Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
Phase: NA
Conditions: Alcohol Drinking, Social Acceptance, Depressive Symptoms, Bullying
Sponsor: University of Pittsburgh

 
 
Providing LGBTQ+ Adolescents with Nurturance, 
Trustworthiness, and Safety (PLANTS): Pilot Cluster-
Randomized Controlled Trial 
 
 
Protocol Number: STUDY21080178 
National Clinical Trial (NCT) Identified Number: NCT05897827 
Principal Investigator: Robert W.S. Coulter 
Sponsor: University of Pittsburgh 
Grant Title: Developing and Piloting a School Staff-Based Intervention to Reduce 
Alcohol and Drug Use Among Sexual Minority Youth 
Grant Number: K01AA027564 
 
Funded by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
Version Number: v1.1 
2024.04.05 

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TABLE OF CONTENTS 
CONFIDENTIALITY STATEMENT ..................................................................... Error! Bookmark not defined. 
STATEMENT OF COMPLIANCE ...................................................................................................................... 1 
INVESTIGATOR’S SIGNATURE ....................................................................................................................... 2 
1 
PROTOCOL SUMMARY ............................................................................................................................. 3 
1.1 
Synopsis ....................................................................................................................................... 3 
1.2 
Schema ........................................................................................................................................ 4 
1.3 
Schedule of Activities ................................................................................................................... 5 
2 
INTRODUCTION ......................................................................................................................................... 6 
2.1 
Study Rationale ............................................................................................................................ 6 
2.2 
Background .................................................................................................................................. 7 
2.3 
Risk/Benefit Assessment .............................................................................................................. 8 
2.3.1 
Known Potential Risks .................................................................................................. 8 
2.3.2 
Known Potential Benefits .............................................................................................. 8 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................. 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 9 
4 
STUDY DESIGN ........................................................................................................................................ 10 
4.1 
Overall Design ............................................................................................................................ 10 
4.2 
Scientific Rationale for Study Design .......................................................................................... 11 
4.3 
Justification for Intervention ........................................................................................................ 11 
4.4 
End-of-Study Definition ............................................................................................................... 12 
5 
STUDY POPULATION ............................................................................................................................... 12 
5.1 
Inclusion Criteria ......................................................................................................................... 12 
5.2 
Exclusion Criteria ........................................................................................................................ 12 
5.3 
Lifestyle Considerations .............................................................................................................. 13 
5.4 
Screen Failures .......................................................................................................................... 13 
5.5 
Strategies for Recruitment and Retention ................................................................................... 13 
6 
STUDY INTERVENTIONS ......................................................................................................................... 13 
6.1 
Study Intervention Administrations ............................................................................................. 13 
6.1.1 
Study Intervention Descriptions .................................................................................. 13 
6.1.2 
Administration and Dosing .......................................................................................... 14 
6.2 
Fidelity ........................................................................................................................................ 15 
6.2.1 
Interventionist Training and Tracking .......................................................................... 15 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 15 
6.4 
Study Intervention Adherence..................................................................................................... 15 
6.5 
Concomitant Therapy ................................................................................................................. 16 
6.5.1 
Rescue Therapy ......................................................................................................... 16 
7 
STUDY INTERVENTION DISCONTINUATION & PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .............................................................................................................. 16 
7.1 
Discontinuation of Study Intervention .......................................................................................... 16 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 16 
7.3 
Lost to Follow-Up ........................................................................................................................ 16 
8 
STUDY ASSESSMENTS AND PROCEDURES......................................................................................... 16 

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Endpoint and Other Non-Safety Assessments ............................................................................ 16 
8.2 
Safety Assessments ................................................................................................................... 22 
8.3 
Adverse Events and Serious Adverse Events ............................................................................. 23 
8.3.1 
Definition of Adverse Events ....................................................................................... 23 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 23 
8.3.3 
Classification of an Adverse Event .............................................................................. 23 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ............................. 24 
8.3.5 
Adverse Event Reporting ............................................................................................ 25 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 25 
8.3.7 
Reporting Events to Participants ................................................................................. 25 
8.3.8 
Events of Special Interest ........................................................................................... 25 
8.3.9 
Reporting of Pregnancy .............................................................................................. 25 
8.4 
Unanticipated Problems .............................................................................................................. 25 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 25 
8.4.2 
Unanticipated Problems Reporting ............................................................................. 25 
8.4.3 
Reporting Unanticipated Problems to Participants ...................................................... 26 
9 
STATISTICAL CONSIDERATIONS ........................................................................................................... 26 
9.1 
Statistical Hypotheses ................................................................................................................ 26 
9.2 
Sample Size Determination ........................................................................................................ 26 
9.3 
Populations for Analyses ............................................................................................................ 27 
9.4 
Statistical Analyses ..................................................................................................................... 27 
9.4.1 
General Approach ...................................................................................................... 27 
9.4.2 
Analysis of the Primary Endpoints .............................................................................. 28 
9.4.3 
Analysis of the Secondary Endpoints .......................................................................... 28 
9.4.4 
Safety Analyses .......................................................................................................... 29 
9.4.5 
Baseline Descriptive Statistics .................................................................................... 29 
9.4.6 
Planned Interim Analyses ........................................................................................... 30 
9.4.7 
Sub-Group Analyses................................................................................................... 30 
9.4.8 
Tabulation of Individual Participant Data ..................................................................... 30 
9.4.9 
Exploratory Analyses ..................................................... Error! Bookmark not defined. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ........................................ 30 
10.1 Regulatory, Ethical, and Study Oversight Considerations ........................................................... 30 
10.1.1 
Informed Consent Process ......................................................................................... 30 
10.1.2 
Study Discontinuation and Closure ............................................................................. 31 
10.1.3 
Confidentiality and Privacy ......................................................................................... 31 
10.1.4 
Future Use of Stored Data .......................................................................................... 32 
10.1.5 
Key Roles and Study Governance .............................................................................. 32 
10.1.6 
Safety Oversight ......................................................................................................... 32 
10.1.7 
Clinical Monitoring ...................................................................................................... 33 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 33 
10.1.9 
Data Handling and Record Keeping ............................................................................ 33 
10.1.10 Protocol Deviations ..................................................................................................... 33 

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10.1.11 Publication and Data Sharing Policy ........................................................................... 34 
10.1.12 Conflict of Interest Policy ............................................................................................ 34 
10.2 Additional Considerations ........................................................................................................... 34 
10.3 Abbreviations and Special Terms ............................................................................................... 35 
10.4 Protocol Amendment History ...................................................................................................... 35 
11 REFERENCES .......................................................................................................................................... 36 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice 
(ICH GCP) and the following: 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR 
Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the 
conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection 
and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to 
the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained 
before any participant is consented. Any amendment to the protocol will require review and approval by the 
IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB 
approved; a determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances that this 
study will be conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations 
and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator:  
Signed: 
Robert W.S. Coulter 
Date: 
2024.04.05 
 
Name: Robert W.S. Coulter 
 
Title: 
Assistant Professor 
 
Investigator Contact Information 
Affiliation: University of Pittsburgh 
Address: 6129 Public Health Building, 130 De Soto Street, Pittsburgh, Pennsylvania, USA 15261 
Telephone: +1-412-624-0647 
Email: robert.ws.coulter@pitt.edu  
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
Synopsis  
Title: 
Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety 
(PLANTS): Pilot Cluster-Randomized Controlled Trial 
Grant Number: 
K01AA027564 
Study Description: 
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. 
Objectives: 
 
Primary Objective:  
-For high school staff, is PLANTS acceptable, usable, appropriate, and feasible? 
Secondary Objectives:  
-To what extent was the PLANTS course and trial successfully implemented and 
safe for high school staff and schools? 
- Among high school staff participants in the PLANTS arm, do they report pre-post 
improvements in active-empathic listening, self-efficacy for supporting, affirming, 
and protecting sexual and gender minority youths, and positive bystander 
intervention behaviors for bullying? 
-Among high school staff, is the PLANTS intervention more efficacious in improving 
their active-empathic listening, self-efficacy for supporting, affirming, and protecting 
SGMY, and positive bystander intervention behaviors for bullying than an email 
intervention of publicly available resources?  
Endpoints: 
Primary Endpoints: Intervention acceptability, usability, appropriateness, and 
feasibility. 
Secondary Endpoints: Intervention efficacy for school staff; Success of intervention 
implementation; Success of trial implementation; Intervention safety. 
Study Population: 
The primary study population is high school staff, aged 18 years old and over, who 
work at high schools in the MetroWest Region outside Boston, Massachusetts.  
Phase or Stage: 
Pilot Phase  
Description of Sites 
Enrolling 
Participants: 
This is a single site study conducted by the University of Pittsburgh. 
 
