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Sexual ViolenceConnectEdNCT02786472

ConnectEd: A Randomized Controlled Trial Connecting Through Educational Training

A study testing Online Bystander Training, Online Substance Abuse Training and In-Person Bystander Training in people with Sexual Violence, run by Heather Bush at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Sexual Violence
What is being tested?
Online Bystander Training, Online Substance Abuse Training and In-Person Bystander Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,178 participants
Where
1 siteUnited States
Study dates
May 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40536-0082

Other trials in United States

About this study

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).
Read the detailed 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.

Conditions
Sexual Violence
Being tested
Online Bystander Training, Online Substance Abuse Training, In-Person Bystander Training, In-Person Combination Training
Keywords
Bystander behaviors, Incoming students, CampusSave, Prevention, Sexual Assault, Incapacitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Bystander TrainingBehavioural

    Also called Haven

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

  • Online Substance Abuse TrainingBehavioural

    Also called AlcoholEdu

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

  • In-Person Bystander TrainingBehavioural

    Also called Green Dot

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

  • In-Person Combination TrainingBehavioural

    Also called ConnectEd

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

Study groups in NCT02786472
Study groupRoleWhat they receive
HavenActive comparatorOnline 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.
Receives: Behavioral: Online Bystander Training
AlcoholEduActive comparatorOnline 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.
Receives: Behavioral: Online Substance Abuse Training
ConnectEdExperimentalIn-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.
Receives: Behavioral: In-Person Combination Training
GreenDotExperimentalIn-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.
Receives: Behavioral: In-Person Bystander Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline, 5 months and 9 months

  2. 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.

    Measured: baseline, about 5 months and 9 months

  3. 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.

    Measured: baseline, 5 months and 9 months

  4. 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.

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

Secondary outcomes (2)
  1. Change in Acceptance of SV/DV Scale

    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.

    Measured: baseline, 5 months and 9 months

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

    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.

    Measured: baseline, 5 months and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
3,178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786472
Sponsor's protocol ID
CDC R01CE 2690.1
Acronym
ConnectEd
Status last verified
Feb 2020
First submitted
20 May 2016
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Bystander Training, Online Substance Abuse Training and In-Person Bystander Training in people with Sexual Violence, run by Heather Bush at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Bystander Behaviors (time frame: baseline, 5 months and 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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