Engendering Healthy Masculinities to Prevent Sexual Violence

NCT ID: NCT02427061

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 868 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-06-30

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.

Conditions

Violence; Sexual Assault

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention Program (Manhood 2.0)

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Control Program (Job Skills Training)

Intervention Type: BEHAVIORAL

Interventions

Intervention Program (Manhood 2.0)

Intervention Type: BEHAVIORAL

Control Program (Job Skills Training)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Miller

Chief, Division of Adolescent and Young Adult Medicine, Children's Hospital, UPMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33351083 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31889621 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29802967 (View on PubMed)

Other Identifiers

14080673

Identifier Type: -

Identifier Source: org_study_id