Description of Study 
Intervention: 
The PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, 
and Safety) intervention course is a community-informed, theory-based intervention 
for training high school staff to better support, affirm, and protect SGMY. The 
intervention is web-based, containing self-paced asynchronous modules and 
synchronous group-based events. The intervention will occur across a period of 
three months. 
Study Duration: 
The estimated study duration is 12 months. 
Participant Duration: 
High school staff will complete all study-related tasks within 9-12 months. 
 
 
 

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1.2 
Schema  
 

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1.3 
Schedule of Activities  
 
 
 
School Screener 
Staff Screener  
(Time 0) 
Staff Baseline Survey  
(Time 1)  
PLANTS Program  
Control Program 
Staff Follow-up Survey 
(Time 2) 
Staff Follow-up 
Interview 
(Time 3) 
SCHOOL DATA 
 
 
 
 
 
Inclusion/exclusion 
X 
 
 
 
 
 
 
Public school data 
X 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
STAFF DATA 
 
 
 
 
 
 
 
Inclusion/exclusion 
 
X 
 
 
 
 
 
Informed consent 
 
X 
 
 
 
 
 
Demographics 
 
 
X 
 
 
X 
 
Social desirability 
bias 
 
 
X 
 
 
X 
 
Existing school 
programs 
 
 
X 
 
 
X 
 
Primary Outcomes 
 
 
 
 
 
 
 
Intervention 
Acceptability, 
Usability, 
Appropriateness, and 
Feasibility 
 
 
 
X 
 
X 
X 
Secondary 
Outcomes 
 
 
 
 
 
 
 
Implementation 
Outcomes 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
Reporting 
 
 
X 
X 
X 
X 
X 
Active Empathetic 
Listening  
 
 
X 
X 
 
X 
X 
Self-efficacy for 
Working with SGMY 
 
 
X 
X 
 
X 
X 
Self-efficacy of 
PLANTS’ Change 
Objectives 
 
 
X 
X 
 
X 
X 
Bystander 
Intervention 
Behaviors for Bullying 
 
 
X 
X 
 
X 
X 

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2 
INTRODUCTION 
 
2.1 
Study Rationale  
Statement of the Problem 
Sexual and gender minority youth (SGMY; i.e., adolescents who identify as gay/lesbian or bisexual, who have 
same-gender sexual behaviors or attractions, who identify as transgender or nonbinary, or whose gender 
identity do match their sex assigned at birth) are at significantly higher risk than their heterosexual peers for 
using drugs (tobacco and marijuana) and alcohol.1-30 Alcohol use is 123-155% higher among sexual minority 
youth than heterosexual youth and up to 250% higher among gender minority youth than cisgender youth.2,5-7 
SGMY are more likely to drink alcohol at earlier ages.1-30 For U.S. teens in 9th grade, binge drinking (4+/5+ 
drinks within 2 hours) was higher among gays/bisexuals vs. heterosexuals (13% vs. 7%) and those with same-
gender sexual behaviors vs. heterosexually-behaving youth (28% vs. 16%).30  These substantial and persistent 
inequities make SGMY a priority population for interventions that reduce drug and alcohol use; thus, 
intervention research for SGMY was deemed a priority by national health agencies.3,31,32 However, there are 
few efficacious alcohol/drug use interventions for SGMY.3 
Rationale Underlying the Intervention 
One way to reduce alcohol and drug use for SGMY is to foster more supportive and inclusive high school 
environments by training school staff (e.g., teachers, principals, nurses, counselors) to effectively support and 
protect SGMY. SGMY who have support from adults at school, greater school connectedness, and lower 
bullying victimization also have reduced depressive symptoms, suicidality, drug use, and alcohol use.5,8,9,33-36 
Unfortunately, SGMY are more likely than their heterosexual peers to lack supportive adults at school, have 
lower school connectedness, and to be victims of bullying.5,6,8,9,37-45 An intervention that trains school staff to 
better understand and support SGMY and engage in positive bystander behaviors that protect SGMY from 
bullying victimization may reduce sexual-orientation disparities in drug and alcohol use. An intervention for 
school staff is further warranted because the presence of gay-straight alliances and SGMY-inclusive school 
policies fail to eliminate sexual-orientation drug and alcohol disparities.4,46-48 This is likely due to school staff’s 
lack of knowledge, skills, and self-efficacy about supporting SGMY—and their lack of training on SGMY.49-51 
Study Intervention: PLANTS Course 
The intervention being studied, PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, 
and Safety), 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 SGMY well-being provided valuable feedback on PLANTS throughout its 
development. 
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, we hypothesize that SGMY will experience less 

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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. 
Rationale for the Clinical Trial 
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. We 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.  
2.2 
Background  
SGMY health equity intervention research is a priority of many major organizations, including NIH, Healthy 
People 2030, and the National Academy of Medicine (formerly the Institute of Medicine).3,31,32,52 To date, little 
NIH-funded intervention research for sexual minority populations has focused on drug and alcohol use.53 As 
shown by the IOM3 and a systematic review we conducted, there exist few efficacious interventions aimed at 
reducing drug and alcohol use for SGMY.54 Our systematic review of the peer-reviewed literature found only 
one alcohol/drug use intervention for SGMY, which was an individual-level intervention with no improvements 
in alcohol, tobacco, or marijuana use.55 Furthermore, the rigor of SGMY-related intervention research can be 
improved by using validated measures and systematic sampling of SGMY, all of which are addressed in this 
study. 
Despite the lack of SGMY intervention research, a robust body of theoretic and empirical research shows 
SGMY disparities in alcohol/drug use and mental health are driven by sexuality- and gender-based 
stigma.5,6,8,39,56-61 Stigma has the dual effect of reducing stigmatized populations’ access to important protective 
factors (such as adult support) while increasing their experiences of risk factors (such as discrimination).58,61 
Thus, reducing sexuality- and gender-based stigma is an essential component of interventions to effectively 
reduce SGMY drug and alcohol disparities. However, sexuality- and gender-based stigma reduction is 
commonly absent in traditional drug/alcohol use programs,62-64 highlighting the need for new SGMY-specific 
interventions. 
Schools provide an ideal setting for SGMY-specific interventions to reduce drug and alcohol use disparities. 
High school students spend ~1,195 hours per year in school,65 providing an ideal place to reach SGMY. SGMY 
regularly interact with adults, including school teachers, principals, nurses, counselors, and social workers, 
who are professionally bound by certifying bodies to support the needs of students, including SGMY.66-70 
Nevertheless, implementing interventions in schools is challenging because of schools’ limited resources, 
increasing demands placed on teachers, and difficulty in acquiring school buy-in. These barriers can be 
overcome by using economical and easily implementable interventions, such as online programs, and 
developing interventions and implementation strategies in collaboration with school collaborators. 
School-based interventions can build upon epidemiologic research identifying factors associated with sexual-
orientation disparities in drug and alcohol use. For example, SGMY are more likely than cisgender 
heterosexuals to experience bullying victimization in school,5,6,8,9,39-44 which is associated with greater and 
mental health problems and alcohol/drug use for SGMY.5,6,8,9,33 Compared with heterosexual youth, SGMY 
report lower prevalence of adult support at school and reduced school connectedness,37-39,45 which is 
associated with better mental health and lower drug and alcohol use.33-35 Therefore, school-based 

