Engendering Healthy Masculinities to Prevent Sexual Violence

Violence Clinical Trial

Official title:

Engendering Healthy Masculinities to Prevent Sexual Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427061
• Other study ID #: 14080673
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Assault
• Violence

Intervention

Behavioral:
• Intervention Program (Manhood 2.0)

• Control Program (Job Skills Training)

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine	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
Other	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	3 months after intervention (Time 2), 9 months after intervention (Time 3)
Other	Change in Recognition of Abuse 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	3 months after intervention (Time 2), 9 months after intervention (Time 3)
Other	Change in Gender Equitable Attitudes from Baseline to Follow Up	Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on gender attitudes scale	3 months after intervention (Time 2), 9 months after intervention (Time 3)
Other	Change in Condom Use Self-Efficacy from Baseline to Follow Up	Assessment of self-efficacy to use condoms comparing baseline and follow up mean scores on a scale assessing confidence to negotiate condom use	3 months after intervention (Time 2), 9 months after intervention (Time 3)
Other	Change in Contraception Attitudes from Baseline to Follow Up	Assessment of attitudes related to contraceptive use comparing baseline and follow up mean scores on a scale assessing contraception attitudes	3 months after intervention (Time 2), 9 months after intervention (Time 3)
Primary	Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3	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)	9 months after intervention (Time 3)
Secondary	Change in Positive Bystander Behavior from Baseline to Follow Up	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)	3 months after intervention (Time 2), 9 months after intervention (Time 3)