Violence, Gender-BasedNCT03994016
Evaluation of the WiseGuyz Program for Adolescent Boys
A study testing WiseGuyz in people with Violence, Gender-Based, run by University of Calgary at 1 site in Canada.
Trial summary
Adolescent dating violence (ADV) is a pressing public health problem in North America, and strategies to prevent perpetration are needed. To this end, a substantial body of research demonstrates the importance of applying a gender lens to target root causes of ADV. Read more about this study
- Who is it for?
- Ages 13 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Gender-Based
- What is being tested?
- WiseGuyz
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2019to 30 Jun 2024
- 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 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- all participants need to be enrolled in the 9th grade in 2019-20, 2021-22 or 2022-23 in order to participate (study length extended due to COVID-19 disruptions in 2019-20, 2020-21 and 2021-22).
Who cannot join
- individuals who are not male-identified and not in the 9th grade at one of the participating schools in 2019-20, 2021-22 or 2022-23 will not be invited to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Adolescent Dating Violence Through Gender-Transformative Healthy Relationships Promotion: The WiseGuyz Program
Adolescent dating violence (ADV) is a pressing public health problem in North America, and strategies to prevent perpetration are needed. To this end, a substantial body of research demonstrates the importance of applying a gender lens to target root causes of ADV. To date, however, there has been limited research on how to specifically engage boys in ADV prevention. As such, this protocol describes the evaluation of a program called WiseGuyz, a community-facilitated, gender-transformative healthy relationships program for mid-adolescent (~ages 13-15) male-identified youth. WiseGuyz aims to reduce male-perpetrated ADV, and improve mental and sexual health, by helping participants identify and deconstruct male gender role norms, and explore healthier, more inclusive ways of being a guy in the world. The primary goal of this evaluation is to explore the impact of WiseGuyz on ADV outcomes among mid-adolescent male-identified youth, using a mixed-methods, longitudinal, quasi-experimental design with a matched comparison group.
Read the detailed description
Study Design and Overview:
In this project, the investigators will examine the association between participation in the WiseGuyz program and ADV outcomes. The investigators will use a mixed-methods, quasi-experimental design with pre-test, post-test and one-year follow-up surveys, engaging participants from two Western Canadian school divisions. Through focus groups with youth participants, the investigators will contextualize quantitative survey data, to deepen understanding of how WiseGuyz may promote the prevention of ADV.
Participants:
The investigators plan to recruit approximately 700-800 grade nine male-identified youth in 7 participating schools.
Procedures:
The investigators will make presentations on the research project to all grade 9 youth at participating schools. Any male-identified youth in grade 9 is welcome to participate, regardless of their involvement with WiseGuyz. Interested participants will need to provide signed parent/guardian consent (paper or electronic) and themselves complete an assent form to participate in the research. Quantitative data will be collected in three cohorts (Cohort One - pre-test: October 2019; post-test: May 2020; one-year follow-up: May 2021; Cohort Two - pre-test: October 2021; post-test: May 2022; one-year follow-up: May 2023; Cohort Three - pre-test: October 2022; post-test: May 2023; one-year follow-up: May 2024). An additional cohort needed to be added due to COVID-19 related study disruptions in 2019-20, 2020-21, and 2021-22.
The investigators will gather qualitative focus group data from approximately 60 WiseGuyz participants immediately post-intervention. Cohort One focus groups will occur in May 2020, Cohort Two focus groups will occur in May 2021. The investigators will also interview school leadership in Spring 2021. *note: due to COVID-19 disruptions, focus groups/interviews will only occur with Cohort 3 in Spring 2023*
To understand program implementation, implementation tracking data will be collected at the start of the program year, immediately following each WiseGuyz session, at the end of each WiseGuyz module, and at the end of the program year. The investigators will collect these data from October 2019-May 2023.
- Conditions
- Violence, Gender-Based
- Being tested
- WiseGuyz
- Keywords
- Adolescent dating violence, Positive mental health, Sexual health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiseGuyzBehavioural
The WiseGuyz program was developed by the Centre for Sexuality (Calgary, AB), and aims to reduce male-perpetrated adolescent dating violence, improve mental and sexual health, and support youth to build healthier, more inclusive relationships in their peer groups, schools and communities, by helping participants identify and deconstruct gender role norms.