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interventions aimed at reducing risk factors and increasing protective factors for SGMY will likely reduce their 
drug and alcohol use disparities. 
In particular, training school staff (e.g., teachers, principals, nurses, counselors) to support, affirm, and protect 
SGMY is hypothesized to reduce bullying victimization, increase school support and connectedness, and 
mitigate SGMY drug and alcohol use.51 Unfortunately, school staff often lack the necessary training to 
effectively support, affirm, and protect SGMY.49,50 Many school staff have a strong desire to support SGMY.50 
However, they report the primary barrier to supporting SGMY is their lack of training.50 In 2014, only 13% of 
teachers across the U.S. received training on SGMY-related issues, and only 29% in Massachsuetts,49 
highlighting the need for SGMY-related professional development training in schools. Offering the free and 
easily accessible online PLANTS intervention to school staff is hypothesized to be beneficial for school staff 
and for reducing disparities in drug and alcohol use for SGMY. 
2.3 
Risk/Benefit Assessment 
 
2.3.1 Known Potential Risks  
Immediate potential risks: 
• 
Breach of confidentiality 
• 
Emotional discomfort 
• 
Backlash from people for supporting SGMY 
Long-term potential risks: 
• 
Breach of confidentiality 
• 
Emotional discomfort 
• 
Backlash from people for supporting SGMY 
2.3.2 Known Potential Benefits  
Immediate potential benefits 
• 
Improved interpersonal relationships with SGMY 
Long-term potential benefits 
• 
Improved interpersonal relationships with SGMY 
• 
This study is highly significant because we currently have limited promotion and prevention programs 
for SGMY. Therefore, the benefit of this systematic program evaluation is that the findings may add to 
the evidence base of violence prevention programs available to help improve health for SGMY. 
2.3.3 Assessment of Potential Risks and Benefits  
This is a minimal risk study because the risks that could occur from participation in the intervention or trial are 
unlikely. Furthermore, we have taken several precautions to minimize potential risks.  
Breach of Confidentiality: It is possible that breach of confidentiality may occur. However, we have taken the 
following active steps to minimize the likelihood of breach of confidentiality. First, all surveys are collected 
electronically via REDCap, a secure web application for building and managing online surveys and databases. 

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While REDCap can be used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and HIPAA-
compliant environments), it is specifically geared to support online data capture for research studies and 
operations. Second, we ask that you complete the survey in a private place where no one can see your 
answers. Surveys can be completed on any computer, tablet, or mobile device, allowing you to complete the 
surveys when they feel most comfortable. Third, only our research team will have access to REDCap. We will 
never share their individual answers with any other school staff or administrators. Fourth, for interviews, we will 
use HIPAA-compliant Zoom accounts and ask that interviews be taken in private quiet spaces. Together, these 
procedures mitigate the risk of breach of confidentiality. 
Emotional discomfort: It is possible that some participants may experience emotional discomfort, 
embarrassment, or distress while answering questions or as a result of intervention/control materials. We take 
the following precautions to protect subjects. First, you do not have to answer any question that makes you 
uncomfortable or that you do not understand. Second, participation in this study is completely voluntary. Third, 
we will not be asking you questions about sensitive traumatic experiences that may have happened to them. 
Together, these procedures mitigate the risk of emotional discomfort for school staff. 
Backlash from people for supporting SGMY: It is possible that some participants may experience backlash, but 
it is unlikely. We take the following precautions to protect subjects from backlash. First, PLANTS encourages 
high school staff to consider their sociopolitical environments before implementing strategies to support SGMY. 
Second, all strategies in PLANTS are suggestions; school staff are not required to implement any strategies 
they do not want to. Third, all information reported in our study are completely confidential; we never share 
identifiable information with anyone outside the study team. Fourth, we will only enroll high school staff from 
schools that agree to participate in the trial, increasing the likelihood that school leadership is in favor of 
supporting SGMY and minimizing potential backlash. 
Overall, this is a minimal risk study: all risks are unlikely to occur, and we provide high school staff with 
suggestions on how to prevent them from happening when they are within their control. Because we currently 
have limited scientific evidence about programs that aim to train high school staff to support, affirm, and protect 
SGMY, the potential benefits of this systematic program implementation far outweigh the minimal risks 
associated with the study. 
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
To evaluate the 
acceptability, 
usability, 
appropriateness, and 
feasibility of PLANTS  
In the follow-up survey, school staff will 
complete the following survey measures: 
- Acceptability of Intervention Measure  
- System Usability Scale 
- Intervention Appropriateness Measure 
- Feasibility of Intervention Measure   
We use validated scales that assess 
high school staff’s perceptions of the 
intervention’s tolerability, user 
friendliness, fit, relevance, and 
successful execution. 
Secondary 
To test the efficacy of 
PLANTS intervention 
for improving SGMY 
behaviors among 
high school staff 
-Active empathic listening 
-Self-efficacy for supporting, affirming, and 
protecting SGMY 
-Self-efficacy of PLANTS change objectives 
-Positive bystander intervention behaviors 
PLANTS is specifically designed to 
target these behavioral outcomes.  

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
To assess PLANTS 
implementation 
-PLANTS participation rate 
-PLANTS completion rate 
-Participation rate in live Zoom events 
 
These measures assess school 
staff’s implementation and uptake of 
the PLANTS intervention. 
To assess trial 
implementation  
-Participation rate 
-Attrition rate 
-Intervention demand 
These measures assess the success 
of the pilot trial in reaching an 
adequate number of school staff. 
To determine the 
safety of PLANTS  
-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. 
Although we anticipate the incidence 
of these adverse events to be low, 
they are the most common and could 
be most harmful to school staff. 
 
4 
STUDY DESIGN 
 
4.1 
Overall Design 
This is a two-armed cluster-randomized controlled pilot trial of the PLANTS intervention versus an active 
control group, EMAILS (E-learning to Maximize Academic Inclusion of LGBTQ+ Students). The single study 
site is the University of Pittsburgh. The primary objective is to assess the acceptability, usability, 
appropriateness, and feasibility of the PLANTS intervention. We hypothesize that high school staff will rate the 
PLANTS intervention as having high acceptability, usability, appropriateness, and feasibility in the follow-up 
survey. 
The secondary objectives are to examine the extent to which the PLANTS course and trial successfully 
implemented and safe for high school staff and schools. We will also evaluate the extent to which, among high 
school staff participants in the PLANTS arm, they report pre-post improvements in active-empathic listening, 
self-efficacy for supporting, affirming, and protecting sexual and gender minority youths, and positive bystander 
intervention behaviors for bullying. We will also assess the extent to which, among high school staff, the 
PLANTS intervention is more efficacious in improving active-empathic listening, self-efficacy for supporting, 
affirming, and protecting SGMY, and positive bystander intervention behaviors for bullying than an email 
intervention of publicly available resources. We hypothesize that participants in PLANTS will report greater 
active-empathic listening, greater self-efficacy for supporting, affirming, and protecting SGMY, and greater 
positive bystander intervention behaviors for bullying in follow-up surveys than participants in the active control 
arm. 
We will randomize schools in an equal 1:1 ratio, stratified by large versus small schools, into intervention or 
active control conditions. We will use block randomization with block sizes of 2, which will be stratified by large 
schools versus not, where large is ≥1000 students. We use block size of 2 because there are only 4 schools in 
this pilot trial. Dr. Coulter (PI) will use Stata (ralloc command) to generate the randomization list, which will be 
entered into REDCap using the randomization module. Because this is a cluster randomized trial, we will 
randomize schools after they are determined to have met all the eligibility requirements and they officially enroll 
in the study. Upon school enrollment, a research assistant will be responsible for entering the school into the 
REDCap database and hitting the “randomize” button. Randomization will occur prior to school staff 

