Evaluation of the Healthy Relationships Program for 2SLGBTQIA+ Youth

December 7, 2023 updated by: Western University, Canada
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Meghan Fournie, MHIS
  • Phone Number: 84360 519-661-2111
  • Email: mfourni8@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 1G7
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to four month follow-up (up to 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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).
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)
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.
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)
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.).
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 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.
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)
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.
Change from baseline to four month follow-up (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Collaborators

Public Health Agency of Canada (PHAC)

Investigators

  • Principal Investigator: Claire Crooks, PhD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

October 3, 2021

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 113468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Development

Clinical Trials on Healthy Relationships Program (HRP) for 2SLGBTQIA+ Youth

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe