- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994016
Evaluation of the WiseGuyz Program for Adolescent Boys
Preventing Adolescent Dating Violence Through Gender-Transformative Healthy Relationships Promotion: The WiseGuyz Program
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- Recruiting
- University of Calgary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WiseGuyz Participant
Individuals in this arm will receive the WiseGuyz program in their grade 9 year.
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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. |
No Intervention: Comparison Participant
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bystander intervention behaviours for violence prevention
Time Frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months
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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).
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Cohort 1: up to 12 months; Cohort 2: up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent dating violence perpetration
Time Frame: Cohort 1: 12 months; Cohort 2: 12 months
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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).
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Cohort 1: 12 months; Cohort 2: 12 months
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Positive mental health
Time Frame: Cohort 1: 12 months; Cohort 2: 12 months
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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).
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Cohort 1: 12 months; Cohort 2: 12 months
|
Bullying perpetration
Time Frame: Cohort 1: 12 months; Cohort 2: 12 months
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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).
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Cohort 1: 12 months; Cohort 2: 12 months
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Friendship closeness
Time Frame: Cohort 1: 12 months; Cohort 2: 12 months
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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).
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Cohort 1: 12 months; Cohort 2: 12 months
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Homophobic name-calling
Time Frame: Cohort 1: 12 months; Cohort 2: 12 months
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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).
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Cohort 1: 12 months; Cohort 2: 12 months
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Sexual health self-efficacy
Time Frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months
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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).
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Cohort 1: up to 12 months; Cohort 2: up to 12 months
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Adherence to male role norms
Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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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).
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Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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Attitudes towards sexual minorities
Time Frame: Cohort 1: Immediate post-test; Cohort 2: immediate post-test
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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).
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Cohort 1: Immediate post-test; Cohort 2: immediate post-test
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Dating abuse awareness
Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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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).
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Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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Intentions to intervene with peers
Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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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).
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Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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Help-seeking
Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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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).
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Cohort 1: Immediate post-test; Cohort 2: Immediate post-test
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REB16-1368
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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