WiseGuyz is offered during instructional time by community-based facilitators from the Centre for Sexuality. WiseGuyz is comprised of 20 sessions across four modules. These sessions typically take the full school year (September-May) to implement.
| Study group | Role | What they receive |
|---|---|---|
| WiseGuyz Participant | Experimental | Individuals in this arm will receive the WiseGuyz program in their grade 9 year. Receives: Behavioral: WiseGuyz |
| Comparison Participant | No intervention | Individuals in this arm will not receive any intervention in their grade 9 year, and will be used to create a matched comparison group for individuals in Arm 1 (WiseGuyz Participants). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bystander intervention behaviours for violence prevention
Change from baseline in positive (e.g., talking to an adult) and negative (e.g., laughing) behaviours among intervention participants as compared to matched controls, as assessed using the Bystander Intervention Behaviors scale (Abebe et al., 2018).
Measured: Cohort 1: up to 12 months; Cohort 2: up to 12 months
Secondary outcomes (11)
Adolescent dating violence perpetration
Change from baseline in overall perpetration (physical, sexual and/or psychological) among intervention participants as compared to matched controls, as assessed using the Conflict In Adolescent Dating Relationships Inventory (CADRI; Wolfe et al., 2001).
Measured: Cohort 1: 12 months; Cohort 2: 12 months
Positive mental health
Change from baseline in overall positive mental health (emotional, social and psychological) among intervention participants as compared to matched controls, as assessed using the Mental Health Continuum-Short Form (MHC-SF; Keyes, 2006).
Measured: Cohort 1: 12 months; Cohort 2: 12 months
Bullying perpetration
Change from baseline in overall bullying perpetration (physical, verbal, social, cyber) among intervention participants as compared to matched controls, as assessed using the School Climate Bullying Survey - Bullying Behavior Sub-Scale (SCBS-BB; Cornell, 2016).
Measured: Cohort 1: 12 months; Cohort 2: 12 months
Friendship closeness
Change from baseline in overall friendship closeness (emotional support, intimate disclosure, companionship, approval, satisfaction) among intervention participants as compared to matched controls, as assessed using the Network of Relationships Inventory - Relationship Qualities Version (NRI-RQV; Buhrmester \& Furman, 2008).
Measured: Cohort 1: 12 months; Cohort 2: 12 months
Homophobic name-calling
Change from baseline in homophobic name-calling among intervention participants as compared to matched controls, as assessed using the Homophobic Content Agent Scale (Poteat \& Espelage, 2007).
Measured: Cohort 1: 12 months; Cohort 2: 12 months
Sexual health self-efficacy
Change from baseline in sexual health self-efficacy among intervention participants as compared to matched controls, as assessed using the Sexual Health Self-Efficacy Scale (Barthalow et al., 2010).
Measured: Cohort 1: up to 12 months; Cohort 2: up to 12 months
Adherence to male role norms
Change from baseline in adherence to male role norms promoting emotional restriction, avoidance of femininity and toughness among intervention participants as compared to matched controls, as assessed using the Male Role Norms Inventory-Adolescent-Revised (MRNI-A-r; Levant et al., 2012).
Measured: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Attitudes towards sexual minorities
Change from baseline in negative attitudes towards sexual minorities among intervention participants as compared to matched controls, as assessed using the Negativity Towards Sexual Minorities scale (NTSM; Levant et al., 2012).
Measured: Cohort 1: Immediate post-test; Cohort 2: immediate post-test
Dating abuse awareness
Change from baseline in dating abuse awareness among intervention participants as compared to matched controls, as assessed using the Dating Abuse Awareness Scale (Abebe et al., 2018).
Measured: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Intentions to intervene with peers
Change from baseline in intentions to intervene with peers (positive bystander behaviour for violence prevention) among intervention participants as compared to matched controls, as assessed using the Intentions to Intervene with Peers scale (Abebe et al., 2018).
Measured: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Help-seeking
Change from baseline in intentions to seek help for behavioural health problems among intervention participants as compared to matched controls, as assessed using the General Help-Seeking Questionnaire (GHSQ; Wilson et al., 2005).
