ABSTRACT
BACKGROUND: Sexual and gender minority youths (lesbian, gay, bisexual, transgender, nonbinary, and queer individuals) face elevated risks of substance use (eg, alcohol and tobacco) and mental health issues (eg, depressive symptoms and suicidality) compared to their cisgender heterosexual peers. These inequities are hypothesized to be reduced by building supportive high school environments via the training of school staff. An intervention that trains school staff to better understand and support sexual and gender minority youths and engage in positive bystander behaviors that protect them from bullying exposure may reduce disparities in drug and alcohol use among them. Experts, school staff, and sexual and gender minority youths developed Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety (PLANTS), a web-based intervention to train school staff on how to support, affirm, and protect sexual and gender minority youths. OBJECTIVE: This paper describes the design of the PLANTS pilot trial primarily aimed at assessing its acceptability, usability, appropriateness, and feasibility. We hypothesize PLANTS will have high acceptability, usability, appropriateness, and feasibility as rated by the school staff. Secondary objectives focus on implementation, safety, and pre-post changes in high school staff outcomes, including self-efficacy and skills (eg, active-empathic listening and bullying intervention). Exploratory objectives focus on the impact of PLANTS on student health outcomes. METHODS: In a 2-arm cluster randomized controlled trial, high schools in Massachusetts are allocated to PLANTS or an active comparator group (publicly available sexual and gender minority youths resources or training). High school staff complete pretest and posttest surveys containing validated scales. Primary outcomes are validated measures of acceptability, usability, appropriateness, and feasibility of the intervention completed by staff during posttest surveys. To test our primary hypotheses for each outcome, we will calculate means and 95% CIs and P values using 1-sample 2-sided t tests against a priori thresholds or benchmarks of success. Secondary outcomes include staff's active-empathetic listening skills, self-efficacy for working with sexual and gender minority youths, bystander intervention behaviors for bullying and cyberbullying, and self-efficacy for PLANTS' change objectives completed during pretest and posttest staff surveys. Staff can also complete a posttest interview guided by the Information-Motivation-Behavior model and Consolidated Framework for Implementation Research. Exploratory outcomes include student-level data collected via the 2021 and 2023 MetroWest Adolescent Health Surveys, a health behavior surveillance system in 30 Massachusetts schools. RESULTS: School enrollment began in May 2023 and participant enrollment began in June 2023. Data collection is expected to be completed by February 2024. CONCLUSIONS: This pilot trial will yield important information about the PLANTS intervention and provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the deleterious health inequities experienced by sexual and gender minority youths. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897827; https://clinicaltrials.gov/study/NCT05897827. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55210.
ABSTRACT
BACKGROUND: Sexual and gender minority youth (SGMY; eg, lesbian, gay, bisexual, and transgender youth) experience myriad substance use and mental health disparities compared with their cisgender (nontransgender) heterosexual peers. Despite much research showing these disparities are driven by experiences of bullying and cyberbullying victimization, few interventions have aimed to improve the health of bullied SGMY. One possible way to improve the health of bullied SGMY is via a Web-accessible game intervention. Nevertheless, little research has examined the feasibility of using a Web-accessible game intervention with SGMY. OBJECTIVE: This study aimed to describe the protocol for a randomized controlled trial (RCT) pilot, testing the feasibility and limited efficacy of a game-based intervention for increasing help-seeking-related knowledge, intentions, self-efficacy, behaviors, productive coping skills use, and coping flexibility and reducing health risk factors and behaviors among SGMY. METHODS: We enrolled 240 SGMY aged 14 to 18 years residing in the United States into a 2-arm prospective RCT. The intervention is a theory-based, community-informed, computer-based, role playing game with 3 primary components: encouraging help-seeking behaviors, encouraging use of productive coping, and raising awareness of Web-based resources. SGMY randomized to both the intervention and control conditions will receive a list of SGMY-inclusive resources, covering a variety of health-related topics. Control condition participants received only the list of resources. Notably, all study procedures are conducted via the internet. We conveniently sampled SGMY using Web-based advertisements. Study assessments occur at enrollment, 1 month after enrollment, and 2 months after enrollment. The primary outcomes of this feasibility study include implementation procedures, game demand, and game acceptability. Secondary outcomes include help-seeking intentions, self-efficacy, and behaviors; productive coping strategies and coping flexibility; and knowledge and use of Web-based resources. Tertiary outcomes include bullying and cyberbullying victimization, loneliness, mental health issues, substance use, and internalized sexual and gender minority stigma. RESULTS: From April to July 2018, 240 participants were enrolled and randomized. Half of the enrolled participants (n=120) were randomized into the intervention condition and half (n=120) into the control condition. At baseline, 52.1% (125/240) of the participants identified as gay or lesbian, 26.7% (64/240) as bisexual, 24.2% (58/240) as queer, and 11.7% (28/240) as another nonheterosexual identity. Nearly half (113/240) of participants were a gender minority: 36.7% (88/240) were cisgender boys, and 16.3% (39/240) were cisgender girls. There were no differences in demographic characteristics between intervention and control condition participants. CONCLUSIONS: Web-accessible game interventions overcome common impediments of face-to-face interventions and present a unique opportunity to reach SGMY and improve their health. This trial will provide data on feasibility and limited efficacy that can inform future Web-based studies and a larger RCT aimed at improving health equity for SGMY. TRIAL REGISTRATION: ClinicalTrials.gov NCT03501264; https://clinicaltrials.gov/ct2/show/NCT03501264 (Archived by WebCite at http://www.webcitation.org/72HpafarW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12164.
