PLANTS Pilot Trial

Not Applicable

Completed

Conditions: Alcohol Drinking
Bullying
Social Acceptance
Depressive Symptoms

Interventions: Behavioral: EMAILS
Behavioral: PLANTS

Registration Number: NCT05897827

Lead Sponsor: University of Pittsburgh

Brief Summary: This pilot cluster-randomized controlled trial will evaluate the PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety) course among high school staff. The primary hypotheses are that the PLANTS course will have high acceptability, usability, appropriateness, and feasibility as reported by high school staff.

Detailed Description: The intervention being studied, PLANTS, is an online-delivered training program, including asynchronous and synchronous activities targeting high school staff. This intervention is informed by the Information-Motivation-Behavior theory to target high school staffs' skills, self-efficacy, knowledge, and outcome expectations. Members of the study population as well as collaborators invested in Sexual and Gender Minority Youth (SGMY) well-being provided valuable feedback on PLANTS throughout its development. Comparison schools will receive the email-based control intervention, E-learning to Maximize Academic Inclusion of LGBTQ+ Students (EMAILS). Staff will receive periodic emails with publicly available resources on similar topics to those of PLANTS.

Regarding the intervention's targeted behavioral outcomes, upon completion of the PLANTS program, high school staff will: provide interpersonal support and affirmation to SGMY; provide educational resources that are inclusive of SGMY; provide safe spaces for SGMY; promote acceptance of SGMY among cisgender heterosexual youth; prevent and reduce bullying, cyberbullying, and harassment of SGMY; evaluate and advocate for SGMY inclusivity and protections in school policies; and maintain the confidentiality of SGMY. By having high school staff achieve these behavioral outcomes, the investigators hypothesize that SGMY will experience less risk factors (e.g., bullying victimization) and more protective factors (e.g., school-based adult support), which will in turn reduce SGMY's substance use and mental health problems.

The primary aim of this clinical trial is to rigorously test the acceptability, usability, appropriateness, and feasibility of the PLANTS intervention using a 2-armed cluster-randomized controlled trial. The investigators will also examine the efficacy of intervention in improving high school staff outcomes as well as implementation and safety outcomes related to the intervention and trial. Results from this pilot trial will provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the ultimate health outcome of SGMY alcohol use.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 99

Inclusion Criteria

Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
Age 18 years old or older
Consents to participate

Exclusion Criteria

• Does not interact with high school students at work

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMAILS	EMAILS	Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.
PLANTS	PLANTS	Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.

Primary Outcome Measures

Name	Time	Method
Mean Value of Acceptability of Intervention Measure	Approximately 4 months after intervention deployment	At follow-up, participants will complete the four-question Acceptability of Intervention Measure (AIM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean acceptability value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more acceptable the intervention.
Mean Score on the System Usability Scale	Approximately 4 months after intervention deployment	At follow-up, participants will complete the ten-question System Usability Scale (SUS) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Strongly agree) to 5 (Strongly disagree). The odd-numbered question responses will be reverse coded. All items will be summed and that sum will be multiplied by 2.5 to produce the final SUS value (ranging from 0-100). The higher the computed value, the more useable the intervention.
Mean Value of Intervention Appropriateness Measure	Approximately 4 months after intervention deployment	At follow-up, participants will complete the four-question Intervention Appropriateness Measure (IAM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean appropriateness value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more appropriate the intervention.
Mean Value of Feasibility of Intervention Measure	Approximately 4 months after intervention deployment	At follow-up, participants will complete the four-question Feasibility of Intervention Measure (FIM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean feasibility value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more feasible the intervention.

Secondary Outcome Measures

Name	Time	Method
Trial Participation Rate	Baseline	The investigators will divide the number of school staff who consent to participate by the total number of school staff who are invited, then multiply by 100 to get a percentage.
Trial Retention Rate	At follow-up (approximately 4 months after baseline)	The investigators will divide the number of school staff who complete the follow-up survey by the total number of school staff who were enrolled, then multiply by 100 to get a percentage.
Intervention Demand	At follow-up (approximately 4 months after baseline)	The investigators will divide the number of participants who adhere to the PLANTS intervention by the total number of school staff who were enrolled at schools randomly assigned the PLANTS intervention and multiply by 100 to obtain a percentage. Adherence is a composite variable ranging from 0-100% comprised of: 55% for online module completion (based on the number of completed items divided by the total number of items offered); 45% for Live Zoom Event attendance (where each event is 15%).
Change in Mean Scores on the Active-Empathic Listening Scale	Baseline and follow-up (approximately 4 months after baseline)	Participants will complete the eleven-item Active-Empathic Listening Scale at baseline and follow-up. Each item uses a seven-point Likert scale for responses, coded from 1 ("never or almost never true") to 7 ("Always or almost always true"). Mean scores will be calculated for all eleven items at each time point. The minimum possible mean value is 1 and the maximum mean value is 7. Higher values represent greater active-empathic listening. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in active-empathic listening from baseline to follow-up.
Change in Mean Scores on Self-efficacy Change Objectives for Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety	Baseline and follow-up (approximately 4 months after baseline)	The investigators have developed items pertaining directly to PLANTS' self-efficacy change objectives. Participants will complete each item using a five-point Likert scale, where 1 represents "not at all certain" and 5 represents "extremely certain." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater self-efficacy. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in self-efficacy from baseline to follow-up.
Change in Mean Scores on the Teacher Bystander Intervention Model in Traditional Bullying Scale	Baseline and follow-up (approximately 4 months after baseline)	Participants will complete the 16-item Teacher Bystander Intervention Model in Traditional Bullying scale, which has five subscales. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater skills related to bystander intervention in bullying. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in bystander intervention skills from baseline to follow-up.
Change in Mean Scores on the Teacher Bystander Intervention Model in Cyberbullying Scale	Baseline and follow-up (approximately 4 months after baseline)	Participants will complete the 16-item Teacher Bystander Intervention Model in Cyberbullying scale, which has five subscales. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater skills related to bystander intervention in cyberbulling. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in bystander intervention skills from baseline to follow-up.
Change in Mean Scores on the Modified Gay Affirmative Practice Scale	Baseline and follow-up (approximately 4 months after baseline)	The investigators have modified the language of the Gay Affirmative Practice Scale to incorporate school-oriented words instead of therapy-oriented words to measure self-efficacy for school staff working with SGMY. Participants will complete the nine-item scale at baseline and follow-up, with each item using a five-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater self-efficacy. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in self-efficacy from baseline to follow-up.
Safety Outcomes	At follow-up (approximately 4 months after baseline)	Investigators assess myriad safety outcomes including parent backlash, social media backlash, school board backlash, suspension or removal from employment, censorship of LGBTQ+ literature/history/stories or removal of books with LGBTQ+ representation from school libraries, and emotional discomfort with intervention and control conditions at follow-up. Response options include frequency of each event occurrence (none, once, twice, 3-9 times, and 10 or more times). Investigators will report the overall frequency of events, frequency of each type of event, and percentage of school staff reporting any event.