Measured: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start15 Sep 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 Violence, Gender-BasedStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- WiseGuyz' integrated and sequential curriculum is comprised of four core modules and 20 sessions per module. Sessions are a mix of targeted education, group discussion, and skills development (e.g., role play). The sequence of the modules is critical as each module builds into the next. The modules are: Module 1: Healthy Relationships (6 sessions) Module 2: Sexual Health (5 sessions) Module 3: Gender, Sexuality and the Media (5 sessions) Module 4: Advocacy and Leadership (4 sessions)
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
- Investigators
- Deinera Exner-Cortens, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994016
- Sponsor's protocol ID
- REB16-1368
- Status last verified
- Dec 2024
- First submitted
- 10 May 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this project may be preserved in a publicly accessible, secure and curated repository or other platform for discovery and reuse by others, but these data will not allow for any identification of individual participants. The investigators are still preparing our IPD sharing plan, and will upload once it is finalized.
Publications
Exner-Cortens D, Hurlock D, Wright A, Carter R, Krause, P. Preliminary evaluation of a gender-transformative healthy relationships program for adolescent boys [published online ahead of print January 31, 2019]. Psychol Men Masculin. doi:10.1037/men0000204
Claussen C. Men engaging boys in healthy masculinity through school-based sexual health education [published online ahead of print August 10, 2018]. Sex Education. doi:10.1080/14681811.2018.1506914
Claussen C. The WiseGuyz Program: Sexual health education as a pathway to supporting changes in endorsement of traditional masculinity ideologies. The Journal of Men's Studies. 25(2): 150-167, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Adolescent Dating Violence Through Gender-Transformative Healthy Relationships Promotion: The WiseGuyz Program
- ClinicalTrials.gov ID
- NCT03994016
- Acronym / sponsor ID
- REB16-1368
- Conditions
- Violence, Gender-Based
- Keywords
- Adolescent dating violence, Positive mental health, Sexual health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Jun 2019 (actual)
- 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.
Adolescent dating violence (ADV) is a pressing public health problem in North America, and strategies to prevent perpetration are needed. To this end, a substantial body of research demonstrates the importance of applying a gender lens to target root causes of ADV. To date, however, there has been limited research on how to specifically engage boys in ADV prevention. As such, this protocol describes the evaluation of a program called WiseGuyz, a community-facilitated, gender-transformative healthy relationships program for mid-adolescent (~ages 13-15) male-identified youth. WiseGuyz aims to reduce male-perpetrated ADV, and improve mental and sexual health, by helping participants identify and deconstruct male gender role norms, and explore healthier, more inclusive ways of being a guy in the world. The primary goal of this evaluation is to explore the impact of WiseGuyz on ADV outcomes among mid-adolescent male-identified youth, using a mixed-methods, longitudinal, quasi-experimental design with a matched comparison group.
Detailed description
Study Design and Overview:
In this project, the investigators will examine the association between participation in the WiseGuyz program and ADV outcomes. The investigators will use a mixed-methods, quasi-experimental design with pre-test, post-test and one-year follow-up surveys, engaging participants from two Western Canadian school divisions. Through focus groups with youth participants, the investigators will contextualize quantitative survey data, to deepen understanding of how WiseGuyz may promote the prevention of ADV.
Participants:
The investigators plan to recruit approximately 700-800 grade nine male-identified youth in 7 participating schools.
Procedures:
The investigators will make presentations on the research project to all grade 9 youth at participating schools. Any male-identified youth in grade 9 is welcome to participate, regardless of their involvement with WiseGuyz. Interested participants will need to provide signed parent/guardian consent (paper or electronic) and themselves complete an assent form to participate in the research. Quantitative data will be collected in three cohorts (Cohort One - pre-test: October 2019; post-test: May 2020; one-year follow-up: May 2021; Cohort Two - pre-test: October 2021; post-test: May 2022; one-year follow-up: May 2023; Cohort Three - pre-test: October 2022; post-test: May 2023; one-year follow-up: May 2024). An additional cohort needed to be added due to COVID-19 related study disruptions in 2019-20, 2020-21, and 2021-22.
