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Trial of a Middle School Coach Gender Violence Prevention Program

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ClinicalTrials.gov Identifier: NCT02331238
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Elizabeth Miller, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 1, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date January 15, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
Change in Positive Bystander Behavior from Baseline to Follow Up [ Time Frame: 3 months and 12 months ]
Assessment of past 3 month positive bystander behavior in athletes when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Athletes report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02331238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
  • Change in Recognition of Abusive Behavior from Baseline to Follow Up [ Time Frame: 3 months and 12 months ]
    Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores on the recognition of abusive behavior scale.
  • Change in Gender Equitable Attitudes Scale from Baseline to Follow Up [ Time Frame: 3 months and 12 months ]
    Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on the gender attitudes scale
  • Change in Intentions to Intervene from Baseline to Follow Up [ Time Frame: 3 months and 12 months ]
    Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores on a scale assessing likelihood of trying to stop disrespectful behaviors among peers.
  • Change in self-reported recent (past 3 month) perpetration of Teen Dating Violence/Sexual Violence at 12 months [ Time Frame: 12 Months ]
    Assessment of Teen Dating Violence/Sexual Violence perpetration comparing baseline summary score with follow up 12 month summary score (whether participants have perpetrated acts of Teen Dating Violence or Sexual Violence towards anyone)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of a Middle School Coach Gender Violence Prevention Program
Official Title  ICMJE Cluster-Randomized Trial of a Middle School Coach Gender Violence Prevention Program
Brief Summary This cluster-randomized school-based study will examine the effectiveness of a program for the primary prevention of perpetration of teen dating violence and sexual violence among middle school male athletes. Engaging men and boys in preventing violence against women and girls is recognized by major global health organizations as a critical public health strategy. "Coaching Boys into Men" is a theory- and evidence based program intended to alter gender norms that foster teen dating violence/sexual violence perpetration, promote bystander intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a 60-minute training and biweekly check-in from a violence prevention advocate to administer the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport season. In a randomized trial of program effectiveness among high school athletes (Centers for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the program demonstrated increased positive bystander intervention behaviors and less verbal abuse perpetration compared to controls. This project seeks to test the effectiveness of this program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing the efficacy of a novel teen dating violence/sexual violence prevention program for middle school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence prevention thus implementing primary prevention that does not rely on teachers or classroom time; and (3) integrating the goal of changing gender norms with the technique of a bystander intervention approach to reduce teen dating violence/sexual violence prevention. The experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either intervention or control (standard coaching) condition. Coaches in intervention schools will receive Coaching Boys into Men training. Baseline surveys will be collected for all intervention and control site athletes entering grades 6-8 at the start of each sports seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months after baseline (Time 3).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Violence
  • Abuse
Intervention  ICMJE Behavioral: "Coaching Boys into Men" program
"Coaching Boys into Men" program consists of 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rational for Coaching Boys into Men and the Coaching Boys into Men Coaches Kit. The coaches use this Coaching Boys into Men toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth.
Study Arms  ICMJE
  • No Intervention: Control School
    Control schools (where the coaches do not receive the "Coaching Boys into Men" training until following academic year ;wait list control)
  • Experimental: Intervention School

    Intervention schools (where coaches receive the Coaching Boys into Men training at start of each sports season).

    "Coaching Boys into Men" program consists of 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rational for Coaching Boys into Men and the Coaching Boys into Men Coaches Kit. The coaches use this Coaching Boys into Men toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth.

    Intervention: Behavioral: "Coaching Boys into Men" program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
973
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2015)
2408
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

School eligibility:

Urban and suburban middle schools in the Pittsburgh, PA region with athletics program

Athlete eligibility:

Ages 11-14 (grades 6-8), student at a participating middle school, participating in an athletic program led by coach participating in the research study

Exclusion Criteria:

School Eligibility:

Middle schools not in the Pittsburgh area

Athlete eligibility:

Outside age range, not participating on a sports team at the middle school in which they are enrolled

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331238
Other Study ID Numbers  ICMJE PRO14020618
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Miller, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Elizabeth Miller, MD, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP