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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01367704
Other study ID # PRO11060186
Secondary ID 1R01CE001561-01
Status Completed
Phase N/A
First received June 1, 2011
Last updated July 16, 2014
Start date October 2009
Est. completion date October 2011

Study information

Verified date July 2014
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Center for Disease Control and Injury Prevention
Study type Interventional

Clinical Trial Summary

Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent females and substantial reports of perpetration by young males, effective prevention programs to prevent ARA are limited. Male athletes are an important target for prevention efforts given their higher rates of abuse perpetration compared to non-athlete peers as well as their social influence among their peers. This cluster-randomized school-based investigation examines the effectiveness of a program for the primary prevention of ARA. "Coaching Boys into Men" (CBIM) is a social norms theory-based program intended to alter norms that foster ARA perpetration, promote bystander intervention, and reduce ARA perpetration by engaging athletic coaches as positive role models to deliver violence prevention scripts and tools to high school age male athletes. Coaches receive a 60-minute training session to administer the intervention to their athletes via 11 lessons across a sport season. Trained high school coaches talk to their male athletes about 1) what constitutes disrespectful and harmful vs. respectful behaviors, 2) promoting more gender-equitable attitudes, and 3) modeling bystander intervention when disrespectful behaviors toward women and girls are witnessed. The current investigation evaluates the intervention in 16 urban high schools randomized either to receive the CBIM program (i.e., intervention schools, n=8) or to a control condition (n=8). Baseline computer-based surveys are collected for all intervention and control site student athletes entering grades 9 through 12 at the start of each of three sports seasons across Year 1 (Time 1). Follow up surveys are collected for these same athletes at the end of their first sports season (Time 2). Participating athletes in grades 9 - 11 at baseline are re-surveyed 12 months after Time 1 to examine the longer term effects of the CBIM intervention (Time 3; N of athletes completing all 3 waves of data collection = 1500). Primary assessment of intervention effects are based on intent-to-treat estimates, utilizing generalized linear mixed models to account for clustering arising from school randomization. Hypothesized outcomes for male athletes include a) an increase in recognition of what constitutes abusive behaviors, b) more gender-equitable attitudes, c) an increase in intentions and reports of bystander intervention regarding ARA, and through these intermediate outcomes, d) a decrease in perpetration of ARA among adolescent male athletes.


Description:

Additional process evaluation includes baseline and follow up surveys with coaches (from both intervention and control arms), individual interviews with coaches, as well as focus groups with students to collect coach and athlete perspectives on the relevance and local impact of the intervention program.


Recruitment information / eligibility

Status Completed
Enrollment 2006
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Male
Age group 14 Years to 18 Years
Eligibility School Eligibility:

Inclusion Criteria

-urban and suburban public high schools in Sacramento region with athletics program

Exclusion Criteria -private high schools, rural high schools

Coach Eligibility:

Inclusion Criteria

- coaching an athletic team at one of the participating schools (intervention or control)

- age 18 or older

Exclusion Criteria

-not coaching an athletic team at the participating schools

Athlete Eligibility:

Inclusion Criteria

- ages 14-18 (grades 9 to 12)

- student at one of the participating high schools

- able to read English

- participating in an athletic program led by a coach willing to participate in the research study

Exclusion Criteria

- outside age range

- not participating on sports team at the high school in which they are enrolled

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
"Coaching Boys Into Men" program
Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM 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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from "not abusive" to "extremely abusive" (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items. 3 months No
Primary Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from "strongly agree" to "strongly disagree" (minimum = 1 and maximum = 5). This scale includes questions modified from Barker's Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items. 3 months No
Primary Change From Baseline to 3 Months Using the Intentions to Intervene Scale Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from "very unlikely" to "very likely" (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items. 3 months No
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