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Evaluation of the WiseGuyz Program for Adolescent Boys

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ClinicalTrials.gov Identifier: NCT03994016
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
University of Calgary

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Violence, Gender-Based Behavioral: WiseGuyz Not Applicable

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 two cohorts (Cohort One - pre-test: October 2019; post-test: May 2020; one-year follow-up: May 2021; Cohort Two - pre-test: October 2020; post-test: May 2021; one-year follow-up: May 2022).

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.

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 2021.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Preventing Adolescent Dating Violence Through Gender-Transformative Healthy Relationships Promotion: The WiseGuyz Program
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: WiseGuyz Participant
Individuals in this arm will receive the WiseGuyz program in their grade 9 year.
Behavioral: WiseGuyz

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).



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Adolescent dating violence perpetration [ Time Frame: Cohort 1: 12 months; Cohort 2: 12 months ]
    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).

  2. Positive mental health [ Time Frame: Cohort 1: 12 months; Cohort 2: 12 months ]
    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).

  3. Bullying perpetration [ Time Frame: Cohort 1: 12 months; Cohort 2: 12 months ]
    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).

  4. Friendship closeness [ Time Frame: Cohort 1: 12 months; Cohort 2: 12 months ]
    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).

  5. Homophobic name-calling [ Time Frame: Cohort 1: 12 months; Cohort 2: 12 months ]
    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).

  6. Sexual health self-efficacy [ Time Frame: Cohort 1: up to 12 months; Cohort 2: up to 12 months ]
    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).

  7. Adherence to male role norms [ Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test ]
    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).

  8. Attitudes towards sexual minorities [ Time Frame: Cohort 1: Immediate post-test; Cohort 2: immediate post-test ]
    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).

  9. Dating abuse awareness [ Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test ]
    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).

  10. Intentions to intervene with peers [ Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test ]
    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).

  11. Help-seeking [ Time Frame: Cohort 1: Immediate post-test; Cohort 2: Immediate post-test ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male-identified youth (self-representation).
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all participants need to be enrolled in the 9th grade in 2019-20 or 2020-21 in order to participate.

Exclusion Criteria:

  • individuals who are not male-identified and not in the 9th grade at one of the participating schools in 2019-20 or 2021-21 will not be invited to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994016


Contacts
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Contact: Deinera Exner-Cortens, PhD 403-220-8871 deinera.exner2@ucalgary.ca
Contact: Emily Matejko, MA emily.matejko@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Deinera Exner-Cortens, PhD    403-220-8871    deinera.exner2@ucalgary.ca   
Contact: Emily Matejko, MA       emily.matejko@ucalgary.ca   
Principal Investigator: Deinera Exner-Cortens, PhD         
Sponsors and Collaborators
University of Calgary
Public Health Agency of Canada (PHAC)
Investigators
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Principal Investigator: Deinera Exner-Cortens, PhD University of Calgary
Additional Information:
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.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03994016    
Other Study ID Numbers: REB16-1368
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Within three years of completion of study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Adolescent dating violence
Positive mental health
Sexual health