Clinical trial NCT05209594: Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth
Official title: Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Development
Keywords: Mental health
Social emotional functioning
Gender identity
Sexual identity
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2022-01-26
Enrollment: 53
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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:

1. A pre-GSA programming survey at the beginning of the school year (October/November 2021).
2. A post-GSA programming survey at the end of the school year (May/June 2022).
3. 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).

2. 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).

Eligibility 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.

Primary outcomes:
measure: Positive social-emotional functioning
timeFrame: Change from baseline to four month follow-up (up to 12 months)
Secondary outcomes:
measure: Gender Sexuality Alliance (GSA) functioning
timeFrame: Change from baseline to four month follow-up (up to 12 months)
measure: Dating violence
timeFrame: Change from baseline to four month follow-up (up to 12 months)
measure: Help-seeking intentions
timeFrame: Change from baseline to four month follow-up (up to 12 months)
measure: Actual help-seeking
timeFrame: Change from baseline to four month follow-up (up to 12 months)
measure: Positive mental health
timeFrame: Change from baseline to four month follow-up (up to 12 months)
measure: Emotional well-being
timeFrame: Change from baseline to four month follow-up (up to 12 months)
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Claire Crooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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