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PLANTS Pilot Trial (PLANTS)

Primary Purpose

Alcohol Drinking, Social Acceptance, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PLANTS
EMAILS
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Sexual and gender minority youth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PLANTS

EMAILS

Arm Description

Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.

Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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%).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 1, 2023
Last Updated
July 30, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05897827
Brief Title
PLANTS Pilot Trial
Acronym
PLANTS
Official Title
Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Social Acceptance, Depressive Symptoms, Bullying
Keywords
Sexual and gender minority youth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-armed cluster-randomized controlled pilot trial of the PLANTS intervention versus an active control group, the EMAILS intervention. The investigators will randomize schools in an equal 1:1 ratio, stratified by large versus small schools, into intervention or active control conditions. The investigators will use block randomization with block sizes of 2, which will be stratified by large schools versus not, where large is ≥1000 students. The investigators use block size of 2 because there are only 4 schools in this pilot trial.
Masking
None (Open Label)
Masking Description
This is an unblinded study. This is an educational intervention that cannot be blinded because study participants will be able to tell which condition they are in based on the content they receive.
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLANTS
Arm Type
Experimental
Arm Description
Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.
Arm Title
EMAILS
Arm Type
Active Comparator
Arm Description
Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.
Intervention Type
Behavioral
Intervention Name(s)
PLANTS
Other Intervention Name(s)
Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMAILS
Other Intervention Name(s)
E-learning to Maximize Academic Inclusion of LGBTQ+ Students
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean value of Acceptability of Intervention Measure
Description
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.
Time Frame
Approximately 4 months after intervention deployment
Title
Mean score on the System Usability Scale
Description
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.
Time Frame
Approximately 4 months after intervention deployment
Title
Mean value of Intervention Appropriateness Measure
Description
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.
Time Frame
Approximately 4 months after intervention deployment
Title
Mean value of Feasibility of Intervention Measure
Description
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.
Time Frame
Approximately 4 months after intervention deployment
Secondary Outcome Measure Information:
Title
Trial participation rate
Description
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.
Time Frame
Baseline
Title
Trial retention rate
Description
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.
Time Frame
At follow-up (approximately 4 months after baseline)
Title
Intervention demand
Description
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%).
Time Frame
At follow-up (approximately 4 months after baseline)
Title
Change in mean scores on the Active-Empathic Listening Scale
Description
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.
Time Frame
Baseline and follow-up (approximately 4 months after baseline)
Title
Change in mean scores on PLANTS' self-efficacy change objectives
Description
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.
Time Frame
Baseline and follow-up (approximately 4 months after baseline)
Title
Change in mean scores on the Teacher Bystander Intervention Model in Traditional Bullying scale
Description
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.
Time Frame
Baseline and follow-up (approximately 4 months after baseline)
Title
Change in mean scores on the Teacher Bystander Intervention Model in Cyberbullying scale
Description
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.
Time Frame
Baseline and follow-up (approximately 4 months after baseline)
Title
Change in mean scores on the modified Gay Affirmative Practice Scale
Description
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.
Time Frame
Baseline and follow-up (approximately 4 months after baseline)
Title
Safety outcomes
Description
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.
Time Frame
At follow-up (approximately 4 months after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Coulter, PhD, MPH
Phone
+1-412-624-0647
Email
robert.ws.coulter@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Coulter, PhD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Coulter, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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