- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427061
Engendering Healthy Masculinities to Prevent Sexual Violence
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- adolescent males ages 13-19
- recruited from youth-serving agencies in the Pittsburgh region
- able to provide their own assent
- English speaking
Exclusion criteria:
- adolescent males younger than 13 years old or older than 19 years old
- not able to provide their own assent
- non- English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Program (Manhood 2.0)
Curricular Content: The 18 hour content will be spread over 3 to 6 sessions (3 weeks duration up to a 2 month period). Youth are guided to explore social constructions of masculinity, describe healthy relationships, discuss healthy sexual behaviors, identify coercive and disrespectful behaviors, and practice skills to intervene when witnessing peers' disrespectful and harmful behaviors, with repeated reflection on gender norms throughout these sessions. Module One focuses on themes of gender and masculinity. Module Two focuses on themes of violence and sexual consent. Module Three focuses on themes of sexual health and decision making. |
|
Active Comparator: Control Program (Job Skills Training)
Youth in the control arm receive the same amount of time with an intervention -- 18 hours of curriculum divided into 3 to 6 sessions, over 3 weeks up to 2 months duration. The control intervention focuses on job skills development. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3
Time Frame: 9 months after intervention (Time 3)
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Assessment of Sexual Violence and Adolescent Relationship Abuse perpetration comparing baseline summary score with follow up summary score (whether they have perpetrated acts of Sexual Violence or Relationship Abuse towards anyone)
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9 months after intervention (Time 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive Bystander Behavior from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
|
Assessment of positive bystander behavior in participants over the past 3 months when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores.
Participants 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)
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Intentions to Intervene from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
|
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
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
|
Change in Recognition of Abuse from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores on the recognition of abusive behavior scale
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Change in Gender Equitable Attitudes from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on gender attitudes scale
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Change in Condom Use Self-Efficacy from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Assessment of self-efficacy to use condoms comparing baseline and follow up mean scores on a scale assessing confidence to negotiate condom use
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Change in Contraception Attitudes from Baseline to Follow Up
Time Frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Assessment of attitudes related to contraceptive use comparing baseline and follow up mean scores on a scale assessing contraception attitudes
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3 months after intervention (Time 2), 9 months after intervention (Time 3)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Miller, MD, University of Pittsburgh
Publications and helpful links
General Publications
- Miller E, Jones KA, Culyba AJ, Paglisotti T, Dwarakanath N, Massof M, Feinstein Z, Ports KA, Espelage D, Pulerwitz J, Garg A, Kato-Wallace J, Abebe KZ. Effect of a Community-Based Gender Norms Program on Sexual Violence Perpetration by Adolescent Boys and Young Men: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028499. doi: 10.1001/jamanetworkopen.2020.28499.
- Miller E, Culyba AJ, Paglisotti T, Massof M, Gao Q, Ports KA, Kato-Wallace J, Pulerwitz J, Espelage DL, Abebe KZ, Jones KA. Male Adolescents' Gender Attitudes and Violence: Implications for Youth Violence Prevention. Am J Prev Med. 2020 Mar;58(3):396-406. doi: 10.1016/j.amepre.2019.10.009. Epub 2019 Dec 27.
- Abebe KZ, Jones KA, Culyba AJ, Feliz NB, Anderson H, Torres I, Zelazny S, Bamwine P, Boateng A, Cirba B, Detchon A, Devine D, Feinstein Z, Macak J, Massof M, Miller-Walfish S, Morrow SE, Mulbah P, Mulwa Z, Paglisotti T, Ripper L, Ports KA, Matjasko JL, Garg A, Kato-Wallace J, Pulerwitz J, Miller E. Engendering healthy masculinities to prevent sexual violence: Rationale for and design of the Manhood 2.0 trial. Contemp Clin Trials. 2018 Aug;71:18-32. doi: 10.1016/j.cct.2018.05.017. Epub 2018 May 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14080673
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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