Sexual ViolenceNCT02659423
Multi-College Bystander Efficacy Evaluation
An observational study of Sexual Violence, run by Ann Coker at 1 site in United States.
Trial summary
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. 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?
- BIC 1, BIC 2 and BIC 3
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2020
- Phase
- Observational
- 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
Study population: Public universities with junior faculty to be mentored in violence prevention Note: sampling unit for primary analyses is the college: answers to questions below refer to students clustered at each institution
Who may be able to join
- Public universities with junior faculty to be mentored in violence prevention
- Undergraduate students at the public 4 year colleges or universities, ages 18-24
Who cannot join
- Private universities, institutions with less than 10,000 undergraduate students
- Graduate or professional students, non-degree seeking or not enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40536-0293
About this study
Official title: Growing Researcher and College Communities Supporting Violence Prevention Research
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. With SaVE's policy intervention requiring bystander interventions, a "natural experiment" has arisen to determine the relative efficacy of students' bystander training across multiple colleges. Investigators propose a quasi-experimental design (using fractional factorials) to evaluate the relative efficacy of three bystander interventions to reduce violence in college communities. Green Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has found that Green Dot is associated with a 20-40% reduction in VAW in college and high school settings.
In aim 1, investigators will compare the relative efficacy of bystander interventions to a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce interpersonal violence victimization and perpetration, and d) increase program cost effectiveness. The three main bystander groups compared will be: exclusively online training, Green Dot (speeches and intensive bystander training), and other skills-based bystander training. Program efficacy data will be obtained from student surveys, campus crime statistics, and surveys with college staff and administrators responsible for selecting and implementing bystander interventions.
Read more
In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher communities will form through researchers' engagement with college recruitment, survey design, data collection and analyses. Specifically investigators will determine the efficacy of this program to increase VAW prevention research productivity defined as a) increasing research skills and b) increasing research communications measured as manuscript submissions, presentations, and publications.
This natural experiment will generate new understanding into efficacy of how bystander programs work. This natural experiment will also provide the VAW research community an opportunity to increase our skill-sets and share our experiences with and help grow the next generation of VAW prevention researchers.
Read the detailed description
- SPECIFIC AIMS Goal 1. Grow Colleges as Communities for Primary Prevention of Violence Against Women Research The opportunity: Because the 2013 Campus Sexual Violence Elimination Act1 (SaVE) now requires bystander training in all publicly funded colleges and universities (hereafter colleges), a "natural experiment" presents itself to determine what components of bystander interventions have greater efficacy. Inclusion of multiple college communities (n=24) provides sufficient statistical power for these comparisons. The timing of this U01 (RFA-CE-15-003) is strategically important for the work investigators propose: to evaluate the efficacy of bystander interventions components (BIC) to reduce violence against women (VAW: operationally defined as intimate partner violence (IPV) and sexual violence (SV)). Investigators propose a quasi-experimental design using fractional factorials. Data to measure program efficacy for bystander and violent behavior outcomes will be obtained from student surveys and campus crime data. Key informant interviews with college administrators responsible for selection and implementation of bystander programs will describe components and attributes of bystander programs important for colleges' adoption, implementation and retention of bystander programs over the 4 years.
The purpose of this quasi-experimental, multi-college study is to evaluate the relative efficacy of newly implemented bystander interventions over time. Because all colleges must adopt an intervention, comparisons will be made prospectively before and after implementation and across program interventions.
Aim 1. Compare the relative efficacy of bystander interventions to a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce violence victimization and perpetration, and d) increase program cost effectiveness. Three BIC comparisons will be: exclusively online training, Green Dot, and other skills-based, interactive bystander programs. Whether training is mandatory will also be evaluated.
Hypothesis 1: Relative to colleges implementing exclusively online training, colleges implementing Green Dot (or other skills-based programs) will significantly a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce violence victimization and perpetration, and d) demonstrate greater cost effectiveness to reduce VAW.
