NCT05209594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

October 3, 2021

Last Update Submit

December 7, 2023

Conditions

Keywords

Mental healthSocial emotional functioningGender identitySexual identity

Outcome Measures

Primary Outcomes (1)

  • Positive social-emotional functioning

    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.

    Change from baseline to four month follow-up (up to 12 months)

Secondary Outcomes (6)

  • Gender Sexuality Alliance (GSA) functioning

    Change from baseline to four month follow-up (up to 12 months)

  • Dating violence

    Change from baseline to four month follow-up (up to 12 months)

  • Help-seeking intentions

    Change from baseline to four month follow-up (up to 12 months)

  • Actual help-seeking

    Change from baseline to four month follow-up (up to 12 months)

  • Positive mental health

    Change from baseline to four month follow-up (up to 12 months)

  • +1 more secondary outcomes

Study Arms (2)

Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth

EXPERIMENTAL

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

Regular GSA Programming

ACTIVE COMPARATOR

Students in grades 9 to 12 participating in regular GSA programming.

Behavioral: Standard GSA Programming

Interventions

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.

Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth

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.

Regular GSA Programming

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6G 1G7, Canada

Location

Related Publications (17)

  • 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.

    BACKGROUND
  • Heck NC. The Potential to Promote Resilience: Piloting a Minority Stress-Informed, GSA-Based, Mental Health Promotion Program for LGBTQ Youth. Psychol Sex Orientat Gend Divers. 2015 Sep;2(3):225-231. doi: 10.1037/sgd0000110.

    PMID: 26366425BACKGROUND
  • 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.

    BACKGROUND
  • Ioverno S, Belser AB, Baiocco R, Grossman AH, Russell ST. The Protective Role of Gay-Straight Alliances for Lesbian, Gay, Bisexual, and Questioning Students: A Prospective Analysis. Psychol Sex Orientat Gend Divers. 2016 Dec;3(4):397-406. doi: 10.1037/sgd0000193.

    PMID: 28042585BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Lowry R, Johns MM, Gordon AR, Austin SB, Robin LE, Kann LK. Nonconforming Gender Expression and Associated Mental Distress and Substance Use Among High School Students. JAMA Pediatr. 2018 Nov 1;172(11):1020-1028. doi: 10.1001/jamapediatrics.2018.2140.

    PMID: 30264092BACKGROUND
  • Padilla YC, Crisp C, Rew DL. Parental acceptance and illegal drug use among gay, lesbian, and bisexual adolescents: results from a national survey. Soc Work. 2010 Jul;55(3):265-75. doi: 10.1093/sw/55.3.265.

    PMID: 20632661BACKGROUND
  • Poteat VP, Heck NC, Yoshikawa H, Calzo JP. Gay-Straight Alliances as settings to discuss health topics: individual and group factors associated with substance use, mental health, and sexual health discussions. Health Educ Res. 2017 Jun 1;32(3):258-268. doi: 10.1093/her/cyx044.

    PMID: 28472258BACKGROUND
  • 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.

    BACKGROUND
  • Russell ST, Fish JN. Mental Health in Lesbian, Gay, Bisexual, and Transgender (LGBT) Youth. Annu Rev Clin Psychol. 2016;12:465-87. doi: 10.1146/annurev-clinpsy-021815-093153. Epub 2016 Jan 14.

    PMID: 26772206BACKGROUND
  • Saewyc EM, Konishi C, Rose HA, Homma Y. School-Based Strategies to Reduce Suicidal Ideation, Suicide Attempts, and Discrimination among Sexual Minority and Heterosexual Adolescents in Western Canada. Int J Child Youth Family Stud. 2014 Jan 1;5(1):89-112. doi: 10.18357/ijcyfs.saewyce.512014.

    PMID: 26793284BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Toomey RB, Ryan C, Diaz RM, Card NA, Russell ST. Gender-nonconforming lesbian, gay, bisexual, and transgender youth: school victimization and young adult psychosocial adjustment. Dev Psychol. 2010 Nov;46(6):1580-9. doi: 10.1037/a0020705.

    PMID: 20822214BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Horseradish Peroxidase

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

PeroxidasesOxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • Claire Crooks, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

January 26, 2022

Study Start

March 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations