NCT02591212

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. 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. 1.Green Dot Intensive Bystander Training (INT) or
  2. 2.Student Wellness Training (active control). Students in each condition will be followed for 9 months, one academic year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 23, 2015

Last Update Submit

October 25, 2016

Conditions

Sexual Violence

Keywords

Bystanding behaviorsCampusPreventionSexual AssaultCampusSave

Outcome Measures

Primary Outcomes (4)

  • Number of Bystanding Behaviors increase bystander efficacy and behaviors by domain (alcohol abuse and violence prevention).

    The primary outcome for this study is bystanding behaviors as measured by the number of behaviors reported by students overall and by domain. Bystanding behaviors are measured through reports of actual behaviors. These primary bystanding behavior outcomes will be used to evaluate the relative efficacy of the intervention(s). As bystanding requires 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, 3 months post, 6 months post).

    One academic year (9 months)

  • Bystanding Behavior Intentions Scale

    One academic year (9 months)

  • Bystanding Behavior Efficacy Scale

    Academic Year (9 months)

  • Bystanding Behaviors Engagement with Peers Scale

    Academic Year (9 months)

Secondary Outcomes (2)

  • Acceptance of SV/DV Scale

    One academic year (9 months)

  • Number of risky behaviors, sexual and alcohol related

    One academic year (9 months)

Other Outcomes (1)

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

    One academic year (9 months)

Study Arms (2)

#ConnectDots

ACTIVE COMPARATOR

Green Dot Intensive Bystander Training (INT Condition) (Randomized): 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. Administered by: UK VIP Delivery Mode: Class or large groups of 100-150 students; training lasts 3 hours Required: Elective. All students randomized to this condition will be scheduled for training.

Behavioral: Green Dot

#ConnectWell

PLACEBO COMPARATOR

Wellness Initiatives for Student Empowerment delivered by UK's Student Wellness Office 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/Student Wellness Ambassadors Delivery Mode: Class or large groups of 100-150 students; training lasts 3 hours Required: Elective. All students randomized to this condition will be scheduled for training

Behavioral: Wellness Initiatives for Student Empowerment

Interventions

Green DotBEHAVIORAL

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.

#ConnectDots
Wellness Initiatives for Student EmpowermentBEHAVIORAL

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.

Also known as: WISE
#ConnectWell

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Incoming University of Kentucky undergraduate students (2015)

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, 40536-0293, United States

Location

Study Officials

  • Heather M Bush, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Ann L Coker, 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
PRINCIPAL INVESTIGATOR
PI Title
Kate Spade & Company Endowed Professor, Associate Professor, Biostatistics

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 29, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

US(1)