The investigators will gather qualitative focus group data from approximately 60 WiseGuyz participants immediately post-intervention. Cohort One focus groups will occur in May 2020, Cohort Two focus groups will occur in May 2021. The investigators will also interview school leadership in Spring 2021. *note: due to COVID-19 disruptions, focus groups/interviews will only occur with Cohort 3 in Spring 2023*
To understand program implementation, implementation tracking data will be collected at the start of the program year, immediately following each WiseGuyz session, at the end of each WiseGuyz module, and at the end of the program year. The investigators will collect these data from October 2019-May 2023.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- WiseGuyz' integrated and sequential curriculum is comprised of four core modules and 20 sessions per module. Sessions are a mix of targeted education, group discussion, and skills development (e.g., role play). The sequence of the modules is critical as each module builds into the next. The modules are: Module 1: Healthy Relationships (6 sessions) Module 2: Sexual Health (5 sessions) Module 3: Gender, Sexuality and the Media (5 sessions) Module 4: Advocacy and Leadership (4 sessions)
| Arm | Type | Receives |
|---|---|---|
| WiseGuyz Participant | Experimental | Behavioral: WiseGuyzIndividuals in this arm will receive the WiseGuyz program in their grade 9 year. |
| Comparison Participant | No intervention | –Individuals in this arm will not receive any intervention in their grade 9 year, and will be used to create a matched comparison group for individuals in Arm 1 (WiseGuyz Participants). |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all participants need to be enrolled in the 9th grade in 2019-20, 2021-22 or 2022-23 in order to participate (study length extended due to COVID-19 disruptions in 2019-20, 2020-21 and 2021-22).
Key exclusion criteria (1 listed)
- individuals who are not male-identified and not in the 9th grade at one of the participating schools in 2019-20, 2021-22 or 2022-23 will not be invited to participate.
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 |
|---|---|---|
| WiseGuyzThe WiseGuyz program was developed by the Centre for Sexuality (Calgary, AB), and aims to reduce male-perpetrated adolescent dating violence, improve mental and sexual health, and support youth to build healthier, more inclusive relationships in their peer groups, schools and communities, by helping participants identify and deconstruct gender role norms. WiseGuyz is offered during instructional time by community-based facilitators from the Centre for Sexuality. WiseGuyz is comprised of 20 sessions across four modules. These sessions typically take the full school year (September-May) to implement. | Behavioural | WiseGuyz Participant |
Primary outcome
Bystander intervention behaviours for violence prevention
Time frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months
Change from baseline in positive (e.g., talking to an adult) and negative (e.g., laughing) behaviours among intervention participants as compared to matched controls, as assessed using the Bystander Intervention Behaviors scale (Abebe et al., 2018).
11 secondary outcomes
Adolescent dating violence perpetration
Time frame: Cohort 1: 12 months; Cohort 2: 12 months
Positive mental health
Time frame: Cohort 1: 12 months; Cohort 2: 12 months
Bullying perpetration
Time frame: Cohort 1: 12 months; Cohort 2: 12 months
Friendship closeness
Time frame: Cohort 1: 12 months; Cohort 2: 12 months
Homophobic name-calling
Time frame: Cohort 1: 12 months; Cohort 2: 12 months
Sexual health self-efficacy
Time frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months
Adherence to male role norms
Time frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Attitudes towards sexual minorities
Time frame: Cohort 1: Immediate post-test; Cohort 2: immediate post-test
Dating abuse awareness
Time frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Intentions to intervene with peers
Time frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
Help-seeking
Time frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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 5 Dec 2024.
- BackgroundExner-Cortens D, Hurlock D, Wright A, Carter R, Krause, P. Preliminary evaluation of a gender-transformative healthy relationships program for adolescent boys [published online ahead of print January 31, 2019]. Psychol Men Masculin. doi:10.1037/men0000204
- BackgroundClaussen C. Men engaging boys in healthy masculinity through school-based sexual health education [published online ahead of print August 10, 2018]. Sex Education. doi:10.1080/14681811.2018.1506914
- BackgroundClaussen C. The WiseGuyz Program: Sexual health education as a pathway to supporting changes in endorsement of traditional masculinity ideologies. The Journal of Men's Studies. 25(2): 150-167, 2016.
- Information on the WiseGuyz programLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this project may be preserved in a publicly accessible, secure and curated repository or other platform for discovery and reuse by others, but these data will not allow for any identification of individual participants. The investigators are still preparing our IPD sharing plan, and will upload once it is finalized.
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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.
Deinera Exner-Cortens, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WiseGuyz in people with Violence, Gender-Based, run by University of Calgary at 1 site in Canada.
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 1 inclusion and 1 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 5 Dec 2024. 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 Canada. 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?
Bystander intervention behaviours for violence prevention (time frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months). 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 NCT03994016, 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 5 Dec 2024.