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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02331238
Other study ID # PRO14020618
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 2018

Study information

Verified date January 2019
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 973
Est. completion date December 2018
Est. primary completion date November 10, 2017
Accepts healthy volunteers No
Gender All
Age group 11 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

Miller E, Tancredi DJ, McCauley HL, Decker MR, Virata MC, Anderson HA, Stetkevich N, Brown EW, Moideen F, Silverman JG. "Coaching boys into men": a cluster-randomized controlled trial of a dating violence prevention program. J Adolesc Health. 2012 Nov;51(5):431-8. doi: 10.1016/j.jadohealth.2012.01.018. Epub 2012 Mar 25. — View Citation

Miller E, Tancredi DJ, McCauley HL, Decker MR, Virata MCD, Anderson HA, O'Connor B, Silverman JG. One-year follow-up of a coach-delivered dating violence prevention program: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):108-112. doi: 10.1016/j.amepre.2013.03.007. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Positive Bystander Behavior from Baseline to Follow Up 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) 3 months and 12 months
Secondary Change in Recognition of Abusive Behavior from Baseline to Follow Up Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores on the recognition of abusive behavior scale. 3 months and 12 months
Secondary Change in Gender Equitable Attitudes Scale from Baseline to Follow Up Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on the gender attitudes scale 3 months and 12 months
Secondary Change in Intentions to Intervene from Baseline to Follow Up 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. 3 months and 12 months
Secondary Change in self-reported recent (past 3 month) perpetration of Teen Dating Violence/Sexual Violence at 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) 12 Months
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