Sex OffensesNCT01878097
Evaluation of Green Dot a Primary Prevention Intervention
A study testing Green Dot Bystander Intevention in people with Sex Offenses, run by University of Kentucky at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of sexual violence (SV) compared with students in comparable high schools randomized not to have Green Dot. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sex Offenses
- What is being tested?
- Green Dot Bystander Intevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89,707 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only high school students attending the intervention or comparison high schools will be eligible. Two groups will be recruited: those receiving bystanding training and those not receiving such training who may or may not be in the social network of those receiving bystanding training.
Who cannot join
- All other high school students in Kentucky
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40536-0293
About this study
Official title: Green Dot Across the Bluegrass: Evaluation of a Primary Prevention Intervention
The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of sexual violence (SV) compared with students in comparable high schools randomized not to have Green Dot. This reduction in sexual violence will be mediated through a reduction in social norms supporting sexual violence (measured with violence acceptance scales) and an increase in bystander behaviors.
Read the detailed description
"Green Dot" is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence. The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of SV compared with students in comparable high schools randomized not to have Green Dot. A high school based controlled intervention trial is being used to test the efficacy of Green Dot. Both panel and cohort survey methods will be used to provide baseline and prospective data on student's attitudes supporting SV, bystander behaviors and violence victimization and perpetration. In 13 Kentucky regions, 2 demographically comparable high schools were recruited to participate in Green Dot intervention either as the intervention or control site. Schools were randomly assigned to the intervention. Study Population includes all students in participating high schools invited to complete anonymous panel surveys beginning spring 2010 through 2014. This state-wide, population-based, multi-site controlled intervention trial provides an empirical test of a promising intervention, which, if proven effective, could result in the primary prevention of SV and a reduction in the health and academic consequences of SV.
- Conditions
- Sex Offenses
- Being tested
- Green Dot Bystander Intevention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Dot Bystander InteventionBehavioural
Intervention allocated at the school level
ControlBehavioural
Awareness Education
| Study group | Role | What they receive |
|---|---|---|
| Green Dot Bystander Training | Experimental | Green Dot intervention Receives: Behavioral: Green Dot Bystander Intevention |
| Control | Active comparator | Awareness Eduation Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model. Data will be collected at baseline and annually for 4 years.
Measured: up to 5 years follow up from baseline intervention
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models. Data will be collected at baseline and annually for 4 years.
Measured: Data will be collected at baseline and annually for 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startNov 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sex OffensesStudies 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
- None (open label)
- Enrolment
- 89,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Coker, University of Kentucky
- Investigators
- Ann L. Coker, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878097
- Sponsor's protocol ID
- 5U01CE001675
- Status last verified
- Feb 2019
- First submitted
- 29 Mar 2013
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Coker AL, Bush HM, Cook-Craig PG, DeGue SA, Clear ER, Brancato CJ, Fisher BS, Recktenwald EA. RCT Testing Bystander Effectiveness to Reduce Violence. Am J Prev Med. 2017 May;52(5):566-578. doi: 10.1016/j.amepre.2017.01.020. Epub 2017 Mar 6.
PubMed 28279546Coker AL, Bush HM, Brancato CJ, Clear ER, Recktenwald EA. Bystander Program Effectiveness to Reduce Violence Acceptance: RCT in High Schools. J Fam Violence. 2019;34(3):153-164. doi: 10.1007/s10896-018-9961-8. Epub 2018 Apr 2.
PubMed 30956390Mennicke AM, Bush HM, Brancato CJ, Coker AL. Bystander Program to Reduce Sexual Violence by Witnessing Parental Intimate Partner Violence Status. Am J Prev Med. 2022 Aug;63(2):262-272. doi: 10.1016/j.amepre.2021.12.022. Epub 2022 Mar 9.
