<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/NCT02983864</url>
  </required_header>
  <id_info>
    <org_study_id>16-F-33</org_study_id>
    <nct_id>NCT02983864</nct_id>
  </id_info>
  <brief_title>Group Alcohol Interventions for College Men</brief_title>
  <official_title>Examining an Integrated Bystander and Alcohol Program for Sexual Assault Perpetration: A Preliminary Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Justice</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the proposed project is to conduct a randomized controlled trial (RCT)&#xD;
      comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape&#xD;
      myth acceptance) for men who receive a group alcohol intervention only to men who receive a&#xD;
      group integrated alcohol and sexual assault intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although research suggests that sexual assault interventions based on Bystander and Social&#xD;
      Norms theory help to reduce sexual assault among college men, these programs do not&#xD;
      completely eliminate sexual assault and their effects tend to fade over time. Unfortunately,&#xD;
      there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual&#xD;
      assault perpetration among college men and (2) whether alcohol interventions can be&#xD;
      incorporated into existing sexual assault programs for college men (i.e., Bystander/Social&#xD;
      Norms programs). Therefore, the objective of the proposed project is to conduct a randomized&#xD;
      controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e.,&#xD;
      bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention&#xD;
      only to men who receive a group integrated alcohol and sexual assault intervention.&#xD;
      Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and&#xD;
      Intervention for College Students (BASICS), an empirically-supported intervention for college&#xD;
      student drinking. The integrated alcohol and sexual assault intervention, which we have&#xD;
      termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will&#xD;
      be modeled after BASICS and empirically-supported Bystander and Social Norms interventions&#xD;
      for sexual assault. The current study will recruit 100 college men who are sanctioned by&#xD;
      their university to receive an alcohol intervention for violating a campus alcohol policy: by&#xD;
      definition an indicated and at-risk population for sexual assault perpetration. Men will be&#xD;
      followed for 6 months to determine the effects of the intervention on sexual assault&#xD;
      perpetration and other primary outcomes (e.g., bystander behavior).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual Experiences Survey</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines potential sexual assault behaviors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bystander Behavior Scale</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines opportunities and engagement in prosocial bystander behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illinois Rape Myth Acceptance Scale</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines rape supportive beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Social Norms Inventory</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines sexual normative beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol use Disorders Identification Test</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Effects of Alcohol</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>A self-report measure that examines expectancies of alcohol use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Sexual Behavior</condition>
  <arm_group>
    <arm_group_label>Alcohol and Relaxation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alcohol and Relationships</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior. The interventions are based on an integrated BASICS and integrated Bystander protocols</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BASICS</intervention_name>
    <description>A one session intervention focused on reducing drinking with motivational interviewing</description>
    <arm_group_label>Alcohol and Relaxation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated BASICS</intervention_name>
    <description>A one session intervention focused on reducing drinking and sexual behavior while drinking</description>
    <arm_group_label>Alcohol and Relationships</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation</intervention_name>
    <description>A one session intervention focused on increasing relaxation skills</description>
    <arm_group_label>Alcohol and Relaxation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Bystander</intervention_name>
    <description>A one session intervention focused on reducing sexual assault with a focus on the role of alcohol</description>
    <arm_group_label>Alcohol and Relationships</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be 18 or older; must be an Ohio University student; must be male; must be&#xD;
             sanctioned to receive an alcohol intervention by Ohio University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian T Wymbs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio University</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</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/NCT02983864
org study id: 16-F-33
nct id: NCT02983864
lead sponsor: 
collaborator: 
has dmc: No
The objective of the proposed project is to conduct a randomized controlled trial (RCT)
      comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape
      myth acceptance) for men who receive a group alcohol intervention only to men who receive a
      group integrated alcohol and sexual assault intervention.
Although research suggests that sexual assault interventions based on Bystander and Social
      Norms theory help to reduce sexual assault among college men, these programs do not
      completely eliminate sexual assault and their effects tend to fade over time. Unfortunately,
      there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual
      assault perpetration among college men and (2) whether alcohol interventions can be
      incorporated into existing sexual assault programs for college men (i.e., Bystander/Social
      Norms programs). Therefore, the objective of the proposed project is to conduct a randomized
      controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e.,
      bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention
      only to men who receive a group integrated alcohol and sexual assault intervention.
      Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and
      Intervention for College Students (BASICS), an empirically-supported intervention for college
      student drinking. The integrated alcohol and sexual assault intervention, which we have
      termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will
      be modeled after BASICS and empirically-supported Bystander and Social Norms interventions
      for sexual assault. The current study will recruit 100 college men who are sanctioned by
      their university to receive an alcohol intervention for violating a campus alcohol policy: by
      definition an indicated and at-risk population for sexual assault perpetration. Men will be
      followed for 6 months to determine the effects of the intervention on sexual assault
      perpetration and other primary outcomes (e.g., bystander behavior).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Sexual Experiences Survey
time frame: 6 months post-intervention
description: A self-report measure that examines potential sexual assault behaviors
measure: Bystander Behavior Scale
time frame: 6 months post-intervention
description: A self-report measure that examines opportunities and engagement in prosocial bystander behavior.
measure: Illinois Rape Myth Acceptance Scale
time frame: 6 months post-intervention
description: A self-report measure that examines rape supportive beliefs
measure: Sexual Social Norms Inventory
time frame: 6 months post-intervention
description: A self-report measure that examines sexual normative beliefs
measure: Alcohol use Disorders Identification Test
time frame: 6 months post-intervention
description: A self-report measure that examines alcohol use
measure: Comprehensive Effects of Alcohol
time frame: 6 months post-intervention
description: A self-report measure that examines expectancies of alcohol use
arm group label: Alcohol and Relaxation
arm group type: Active Comparator
description: This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention
arm group label: Alcohol and Relationships
arm group type: Active Comparator
description: This arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior. The interventions are based on an integrated BASICS and integrated Bystander protocols
intervention type: Behavioral
intervention name: BASICS
description: A one session intervention focused on reducing drinking with motivational interviewing
arm group label: Alcohol and Relaxation
intervention type: Behavioral
intervention name: Integrated BASICS
description: A one session intervention focused on reducing drinking and sexual behavior while drinking
arm group label: Alcohol and Relationships
intervention type: Behavioral
intervention name: Relaxation
description: A one session intervention focused on increasing relaxation skills
arm group label: Alcohol and Relaxation
intervention type: Behavioral
intervention name: Integrated Bystander
description: A one session intervention focused on reducing sexual assault with a focus on the role of alcohol
arm group label: Alcohol and Relationships
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian T Wymbs, PhD
role: Principal Investigator
affiliation: Ohio University
responsible party type: Sponsor
mesh term: Alcohol Drinking
sharing ipd: No