Goal 2. Grow Communities of Violence Against Women Prevention Researchers The opportunity: This "natural experiment" also offers a unique opportunity for more senior VAW prevention researchers to share their expertise with each other and with more junior researchers, i.e. grow a researcher community. Team science is increasingly required in violence prevention research yet funding mechanisms supporting cross-institutional and cross-disciplinary career development grants in violence prevention are limited.
The purpose: Investigators propose a researcher community collaborative to grow the next generation of VAW researchers. Through engaging multiple public universities as our research community partners (Goal 1), investigators have the added opportunity to partner as a researcher community to both a) conduct better research because a broader skill-set can be engaged and b) share our research skill-sets with more junior researchers.
Aim 2. Determine the efficacy of this collaborative to increase VAW prevention researchers' productivity defined as a) research skills and b) research communications measured as manuscript submissions, presentations, and publications. Both senior and junior researchers will be members of this collaborative and included in prospective qualitative and quantitative assessment.
Hypothesis 2: Participation within research communities will, over time, increase research productivity for both senior and more junior collaborative members relative to their productivity prior to study participation.
Expected outcomes:
(Aim 1) This study will identify components of bystander programs associated with greater violence prevention efficacy and greater cost-effectiveness. Currently colleges have limited data or experience to make informed decisions regarding selecting a bystander intervention, now required by SaVE. With the range of bystander program comparisons afforded by including up to 24 multiple college communities, investigators will have the ability to measure relative bystander program efficacy (which programs are associated with the greater reduction in violence), which programs are associated with lower program implementation costs, and the programs associated with the lower cost to violence reduction ratio.
(Aim 2) As both senior and junior researchers are engaged in college recruitment, mixed-method data collection, and data analyses, research skill-sets will be shared such that senior researchers learn newer research approaches and junior researchers learn skills in survey design and conduct, measurement and surveying on sensitive topics), data analyses, and research communication.
Benchmarks for Success will be measured: [Aim 1] as our ability to recruit 24 colleges, conduct key informant interviews and annual undergraduate surveys, and final analyses by Fall 2019; and [Aim 2] by our ability, as a collaborative, to recruit and retain VAW prevention researchers from identified colleges and provide mentoring and training needed to advance their research skills.
- Conditions
- Sexual Violence
- Being tested
- BIC 1, BIC 2, BIC 3
- 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.
BIC 1Behavioural
BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
BIC 2Behavioural
BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
BIC 3Behavioural
BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
| Study group | Role | What they receive |
|---|---|---|
| Green Dot BIC 1 | Bystander Intervention Components Clusters will include at least a component of Green Dot.
E.g. Comparisons will be made across schools that have Green Dot versus those that don't have Green Dot. (BIC 1) Receives: Behavioral: BIC 1 | |
| Online BIC 2 | Bystander Intervention Components Clusters will include at least a component of online bystander training.
E.g. Comparisons will be made across schools that have online bystander training versus those that do not. (BIC 2) Receives: Behavioral: BIC 2 | |
| Alternative programs BIC 3 | Bystander Intervention Components Clusters will include at least a component of Green Dot.
E.g. Comparisons will be made across schools that have alternative program versus those that do not. (BIC 3) Receives: Behavioral: BIC 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Violence Victimization and Perpetration at the college level using AAU measures of sexual violence, dating violence, sexual harassment and stalking
Interpersonal Violence defined as sexual violence, partner violence, stalking and sexual harassment
Measured: Up to 60 months
Secondary outcomes (1)
Bystander behavior measures at the college level based on of Banyard, Plante & Monynihan bystanding scale
Bystander intentions, perceived efficacy, behaviors and actions to engage peers in prevention
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionDec 2020
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann Coker
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Ann Coker, University of Kentucky
- Investigators
- Ann L Coker, PhD, Principal investigator, University of KentuckyHeather M Bush, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659423
- Sponsor's protocol ID
- RFA-CE-15-003
- Status last verified
- Mar 2021
- First submitted
- 11 Jan 2016
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Researcher and College Communities Supporting Violence Prevention Research
- ClinicalTrials.gov ID
- NCT02659423
- Acronym / sponsor ID
- RFA-CE-15-003
- Conditions
- Sexual Violence
- Keywords
- Bystanding behaviors, Campus, Prevention, Sexual Assault, CampusSave
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ann CokerUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Jan 2016 (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.