PubMed 35279345
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Dot Across the Bluegrass: Evaluation of a Primary Prevention Intervention
- ClinicalTrials.gov ID
- NCT01878097
- Acronym / sponsor ID
- 5U01CE001675
- Conditions
- Sex Offenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89,707 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Posted 9 Aug 2017
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 study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of sexual violence (SV) compared with students in comparable high schools randomized not to have Green Dot. This reduction in sexual violence will be mediated through a reduction in social norms supporting sexual violence (measured with violence acceptance scales) and an increase in bystander behaviors.
Detailed description
"Green Dot" is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence. The purpose of this study is to evaluate the statewide application of Green Dot among high schools students. We hypothesize that students in high schools with Green Dot will over time report lower rates of SV compared with students in comparable high schools randomized not to have Green Dot. A high school based controlled intervention trial is being used to test the efficacy of Green Dot. Both panel and cohort survey methods will be used to provide baseline and prospective data on student's attitudes supporting SV, bystander behaviors and violence victimization and perpetration. In 13 Kentucky regions, 2 demographically comparable high schools were recruited to participate in Green Dot intervention either as the intervention or control site. Schools were randomly assigned to the intervention. Study Population includes all students in participating high schools invited to complete anonymous panel surveys beginning spring 2010 through 2014. This state-wide, population-based, multi-site controlled intervention trial provides an empirical test of a promising intervention, which, if proven effective, could result in the primary prevention of SV and a reduction in the health and academic consequences of SV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Dot Bystander Training | Experimental | Behavioral: Green Dot Bystander InteventionGreen Dot intervention |
| Control | Active comparator | Behavioral: ControlAwareness Eduation |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Only high school students attending the intervention or comparison high schools will be eligible. Two groups will be recruited: those receiving bystanding training and those not receiving such training who may or may not be in the social network of those receiving bystanding training.
Key exclusion criteria (1 listed)
- All other high school students in Kentucky
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 Dot Bystander InteventionIntervention allocated at the school level | Behavioural | Green Dot Bystander Training |
| ControlAwareness Education | Behavioural | Control |
Primary outcome
Average Number of Sexual Assault Events Used (Perpetrated) Per School.
Time frame: up to 5 years follow up from baseline intervention
Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model. Data will be collected at baseline and annually for 4 years.
Average Number of Sexual Assaults Experienced (Victimization) Events Per School.
Time frame: Data will be collected at baseline and annually for 4 years.
Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models. Data will be collected at baseline and annually for 4 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28279546Coker AL, Bush HM, Cook-Craig PG, DeGue SA, Clear ER, Brancato CJ, Fisher BS, Recktenwald EA. RCT Testing Bystander Effectiveness to Reduce Violence. Am J Prev Med. 2017 May;52(5):566-578. doi: 10.1016/j.amepre.2017.01.020. Epub 2017 Mar 6.
- Results publication: PubMed 30956390Coker AL, Bush HM, Brancato CJ, Clear ER, Recktenwald EA. Bystander Program Effectiveness to Reduce Violence Acceptance: RCT in High Schools. J Fam Violence. 2019;34(3):153-164. doi: 10.1007/s10896-018-9961-8. Epub 2018 Apr 2.
- Derived from this study: PubMed 35279345Mennicke AM, Bush HM, Brancato CJ, Coker AL. Bystander Program to Reduce Sexual Violence by Witnessing Parental Intimate Partner Violence Status. Am J Prev Med. 2022 Aug;63(2):262-272. doi: 10.1016/j.amepre.2021.12.022. Epub 2022 Mar 9.
Related trials for Sex Offenses
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
RecruitingObservational study
Epidemiology of French Sexual Offenders. A Cross-sectional Study
Psychiatric Disorder
Recruiting
Project CONSENT: Cognitive Behavioral Therapy to Prevent Sexual Recidivism
Sexual Offending Behavior
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
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 Bystander Intevention in people with Sex Offenses, 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 1 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 2019. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Number of Sexual Assault Events Used (Perpetrated) Per School. (time frame: up to 5 years follow up from baseline intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878097, which also lists 3 linked publications.
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 2019.