ConnectEd: A Randomized Controlled Trial Connecting Through Educational Training
Condition: Sexual Violence
Study type: Interventional

Summary: 
      The purpose of this randomized intervention pilot is to evaluate the relative efficacy of
      bystander training elements (delivery mode and integration of substance abuse prevention)
      among cohorts of incoming undergraduates at the University of Kentucky, a nationally
      recognized leader in addressing sexual violence through bystander intervention programming.
      Consenting students will be randomized to one of the following training conditions:

        1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training
           (GreenDot);

        2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse
           Prevention Training;

        3. Online Bystander-based Sexual Violence Prevention Training (Haven), and;

        4. Online Substance Abuse Training (AlcoholEdu).
    

Detailed description: 
      Rates of sexual violence (SV) or dating violence (DV) remain high among college students (22%
      in the past year for female undergraduates). Binge drinking commonly occurs (25% of
      undergraduates report binge drinking in the past month) and is a strong predictor of sexual
      risk taking and violence victimization and perpetration. Given connections between SV/DV risk
      and alcohol use and abuse, many advocate prevention programming to jointly address SV/DV and
      alcohol abuse. Bystander interventions, recognized as promising violence prevention
      strategies, are unique in their engagement of all community members to 1) recognize
      situations that may become violent and 2) learn to safely and effectively intervene to reduce
      violence risk. Based on their promise, the Campus Sexual Violence Elimination Act (SaVE) now
      requires all publicly-funded colleges to provide bystander intervention in the hopes of
      reducing sexual violence. No randomized intervention trial has compared bystander
      interventions focused exclusively on SV/DV prevention with those additionally addressing
      alcohol abuse prevention within the bystander context. We propose such an experimental trial
      at the University of Kentucky (UK), a nationally recognized leader in addressing sexual
      violence through bystander intervention programming. The purpose of this randomized
      intervention trial is to evaluate the relative efficacy of bystander training elements. In
      this study will be randomized to one of the following: 1) Online Bystander Training (Haven),
      2) Online Substance Abuse Training (AlcoholEdu), 3) In-person Bystander Training (Green Dot
      Intensive Training), or 4) In-person Bystander/Substance Abuse Training (ConnectEd). Aim 1:
      Evaluate methods to capture behaviors and diffusion of training through social media
      communications (e.g., Facebook, Twitter, Instagram). Aim 2: Determine the relative efficacy
      of the three bystander training conditions to a) increase bystander efficacy and behaviors by
      domain (alcohol abuse and violence prevention), b) reduce acceptance of SV/DV, alcohol's role
      in sexuality, and alcohol use / abuse, and c) reduce risk taking behaviors by domains of
      sexual behavior and alcohol use or abuse. Aim 3: Determine the relative cost of implementing
      bystander approaches and their cost effectiveness. Design: Incoming UK undergraduates will be
      recruited and randomized to one of the four conditions and followed for 9 months, one
      academic year (n=4000, total over 2 academic year cohorts). A mixed-method approach will be
      used to measure intervention fidelity and costs over time and by condition. Using the most
      rigorous design available, we seek to generate new understanding of how novel bystander
      intervention approaches work to reduce not only SV/DV risk taking behaviors but also reduce
      alcohol abuse.

      Incoming students will be invited to participate in a randomized trial testing bystander
      program efficacy. Those consenting to study participation will be randomized to one of the
      four conditions. These conditions include:

        1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training
           (GreenDot);

        2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse
           Prevention Training (WellAware);

        3. Online Bystander-based Sexual Violence Prevention Training (Haven), and;

        4. Online Substance Abuse Training (AlcoholEdu).

      All incoming students (17-24) agreeing to study participation will be invited to complete
      surveys at baseline (prior to training), and at end of the fall and spring semesters.
      Additionally, students will be asked to complete micro-surveys using the myUK app.

      Student recruitment will be conducted as students are entering UK during their summer
      orientation (June and July). We anticipate that at 45-50% of students will agree to study
      participation and provide data; thus our final participant pool is expected to consist of
      4,000 participants from academic years 2016 and 2017.

      Continuous variables will be summarized with descriptive statistics (n, mean, standard
      deviation, median, first and third quartiles, and min and max); categorical variables will be
      described with counts and percentages. Change scores and percent change scores will be
      calculated from baseline (prior to start of first academic year) as well as from end of Fall
      to Spring within each academic year. Numerical and graphical summaries will be provided
      overall, by subpopulation within college communities (e.g., by gender, sexual attraction,
      fraternity/sorority or athletic team membership) and most importantly by training condition.
      Simple comparisons of groups will be made using ANOVA for continuous variables and chi-square
      tests for categorical outcomes. Comparisons between groups will be conducted as randomized;
      simple comparisons of continuous variables between groups will be performed using ANOVA and
      chi-square tests of independence for categorical variables. Although groups will be randomly
      assigned, potential confounders will be examined with bivariate analyses and comparisons
      requiring covariate adjustment will use regression modeling (e.g. ANCOVA, logistic
      regression). Planned subgroup analyses include analyses by gender group, by sexual
      attraction, by Greek life participation. These will also be conducted as randomized and as
      received. Effect modification will also be assessed by including interactions in regression
      models (linear, logistic, and mixed models depending on outcomes and the presence of
      longitudinal measures). SAS v9.4 will be used for all data management and statistical
      analysis; a significance level of 0.01 will be used for all statistical tests.
    

Intervention name(s): Online Bystander Training; Online Substance Abuse Training; In-Person Bystander Training; In-Person Combination Training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Large groups of 120-150 students will complete Haven training via computer; training lasts duration of the online program.; Large groups of 120-150 students will complete EverFi training via computer; training lasts duration of the online program.; In-person training of large groups of 120-150 students; training lasts 3-4 hours; In-person training of large groups of 120-150 students; training lasts 3-4 hours
Other intervention name(s): Haven; AlcoholEdu; Green Dot; ConnectEd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Bystander behaviors; Incoming students; CampusSave; Prevention; Sexual Assault; Incapacitation