PLANTS Pilot Trial

Depressive Symptoms Clinical Trial

— PLANTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897827
• Other study ID #: STUDY23040142
• Secondary ID: K01AA027564
• Status: Completed
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Bullying
• Depression
• Depressive Symptoms
• Social Acceptance

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)