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. With SaVE's policy intervention requiring bystander interventions, a "natural experiment" has arisen to determine the relative efficacy of students' bystander training across multiple colleges. Investigators propose a quasi-experimental design (using fractional factorials) to evaluate the relative efficacy of three bystander interventions to reduce violence in college communities. Green Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has found that Green Dot is associated with a 20-40% reduction in VAW in college and high school settings.
In aim 1, investigators will compare the relative efficacy of bystander interventions to a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce interpersonal violence victimization and perpetration, and d) increase program cost effectiveness. The three main bystander groups compared will be: exclusively online training, Green Dot (speeches and intensive bystander training), and other skills-based bystander training. Program efficacy data will be obtained from student surveys, campus crime statistics, and surveys with college staff and administrators responsible for selecting and implementing bystander interventions.
In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher communities will form through researchers' engagement with college recruitment, survey design, data collection and analyses. Specifically investigators will determine the efficacy of this program to increase VAW prevention research productivity defined as a) increasing research skills and b) increasing research communications measured as manuscript submissions, presentations, and publications.
This natural experiment will generate new understanding into efficacy of how bystander programs work. This natural experiment will also provide the VAW research community an opportunity to increase our skill-sets and share our experiences with and help grow the next generation of VAW prevention researchers.
Detailed description
- SPECIFIC AIMS Goal 1. Grow Colleges as Communities for Primary Prevention of Violence Against Women Research The opportunity: Because the 2013 Campus Sexual Violence Elimination Act1 (SaVE) now requires bystander training in all publicly funded colleges and universities (hereafter colleges), a "natural experiment" presents itself to determine what components of bystander interventions have greater efficacy. Inclusion of multiple college communities (n=24) provides sufficient statistical power for these comparisons. The timing of this U01 (RFA-CE-15-003) is strategically important for the work investigators propose: to evaluate the efficacy of bystander interventions components (BIC) to reduce violence against women (VAW: operationally defined as intimate partner violence (IPV) and sexual violence (SV)). Investigators propose a quasi-experimental design using fractional factorials. Data to measure program efficacy for bystander and violent behavior outcomes will be obtained from student surveys and campus crime data. Key informant interviews with college administrators responsible for selection and implementation of bystander programs will describe components and attributes of bystander programs important for colleges' adoption, implementation and retention of bystander programs over the 4 years.
The purpose of this quasi-experimental, multi-college study is to evaluate the relative efficacy of newly implemented bystander interventions over time. Because all colleges must adopt an intervention, comparisons will be made prospectively before and after implementation and across program interventions.
Aim 1. Compare the relative efficacy of bystander interventions to a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce violence victimization and perpetration, and d) increase program cost effectiveness. Three BIC comparisons will be: exclusively online training, Green Dot, and other skills-based, interactive bystander programs. Whether training is mandatory will also be evaluated.
Hypothesis 1: Relative to colleges implementing exclusively online training, colleges implementing Green Dot (or other skills-based programs) will significantly a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce violence victimization and perpetration, and d) demonstrate greater cost effectiveness to reduce VAW.
Goal 2. Grow Communities of Violence Against Women Prevention Researchers The opportunity: This "natural experiment" also offers a unique opportunity for more senior VAW prevention researchers to share their expertise with each other and with more junior researchers, i.e. grow a researcher community. Team science is increasingly required in violence prevention research yet funding mechanisms supporting cross-institutional and cross-disciplinary career development grants in violence prevention are limited.