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screening/enrollment and prior to intervention delivery. We will conceal allocation from schools. 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. Unblinding could introduce bias, 
including social desirability bias, attrition bias, bias in intervention participation, and bias in reporting adverse 
events. Outcomes are assessed via self-reported online surveys, so there is no concern about bias about the 
blinding for outcome assessors. 
PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety) 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 approximately 20 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. Each module includes recorded 
presentations, student testimonials, activities, and downloadable resources for future reference. Every month, 
7-9 lessons are opened. There are 2-3 synchronous group events delivered via Zoom that are 1.5 hours each.  
The active control arm is an email-based intervention, EMAILS (E-learning to Maximize Academic Inclusion of 
LGBTQ+ Students), in which existing public resources for supporting, affirming, and protecting LGBTQ+ are 
emailed to participants. All of these resources are also provided to intervention participants. The topics of the 
email intervention are similar to those of PLANTS. 
At the 4 enrolled schools, we will administer online surveys to all staff members (i.e., a census of teachers, 
administrators, nurses, counselors) via REDCap software. With staff emails provided by administrators, we will 
send staff a screening survey, consent form, and baseline survey. Subsequently, we will sample a subset of 
the intervention and control groups for individual interviews to explore implementation outcomes more deeply. 
4.2 
Scientific Rationale for Study Design 
We chose to randomize at the school level as opposed to the individual level for several reasons. We view 
PLANTS as an intervention that can be implemented within schools as a whole to foster more inclusive, 
supportive, affirming, and protective environments for SGMY. We also minimize contamination amongst school 
staff by randomizing at school versus individual levels. By randomizing at the school level, we can estimate the 
impact that the intervention has had on all youth within a school by leveraging existing surveillance data that 
assesses censuses of students (such as the MetroWest Adolescent Health Survey). By leveraging existing 
health surveillance infrastructures, our study will yield large sample sizes and high statistical power for finding 
health-promoting effects at the individual level. 
The comparison group selection was challenging because there is no gold standard for improving school-
based environments for SGMY by changing behaviors of high school staff. Nevertheless, we decided to select 
a practical alternative to the PLANTS intervention; therefore, the active control materials will be freely available 
online courses that aim to improve SGMY school environments. Note that this is an active control intervention, 
therefore all participants in this group are expected to receive training in the primary outcomes of the PLANTS 
interventions. Compared to using a placebo or pure control, our ability to find differences between these the 
study harms is somewhat hampered. However, we believe using an active control arm is more ethical given 
the minimal risks of participation in such online trainings plus their potential impact for bolstering environments 
for SGMY well-being. 
4.3 
Justification for Intervention 

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We decided to deliver PLANTS using an online design because this model is more scalable than traditional in-
person trainings, thereby reaching more people. We include both synchronous and asynchronous modules, as 
there is evidence that both is better than asynchronous training only. The length of the intervention evolved 
throughout the development of the project with feedback from the community. The number of asynchronous 
elements were identified through our intervention mapping process and by chunking PLANTS’ performance 
objectives into complementary components. The lengths of videos were determined based on expertise 
provided by teaching and learning experts. Because this is a pilot study including intervention adherence, a 
participant will have to complete at least one item in the PLANTS intervention to have evaluable data. 
4.4 
End-of-Study Definition 
A participant is considered to have completed the study if they have completed the baseline and follow-up 
surveys. The post-intervention interview is optional and will be conducted with a sub-sample of the study 
participants. 
The end of the study is defined as completion of the follow-up survey or completion of the staff follow-up 
interview, as shown in the Schedule of Activities. 
5 
STUDY POPULATION 
 
5.1 
Inclusion Criteria 
School Inclusion Criteria: 
To be eligible to participate in this study, schools must meet all of the following criteria: 
• 
Participated in the 2021 MetroWest Adolescent Health Survey (MWAHS) 
• 
Plan to participate in the 2023 MWAHS 
• 
Grant us permission to access their MWAHS data 
• 
Willing and able to provide emails addresses for all school staff 
• 
Willing and able to provide us a letter of support denoting their participation in our study 
Staff Inclusion Criteria: 
To be eligible to participate in this study, staff must meet all of the following criteria: 
• 
Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts  
• 
Age 18 years old or older  
• 
Consents to participate 
 
5.2 
Exclusion Criteria 
School Exclusion Criteria: 
N/A 
Staff Exclusion Criteria: 
An individual who meets any of the following criteria will be excluded from participation in this study: 

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• 
Does not interact with high school students at work 
5.3 
Lifestyle Considerations 
N/A 
5.4 
Screen Failures 
Individuals who do not meet the criteria for participation in this trial (screen failure) are unlikely to meet them 
within the study window and will not be rescreened. 
5.5 
Strategies for Recruitment and Retention 
School Staff 
Recruitment. For high schools to be eligible to enroll in our study, school administrators must be willing to 
provide email addresses for all school staff members so that we can adequately recruit all staff in the high 
school. At the enrolled high schools, we will administer online surveys via REDCap to all staff members that 
interact with students (e.g., a census of teachers, administrators, nurses, counselors). We will email 
participants a screener survey to confirm their eligibility for participation, a consent form, and a baseline 
survey. We will also place study advertisements in their school mailboxes.  
Retention. The follow-up survey will be delivered post-intervention. Several methods used by Dr. Coulter and 
his mentorship team have proven valuable in retention of participants in longitudinal studies. To keep 
participants engaged, we will: inform participants at the beginning about the anticipated time burden and 
associated incentives; provide participants with clear instructions about their tasks; send personalized reminder 
emails and text messages to participants who have not completed a survey; email participants 1 day in 
advance of their survey, reminding them to look out for the upcoming survey email and to check spam filters; 
encourage participants to reach out to us when they have questions or concerns via email, phone, or text; and 
provide participants with escalating incentives that increase each survey. We will monitor retention on a weekly 
basis and more frequently if needed to ensure we are maintaining high retention.  
Incentives. To incentivize school staff to complete the baseline survey, we will provide $20 gift cards to each 
participant and will raffle $30 gift cards to 20% of participants who take the baseline survey within each school. 
To incentivize school staff to complete the follow-up survey, we will provide $30 gift cards to each participant 
who completes the survey will and raffle $40 gift cards to 20% of participants who take the follow-up survey 
within each school. For staff who complete the follow-up interview, we will provide $50 incentive as a thank you 
for their time. 
6 
STUDY INTERVENTIONS 
 
6.1 
Study Intervention Administrations 
 
6.1.1 Study Intervention Descriptions 
We have two study conditions, intervention and active control. We describe each condition using the TIDieR 
Checklist.71 
PLANTS Course: Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety  

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This intervention, PLANTS Course, is an online training program for high school staff. The behavioral 
outcomes of PLANTS are to train high school staff to: provide interpersonal support and affirmation to SGMY; 
support LGBTQ+ students in meeting their basic needs; provide educational resources that are inclusive of 
LGBTQ+ students; provide safe spaces for LGBTQ+ students; promote acceptance of LGBTQ+ students 
among non-LGBTQ+ students; prevent and reduce bullying, cyberbullying, and harassment of LGBTQ+ 
students; evaluate and advocate for LGBTQ+ inclusivity and protections in school policies; and maintain the 
confidentiality of LGBTQ+ students. To achieve these outcomes, we harnessed Information-Motivation-
Behavior theory to target high school staff’s skills, self-efficacy, knowledge, and outcome expectations. 
PLANTS uses asynchronous and synchronous online activities with 3 primary sections: Trustworthiness, 
Safety, and Nurturance. Each section includes, as asynchronous activities, recorded presentations, student 
testimonials, activities, and downloadable resources for future reference. There are required synchronous Live 
Zoom Events delivered via Zoom that are 1.5 hours each. Live Zoom Events will be moderated by a trained 
interventionist and will be tailored to the need of participants. Three Live Zoom Event are offered and 
participants are required to complete all three. Sections are opened once a month for ~3 months. The modules 
were developed by my research team, including undergraduate students and graduate students with a variety 
of academic backgrounds, in partnership with high school staff and other professionals specialize in LGBTQ+ 
youth or education. We use Canvas Learning Management Software to deliver PLANTS. We will monitor 
intervention compliance and fidelity via module questionnaires, Canvas informatics, event attendance, and 
follow-up survey questionnaires.  
EMAILS: E-learning to Maximize Academic Inclusion of LGBTQ+ Students 
The active control, EMAILS, is an email-based intervention in which existing online resources for supporting, 
affirming, and protecting LGBTQ+ are emailed to participants. These resources are also provided to 
intervention participants. The topics covered by EMAILS are similar to those of PLANTS, though there are 
some unique aspects to PLANTS. This intervention is informed by the Information-Motivation-Behavior theory 
as well. EMAILS includes the following publicly available materials: 
• 
Adagio Health LGBTQ+ Professionalism Training (https://youtu.be/VX9tDt3gOto) 
• 
Imi (Audience is LGBTQ+ teens, https://imi.guide/) 
• 
The Safe Zone Project (https://thesafezoneproject.com/)  
These intervention activities include self-paced modules, YouTube videos, and PowerPoints. There is no direct 
human interaction in this intervention other than email. EMAILS participants are individually emailed using a 
duration and pace similar to PLANTS (e.g., lasts 3 months). The intervention takes place entirely online. We 
will not be doing any tailoring of these materials to specific audiences, other than compiling various resources. 
We will monitor active control compliance and fidelity via email clicks by sending emails with training links from 
REDCap to participants, and then participants click on the training links in Qualtrics for tracking purposes. We 
will also use follow-up survey questionnaires to assess use of EMAILS.  
6.1.2 Administration and Dosing 
PLANTS online modules will be administered online via Canvas. Sections will be opened once per month, and 
there are a total of 3 sections over 3 months. The synchronous Live Events will be administered via Zoom. 
There are a total of 3 events. A “Full Dose” of the PLANTS intervention includes completion of all the online 
modules and 3 Live Zoom Events. The Live Zoom Events are required to be administered by trained 
interventionists (the PI or Research Assistants). In the Live Zoom Events, participants will interact with each 
other and a shared interventionist in a virtual environment. Active control materials cannot be tracked as easily 

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because these online trainings are administered via other agency’s websites (not the study team’s website). 
There are no interventionists in the active control arm. 
6.2 
Fidelity 
 
6.2.1 Interventionist Training and Tracking 
The PLANTS Live Zoom Events require effort be made to check that the intervention is appropriately 
conducted by the interventionists. For each Live Zoom Event, the research assistant(s) will keep detailed notes 
of the sessions. We will then check these notes against the change methods and learning objectives for each 
module to ensure fidelity of the intervention. We will also monitor implementation of the PLANTS asynchronous 
online modules by checking that the release dates are met in the online platform. We use Canvas Learning 
Management Software to deliver PLANTS. We will monitor intervention compliance and fidelity via module 
questionnaires, Canvas informatics, event attendance, and follow-up survey questionnaires. 
EMAILS has no direct human interaction in this intervention other than email. We will track delivery of EMAILS 
by checking sent emails against an implementation plan. We will monitor active control compliance and fidelity 
via email clicks by sending emails with training links from Qualtrics to participants, and then participants click 
on the training links in Qualtrics for tracking purposes. We will also use follow-up survey questionnaires to 
assess use of EMAILS.  
6.3 
Measures to Minimize Bias: Randomization and Blinding 
We will randomize schools in an equal 1:1 ratio, stratified by large versus small schools, into intervention or 
active control conditions. We will use permuted block allocation (with block size=2) to randomize schools to the 
intervention or active control conditions. We use block size of 2 because there are only 4 schools in this pilot 
trial. The permuted blocks will be created using the “ralloc” package for Stata. We will use REDCap’s 
Randomization Module. We will randomize schools after they enroll in the study, but before school staff 
complete baseline surveys. Dr. Coulter will create the randomization files in Stata, and the study coordinator 
will allocate schools to conditions in REDCap. We will conceal allocation from schools.  
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.  Unblinding could 
introduce bias, including social desirability bias, attrition bias, bias in intervention participation, and bias in 
reporting adverse events. Outcomes are assessed via self-reported online surveys, so there is no concern 
about bias about the blinding for outcome assessors. We do not anticipate planned or unplanned breaking of 
randomization allocation to participants or schools. 
6.4 
Study Intervention Adherence 
We will make the following efforts to confirm that the subject of the PLANTS intervention is adherent: 
• 
Participants will be required to click “completed” in Canvas modules when they are completed. 
• 
We will ask participants to register for the Live Zoom Events. 
• 
We will track attendance at Live Zoom Events. 
• 
We will contact participants if they have yet to complete the modules or Live Zoom Events. 
Canvas module completion and Live Zoom Event attendance will be used to calculate study intervention 
adherence. 

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For the active control arm, we will ask participants to self-report completion of the online trainings in 
questionnaires sent after each email and in the follow-up survey if they completed the trainings. 
6.5 
Concomitant Therapy 
N/A 
6.5.1 Rescue Therapy 
N/A 
7 
STUDY INTERVENTION DISCONTINUATION & PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
Discontinuation of Study Intervention 
N/A 
7.2 
Participant Discontinuation/Withdrawal from the Study 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may 
discontinue a participant from the study for the following reasons: 
• 
Lost-to-follow up; unable to contact subject 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Protocol 
Deviation Form. Subjects who sign the informed consent form and subsequently withdraw, or are discontinued 
from the study, will not be replaced. 
7.3 
Lost to Follow-Up 
A participant will be considered lost to follow-up if they fail to complete the follow-up survey and study staff are 
unable to contact the participant after at least 3 attempts.  
The following actions must be taken if a participant fails to complete a study visit: 
• 
Staff will attempt to contact the participant, encourage completion of the study activity, counsel the 
participant on the importance of maintaining study participation, and ascertain if the participant wishes 
to continue in the study. 
• 
Before a participant is deemed lost to follow-up, staff will make every effort to regain contact with the 
participant (where possible, 3 telephone calls, 3 texts, and 3 emails, if necessary). These contact 
attempts will be documented in the participant’s study file.  
• 
Should the participant continue to be unreachable, the participant will be considered lost to follow-up. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
Endpoint and Other Non-Safety Assessments 
School Screener 

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1. Inclusion/exclusion will be assessed over Qualtrics, the phone, Zoom, or in-person by study staff to 
school administrators. These are the exact questions: 
a. Does your school plan to participate in the 2023 MetroWest Adolescent Health Survey? 
b. Does your school plan to participate in the 2025 MetroWest Adolescent Health Survey? 
c. Does your school grant us permission to access your MWAHS data? 
d. Will your school provide emails addresses for all school staff so we can recruit them to the trial? 
e. Will your school provide our team with a letter of support denoting their participation in our 
study? 
2. Public school data: We will gather all publicly available data from the Massachusetts Department of 
Elementary and Secondary Education website, including school size. 
3. Randomization: Upon enrollment of a school, we will randomize them to either PLANTS or EMAILS 
based on our stratified blocked randomization. 
Staff Screener (Time 0) 
1. Inclusion/exclusion will be self-administered via REDCap by high school staff. These are the exact 
questions: 
a. Which schools do you currently work at? [drop down list of MetroWest Schools + “Somewhere 
else” + write-in] 
b. How often do you interact with students at your job? [0: Daily; 1: Weekly; 2: Monthly; 3: Yearly; 
4: Never] 
c. How old are you? [integer validation] 
2. Informed consent: We will provide informed consent materials online via REDCap. 
Staff Baseline Survey (Time 1) 
These surveys are self-administered online via REDCap by high school staff. The following measures are 
included in the baseline surveys: 
1. Demographics: We assess schools staff’s role(s) in school,72 years working as a staff member,72 age, 
race/ethnicity,73 gender identity (including transgender status),74 sex assigned at birth,74 sexual 
identity,73 past contact with sexual and gender minorities,75 past encounters working with SGMY,76 
previous professional development related to working with SGMY, highest education level achieved, 
religious affiliation, and religiosity.77 We also measure attitudes towards LGBTQ people using the 
Modified Attitudes Toward Lesbians and Gay Men (Herek & McLemore, 2011; Strong, 2013) Scale. 78-80 
This scale has four subscale domains about attitudes towards: gay men (α range = 0.75-0.76)81; 
lesbian women (α range 0.76-0.79); bisexual people; (α range = 0.79-0.8181; lesbian women (α range 
0.76-0.79)81; bisexual people; (α range = 0.79-0.81)81; transgender people (α range = 0.79)81; and 
nonbinary people (newly created). Each subscale has three items (e.g., “Having sex with both males 
and females is just plain wrong”). Response options included a five-point Likert scale ranging from 
“strongly agree” to “strongly disagree.”  
2. Active-empathic listening skills: We use the valid and reliable Active-Empathic Listening Scale 
containing 11 items (Bodie, 2011; Gearhart & Bodie, 2011). This scale has three domains: sensing (4 
items; e.g., “I listen for more than just the spoken words”); processing (3 items; e.g., “I summarize 
points of agreement and disagreement when appropriate”); and responding (4 items; e.g., “I assure 
others that I am listening by using verbal acknowledgements”). Response options included a 7-point 
Likert scale ranging from “Never or almost never true” to “always or almost always true.” We will 

