Clinical trial NCT02427061: Engendering Healthy Masculinities to Prevent Sexual Violence
Official title: Engendering Healthy Masculinities to Prevent Sexual Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Sexual Assault
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2015-04-27
Enrollment: 868
Sex: MALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents and associated with poor health. Global health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health strategy. This study aims to test, via a two arm cluster randomized controlled trial, a "gender transformative" SV/ARA perpetration prevention program among African American adolescent males ages 13-19 (target is high school age) implemented in a community-based setting. "Gender transformative" refers to a theory- and evidence-based approach to alter gender norms that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA perpetration, this program integrates analysis of social norms that condone violence against women, sexual health promotion, and skills in bystander intervention -- an approach that has been implemented in multiple non-U.S. settings among young adult males with reductions in violence, development of more equitable gender attitudes, and less risky sexual behaviors. This will be the first test of such a gender transformative program among adolescent males in the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840 adolescent males ages 14-19), this study will assess the effectiveness of "Manhood 2.0" (proposed name for this gender transformative program) compared to a job skills curriculum. Three months after the end of the program (Time 2), compared to controls, youth will demonstrate increased positive bystander intervention behaviors (secondary outcome). Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers. Nine months after intervention completion (Time 3), youth will report less perpetration of SV and ARA toward females (Primary Outcome) compared to controls. This study will provide urgently needed information about the effectiveness of a gender transformative program that combines healthy sexuality skills, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males.


Eligibility criteria: 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

Primary outcomes:
measure: Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3
timeFrame: 9 months after intervention (Time 3)
Secondary outcomes:
measure: Change in Positive Bystander Behavior from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
Other outcomes:
measure: Change in Intentions to Intervene from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
measure: Change in Recognition of Abuse from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
measure: Change in Gender Equitable Attitudes from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
measure: Change in Condom Use Self-Efficacy from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
measure: Change in Contraception Attitudes from Baseline to Follow Up
timeFrame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.