Adolescent DevelopmentNCT05209594
Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth
A study testing Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth and Standard GSA Programming in people with Adolescent Development, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Adolescent Development
- What is being tested?
- Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth and Standard GSA Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 1 Oct 2023
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All students participating in the GSA at invention and comparison sites are eligible to participate
- Age 13 to 19 years old
Who cannot join
- Students with low literacy or cognitive functioning may not be able to complete the self-report measures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study Background and Design:
Two-spirit, lesbian, gay, bisexual, trans, queer, intersex, and asexual (2SLGBTQIA+) youth experience disproportionately negative outcomes compared to their heterosexual and cisgender peers in a range of domains, including mental health, problematic substance use, and violence. The heightened risk experienced by these youth appears to be in large part a function of the discrimination and minority stress that they face. Antihomophobic and anti-transphobic school policies and programs can play a protective role in the lives of 2SLGBTQIA+ youth. For example, 2SLGBTQIA+ youth who attend schools that have Genders and Sexualities Alliance/Gay-Straight Alliances (GSAs) are at a lower risk for negative health behaviours, including alcohol and substance use and report increased psychological well-being and psychosocial functioning. Research has found that school staff (e.g., GSA advisors) require more guidance, training, networking opportunities to build their capacity to support 2SLGBTQIA+ youth. Some prominent program developers/academics in the field have suggested that GSAs should offer structured programming depending on the needs and desired of each group, to encourage 2SLGBTQIA+ youth to process and cope with victimization in healthy ways.
The Healthy Relationships Program (HRP) for 2SLGBTQIA + Youth fills a gap in mental health promotion and healthy relationship programming for queer, trans, and gender diverse youth. The program has been piloted in Ontario schools and community agencies and was well received by both facilitators and participants. This study will scale up our previous work and undertake a quasi-experimental, mixed-method evaluation of the HRP for 2SLGBTQIA+ youth with school partners across Canada. The HRP for 2SLGBTQIA+ Youth will be delivered nationally within 10 high school GSAs, and 10 GSAs with standard programming will be utilized as a comparison group. GSA members (students in grades 9 to 12) will participate in pre, post and follow-up surveys. The use of three-time points allows the investigators to look at program impacts within a reasonable timeframe, and to identify potential mechanisms at post-intervention that could mediate changes at follow-up.
By comparing the experiences of GSA members who participate in the HRP for 2SLGBTQIA+ Youth with those who participate in standard GSA programming, investigators will be able to evaluate the relative benefits of standard GSA programming versus formalized/structured programming. Specifically, investigators will be able to determine the extent to which the HRP for 2SLGBTQIA+ Youth promotes positive mental health and well-being among 2SLGBTQIA+ youth and their allies. The study will identify changes in social-emotional assets and resilience, youth well-being, mental health, identity affirmation, dating violence and help-seeking.
Participants:
GSA members (students in grades 9 to 12) participating in high school GSAs where the HRP for 2SLGBTQIA+ Youth is delivered, and GSA members participating in high school GSAs delivering standard programming. Although GSAs vary in size, investigators conservatively estimate that approximately 100 GSA members will participate in this study (i.e., 5 youth from each of the 20 schools - 10 intervention and 10 non-intervention). However, the total number of youth participants may vary considerably since GSAs vary in size (2 to 30+ students).
Procedures:
The school boards partnering on this study will assist in identifying intervention and comparison school sites within their district. All intervention GSA advisors will receive a two-day training on the HRP for 2SLGBTQIA+ youth. GSA members (students in grades 9 to 12) from intervention and comparison sites will be invited to participate in any of the following research activities:
- A pre-GSA programming survey at the beginning of the school year (October/November 2021).
- A post-GSA programming survey at the end of the school year (May/June 2022).
- A follow-up survey at the beginning of the next school year (October 2022). They will also be invited to participate in an interview at the end of the school year.
Investigators will recruit a second cohort the following year if needed to reach the sample size (i.e., number of schools). If a second cohort is included, the timing would be:
A pre-GSA programming survey at the beginning of the school year (October/November 2022).
- A post-GSA programming survey at the end of the school year (May/June 2023). 3. A follow-up survey at the beginning of the next school year (October 2023). They will also be invited to participate in an interview at the end of the school year.
GSA members will consent to their own participation to protect them for requiring to disclose their sexual orientation and/or gender identity to their parents as a condition for research participation. Guardian consent will only be obtained if absolutely required by a partnering school board.
