A Pilot of Bystander Training Programming in Sexual Violence and Subtance Abuse
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.
      Per university policy, all incoming undergraduates will participate in mandatory online
      training covering sexual violence awareness, bystander concepts, and alcohol use/abuse.
      Consenting students will be randomized to one of the following training conditions:

        1. Green Dot Intensive Bystander Training (INT) or

        2. Student Wellness Training (active control). Students in each condition will be followed
           for 9 months, one academic year.
    

Detailed description: 
      Overview: Incoming students will be invited to participate in a randomized pilot testing
      bystander program efficacy. Those consenting to study participation will be randomized to one
      of the three conditions. All students are required to take Online sexual violence, bystander
      and alcohol awareness training (UK mandated HAVEN + Alcohol Edu). Those consenting to study
      participation will be randomized to one of three conditions: Green Dot (INT) or Student
      Wellness skills training (active control) provided by UK Student Affairs staff in the
      Violence Intervention and Prevention Center or the Student Wellness Office. All students
      agreeing to study participation will be invited to complete surveys at baseline (prior to
      training), and at 2-3 months after training and 6 months following training (late April,
      early May). For this pilot, students will be contacted for participation in November of their
      first year, we anticipate approximately 1,500 students.

      Mandatory (UK) Online Training: Alcohol abuse and violence prevention using bystander
      approach AlcoholEdu: Confidential substance abuse education course which uses a science-based
      approach to educate students about alcohol and its effects. Whether the student drinks or
      not, the course will help them make informed decisions about alcohol and better deal with
      drinking behavior that may occur around them. AlcoholEdu is used by more than 500 colleges
      nationwide through EVERFi.

      Haven provides students with definitions and statistics associated with sexual assault and
      relationship violence, bystander skills and strategies, and campus policies and resources.
      The trainings are "personalized and reflective" and incorporate the student's "unique
      perspectives and experiences." This 45-minute training is mandatory and students are asked to
      complete a follow-up survey 45-days after the training. Because this training is mandatory
      for all incoming students, all students are expected to have exposure to this training.

      INT Condition (Randomized): Delivered by UK's Violence Intervention and Prevention (see
      letter from Director Henry):

      Green Dot bystander intervention program (www.livethegreendot.com) Programming: Seeks to
      empower potential bystanders (students) to actively engage their peers in violence
      prevention. Intensive bystander training involves interactive, skill development with
      role-play of bystander behaviors. This program focuses on building knowledge and skills
      related to interpersonal violence and being an active bystander. There is a structured
      curriculum for both introductory sessions and longer, skill-building sessions. This is
      currently provided at UK in classrooms, residence halls, etc. Tailored programming is
      provided to Greek organizations, Living Learning Communities, faculty/staff, etc. While a
      Popular Opinion Leader strategy13 has been used in prior training, for this trial all
      incoming students randomized to this condition will be offered intensive bystander training.

      Administered by: UK VIP Delivery Mode: Class or large groups of 120-150 students; training
      lasts 3-4 hours Required: Elective. All students randomized to this condition will be
      scheduled for training.

      NOTE: Green Dot Speeches will be supplemental to Intensive Green Dot Bystander training.
      Speeches are often given through planned events (UK 101) or students, faculty or staff can
      request such presentations. These speeches will continue to occur as usual. As the aim of
      this study is to compare bystander intensive training, we will not attempt to limit
      participation to Green Dot Speeches.

      Training Control Condition (Randomized): Delivered by UK's Student Wellness Office (Drew M.
      Smith) Programming: Addresses elements of student wellness including campus resources for
      health issues, AOD abuse prevention/harm reduction strategies, time management and study
      tips, stress management and reduction, and healthy coping strategies. Training may also
      provide information on academic resources, money management, and other elements of healthy
      adaptation to college life.

      Administered by: UK VIP Delivery Mode: Class or large groups of 120-150 students; training
      lasts 3-4 hours Required: Elective. All students randomized to this condition will be
      scheduled for training.

      General Statistical Considerations. 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 for follow-ups at 4- and 9-months.
      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).

      Analysis Plan: The primary purpose of the pilot is to determine feasibility and to examine
      strategies for recruiting and training students. However, the primary analysis is the as
      randomized comparison of the cumulative reports of bystanding behaviors collected during the
      academic year between the two training conditions. A one-way ANOVA (with corresponding
      post-hoc tests to compare specific groups) will be used to compare the primary outcome of
      bystander behaviors (measured as the sum of frequency responses to bystander behaviors over
      the academic year) between those randomzied to INT versus SubINT conditions. Analyses will be
      conducted without adjustment, adjusting only for academic year, and adjusting for potential
      confounders not controlled for by randomization. Secondary outcomes will also be compared
      using a one-way ANOVA. A two-sided significance level of 0.01 will be used to protect against
      a Type I error in the presence of multiple comparisons. Post-hoc comparisons of groups will
      only be conducted when the overall F-test suggests differences between groups. All analyses
      for primary outcomes for will be conducted using comparison groups as randomized for an
      intent-to-treat (ITT) analysis. For those who are lost to follow-up, multiple imputation will
      be used in the ITT analysis. Sensitivity analyses using as observed data and single
      imputation (LOCF) will also be conducted. We will also perform analyses using a modified ITT
      (mITT), where participants electing not to pursue the intensive training are excluded, but
      groups are still compared as randomized. The primary analysis is the longitudinal analyses
      will be conducted using linear mixed models (PROC MIXED) to investigate differences between
      conditions, trends over time, and whether the time trends differ between conditions.
      Longitudinal analyses will be conducted by academic year but academic years will also be
      combined. For combined academic years, the time variable will be included with respect to the
      online training and academic year will be investigated as a potential confounder. 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).
      Participation and completing non-mandatory trainings will be examined overall and by subgroup
      as well. 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): Green Dot; Wellness Initiatives for Student Empowerment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Green Dot bystander intervention program (www.livethegreendot.com) seeks to empower potential bystanders (students) to actively engage their peers in violence prevention. Intensive bystander training involves interactive, skill development with role-play of bystander behaviors. This program focuses on building knowledge and skills related to interpersonal violence and being an active bystander. There is a structured curriculum for both introductory sessions and longer, skill-building sessions.; Wellness training to be provided in modules by Student Wellness ambassadors (http://www.uky.edu/wise). The Student Wellness Ambassadors mission is to inform students on aspects of wellness such as alcohol, drugs, mental health, general well-being, and financial wellness in orer to promote safe and responsible lifestyle decisions. Intervention will address elements of student wellness including campus resources for health issues, AOD abuse prevention/harm reduction strategies, time management and study tips, stress management and reduction, and healthy coping strategies. Training may also provide information on academic resources, money management, and other elements of healthy adaptation to college life.
Other intervention name(s): WISE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Bystanding behaviors; Campus; Prevention; Sexual Assault; CampusSave