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calculate the mean score for the total scale. Prior research shows Cronbach’s alphas range from 0.88-
0.90.81 
3. Self-efficacy for working with SGMY: We assess participants’ perceived abilities for working with 
LGBTQ high school students using 9 items adapted from the Gay Affirmative Practice Scale.82 
Originally for social work practitioners, we adapted this scale by using school-oriented words instead of 
therapy-oriented words (e.g., “students” instead of “clients”). Example items included “I am able to help 
LGBTQ students develop positive identities as LGBTQ individuals” and “I am able to challenge 
misinformation about LGBTQ individuals in the classroom.” Response options included a five-point 
Likert scale ranging from “strongly agree” to “strongly disagree.” We will calculate the mean score for 
the scale. In a prior study, Cronbach’s alpha = 0.90.81 
4. Bystander intervention behaviors for bullying: Two multidimensional scales (Teacher Bystander 
Intervention Model in Traditional Bullying and Cyberbullying83,84) measuring 5 subscales of bystander 
behaviors each: noticing the event (3 items), interpreting event as an emergency (3 items); accepting 
responsibility to help (3 items); knowing how to help (3 items); and implementing intervention decision 
(4 items). The psychometric properties of these subscales are good (Cronbach’s alphas range=0.57-
0.88). We will calculate average subscale scores. We will add items to these scales to specify SGMY-
related bullying events using language from GLSEN’s National School Climate Survey.85  
5. Self-efficacy of PLANTS’ change objectives: Given the limited research contained validated scales 
of behavior change pertaining to LGBTQ inclusive practices in schools, our team has developed items 
pertaining directly to the self-efficacy change objectives in PLANTS. Each question will be asked on a 
scale of 1-5 (1: not at all certain; 2: slightly certain; 3: moderately certain; 4: very certain; 5: extremely 
certain).  
a. Provide interpersonal support and affirmation. How certain are you that you are able to 
successfully: ask students about their chosen names? Use students’ chosen names? Ask 
students about their pronouns? Use students’ pronouns? use "reinforcing language" with 
students? “affirmations” with students? share about your personal connections to the LGBTQ+ 
community with your LGBTQ+ students?  
b. Support LGBTQ+ students in meeting their basic needs. How certain are you that you are 
able to successfully: offer safe locations where gender diverse youth can use the bathroom 
(e.g., gender neural bathrooms, staff bathrooms)? offer non-stigmatizing locations where gender 
diverse youth can use the bathroom (e.g., gender neural bathrooms, staff bathrooms)? Offer 
nearby locations where gender diverse youth can use the bathroom (e.g., gender neural 
bathrooms, staff bathrooms)? refer LGBTQ+ students to LGBTQ affirming outside-school 
resources? 
c. Provide educational resources that are inclusive of LGBTQ+ students. How certain are you 
that you can successfully: find LGBTQ+ resources? put LGBTQ+ resources where students can 
easily access them? defend LGBTQ+ inclusive curriculum? integrate LGBTQ+ people, history, 
or issues into your coursework? Implement LGBTQ+ inclusivity in your curriculum? assess 
curriculum for LGBTQ+ inclusivity? inform students about LGBTQ+ resources? 
d. Provide safe spaces for LGBTQ+ students. How certain are you that you can successfully: 
wear iconography of LGBTQ+ pride and acceptance? display iconography of LGBTQ+ pride 
and acceptance for their rooms/offices? display iconography of LGBTQ+ pride and acceptance 
in common areas? observe LGBTQ+ related holidays and events? Establish a gender-sexuality 
alliance? Oversee a gender-sexuality alliance? be a Point Person? Provide LGBTQ+ students 
with a safe space? 

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e. Promote acceptance of LGBTQ+ students among non-LGBTQ+ students. How certain are 
you that you can successfully: politely correct people who use students' incorrect names? 
politely correct people who use students' incorrect pronouns? teach students about LGBTQ+ 
terminology in a positive manner? provide positive verbal reinforcement when non-LGBTQ+ 
students do something LGBTQ-inclusive? 
f. Prevent and reduce bullying, cyberbullying, and harassment of LGBTQ+ students. How 
certain are you that you can successfully: define anti-LGBTQ+ bullying and harassment? 
implement classroom guidelines and meetings? intervene in anti-LGBTQ+ bullying and 
harassment? convene an anti-LGBTQ+ bullying task force when necessary? follow-up with 
victims and bystanders of anti-LGBTQ+ bullying? use non-confrontational ways to engage with 
perpetrators of anti-LGBTQ+ bullying? enforce clear consequences for people who bully others? 
explain to students why anti-LGBTQ+ bullying is harmful and wrong? advocate for evidence-
based bullying prevention programming? 
g. Evaluate and advocate for LGBTQ+ inclusivity and protections in school policies. How 
certain are you that you can successfully: obtain LGBTQ+ students' feedback about the 
inclusivity and protections for LGBTQ+ students in existing school policies? Amend/dismantle 
school policies and practices that negatively affect LGBTQ+ students? evaluate how inclusive 
and protective their school policies are for LGBTQ+ students and staff? share statistics to 
advocate for LGBTQ+ inclusivity and protections in school policies? share personal stories to 
advocate for LGBTQ+ inclusivity and protections in school policies? use required methods (e.g., 
school board propositions) to create/amend school policy? examine how well your school’s 
LGBTQ+ related policies align with local, state, and federal school laws and policies?  
h. Maintain the confidentiality of LGBTQ+ students. How certain are you that you can 
successfully: keep students' sexual orientations confidential? keep students' gender identities 
confidential? make students aware of mandatory reporting guidelines? assess students' safety 
concerns surrounding disclosure of their LGBTQ+ identity? establish or amend school policies 
that protect the confidentiality of students' sexual orientations and gender identities? 
6. Social desirability bias: We will assess school staff’s social desirability biases using the short form of 
the Marlowe-Crowne Social Desirability Scale.86 The short form of the scale uses 13 self-reported 
measures of individual characteristics, such as personality and attitudes, to understand the social 
desirability bias of individuals.87 The psychometric properties of this scale have shown it to be reliable 
compared to the Social Desirability Scale developed by Edwards; its use has been studied for both 
adolescents and adults.88 We will calculate the social desirability biases of each school staff member 
based on their responses to the measures during the baseline survey. 
7. Existing school programs: We will ask each staff member about their school’s presence and types of 
bullying prevention programs, substance use prevention/treatment program, mental health 
prevention/treatment programs, intervention programs and policies for SGMY.  
Staff Follow-up Survey (Time 2) 
1. Demographics: We will re-ask questions pertaining to demographics that were skipped in the baseline 
survey. 
2. Intervention acceptability, appropriateness, and feasibility: Three of the primary outcomes of this 
study are intervention acceptability (perceptions that the intervention is tolerable); intervention 
appropriateness (perceived fit and relevance of the intervention); and intervention feasibility (the extent 
to which the PLANTS intervention is successfully used and executed). These outcomes are measured 
via three scales with strong psychometric properties: structural, substantive, known-groups, and 