The purpose: Investigators propose a researcher community collaborative to grow the next generation of VAW researchers. Through engaging multiple public universities as our research community partners (Goal 1), investigators have the added opportunity to partner as a researcher community to both a) conduct better research because a broader skill-set can be engaged and b) share our research skill-sets with more junior researchers.
Aim 2. Determine the efficacy of this collaborative to increase VAW prevention researchers' productivity defined as a) research skills and b) research communications measured as manuscript submissions, presentations, and publications. Both senior and junior researchers will be members of this collaborative and included in prospective qualitative and quantitative assessment.
Hypothesis 2: Participation within research communities will, over time, increase research productivity for both senior and more junior collaborative members relative to their productivity prior to study participation.
Expected outcomes:
(Aim 1) This study will identify components of bystander programs associated with greater violence prevention efficacy and greater cost-effectiveness. Currently colleges have limited data or experience to make informed decisions regarding selecting a bystander intervention, now required by SaVE. With the range of bystander program comparisons afforded by including up to 24 multiple college communities, investigators will have the ability to measure relative bystander program efficacy (which programs are associated with the greater reduction in violence), which programs are associated with lower program implementation costs, and the programs associated with the lower cost to violence reduction ratio.
(Aim 2) As both senior and junior researchers are engaged in college recruitment, mixed-method data collection, and data analyses, research skill-sets will be shared such that senior researchers learn newer research approaches and junior researchers learn skills in survey design and conduct, measurement and surveying on sensitive topics), data analyses, and research communication.
Benchmarks for Success will be measured: [Aim 1] as our ability to recruit 24 colleges, conduct key informant interviews and annual undergraduate surveys, and final analyses by Fall 2019; and [Aim 2] by our ability, as a collaborative, to recruit and retain VAW prevention researchers from identified colleges and provide mentoring and training needed to advance their research skills.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Green Dot BIC 1 | – | Behavioral: BIC 1Bystander Intervention Components Clusters will include at least a component of Green Dot. E.g. Comparisons will be made across schools that have Green Dot versus those that don't have Green Dot. (BIC 1) |
| Online BIC 2 | – | Behavioral: BIC 2Bystander Intervention Components Clusters will include at least a component of online bystander training. E.g. Comparisons will be made across schools that have online bystander training versus those that do not. (BIC 2) |
| Alternative programs BIC 3 | – | Behavioral: BIC 3Bystander Intervention Components Clusters will include at least a component of Green Dot. E.g. Comparisons will be made across schools that have alternative program versus those that do not. (BIC 3) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Public universities with junior faculty to be mentored in violence prevention Note: sampling unit for primary analyses is the college: answers to questions below refer to students clustered at each institution
Key inclusion criteria (2 listed)
- Public universities with junior faculty to be mentored in violence prevention
- Undergraduate students at the public 4 year colleges or universities, ages 18-24
Key exclusion criteria (2 listed)
- Private universities, institutions with less than 10,000 undergraduate students
- Graduate or professional students, non-degree seeking or not enrolled
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 |
|---|---|---|
| BIC 1BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training. | Behavioural | Green Dot BIC 1 |
| BIC 2BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training. | Behavioural | Online BIC 2 |
| BIC 3BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training. | Behavioural | Alternative programs BIC 3 |
Primary outcome
Interpersonal Violence Victimization and Perpetration at the college level using AAU measures of sexual violence, dating violence, sexual harassment and stalking
Time frame: Up to 60 months
Interpersonal Violence defined as sexual violence, partner violence, stalking and sexual harassment
1 secondary outcome
Bystander behavior measures at the college level based on of Banyard, Plante & Monynihan bystanding scale
Time frame: Up to 60 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 15 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Ann L Coker, PhD principal investigator
University of Kentucky
Heather M Bush, 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?
An observational study of Sexual Violence, run by Ann Coker 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 2 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 15 Mar 2021. 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?
Interpersonal Violence Victimization and Perpetration at the college level using AAU measures of sexual violence, dating violence, sexual harassment and stalking (time frame: Up to 60 months). 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 15 Mar 2021.