Planned analyses:
Investigators will explore the pre-test data through bivariate analyses to investigate baseline equivalency between intervention and comparison groups using chi-square or t-test as appropriate; any unbalanced covariates will be controlled for in multivariate models. (If two cohorts, cohort differences on baseline characteristics will also be investigated). Youth will be clustered within GSAs, and so associations with outcomes variables at follow-up will be explored using multilevel models. This will allow us to control for both individual and site-level covariates. Intent-to-test analyses will be used, and missing data will be addressed using full information maximum likelihood. The main predictor for all models will be group status (intervention vs. comparison).
- Conditions
- Adolescent Development
- Being tested
- Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth, Standard GSA Programming
- Keywords
- Mental health, Social emotional functioning, Gender identity, Sexual identity
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Relationships Program (HRP) for 2SLGBTQIA+ YouthBehavioural
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.
Standard GSA ProgrammingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth |
| Regular GSA Programming | Active comparator | Students in grades 9 to 12 participating in regular GSA programming. Receives: Behavioral: Standard GSA Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to four month follow-up (up to 12 months)
Secondary outcomes (6)
Gender Sexuality Alliance (GSA) functioning
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.
Measured: Change from baseline to four month follow-up (up to 12 months)
Dating violence
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).
Measured: Change from baseline to four month follow-up (up to 12 months)
Help-seeking intentions
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.
Measured: Change from baseline to four month follow-up (up to 12 months)
Actual help-seeking
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.).
Measured: Change from baseline to four month follow-up (up to 12 months)
Positive mental health
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.
Measured: Change from baseline to four month follow-up (up to 12 months)
Emotional well-being
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.
Measured: Change from baseline to four month follow-up (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- 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)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
- Investigators
- Claire Crooks, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209594
- Sponsor's protocol ID
- 113468
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 26366425Heck, 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.
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.
PubMed 28042585Lapointe, 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.
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.
PubMed 30264092Padilla 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.
PubMed 20632661Poteat 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.
PubMed 28472258Poteat, 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.
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.
PubMed 26772206Saewyc 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.
PubMed 26793284Taylor, 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth
- ClinicalTrials.gov ID
- NCT05209594
- Acronym / sponsor ID
- 113468
- Conditions
- Adolescent Development
- Keywords
- Mental health, Social emotional functioning, Gender identity, Sexual identity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Jan 2022 (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.
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.
Detailed description
Study Background and Design:
Two-spirit, lesbian, gay, bisexual, trans, queer, intersex, and asexual (2SLGBTQIA+) youth experience disproportionately negative outcomes compared to their heterosexual and cisgender peers in a range of domains, including mental health, problematic substance use, and violence. The heightened risk experienced by these youth appears to be in large part a function of the discrimination and minority stress that they face. Antihomophobic and anti-transphobic school policies and programs can play a protective role in the lives of 2SLGBTQIA+ youth. For example, 2SLGBTQIA+ youth who attend schools that have Genders and Sexualities Alliance/Gay-Straight Alliances (GSAs) are at a lower risk for negative health behaviours, including alcohol and substance use and report increased psychological well-being and psychosocial functioning. Research has found that school staff (e.g., GSA advisors) require more guidance, training, networking opportunities to build their capacity to support 2SLGBTQIA+ youth. Some prominent program developers/academics in the field have suggested that GSAs should offer structured programming depending on the needs and desired of each group, to encourage 2SLGBTQIA+ youth to process and cope with victimization in healthy ways.
The Healthy Relationships Program (HRP) for 2SLGBTQIA + Youth fills a gap in mental health promotion and healthy relationship programming for queer, trans, and gender diverse youth. The program has been piloted in Ontario schools and community agencies and was well received by both facilitators and participants. This study will scale up our previous work and undertake a quasi-experimental, mixed-method evaluation of the HRP for 2SLGBTQIA+ youth with school partners across Canada. The HRP for 2SLGBTQIA+ Youth will be delivered nationally within 10 high school GSAs, and 10 GSAs with standard programming will be utilized as a comparison group. GSA members (students in grades 9 to 12) will participate in pre, post and follow-up surveys. The use of three-time points allows the investigators to look at program impacts within a reasonable timeframe, and to identify potential mechanisms at post-intervention that could mediate changes at follow-up.
By comparing the experiences of GSA members who participate in the HRP for 2SLGBTQIA+ Youth with those who participate in standard GSA programming, investigators will be able to evaluate the relative benefits of standard GSA programming versus formalized/structured programming. Specifically, investigators will be able to determine the extent to which the HRP for 2SLGBTQIA+ Youth promotes positive mental health and well-being among 2SLGBTQIA+ youth and their allies. The study will identify changes in social-emotional assets and resilience, youth well-being, mental health, identity affirmation, dating violence and help-seeking.
