NCT02786472

Brief 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. 1.In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training (GreenDot);
  2. 2.In-person Green Dot Intensive Bystander Training combined with Substance Abuse Prevention Training;
  3. 3.Online Bystander-based Sexual Violence Prevention Training (Haven), and;
  4. 4.Online Substance Abuse Training (AlcoholEdu).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.6 years

First QC Date

May 20, 2016

Last Update Submit

February 19, 2020

Conditions

Keywords

Bystander behaviorsIncoming studentsCampusSavePreventionSexual AssaultIncapacitation

Outcome Measures

Primary Outcomes (4)

  • Number of Bystander Behaviors

    The primary outcome for this study is bystander behaviors as measured by the number of behaviors reported by students overall and by domain. Bystander behaviors are measured through reports of actual behaviors. These primary bystander behavior outcomes will be used to evaluate the relative efficacy of the intervention(s). As bystander behaviors require opportunity, these primary outcomes will be examined accounting for the presence of opportunity to bystand. The primary analysis will be the comparison of these outcomes over time using mixed models, with a particular interest on whether there is a condition by time interaction (time: baseline, 5 months post, 9 months post).

    baseline, 5 months and 9 months

  • Change in Bystander Behavior Intentions Scale

    Students will report their intention to engage in bystander behaviors. The scale used to report this is a five point Likert scale. Questions include measures such as, likelihood of becoming involved based on their relation to the individual and likelihood to report based on disciplinary actions. The changes that are measured throughout the academic year will be used to report intentions in bystander behavior.

    baseline, about 5 months and 9 months

  • Change in Bystander Behavior Efficacy Scale

    Students will report their self efficacy in their ability to preform bystander behaviors. The scale used to report this efficacy is a five point Likert scale. Questions include measures such as, self reported ability to recognize risky situations and reported skill set of prevention of violence behaviors. The changes that are measured throughout the academic year will be used to report efficacy in bystander behavior.

    baseline, 5 months and 9 months

  • Count of Bystander Behaviors Engagement with Peers

    Students will report bystander behaviors that they participated in with their peers. These are reported using multiple choice and open ended questions to describe the event and the action taken by an individual who engaged in a bystander behavior. Questions include what bystander action was preformed, where the incident occurred, and number of times this event occurred. The number of times students indicate these behaviors will be combined across surveys.

    about 2 months, about 4 months, 5 months, about 7 months, and 9 months

Secondary Outcomes (2)

  • Change in Acceptance of SV/DV Scale

    baseline, 5 months and 9 months

  • Count of self-reported risky behaviors, sexual and alcohol related

    baseline, 5 months and 9 months

Other Outcomes (1)

  • Social media and campus communications (e.g., Twitter, Instagram, Facebook, myUK)

    One Academic Year (9 months)

Study Arms (4)

Haven

ACTIVE COMPARATOR

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.

Behavioral: Online Bystander Training

AlcoholEdu

ACTIVE COMPARATOR

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.

Behavioral: Online Substance Abuse Training

ConnectEd

EXPERIMENTAL

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.

Behavioral: In-Person Combination Training

GreenDot

EXPERIMENTAL

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.

Behavioral: In-Person Bystander Training

Interventions

Large groups of 120-150 students will complete Haven training via computer; training lasts duration of the online program.

Also known as: Haven
Haven

Large groups of 120-150 students will complete EverFi training via computer; training lasts duration of the online program.

Also known as: AlcoholEdu
AlcoholEdu

In-person training of large groups of 120-150 students; training lasts 3-4 hours

Also known as: Green Dot
GreenDot

In-person training of large groups of 120-150 students; training lasts 3-4 hours

Also known as: ConnectEd
ConnectEd

Eligibility Criteria

Age17 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0082, United States

Location

MeSH Terms

Interventions

Convolutional Neural Networks

Intervention Hierarchy (Ancestors)

Neural Networks, ComputerMathematical Concepts

Study Officials

  • Heather M Bush, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR
  • Ann L Coker, MPH, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Biostatistics

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations