ViolenceNCT02331238
Trial of a Middle School Coach Gender Violence Prevention Program
A study testing "Coaching Boys into Men" program in people with Violence and Abuse, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- What is being tested?
- "Coaching Boys into Men" program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Cluster-Randomized Trial of a Middle School Coach Gender Violence Prevention Program
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).
- Being tested
- "Coaching Boys into Men" program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Coaching Boys into Men" programBehavioural
"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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: "Coaching Boys into Men" program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months and 12 months
Secondary outcomes (4)
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.
Measured: 3 months and 12 months
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
Measured: 3 months and 12 months
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.
Measured: 3 months and 12 months
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)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion10 Nov 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Elizabeth Miller, University of Pittsburgh
- Investigators
- Elizabeth Miller, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331238
- Sponsor's protocol ID
- PRO14020618
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23084163Miller 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.
PubMed 23790995Jones 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.
PubMed 33481150Miller 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.
PubMed 31930358Abebe 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.
PubMed 28821469
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-Randomized Trial of a Middle School Coach Gender Violence Prevention Program
- ClinicalTrials.gov ID
- NCT02331238
- Acronym / sponsor ID
- PRO14020618
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2015
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: "Coaching Boys into Men" programIntervention 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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Urban and suburban middle schools in the Pittsburgh, PA region with athletics program
- 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
Key exclusion criteria (4 listed)
- Middle schools not in the Pittsburgh area
- Outside age range, not participating on a sports team at the middle school in which they are enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | Intervention School |
Primary outcome
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)
4 secondary outcomes
Change in Recognition of Abusive Behavior from Baseline to Follow Up
Time frame: 3 months and 12 months
Change in Gender Equitable Attitudes Scale from Baseline to Follow Up
Time frame: 3 months and 12 months
Change in Intentions to Intervene from Baseline to Follow Up
Time frame: 3 months and 12 months
Change in self-reported recent (past 3 month) perpetration of Teen Dating Violence/Sexual Violence at 12 months
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 23084163Miller 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.
- Background: PubMed 23790995Miller 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.
- Derived from this study: PubMed 33481150Jones 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.
- Derived from this study: PubMed 31930358Miller 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.
- Derived from this study: PubMed 28821469Abebe 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.
Related trials for Violence
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Miller, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Coaching Boys into Men" program in people with Violence and Abuse, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive Bystander Behavior from Baseline to Follow Up (time frame: 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02331238, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.