Sexual ViolenceP_ConnectEDNCT02591212
A Pilot of Bystander Training Programming in Sexual Violence and Subtance Abuse
A study testing Green Dot and Wellness Initiatives for Student Empowerment in people with Sexual Violence, run by University of Kentucky at 1 site in United States.
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 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Green Dot and Wellness Initiatives for Student Empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Incoming University of Kentucky undergraduate students (2015)
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, 40536-0293
About this study
Official title: Connecting Through Educational Training: A Pilot of Bystander Training Programming in Sexual Violence and Subtance Abuse
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:
- Green Dot Intensive Bystander Training (INT) or
- Student Wellness Training (active control). Students in each condition will be followed for 9 months, one academic year.
Read the detailed description
Overview: Incoming students will be invited to participate in a randomized pilot testing bystander program efficacy. Those consenting to study participation will be randomized to one of the three conditions. All students are required to take Online sexual violence, bystander and alcohol awareness training (UK mandated HAVEN + Alcohol Edu). Those consenting to study participation will be randomized to one of three conditions: Green Dot (INT) or Student Wellness skills training (active control) provided by UK Student Affairs staff in the Violence Intervention and Prevention Center or the Student Wellness Office. All students agreeing to study participation will be invited to complete surveys at baseline (prior to training), and at 2-3 months after training and 6 months following training (late April, early May). For this pilot, students will be contacted for participation in November of their first year, we anticipate approximately 1,500 students.
Mandatory (UK) Online Training: Alcohol abuse and violence prevention using bystander approach AlcoholEdu: 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.
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.
INT Condition (Randomized): Delivered by UK's Violence Intervention and Prevention (see letter from Director Henry):
Green Dot bystander intervention program (www.livethegreendot.com) Programming: 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. This is currently provided at UK in classrooms, residence halls, etc. Tailored programming is provided to Greek organizations, Living Learning Communities, faculty/staff, etc. While a Popular Opinion Leader strategy13 has been used in prior training, for this trial all incoming students randomized to this condition will be offered intensive bystander training.
Administered by: UK VIP Delivery Mode: Class or large groups of 120-150 students; training lasts 3-4 hours Required: Elective. All students randomized to this condition will be scheduled for training.
NOTE: Green Dot Speeches will be supplemental to Intensive Green Dot Bystander training. Speeches are often given through planned events (UK 101) or students, faculty or staff can request such presentations. 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.
Training Control Condition (Randomized): Delivered by UK's Student Wellness Office (Drew M. Smith) 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 Delivery Mode: Class or large groups of 120-150 students; training lasts 3-4 hours Required: Elective. All students randomized to this condition will be scheduled for training.
General Statistical Considerations. 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 for follow-ups at 4- and 9-months. 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).
Analysis Plan: The primary purpose of the pilot is to determine feasibility and to examine strategies for recruiting and training students. However, the primary analysis is the as randomized comparison of the cumulative reports of bystanding behaviors collected during the academic year between the two training conditions. A one-way ANOVA (with corresponding post-hoc tests to compare specific groups) will be used to compare the primary outcome of bystander behaviors (measured as the sum of frequency responses to bystander behaviors over the academic year) between those randomzied to INT versus SubINT conditions. Analyses will be conducted without adjustment, adjusting only for academic year, and adjusting for potential confounders not controlled for by randomization. Secondary outcomes will also be compared using a one-way ANOVA. A two-sided significance level of 0.01 will be used to protect against a Type I error in the presence of multiple comparisons. Post-hoc comparisons of groups will only be conducted when the overall F-test suggests differences between groups. All analyses for primary outcomes for will be conducted using comparison groups as randomized for an intent-to-treat (ITT) analysis. For those who are lost to follow-up, multiple imputation will be used in the ITT analysis. Sensitivity analyses using as observed data and single imputation (LOCF) will also be conducted. We will also perform analyses using a modified ITT (mITT), where participants electing not to pursue the intensive training are excluded, but groups are still compared as randomized. The primary analysis is the longitudinal analyses will be conducted using linear mixed models (PROC MIXED) to investigate differences between conditions, trends over time, and whether the time trends differ between conditions. Longitudinal analyses will be conducted by academic year but academic years will also be combined. For combined academic years, the time variable will be included with respect to the online training and academic year will be investigated as a potential confounder. 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). Participation and completing non-mandatory trainings will be examined overall and by subgroup as well. 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
- Green Dot, Wellness Initiatives for Student Empowerment
- Keywords
- Bystanding behaviors, Campus, Prevention, Sexual Assault, CampusSave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green DotBehavioural
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.
Wellness Initiatives for Student EmpowermentBehavioural
Also called WISE
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.
| Study group | Role | What they receive |
|---|---|---|
| #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. Receives: 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 Receives: Behavioral: Wellness Initiatives for Student Empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One academic year (9 months)
Bystanding Behavior Intentions Scale
Measured: One academic year (9 months)
Bystanding Behavior Efficacy Scale
Measured: Academic Year (9 months)
Bystanding Behaviors Engagement with Peers Scale
Measured: Academic Year (9 months)
Secondary outcomes (2)
Acceptance of SV/DV Scale
Measured: One academic year (9 months)
Number of risky behaviors, sexual and alcohol related
Measured: One academic year (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Heather Bush, University of Kentucky
- Investigators
- Heather M Bush, PhD, Principal investigator, University of KentuckyAnn L Coker, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591212
- Sponsor's protocol ID
- CDC R01CE 2690
- Acronym
- P_ConnectED
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Through Educational Training: A Pilot of Bystander Training Programming in Sexual Violence and Subtance Abuse
- ClinicalTrials.gov ID
- NCT02591212
- Acronym / sponsor ID
- P_ConnectED / CDC R01CE 2690
- Conditions
- Sexual Violence
- Keywords
- Bystanding behaviors, Campus, Prevention, Sexual Assault, CampusSave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Green Dot Intensive Bystander Training (INT) or
- Student Wellness Training (active control). Students in each condition will be followed for 9 months, one academic year.
