ViolenceNCT02427061
Engendering Healthy Masculinities to Prevent Sexual Violence
A study testing Intervention Program (Manhood 2.0) in people with Violence and Sexual Assault, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years, men only
- Conditions the study is for
- Violence, Sexual Assault
- What is being tested?
- Intervention Program (Manhood 2.0)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 868 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescent males ages 13-19
- recruited from youth-serving agencies in the Pittsburgh region
- able to provide their own assent
- English speaking
Who cannot join
- adolescent males younger than 13 years old or older than 19 years old
- not able to provide their own assent
- non- English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine
Pittsburgh, Pennsylvania, 15213
About this study
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
- Being tested
- Intervention Program (Manhood 2.0), Control Program (Job Skills Training)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Program (Manhood 2.0)Behavioural
Control Program (Job Skills Training)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program (Manhood 2.0) | Experimental | 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. Receives: Behavioral: Intervention Program (Manhood 2.0) |
| Control Program (Job Skills Training) | Active comparator | 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. Receives: Behavioral: Control Program (Job Skills Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months after intervention (Time 3)
Secondary outcomes (1)
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)
Measured: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Elizabeth Miller, University of Pittsburgh
- Investigators
- Elizabeth Miller, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427061
- Sponsor's protocol ID
- 14080673
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33351083Miller 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.
PubMed 31889621Abebe 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.
PubMed 29802967
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engendering Healthy Masculinities to Prevent Sexual Violence
- ClinicalTrials.gov ID
- NCT02427061
- Acronym / sponsor ID
- 14080673
- Conditions
- Violence, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program (Manhood 2.0) | Experimental | Behavioral: 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. |
| Control Program (Job Skills Training) | Active comparator | 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adolescent males ages 13-19
- recruited from youth-serving agencies in the Pittsburgh region
- able to provide their own assent
- English speaking
Key exclusion criteria (3 listed)
- adolescent males younger than 13 years old or older than 19 years old
- not able to provide their own assent
- non- English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Program (Manhood 2.0) | Behavioural | Intervention Program (Manhood 2.0) |
| Control Program (Job Skills Training) | Behavioural | Control Program (Job Skills Training) |
Primary outcome
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)
1 secondary outcome
Change in Positive Bystander Behavior from Baseline to Follow Up
Time frame: 3 months after intervention (Time 2), 9 months after intervention (Time 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Derived from this study: PubMed 33351083Miller 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.
- Derived from this study: PubMed 31889621Miller 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.
- Derived from this study: PubMed 29802967Abebe 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.
Related trials for Violence
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Miller, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Program (Manhood 2.0) in people with Violence and Sexual Assault, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported perpetration of Sexual Violence and Adolescent Relationship Abuse at Time 3 (time frame: 9 months after intervention (Time 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427061, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.