#xD;
      of the project. In Phase II, the investigators will fully develop the skills building&#xD;
      curriculum materials and conduct a rigorous randomized controlled trial to examine the impact&#xD;
      of the intervention. Forty colleges will be randomized into either an intervention group that&#xD;
      will receive the new intervention or a treatment-as-usual control group that will receive the&#xD;
      existing information on sexual violence provided at the school. At the end of a two-month&#xD;
      intervention period, and at 6- and 12month follow-up assessments, the investigators will&#xD;
      compare changes in behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse,&#xD;
      and sexual violence. The ultimate intervention holds promise for wide dissemination as an&#xD;
      evidence-based primary prevention approach for sexual violence to four-year colleges,&#xD;
      community or junior colleges, universities, graduate and professional schools, for-profit&#xD;
      schools, trade schools, and career and technical schools.&#xD;
&#xD;
      Phase II Specific Aims&#xD;
&#xD;
        1. Fully develop the sexual violence primary prevention skills building curriculum&#xD;
           materials;&#xD;
&#xD;
        2. Conduct a randomized controlled trial to examine the impact of the intervention;&#xD;
           randomize 40 colleges into either an intervention group that will receive the new&#xD;
           intervention or a treatment-as-usual control group that will receive the existing&#xD;
           information on sexual violence provided at the school;&#xD;
&#xD;
        3. Conduct an outcome evaluation by assessing changes in the two experimental conditions&#xD;
           with regards to behaviors, norms, attitudes, and knowledge regarding alcohol, drug&#xD;
           abuse, and sexual violence at the end of the two-month intervention period, and at 6-&#xD;
           and 12-month follow-up assessments;&#xD;
&#xD;
        4. Conduct a process evaluation to document and monitor all Phase II project activities;&#xD;
&#xD;
        5. Disseminate research findings to the scientific and practice communities;&#xD;
&#xD;
        6. Create a provider training mechanism to promote dissemination and sustainability of the&#xD;
           intervention;&#xD;
&#xD;
        7. Based on the commercialization plan, implement a marketing strategy for the new primary&#xD;
           prevention program aimed at institutions of higher education across the country.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual violence behaviors, norms, and attitudes at baseline</measure>
    <time_frame>Pre-test (prior to participating in the first session/module of the intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention</measure>
    <time_frame>Post-test (within 2 weeks of completing final session/module of the intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline sexual violence behaviors, norms, and attitudes at 6-months</measure>
    <time_frame>6-month followup (within 6-7 months of completing final session of intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline sexual violence behaviors, norms, and attitudes at 12-months</measure>
    <time_frame>12-month followup (within 12-13 months of completing final session of intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Substance use and abuse behaviors, norms, and attitudes at baseline</measure>
    <time_frame>Pre-test (prior to participating in the first session/module of the intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention</measure>
    <time_frame>Post-test (within 2 weeks of completing final session/module of the intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months</measure>
    <time_frame>6-month followup (within 6-7 months of completing final session of intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months</measure>
    <time_frame>12-month followup (within 12-13 months of completing final session of intervention)</time_frame>
    <description>The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Sexual Violence</condition>
  <condition>Substance Use</condition>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>LifeSkills Training for College</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LifeSkills Training for College</intervention_name>
    <description>The intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence.</description>
    <arm_group_label>LifeSkills Training for College</arm_group_label>
    <other_name>LifeSkills Training</other_name>
    <other_name>LST</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  College students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairment or severe learning disabilities, as screened by field&#xD;
             staff at participating sites&#xD;
&#xD;
          -  Any previous experience with the intervention program will also exclude adolescents&#xD;
             from participating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth W Griffin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Promotion Associates, Inc.</affiliation>
  </overall_official>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Health Promotion Associates, Inc.</investigator_affiliation>
    <investigator_full_name>Kenneth W Griffin</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037866
org study id: R44DA039602-01
nct id: NCT03037866
lead sponsor: 
has dmc: Yes
This project is designed to address the urgent need for an effective primary prevention
      approach to the problem of sexual violence among college students. The project involves
      developing, feasibility testing, and testing for effectiveness an innovative new approach to
      the primary prevention of sexual violence, alcohol, and drug abuse among college students
      utilizing both online e-learning and small group facilitator-led intervention modalities. The
      intervention is an adaptation of the successful evidence-based substance abuse and violence
      prevention approach called Life Skills Training (LST). The adapted intervention is designed
      to address the relationship between sexual violence and substance abuse; positively change
      social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify
      and appropriately respond to problematic situations; and build social, self-regulation, and
      relationship skills through interactive learning and behavioral rehearsal scenarios. At the
      conclusion of the study, the investigators expect to be able to widely disseminate and market
      a new evidence-based primary prevention intervention for sexual violence for use in a variety
      of higher educational settings.
This proposal is designed to address the urgent need for an effective primary prevention
      approach to the problem of sexual violence among college students. It is estimated that 1 in
      every 5 college women has been sexually assaulted while in college. There is a dearth of
      primary prevention strategies that have demonstrated significant reductions in sexual
      violence in college students as part of a rigorously designed evaluation. Research shows that
      many victims of sexual assault are abused while drunk, under the influence of drugs, or
      otherwise incapacitated, and that incidents of sexual violence typically occur in college
      party settings where the victim knows the perpetrator and the perpetrator has been drinking
      or using drugs. In Phase I of this study, the investigators established the feasibility,
      relevance, and appeal of the new primary prevention program for sexual violence, alcohol, and
      drug abuse for incoming college students. The program is an adaptation of a successful
      evidence-based substance abuse and violence prevention approach called Life Skills Training
      (LST). The LST approach is designed to build personal self-management skills, social skills,
      and other life skills needed to reduce substance abuse and violence, increase resilience, and
      successfully navigate developmental tasks. In Phase I, the investigators developed the full
      scope and sequence of the program which outlines the learning objectives and activities of
      the of the online e-learning modules and small group facilitator-led sessions; developed
      relevant prototype materials to represent a subset of the full program; conducted formative
      research to establish the feasibility, relevance, and appeal of the intervention through a
      series of focus groups with college students and key informant interviews with college
      prevention staff; and recruited over 40 colleges and universities to participate in Phase II
      of the project. In Phase II, the investigators will fully develop the skills building
      curriculum materials and conduct a rigorous randomized controlled trial to examine the impact
      of the intervention. Forty colleges will be randomized into either an intervention group that
      will receive the new intervention or a treatment-as-usual control group that will receive the
      existing information on sexual violence provided at the school. At the end of a two-month
      intervention period, and at 6- and 12month follow-up assessments, the investigators will
      compare changes in behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse,
      and sexual violence. The ultimate intervention holds promise for wide dissemination as an
      evidence-based primary prevention approach for sexual violence to four-year colleges,
      community or junior colleges, universities, graduate and professional schools, for-profit
      schools, trade schools, and career and technical schools.

