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Trial record 1 of 1 for:    NCT02427061
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Engendering Healthy Masculinities to Prevent Sexual Violence

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ClinicalTrials.gov Identifier: NCT02427061
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Elizabeth Miller, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE April 17, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3 [ Time Frame: 6 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Change in Positive Bystander Behavior from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 months after intervention (Time 3) ]
Assessment of past 3 month 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)
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: April 24, 2015)
  • Change in Intentions to Intervene from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 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
  • Change in Recognition of Abuse from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 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
  • Change in Gender Equitable Attitudes from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 months after intervention (Time 3) ]
    Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on gender attitudes scale
  • Increased intentions to intervene with peers [ Time Frame: 3 weeks up to 2 months (Time 2), 6 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
  • Change in Condom Use Self-Efficacy from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 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
  • Change in Contraception Attitudes from Baseline to Follow Up [ Time Frame: 3 weeks up to 2 months (Time 2), 6 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
 
Descriptive Information
Brief Title  ICMJE Engendering Healthy Masculinities to Prevent Sexual Violence
Official Title  ICMJE Engendering Healthy Masculinities to Prevent Sexual Violence
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Violence
  • Sexual Assault
Intervention  ICMJE
  • Behavioral: Intervention Program (Manhood 2.0)
  • Behavioral: Control Program (Job Skills Training)
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Intervention Program (Manhood 2.0)
  • 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.

    Intervention: Behavioral: Control Program (Job Skills Training)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
868
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2015)
840
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427061
Other Study ID Numbers  ICMJE 14080673
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Miller, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Elizabeth Miller, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP