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Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth

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ClinicalTrials.gov Identifier: NCT05209594
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:
The Healthy Relationships Program (HRP) for two-spirit, lesbian, gay, bisexual, trans, queer, intersex, and asexual (2SLGBTQIA+) Youth is a flexible and adaptable 17-session mental health promotion and healthy relationship program for gender, sexual, and romantic minority youth. It helps build resiliency and promote well-being among 2SLGBTQIA+ youth. It affirms, validates, and celebrates sexual and gender diversity, cultivates a caring and supportive community, and helps 2SLGBTQIA+ youth develop skills and strategies that promote healthy relationships. Investigators will evaluate the HRP for 2SLGBTQIA+ youth in 10 intervention and 10 comparison Genders and Sexualities Alliance/Gay-Straight Alliances (GSAs) in schools across Canada. GSA advisors (educators) at intervention schools will receive training in the program prior to implementation. GSA members (students in grades 9 to 12) at both intervention and comparison sites will participate in a survey at three time points: (1) pre-GSA programming survey at the beginning of the school year, (2) a post-GSA programming survey at the end of the school year, and (3) a follow-up survey at the beginning of the next school year. The primary outcome is social-emotional functioning.

Condition or disease Intervention/treatment Phase
Adolescent Development Behavioral: Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth Behavioral: Standard GSA Programming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: GSA members (students in grades 9 to 12) will be assessed in one of two arms. The intervention arm includes GSAs that will implement the Healthy Relationships Program (HRP) for two-spirit, lesbian, gay, bisexual, trans, queer, intersex, and asexual (2SLGBTQIA+) youth. The comparison arm will be GSAs where standard GSA programming is delivered.
Masking: None (Open Label)
Masking Description: Due to the nature of the intervention, it is not possible to have blinded conditions. Most school-based prevention programs of this type are not blinded.
Primary Purpose: Prevention
Official Title: Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Teen Development

Arm Intervention/treatment
Experimental: Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth
Students in grades 9 to 12 participating in GSAs where the HRP for 2SLGBTQIA+ Youth is being implemented.
Behavioral: Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth
The Healthy Relationships Program (HRP) for Two-Spirit, Lesbian, Gay, Bisexual, Trans, Queer, Intersex, and Asexual + (2SLGBTQIA+) Youth is a small group positive mental health promotion program for gender, sexual, and romantic minority youth. It helps build resiliency and promote well-being among 2SLGBTQIA+ youth. It affirms, validates, and celebrates sexual and gender diversity, cultivates a caring and supportive community, and helps 2SLGBTQIA+ youth develop skills and strategies that promote healthy relationships. This trauma-informed, strengths-focused program explores stressors unique to 2SLGBTQIA+ youth, including identity and expression invalidation, stigma, prejudice and discrimination, internalized oppression, coming out, safety, and microaggressions. This program includes 17 sessions, each lasting approximately 45 minutes. It may be delivered in school-based Genders and Sexualities Alliances/Gay-Straight Alliances (GSA) or 2SLGBTQIA+ youth group settings.

Active Comparator: Regular GSA Programming
Students in grades 9 to 12 participating in regular GSA programming.
Behavioral: Standard GSA Programming
Students at comparison sites will participate in standard GSA programming, a safe space for 2SLGBTQIA+ youth and their allies to meet, develop relationships, support each other, socialize, and learn about sexuality and gender-related topics, and lobby for social change.




Primary Outcome Measures :
  1. Positive social-emotional functioning [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Measured by the Social-Emotional Assets and Resiliency Scales-Adolescent (SEARS-A) that assesses social-emotional assets of responsibility, self-regulation, social competence, and empathy. Participants respond to the 35 items on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). The combined total score ranges from 0 to 105 with higher scores indicating greater social-emotional strengths.


Secondary Outcome Measures :
  1. Gender Sexuality Alliance (GSA) functioning [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    GSA functioning as measured by the adapted school climate and connectedness survey. Participants respond to the 39 items on a 5-point Likert scale from strongly disagree to strongly agree. The total score ranges from 39 to 195.

  2. Dating violence [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Dating violence perpetration as measured by the Conflict in Adolescent Dating Relationships Inventory (short form). Participants respond to the 20 items on a 4-point Likert scale (0 = never, 1 = seldom, 2 = sometimes, 3 = often). The sum of the perpetrator and victimization items are calculated (10 items each). Scores range from 0 to 30 with higher scores indicating a higher incidence of abusive behaviour (perpetrator items) or victim of abuse (victimization items).

  3. Help-seeking intentions [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Self-reported intentions to seek help as measured by General Help-seeking Questionnaire. Participants indicate their likelihood to seek help for a personal or emotional problem from the people listed on a 4-point Likert scale (1= very unlikely, 2=unlikely, 3=likely, 4=very likely). A mean score is calculated on the items with the higher score indicating a higher likelihood to seek help for a problem.

  4. Actual help-seeking [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Actual help-seeking over the past 2 weeks as measured by the Actual Help Seeking Questionnaire. Participants check the people they have sought help from over a two-week period for a personal or emotional problem and then describe the type of problem. A score for the total number of people they sought help from is calculated and open-ended descriptions are coded for type of problem (e.g., mental health, relationships, school, etc.).

  5. Positive mental health [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Emotional well-being and aspects of psychological and social functioning that occur within the past month as measured by the Adolescent Mental Health Continuum-Short Form. Participants rate 14 items on a 6-point Likert scale from 0=Never to 5 = Every day. Scores range from 0 to 70 with higher scores indicating higher experience of positive mental health.

  6. Emotional well-being [ Time Frame: Change from baseline to four month follow-up (up to 12 months) ]
    Stress and depression items from modified Depression Anxiety Stress Scales (DASS-21). Participants rate the 14 stress and depression items on a 4-point Likert scale from 0=never to 3 = more than two times. Total scores are calculated for the stress and depression subscales with a range of 0 to 21 with higher scores indicating higher stress or depression.



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All students participating in the GSA at invention and comparison sites are eligible to participate
  • Age 13 to 19 years old

Exclusion Criteria:

  • Students with low literacy or cognitive functioning may not be able to complete the self-report measures.

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): NCT05209594


Contacts
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Contact: Meghan Fournie, MHIS 519-661-2111 ext 84360 mfourni8@uwo.ca

Sponsors and Collaborators
Western University, Canada
Public Health Agency of Canada (PHAC)
Investigators
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Principal Investigator: Claire Crooks, PhD Western University
Additional Information:
Publications:
Graybill, E. C., Varjas, K., Meyers, J., Dever, B. V., Greenberg, D., Roach, A. T., & Morillas, C. (2015). Demographic trends and advocacy experiences of Gay-Straight Alliance advisors. Journal of LGBT Youth, 12(4), 436-461.
Heck, N. C., Flentje, A., & Cochran, B. N. (2011). Offsetting risks: High school gay-straight alliances and lesbian, gay, bisexual, and transgender (LGBT) youth. School Psychology Quarterly, 26(2), 161-174.
Lapointe, A., & Crooks, C. V. (2018). GSA members' experiences with a structured program to promote well-being. Journal of LGBT Youth. doi: 10.1080/19361653.2018.1479672
Lapointe, A., & Crooks, C. V. (in preparation). Supports and strategies suggested by educators to enhance the delivery of a mental health promotion program offered in GSAs. Manuscript in preparation for submission to the Journal of Evaluation and Program Planning.
Lapointe, A., Dunlop, C., Crooks, C. V. (2018). Feasibility and fit of a mental health promotion program for LGBTQ+ youth. Manuscript accepted for publication in the Journal of Youth Development.
Legislative Assembly of Ontario (2012). Bill 13, (Chapter 5) Statutes of Ontario, 2012: An act to amend the Education Act with respect to bullying and other matters. Toronto, ON: Legislative Assembly of Ontario.
Poteat, V. P., Sinclair, K. O., DiGiovanni, C. D., Koenig, B. W., & Russell, S. T. (2013). Gay-straight alliances are associated with student health: A multischool comparison of LGBTQ and heterosexual youth. Journal of Research on Adolescence, 23(2), 319-330.
Taylor, C., Meyer, E. J., Peter, T., Ristock, J., Short, D., & Campbell, C. (2016). Gaps between beliefs, perceptions, and practices: The every teacher project on LGBTQ-inclusive education in Canadian schools. Journal of LGBT Youth, 13(1-2), 112-140.
Taylor, C., Peter, T., McMinn, T. L., Elliott, T., Beldom, S., Ferry, A., Gross, Z., Paquin, S., & Schachter, K. (2011). Every class in every school: The first national climate survey on homophobia, biphobia, and transphobia in Canadian schools. Toronto, ON: EGALE Canada Human Rights Trust.

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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT05209594    
Other Study ID Numbers: 113468
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Western University, Canada:
Mental health
Social emotional functioning
Gender identity
Sexual identity