      Phase II Specific Aims

        1. Fully develop the sexual violence primary prevention skills building curriculum
           materials;

        2. Conduct a randomized controlled trial to examine the impact of the intervention;
           randomize 40 colleges into either an intervention group that will receive the new
           intervention or a treatment-as-usual control group that will receive the existing
           information on sexual violence provided at the school;

        3. Conduct an outcome evaluation by assessing changes in the two experimental conditions
           with regards to behaviors, norms, attitudes, and knowledge regarding alcohol, drug
           abuse, and sexual violence at the end of the two-month intervention period, and at 6-
           and 12-month follow-up assessments;

        4. Conduct a process evaluation to document and monitor all Phase II project activities;

        5. Disseminate research findings to the scientific and practice communities;

        6. Create a provider training mechanism to promote dissemination and sustainability of the
           intervention;

        7. Based on the commercialization plan, implement a marketing strategy for the new primary
           prevention program aimed at institutions of higher education across the country.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sexual violence behaviors, norms, and attitudes at baseline
time frame: Pre-test (prior to participating in the first session/module of the intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention
time frame: Post-test (within 2 weeks of completing final session/module of the intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline sexual violence behaviors, norms, and attitudes at 6-months
time frame: 6-month followup (within 6-7 months of completing final session of intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline sexual violence behaviors, norms, and attitudes at 12-months
time frame: 12-month followup (within 12-13 months of completing final session of intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Substance use and abuse behaviors, norms, and attitudes at baseline
time frame: Pre-test (prior to participating in the first session/module of the intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention
time frame: Post-test (within 2 weeks of completing final session/module of the intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months
time frame: 6-month followup (within 6-7 months of completing final session of intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
measure: Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months
time frame: 12-month followup (within 12-13 months of completing final session of intervention)
description: The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
arm group label: LifeSkills Training for College
arm group type: Experimental
description: All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules).
arm group label: Treatment as Usual (Control)
arm group type: No Intervention
description: All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools.
intervention type: Behavioral
intervention name: LifeSkills Training for College
description: The intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence.
arm group label: LifeSkills Training for College
other name: LifeSkills Training
other name: LST
criteria: 
gender: All
minimum age: 18 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth W Griffin, PhD
role: Principal Investigator
affiliation: National Health Promotion Associates, Inc.
responsible party type: Principal Investigator
investigator affiliation: National Health Promotion Associates, Inc.
investigator full name: Kenneth W Griffin
investigator title: Senior Research Scientist
mesh term: Substance-Related Disorders
sharing ipd: No