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discriminant validity; good test-retest reliability (r’s=.73-.88); good internal consistency among 
scientists, providers, parents of trans youth, and SGMY (α’s=.84-.94); and 5th grade literacy levels. 
High school staff participants will complete surveys at the 4-month follow-up online survey. For 
intervention acceptability, participants will complete a short survey including the Acceptability of 
Intervention Measure (AIM). AIM has 4 items (e.g., “The PLANTS intervention was appealing to me”) 
using a 5-point Likert-type scale from (1) “Complete disagree” to (5) “Completely agree.” We will 
calculate a mean score for each participant. For intervention appropriateness, participants will complete 
a valid and reliable measure, the Intervention Appropriateness Measure (IAM). FIM has four items (e.g., 
“The PLANTS intervention was applicable”) and uses a 5-point Likert-type scale, ranging from (1) 
“Complete disagree” to (5) “Completely agree.” We will calculate a mean score for each participant. For 
intervention feasibility, participants will complete a short valid and reliable measure, the Feasibility of 
Intervention Measure (FIM). FIM has 4 items (e.g., “The PLANTS intervention was easy to use”) and 
uses a 5-point Likert-type scale, from (1) “Complete disagree” to (5) “Completely agree.” We will 
calculate a mean score for each participant. 
3. Intervention usability: The fourth primary outcome of this study is intervention usability (perception 
that the intervention can be used effectively, efficiently, and satisfactorily). The 10-item System 
Usability Scale (SUS) has been shown be valid and reliable measure of program usability.93 All items 
use a 5-point Likert-type scale, ranging from (1) “Strongly disagree” to (5) “Strongly agree”. We will 
calculate scores for the total scale (0-100) as recommended.94 
4. Active-empathic listening skills: We use the valid and reliable Active-Empathic Listening Scale 
containing 11 items (Bodie, 2011; Gearhart & Bodie, 2011). This scale has three domains: sensing (4 
items; e.g., “I listen for more than just the spoken words”); processing (3 items; e.g., “I summarize 
points of agreement and disagreement when appropriate”); and responding (4 items; e.g., “I assure 
others that I am listening by using verbal acknowledgements”). Response options included a 7-point 
Likert scale ranging from “Never or almost never true” to “always or almost always true.” We will 
calculate the mean score for the total scale. Prior research shows Cronbach’s alphas range from 0.88-
0.90. 81 
5. Self-efficacy for working with SGMY: We assess participants’ perceived abilities for working with 
LGBTQ high school students using 9 items adapted from the Gay Affirmative Practice Scale.82 
Originally for social work practitioners, we adapted this scale by using school-oriented words instead of 
therapy-oriented words (e.g., “students” instead of “clients”). Example items included “I am able to help 
LGBTQ students develop positive identities as LGBTQ individuals” and “I am able to challenge 
misinformation about LGBTQ individuals in the classroom.” Response options included a five-point 
Likert scale ranging from “strongly agree” to “strongly disagree.” We will calculate the mean score for 
the scale. In a prior study, Cronbach’s alpha = 0.90.81 
6. Bystander intervention behaviors for bullying: Two multidimensional scales (Teacher Bystander 
Intervention Model in Traditional Bullying and Cyberbullying83,84) measuring 5 subscales of bystander 
behaviors: noticing the event (3 items), interpreting event as an emergency (3 items); accepting 
responsibility to help (3 items); knowing how to help (3 items); and implementing intervention decision 
(4 items). We will adapt these scales to specify SGMY-related bullying events using language from 
GLSEN’s National School Climate Survey.85  
7. Self-efficacy of PLANTS’ change objectives: Given the limited research contained validated scales 
of behavior change pertaining to LGBTQ inclusive practices in schools, our team has developed items 
pertaining directly to the self-efficacy change objectives in PLANTS. Each question will be asked on a 
scale of 1-5 (1: not at all certain; 2: slightly certain; 3: moderately certain; 4: very certain; 5: extremely 
certain).  

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a. Provide interpersonal support and affirmation. How certain are you that you are able to 
successfully: ask students about their chosen names? Use students’ chosen names? Ask 
students about their pronouns? Use students’ pronouns? use "positive teacher language"? 
share about your personal connections to the LGBTQ+ community with your LGBTQ+ students?  
b. Support LGBTQ+ students in meeting their basic needs. How certain are you that you are 
able to successfully: offer safe locations where gender diverse youth can use the bathroom 
(e.g., gender neural bathrooms, staff bathrooms)? offer non-stigmatizing locations where gender 
diverse youth can use the bathroom (e.g., gender neural bathrooms, staff bathrooms)? Offer 
nearby locations where gender diverse youth can use the bathroom (e.g., gender neural 
bathrooms, staff bathrooms)? refer LGBTQ+ students to LGBTQ affirming outside-school 
resources? 
c. Provide educational resources that are inclusive of LGBTQ+ students. How certain are you 
that you can successfully: find LGBTQ+ resources? put LGBTQ+ resources where students can 
easily access them? defend LGBTQ+ inclusive curriculum? integrate LGBTQ+ people, history, 
or issues into your coursework? Implement LGBTQ+ inclusivity in your curriculum? assess 
curriculum for LGBTQ+ inclusivity? inform students about LGBTQ+ resources? 
d. Provide safe spaces for LGBTQ+ students. How certain are you that you can successfully: 
wear iconography of LGBTQ+ pride and acceptance? display iconography of LGBTQ+ pride 
and acceptance for their rooms/offices? display iconography of LGBTQ+ pride and acceptance 
in common areas? observe LGBTQ+ related holidays and events? Establish a gender-sexuality 
alliance? Oversee a gender-sexuality alliance? be a Point Person? Provide LGBTQ+ students 
with a safe space? 
e. Promote acceptance of LGBTQ+ students among non-LGBTQ+ students. How certain are 
you that you can successfully: politely correct people who use students' incorrect names? 
politely correct people who use students' incorrect pronouns? teach students about LGBTQ+ 
terminology in a positive manner? provide positive verbal reinforcement when non-LGBTQ+ 
students do something LGBTQ-inclusive? 
f. Prevent and reduce bullying, cyberbullying, and harassment of LGBTQ+ students. How 
certain are you that you can successfully: define anti-LGBTQ+ bullying and harassment? 
implement classroom guidelines and meetings? intervene in anti-LGBTQ+ bullying and 
harassment? convene an anti-LGBTQ+ bullying task force when necessary? follow-up with 
victims and bystanders of anti-LGBTQ+ bullying? use non-confrontational ways to engage with 
perpetrators of anti-LGBTQ+ bullying? enforce clear consequences for people who bully others? 
explain to students why anti-LGBTQ+ bullying is harmful and wrong? advocate for evidence-
based bullying prevention programming? 
g. Evaluate and advocate for LGBTQ+ inclusivity and protections in school policies. How 
certain are you that you can successfully: obtain LGBTQ+ students' feedback about the 
inclusivity and protections for LGBTQ+ students in existing school policies? Amend/dismantle 
school policies and practices that negatively affect LGBTQ+ students? evaluate how inclusive 
and protective their school policies are for LGBTQ+ students and staff? share statistics to 
advocate for LGBTQ+ inclusivity and protections in school policies? share personal stories to 
advocate for LGBTQ+ inclusivity and protections in school policies? use required methods (e.g., 
school board propositions) to create/amend school policy? examine how well your school’s 
LGBTQ+ related policies align with local, state, and federal school laws and policies?  
h. Maintain the confidentiality of LGBTQ+ students. How certain are you that you can 
successfully: keep students' sexual orientations confidential? keep students' gender identities 

