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Evaluation of Green Dot a Primary Prevention Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Ann Coker, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01878097
First received: March 29, 2013
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 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 and an increase in bystander behaviors.


Condition Intervention
Sex Offenses
Behavioral: Green Dot Bystander Intevention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Green Dot Across the Bluegrass: Evaluation of a Primary Prevention Intervention

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Sexual Violence Victimization and Perpetration [ Time Frame: Survey all students in each high school between February-April 2010-2014(up to 4 years) ] [ Designated as safety issue: Yes ]

    3 items measuring sexual violence victimization and 3 items measuring sexual violence perpetration. Items address attempted or complete forced sexual activity; unwanted sex due to being too drunk or drugged to consent; coerced sexual activity.

    These measures were based on the Centers for Disease Control and Prevention (CDC) National Intimate Partner and Sexual Violence Survey (NISVS).

    5 items addressing reproductive coercion were included (victimization only). These items were based on research by Miller, Elizabeth, Michele R. Decker, Heather L. McCauley, Daniel J. Tancredi, Rebecca R. Levenson, Jeffrey Waldman, Phyllis Schoenwald, and Jay G. Silverman. "Pregnancy Coercion, Intimate Partner Violence and Unintended Pregnancy." Contraception 81.4 (2010): 316-22.

    3 items addressing sexual harassment were also included and asked as both victimization and perpetration.



Secondary Outcome Measures:
  • Increase in bystanding behaviors [ Time Frame: Annual measures violence at baseline (pre-intervention) and 4 years post intervention ] [ Designated as safety issue: No ]

    7 items measuring self-reports of students actively engaging their peers in behaviors that may prevent violence.

    Response options: 0 times, 1-2 times, 3-5 times, 6-9 times, 10 or more times, didn't see or hear someone doing this

    1. Tell someone to stop talking down to, harassing, or messing with someone else.
    2. Speak up when you heard that someone who was forced to have sex or hurt by a boyfriend/girlfriend was to blame.
    3. Talk to a friend who was being physically hurt by a boyfriend/girlfriend.
    4. Ask someone that looked very upset at a party if they were okay or needed help.
    5. Ask a friend if they needed to be walked or driven home from a party if they looked upset.
    6. Spoke up to someone who was bragging or making excuses for forcing someone to have sex with them.
    7. Got help for a friend because they had been forced to have sex or were physically hurt by a boyfriend/girlfriend.

    Above items repeated to measure student observing others doing these behaviors.


  • Social Norms of violence acceptance [ Time Frame: Annual measures violence at baseline (pre-intervention) and 4 years post intervention ] [ Designated as safety issue: No ]
    Two measures used: Illinois Rape Myth Acceptance Scale measure students' beliefs about rape which may indicate social norms supporting sexual violence. 5-item Acceptance of General Dating Violence Scale(21) was used to measure norms supporting dating violence.

  • Social Networks [ Time Frame: Annual measures violence at baseline (pre-intervention) and 4 years post intervention ] [ Designated as safety issue: No ]
    Measure of how the bystander intervention is diffused throughout student social networks. Each trained student provides the names of 5 friends / acquaintances. Analyses measures the numbers of students indirectly receiving training via trained student. Panel surveys also measure impact of diffusion through observing others' bystanding behaviors


Estimated Enrollment: 80000
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green Dot Bystander Training
26 high schools: 13 receiving Green Dot intervention and 13 no intervention
Behavioral: Green Dot Bystander Intevention
Intervention allocated at the school level

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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

All other high school students in Kentucky

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878097

Contacts
Contact: Ann L. Coker, PhD, MPH 859-323-6758 Ann.Coker@uky.edu
Contact: Patricia G. Cook-Craig, PhD 859-323-7407

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0293
Principal Investigator: Ann L. Coker, PhD, MPH         
Sub-Investigator: Patricia G. Cook-Craig, PhD         
Sub-Investigator: Heather M. Bush, PhD         
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Ann L. Coker, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Ann Coker, Professor and Endowed Chair, University of Kentucky
ClinicalTrials.gov Identifier: NCT01878097     History of Changes
Other Study ID Numbers: 5U01CE001675
Study First Received: March 29, 2013
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014