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Completed

NCT Number: NCT02427061

Engendering Healthy Masculinities to Prevent Sexual Violence

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.

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Key information

Age range

13 year–19 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Program (Manhood 2.0)

Behavioral

Control Program (Job Skills Training)

Behavioral

Primary outcomes

  1. Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3

    Time frame: 9 months after intervention (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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

  2. Change in Recognition of Abuse from Baseline to Follow Up

    Time frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)

    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. Change in Gender Equitable Attitudes from Baseline to Follow Up

    Time frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)

    Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on gender attitudes scale

  4. 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)

    Assessment of self-efficacy to use condoms comparing baseline and follow up mean scores on a scale assessing confidence to negotiate condom use

  5. Change in Contraception Attitudes from Baseline to Follow Up

    Time frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)

    Assessment of attitudes related to contraceptive use comparing baseline and follow up mean scores on a scale assessing contraception attitudes

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2015
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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