Connect_ED: A Randomized Controlled Trial Connecting Through Educational Training

Overview: 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 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), Green
Dot Substance (SubINT), 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). 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 6,000 participants from all three academic years.

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, Years 1-3): 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.

SUBINT Condition (Randomized, Years 2 and 3): Green Dot Intensive Bystander Training AND
Substance Abuse Prevention cross-programming. The intentional coordination between substance
abuse and violence prevention programming could become a national model, as many
institutions have difficulty navigating the two areas. Proposed methods of education,
intervention, and prevention include: utilization of similar wording, messaging, and
nomenclature between areas, development of cross-messaging in presentations and workshops
made by both offices, creation of a joint strategic plan between the VIP Center and the WISE
through the utilization of information gathered in the CORE Alcohol and Drug Survey, CATS ,
AlcoholEdu, and Haven.

Administered by UK VIP AND UK Wellness Program 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

Proposed structure of this joint program would include:

- Basic description of the issues of interpersonal violence and substance use/abuse.

- Persuasive components to highlight the presenter's connection to this issue and to
encourage participants to explore their own connection.

- An introduction to the "Three D's" of intervention in problematic situations. In depth
training would be provided to select audiences in group settings. This would include:
In-depth information related to interpersonal violence and substance use/abuse,
activities to help participants explore their connection to these issues; information
and activities related to the culture of violence, drinking and drug use and how
everyone has a role in impacting that culture; information about bystanding and
barriers to taking action when they encounter problem situations; participant
self-evaluation of their own attitudes, beliefs and biases around these issues;
in-depth skill building activities to prepare participants to safely intervene in
problem situations; plans for follow up meetings with participants to continue to
provide information and build connection between participants from various SUBINT
groups.

- SUBINT is being used only for this proposal and would not be the permanent name of
this project.

Training Control Condition (Randomized, Years 1-3): 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 analysis is the as randomized comparison of the cumulative
reports of bystanding behaviors collected during the academic year between the three
training conditions. The primary analysis will involve the comparison of the three
conditions in academic years starting in Fall 2016 and 2017, but comparisons of online alone
and Green Dot will also be conducted using all three years of academic data. A one-way ANOVA
(with corresponding post-hoc tests to compare specific groups) will be used to compare the
primary outcome of bystanding behaviors (measured as the sum of frequency responses to
bystander behaviors over the academic year) between those with online alone versus those
with add-on training (INT or 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. Although efforts will be made to fully explain the
INT prior to randomization, it is expected that those randomized to receive INT may not
elect to participate in the intensive trainings; this expectation is reflected in smaller
planned effect sizes. However, 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. Additional
analyses using the same methodological strategies will also be conducted considering all
incoming cohorts (2015-17) for comparisons between Green Dot and online alone; these will be
considered secondary as the primary goal is to examine the relative efficacy of the three
conditions. 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.

Inclusion Criteria:

-Incoming University of Kentucky undergraduate students in academic years starting in
2015, 2016, and 2017

Exclusion Criteria:

- Any current/non-incoming University of Kentucky student

- Any student primarily enrolled at another college or university