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ConnectEd: A Randomized Controlled Trial Connecting Through Educational Training (ConnectEd)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786472
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Heather Bush, University of Kentucky

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. 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).

Condition or disease Intervention/treatment Phase
Sexual Violence Behavioral: Online Bystander Training Behavioral: Online Substance Abuse Training Behavioral: In-Person Bystander Training Behavioral: In-Person Combination Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: ConnectEd: A Randomized Controlled Trial Connecting Through Educational Training
Study Start Date : May 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Haven
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
Large groups of 120-150 students will complete Haven training via computer; training lasts duration of the online program.
Other Name: Haven

Active Comparator: AlcoholEdu
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
Large groups of 120-150 students will complete EverFi training via computer; training lasts duration of the online program.
Other Name: AlcoholEdu

Experimental: ConnectEd
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
In-person training of large groups of 120-150 students; training lasts 3-4 hours
Other Name: ConnectEd

Experimental: GreenDot

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
In-person training of large groups of 120-150 students; training lasts 3-4 hours
Other Name: Green Dot




Primary Outcome Measures :
  1. Number of Bystander Behaviors [ Time Frame: baseline, 5 months and 9 months ]
    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).

  2. Change in Bystander Behavior Intentions Scale [ Time Frame: baseline, about 5 months and 9 months ]
    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.

  3. Change in Bystander Behavior Efficacy Scale [ Time Frame: baseline, 5 months and 9 months ]
    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.

  4. Count of Bystander Behaviors Engagement with Peers [ Time Frame: about 2 months, about 4 months, 5 months, about 7 months, and 9 months ]
    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.


Secondary Outcome Measures :
  1. Change in Acceptance of SV/DV Scale [ Time Frame: baseline, 5 months and 9 months ]
    Students will be asked questions that describe their acceptance of sexual violence and dating violence. The scale used to report this acceptance are a five point Likert scale. Questions include measures such as, fights add excitement to a romantic relationship and people who wear revealing clothing are asking for trouble. The changes that are measured throughout the academic year will be used to report change in acceptance of sexual violence and dating violence behaviors.

  2. Count of self-reported risky behaviors, sexual and alcohol related [ Time Frame: baseline, 5 months and 9 months ]
    Students will be asked about frequency of binge drinking, incapacitation, and opportunities to observe high risk situations. The number of times students indicate these behaviors will be combined across follow-up surveys.


Other Outcome Measures:
  1. Social media and campus communications (e.g., Twitter, Instagram, Facebook, myUK) [ Time Frame: One Academic Year (9 months) ]
    This is an exploratory outcome to determine potential diffusion of interventions. Students electing to participate in this part of the trial, will have posts and comments aggregated over the study period. Sentiment analysis and word clouds will be used to determine if language from trainings diffuse into social media communications.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786472


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0082
Sponsors and Collaborators
Heather Bush
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Heather M Bush, PhD University of Kentucky
Principal Investigator: Ann L Coker, MPH, PhD University of Kentucky
  Study Documents (Full-Text)

Documents provided by Heather Bush, University of Kentucky:
Informed Consent Form  [PDF] March 4, 2018

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Responsible Party: Heather Bush, Associate Professor, Biostatistics, University of Kentucky
ClinicalTrials.gov Identifier: NCT02786472    
Other Study ID Numbers: CDC R01CE 2690.1
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heather Bush, University of Kentucky:
Bystander behaviors
Incoming students
CampusSave
Prevention
Sexual Assault
Incapacitation