NCT02331238

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
973

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

January 1, 2015

Last Update Submit

January 12, 2019

Conditions

ViolenceAbuse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Recognition of Abusive Behavior from Baseline to Follow Up

    3 months and 12 months

  • Change in Gender Equitable Attitudes Scale from Baseline to Follow Up

    3 months and 12 months

  • Change in Intentions to Intervene from Baseline to Follow Up

    3 months and 12 months

  • Change in self-reported recent (past 3 month) perpetration of Teen Dating Violence/Sexual Violence at 12 months

    12 Months

Study Arms (2)

Control School

NO INTERVENTION

Control schools (where the coaches do not receive the "Coaching Boys into Men" training until following academic year ;wait list control)

Intervention School

EXPERIMENTAL

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.

Behavioral: "Coaching Boys into Men" program

Interventions

"Coaching Boys into Men" programBEHAVIORAL

"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 School

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • 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.

    PMID: 23084163BACKGROUND

  • 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.

    PMID: 23790995BACKGROUND

  • Jones KA, Tancredi DJ, Abebe KZ, Paglisotti T, Miller E. Cases of Sexual Assault Prevented in an Athletic Coach-Delivered Gender Violence Prevention Program. Prev Sci. 2021 May;22(4):504-508. doi: 10.1007/s11121-021-01210-1. Epub 2021 Jan 22.

    PMID: 33481150DERIVED

  • Miller E, Jones KA, Ripper L, Paglisotti T, Mulbah P, Abebe KZ. An Athletic Coach-Delivered Middle School Gender Violence Prevention Program: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2020 Mar 1;174(3):241-249. doi: 10.1001/jamapediatrics.2019.5217.

    PMID: 31930358DERIVED

  • Abebe KZ, Jones KA, Ciaravino S, Ripper L, Paglisotti T, Morrow SE, Grafals M, Van Dusen C, Miller E. A cluster-randomized trial of a middle school gender violence prevention program: Design, rationale, and sample characteristics. Contemp Clin Trials. 2017 Nov;62:11-20. doi: 10.1016/j.cct.2017.08.007. Epub 2017 Aug 15.

    PMID: 28821469DERIVED

Study Officials

  • Elizabeth Miller, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Adolescent and Young Adult Medicine, Children's Hospital, University of Pittsburgh Medical Center

Study Record Dates

First Submitted

January 1, 2015

First Posted

January 6, 2015

Study Start

March 1, 2015

Primary Completion

November 10, 2017

Study Completion

December 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

US(1)