Detailed description
Overview: Incoming students will be invited to participate in a randomized pilot testing bystander program efficacy. Those consenting to study participation will be randomized to one of the three conditions. All students are required to take Online sexual violence, bystander and alcohol awareness training (UK mandated HAVEN + Alcohol Edu). Those consenting to study participation will be randomized to one of three conditions: Green Dot (INT) or Student Wellness skills training (active control) provided by UK Student Affairs staff in the Violence Intervention and Prevention Center or the Student Wellness Office. All students agreeing to study participation will be invited to complete surveys at baseline (prior to training), and at 2-3 months after training and 6 months following training (late April, early May). For this pilot, students will be contacted for participation in November of their first year, we anticipate approximately 1,500 students.
Mandatory (UK) Online Training: Alcohol abuse and violence prevention using bystander approach AlcoholEdu: 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.
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.
INT Condition (Randomized): Delivered by UK's Violence Intervention and Prevention (see letter from Director Henry):
Green Dot bystander intervention program (www.livethegreendot.com) Programming: 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. This is currently provided at UK in classrooms, residence halls, etc. Tailored programming is provided to Greek organizations, Living Learning Communities, faculty/staff, etc. While a Popular Opinion Leader strategy13 has been used in prior training, for this trial all incoming students randomized to this condition will be offered intensive bystander training.
Administered by: UK VIP Delivery Mode: Class or large groups of 120-150 students; training lasts 3-4 hours Required: Elective. All students randomized to this condition will be scheduled for training.
NOTE: Green Dot Speeches will be supplemental to Intensive Green Dot Bystander training. Speeches are often given through planned events (UK 101) or students, faculty or staff can request such presentations. 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.
Training Control Condition (Randomized): Delivered by UK's Student Wellness Office (Drew M. Smith) 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 Delivery Mode: Class or large groups of 120-150 students; training lasts 3-4 hours Required: Elective. All students randomized to this condition will be scheduled for training.
General Statistical Considerations. 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 for follow-ups at 4- and 9-months. 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).
Analysis Plan: The primary purpose of the pilot is to determine feasibility and to examine strategies for recruiting and training students. However, the primary analysis is the as randomized comparison of the cumulative reports of bystanding behaviors collected during the academic year between the two training conditions. A one-way ANOVA (with corresponding post-hoc tests to compare specific groups) will be used to compare the primary outcome of bystander behaviors (measured as the sum of frequency responses to bystander behaviors over the academic year) between those randomzied to INT versus SubINT conditions. Analyses will be conducted without adjustment, adjusting only for academic year, and adjusting for potential confounders not controlled for by randomization. Secondary outcomes will also be compared using a one-way ANOVA. A two-sided significance level of 0.01 will be used to protect against a Type I error in the presence of multiple comparisons. Post-hoc comparisons of groups will only be conducted when the overall F-test suggests differences between groups. All analyses for primary outcomes for will be conducted using comparison groups as randomized for an intent-to-treat (ITT) analysis. For those who are lost to follow-up, multiple imputation will be used in the ITT analysis. Sensitivity analyses using as observed data and single imputation (LOCF) will also be conducted. We will also perform analyses using a modified ITT (mITT), where participants electing not to pursue the intensive training are excluded, but groups are still compared as randomized. The primary analysis is the longitudinal analyses will be conducted using linear mixed models (PROC MIXED) to investigate differences between conditions, trends over time, and whether the time trends differ between conditions. Longitudinal analyses will be conducted by academic year but academic years will also be combined. For combined academic years, the time variable will be included with respect to the online training and academic year will be investigated as a potential confounder. 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). Participation and completing non-mandatory trainings will be examined overall and by subgroup as well. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #ConnectDots | Active comparator | Behavioral: Green DotGreen 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. |
| #ConnectWell | Placebo comparator | Behavioral: Wellness Initiatives for Student EmpowermentWellness 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Incoming University of Kentucky undergraduate students (2015)
Key exclusion criteria (2 listed)
- Any current/non-incoming University of Kentucky student
- Any student primarily enrolled at another college or university
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green DotGreen 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. | Behavioural | #ConnectDots |
| Wellness Initiatives for Student EmpowermentAlso: WISEWellness 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. | Behavioural | #ConnectWell |
Primary outcome
Number of Bystanding Behaviors increase bystander efficacy and behaviors by domain (alcohol abuse and violence prevention).
Time frame: One academic year (9 months)
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).
Bystanding Behavior Intentions Scale
Time frame: One academic year (9 months)
Bystanding Behavior Efficacy Scale
Time frame: Academic Year (9 months)
Bystanding Behaviors Engagement with Peers Scale
Time frame: Academic Year (9 months)
2 secondary outcomes
Acceptance of SV/DV Scale
Time frame: One academic year (9 months)
Number of risky behaviors, sexual and alcohol related
Time frame: One academic year (9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather M Bush, PhD principal investigator
University of Kentucky
Ann L Coker, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Dot and Wellness Initiatives for Student Empowerment in people with Sexual Violence, run by University of Kentucky 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 26 Oct 2016. 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. Some participants in this study may receive a placebo. 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 Bystanding Behaviors increase bystander efficacy and behaviors by domain (alcohol abuse and violence prevention). (time frame: One academic year (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 26 Oct 2016.