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ConnectEd: A Randomized Controlled Trial Connecting Through Educational Training

H

Heather Bush

Status

Completed

Conditions

Sexual Violence

Treatments

Behavioral: In-Person Bystander Training
Behavioral: Online Bystander Training
Behavioral: Online Substance Abuse Training
Behavioral: In-Person Combination Training

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02786472
CDC R01CE 2690.1

Details and patient eligibility

About

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).

Full 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.

Enrollment

3,178 patients

Sex

All

Ages

17 to 24 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

-Incoming University of Kentucky undergraduate students (2016, 2017)

Exclusion criteria

  • Any current/non-incoming University of Kentucky student
  • Any student primarily enrolled at another college or university

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3,178 participants in 4 patient groups

Haven
Active Comparator group
Description:
Online Bystander Training or 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.
Treatment:
Behavioral: Online Bystander Training
AlcoholEdu
Active Comparator group
Description:
Online Substance Abuse Training or AlcoholEdu provides 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.
Treatment:
Behavioral: Online Substance Abuse Training
ConnectEd
Experimental group
Description:
In-person Combination Training provides Green Dot Intensive Bystander Training AND Substance Abuse Prevention cross-programming to develop ConnectED. The intentional coordination between substance abuse and violence prevention programming 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 bystander behaviors and barriers to taking action when they encounter problem situations; participant self-evaluation of their own attitudes, beliefs and biases around these issues; and, in-depth skill building activities to prepare participants to safely intervene in problem situations.
Treatment:
Behavioral: In-Person Combination Training
GreenDot
Experimental group
Description:
In-person Bystander Training provides 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. While a Popular Opinion Leader strategy has been used in prior training, for this trial all incoming students randomized to this condition will be offered intensive bystander training. NOTE: Green Dot Speeches will be supplemental to Intensive Green Dot Bystander training. 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.
Treatment:
Behavioral: In-Person Bystander Training

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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