PLANTS Pilot Trial (PLANTS)

Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Depressive Symptoms; Bullying; Social Acceptance
• Intervention / Treatment: Behavioral: PLANTS; Behavioral: EMAILS

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Coulter, PhD, MPH; Phone Number: +1-412-624-0647; Email: robert.ws.coulter@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLANTS; Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.	Behavioral: PLANTS; PLANTS intervention is an online-delivered training program, including asynchronous and synchronous activities. This intervention was informed by the Information-Motivation-Behavior theory to target skills, self-efficacy, knowledge, and outcome expectations. There are 3 asynchronous online modules that cover a variety of topics including lessons on LGBTQ+ terminology, names and pronouns, resources, antibullying, gender neutral bathrooms, student confidentiality, active empathic listening, and school policies. Module include recorded presentations, student testimonials, activities, and downloadable resources for future reference. Every month, 7-9 lessons are opened. There are 2 synchronous group events delivered via Zoom and are 1.5 hours each.; Other Names: Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety
Active Comparator: EMAILS; Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.	Behavioral: EMAILS; The active control arm is an email-based intervention, EMAILS, in which existing public resources for supporting, affirming, and protecting LGBTQ+ students are emailed to participants.; Other Names: E-learning to Maximize Academic Inclusion of LGBTQ+ Students

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean value of Acceptability of Intervention Measure	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 higher the computed mean value, the more acceptable the intervention.	Approximately 4 months after intervention deployment
Mean score on the System Usability Scale	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. The higher the computed value, the more useable the intervention.	Approximately 4 months after intervention deployment
Mean value of Intervention Appropriateness Measure	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 higher the computed mean value, the more appropriate the intervention.	Approximately 4 months after intervention deployment
Mean value of Feasibility of Intervention Measure	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 higher the computed mean value, the more feasible the intervention.	Approximately 4 months after intervention deployment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial participation rate	The investigators will divide the number of school staff who consent to participate by the total number of school staff who are invited, then multiplied by 100 to get a percentage.	Baseline
Trial retention rate	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 multiplied by 100 to get a percentage.	At follow-up (approximately 4 months after baseline)
Intervention demand	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. 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%).	At follow-up (approximately 4 months after baseline)
Change in mean scores on the Active-Empathic Listening Scale	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 and then compared.	Baseline and follow-up (approximately 4 months after baseline)
Change in mean scores on PLANTS' self-efficacy change objectives	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." Investigators will calculate the average of these responses at each timepoint and then compare them.	Baseline and follow-up (approximately 4 months after baseline)
Change in mean scores on the Teacher Bystander Intervention Model in Traditional Bullying scale	Participants will complete the 16-item Teacher Bystander Intervention Model in Traditional Bullying scale. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Investigators will calculate the average of these responses at each timepoint and then compare them.	Baseline and follow-up (approximately 4 months after baseline)
Change in mean scores on the Teacher Bystander Intervention Model in Cyberbullying scale	Participants will complete the 16-item Teacher Bystander Intervention Model in Cyberbullying scale. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Investigators will calculate the average of these responses at each timepoint and then compare them.	Baseline and follow-up (approximately 4 months after baseline)
Change in mean scores on the modified Gay Affirmative Practice Scale	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). Investigators will calculate the average of these responses at each timepoint and then compare them.	Baseline and follow-up (approximately 4 months after baseline)
Safety outcomes	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.	At follow-up (approximately 4 months after baseline)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Robert Coulter, PhD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Sexual and gender minority youth
• Additional Relevant MeSH Terms: Behavioral Symptoms; Drinking Behavior; Aggression; Alcohol Drinking; Depression; Bullying
• Other Study ID Numbers: STUDY23040142; K01AA027564 (U.S. NIH Grant/Contract)

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