Participants:
GSA members (students in grades 9 to 12) participating in high school GSAs where the HRP for 2SLGBTQIA+ Youth is delivered, and GSA members participating in high school GSAs delivering standard programming. Although GSAs vary in size, investigators conservatively estimate that approximately 100 GSA members will participate in this study (i.e., 5 youth from each of the 20 schools - 10 intervention and 10 non-intervention). However, the total number of youth participants may vary considerably since GSAs vary in size (2 to 30+ students).
Procedures:
The school boards partnering on this study will assist in identifying intervention and comparison school sites within their district. All intervention GSA advisors will receive a two-day training on the HRP for 2SLGBTQIA+ youth. GSA members (students in grades 9 to 12) from intervention and comparison sites will be invited to participate in any of the following research activities:
- A pre-GSA programming survey at the beginning of the school year (October/November 2021).
- A post-GSA programming survey at the end of the school year (May/June 2022).
- A follow-up survey at the beginning of the next school year (October 2022). They will also be invited to participate in an interview at the end of the school year.
Investigators will recruit a second cohort the following year if needed to reach the sample size (i.e., number of schools). If a second cohort is included, the timing would be:
A pre-GSA programming survey at the beginning of the school year (October/November 2022).
- A post-GSA programming survey at the end of the school year (May/June 2023). 3. A follow-up survey at the beginning of the next school year (October 2023). They will also be invited to participate in an interview at the end of the school year.
GSA members will consent to their own participation to protect them for requiring to disclose their sexual orientation and/or gender identity to their parents as a condition for research participation. Guardian consent will only be obtained if absolutely required by a partnering school board.
Planned analyses:
Investigators will explore the pre-test data through bivariate analyses to investigate baseline equivalency between intervention and comparison groups using chi-square or t-test as appropriate; any unbalanced covariates will be controlled for in multivariate models. (If two cohorts, cohort differences on baseline characteristics will also be investigated). Youth will be clustered within GSAs, and so associations with outcomes variables at follow-up will be explored using multilevel models. This will allow us to control for both individual and site-level covariates. Intent-to-test analyses will be used, and missing data will be addressed using full information maximum likelihood. The main predictor for all models will be group status (intervention vs. comparison).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth | Experimental | Behavioral: Healthy Relationships Program (HRP) for 2SLGBTQIA+ YouthStudents in grades 9 to 12 participating in GSAs where the HRP for 2SLGBTQIA+ Youth is being implemented. |
| Regular GSA Programming | Active comparator | Behavioral: Standard GSA ProgrammingStudents in grades 9 to 12 participating in regular GSA programming. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All students participating in the GSA at invention and comparison sites are eligible to participate
- Age 13 to 19 years old
Key exclusion criteria (1 listed)
- Students with low literacy or cognitive functioning may not be able to complete the self-report measures.
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 |
|---|---|---|
| Healthy Relationships Program (HRP) for 2SLGBTQIA+ YouthThe 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. | Behavioural | Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth |
| Standard GSA ProgrammingStudents 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. | Behavioural | Regular GSA Programming |
Primary outcome
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.
6 secondary outcomes
Gender Sexuality Alliance (GSA) functioning
Time frame: Change from baseline to four month follow-up (up to 12 months)
Dating violence
Time frame: Change from baseline to four month follow-up (up to 12 months)
Help-seeking intentions
Time frame: Change from baseline to four month follow-up (up to 12 months)
Actual help-seeking
Time frame: Change from baseline to four month follow-up (up to 12 months)
Positive mental health
Time frame: Change from baseline to four month follow-up (up to 12 months)
Emotional well-being
Time frame: Change from baseline to four month follow-up (up to 12 months)
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 11 Dec 2023.
- BackgroundGraybill, 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: PubMed 26366425Heck 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.
- BackgroundHeck, 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: PubMed 28042585Ioverno 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.
- BackgroundLapointe, 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
- BackgroundLapointe, 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.
- BackgroundLapointe, 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.
- BackgroundLegislative 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: PubMed 30264092Lowry 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.
- Background: PubMed 20632661Padilla 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.
- Background: PubMed 28472258Poteat 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.
- BackgroundPoteat, 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.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Claire Crooks, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth and Standard GSA Programming in people with Adolescent Development, run by Western University, Canada 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 2 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 11 Dec 2023. 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?
Positive social-emotional functioning (time frame: Change from baseline to four month follow-up (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 NCT05209594, which also lists 17 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 11 Dec 2023.