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confidential? make students aware of mandatory reporting guidelines? assess students' safety 
concerns surrounding disclosure of their LGBTQ+ identity? establish or amend school policies 
that protect the confidentiality of students' sexual orientations and gender identities? 
8. Social desirability bias: We will re-ask questions pertaining to social desirability bias that were 
skipped in the baseline survey. 
Staff Follow-up Interview (Time 3) 
The purpose of this interview is to better understand trial and intervention implementation. Interview domains 
and questions are guided by the Consolidated Framework for Intervention Research (CFIR). Question domains 
include: 
• 
Intervention characteristics: Relative advantage, adaptability, complexity, design quality and 
packaging 
• 
Outer setting: External policies and incentives 
• 
Inner setting: Structural characteristics, networks and communications, culture, implementation 
climate, tension for change, compatibility, relative priority, goals and feedback, learning climate, 
readiness for implementation, leadership engagement, available resources 
• 
Characteristics of individuals: Knowledge and beliefs about the intervention, self-efficacy, individual 
stage of change 
• 
Process: Opinion leaders, champions 
PLANTS Course-embedded Questionnaires 
Throughout the PLANTS program we will embed “Confidence Checks” and “Feedback” questions. Results 
from these items will be descriptively summarized and presented.  
8.2 
Safety Assessments 
In each staff survey, we will assess the following variables. In addition to the questions below, we will also 
leave open-ended text boxes so people can provide more detail on the incident. 
Variables 
Description 
Levels/range 
Justification 
Parent backlash 
Contact from disgruntled 
parents/guardians of students 
because LGBTQ+ inclusivity is 
in the classroom 
Yes/no + 
Frequency 
Parents may not be comfortable 
with the education their children 
are receiving and ask questions 
that educators may not be 
comfortable or feel safe 
answering. 
Social media backlash People attack school staff or 
the school for supporting 
LGBTQ+ youth 
Yes/no + 
Frequency 
This is happening all over the 
country 
School board backlash School board gets upset or 
concerned about staff 
supporting LGBTQ+ youth 
Yes/no + 
Frequency 
This is happening all over the 
country 
Suspension or removal 
from employment 
Staff receive negative 
consequences from employer 
about supporting LGBTQ+ 
youth 
Yes/no + 
Frequency 
This is happening all over the 
country 

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Censorship of 
LGBTQ+ 
literature/history/stories 
or removal of books 
with LGBTQ+ 
representation from 
school libraries. 
Promotion and integration of 
LGBTQ+ issues, history, 
stories into the school 
curriculum could lead to 
attempts to censor that 
information by parents, school 
boards, and higher ups in the 
education system. Oftentimes 
this has been justified as 
avoiding “controversial/political 
topics'' in schools. There is the 
possibility that teachers who 
teach about 
“controversial/political” topics 
could be silenced via threats of 
losing their jobs. 
Yes/no + 
frequency/quantity
This is happening throughout the 
country 
Emotional discomfort 
with PLANTS 
Staff are uncomfortable with 
the training program. 
Likert 5-point 
scale + Open-
ended 
Some topics may provoke 
discomfort. 
Study team members will have contact staff and will be able to report adverse events in the appropriate case 
report form. In the post-trial interviews, we will interview a subset of participants who reported experiencing 
adverse events. We will ask questions about the AE during interviews, which will help support knowledge of 
the study intervention effects. We will follow-up with individuals if the event is severe (see the MOP). 
8.3 
Adverse Events and Serious Adverse Events 
 
8.3.1 Definition of Adverse Events 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical occurrence 
associated with the use of an intervention in humans, whether or not considered intervention-related. 
 
8.3.2 Definition of Serious Adverse Events 
An adverse event is considered “serious” if, in the view of either the investigator or sponsor, it results in any of 
the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or a congenital anomaly/birth defect.  Important medical events that may not result in 
death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition. 
8.3.3 Classification of an Adverse Event 
8.3.3.1 Severity of Event 
Dr. Coulter will classify the severity of an adverse event which is a qualitative assessment of the degree of 
intensity, and will be classified as follows:  
• 
Mild: Does not impact (in any way) the participant’s functioning or well-being at work. 

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• 
Moderate: Impacts the participant’s functioning or well-being at work but is not life-threatening, 
incapacitating, or job-loss threatening. 
• 
Severe: Severely affects well-being at work; employment termination; lawsuit; fatal, life threatening, 
permanently disabling; severely incapacitating and/or prolongs inpatient hospitalization. 
 
8.3.3.2 Relationship to Study Intervention 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, assessed 
by an appropriately-trained investigator based on temporal relationship and their scientific judgment. The 
degree of certainty about causality will be graded using the categories below. 
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility that the 
study procedures caused the AE, or there is a temporal relationship between the study procedures and 
the event. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, there is 
no temporal relationship between the study procedures and event onset, or an alternate etiology has 
been established. 
 
8.3.3.3 Expectedness  
Dr. Coulter will be responsible for determining whether an adverse event (AE) is expected or unexpected. An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the study procedures. 
 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up 
An unsolicited AE would occur without any prompting or in response to a general question such as “Have you 
noticed anything different since you started the study?” A solicited AE is one that is specifically solicited such 
as “Have you experienced any problems at work since starting this study intervention?” 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of study 
personnel via surveys, Live Zoom events, interviews, or contact with a study participant or upon review by a 
study monitor. We will solicit information about AEs directly in surveys and interviews. 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form (CRF). 
Information to be collected includes event description, time of onset, the PI assessment of severity, relationship 
to study procedures (assessed only by those with the training and authority to make a report), and time of 
resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately 
regardless of relationship. All AEs will be followed to adequate resolution. 
Any adverse event that is present at the time that the participant is screened will be considered as baseline 
and not reported as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at 
each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
The PI will record events with start dates occurring any time after informed consent is obtained until 7 (for non-
serious AEs) or 30 days (for SAEs) after the last day of study participation. Events will be followed for outcome 
information until resolution or stabilization. 

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8.3.5 Adverse Event Reporting  
Any adverse events will be reported to the Office of Human Research Subjects Protection in accordance with 
the policy described in Chapter 3, Section 3.3 of the University of Pittsburgh’s IRB Reference Manual. All 
adverse events will be reported to Funding IC at the National Institute of Health.  
 
8.3.6 Serious Adverse Event Reporting  
If any serious adverse event occurs (death, life threatening, new serious, or permanent disability), it will be 
reported within 48 hours to the IRB. Specific information that will be recorded on the study protocol’s adverse 
event form will include details of the adverse event, treatment required for the event, the participant’s condition 
after the event, an estimate of the extent of injury, and ways to prevent similar events from occurring in the 
future. SAEs and unanticipated events which are considered “at least possibly related” during the treatment 
and follow-up phases must be reported to the local IRB and to the NIAAA project officer within 48 hours of 
knowledge of the SAE. All other SAEs and unanticipated events must be reported within the time period 
mandated by the local IRB. 
8.3.7 Reporting Events to Participants  
N/A 
8.3.8 Events of Special Interest  
N/A 
8.3.9 Reporting of Pregnancy  
N/A 
8.4 
Unanticipated Problems 
 
8.4.1 Definition of Unanticipated Problems 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved 
research protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  Unanticipated Problems Reporting  
The Principal Investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 

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• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the funding agency 
within 48 hours of the investigator becoming aware of the event. 
• 
Any other UP will be reported to the IRB and to the funding agency within 10 days of the investigator 
becoming aware of the problem. 
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s written 
reporting procedures), the supporting agency head (or designee), and the Office for Human Research 
Protections (OHRP) within 14 days of the IRB’s receipt of the report of the problem from the 
investigator. 
 
8.4.3 Reporting Unanticipated Problems to Participants  
N/A 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
Statistical Hypotheses 
Below we describe our formal statistical analysis plan. At ClinicalTrials.gov, this plan will be posted publicly and 
registered before the study begins. We also plan to publish a protocol paper. 
Primary Endpoint Hypothesis: 
We hypothesize that high school staff will rate the PLANTS intervention as having high acceptability, usability, 
appropriateness, and feasibility in the follow-up survey. We based our benchmarks of success (which are 
means >3.75 out of 5 for FIM, AIM, IAM and > 70 out of 100 for SUS) on prior research.95-103 
Secondary Endpoint Hypotheses: 
Regarding trial implementation and PLANTS safety, we hypothesize: school staff will have high participation 
rates in the study (≥50% consent); school staff will have a low attrition rate for the follow-up survey (≤25% 
drop-out); high school staff in the PLANTS arm will have high intervention demand (≥75% adhere to the 
intervention protocol); and high school staff in the PLANTS arm will have low adverse event prevalence (≤20% 
of PLANTS participants will report adverse events). 
We hypothesize that participants in PLANTS will report greater active-empathic listening, greater self-efficacy 
for supporting, affirming, and protecting SGMY, and greater positive bystander intervention behaviors for 
bullying in follow-up surveys than participants in the active control arm. 
9.2 
Sample Size Determination 
Primary Endpoints 

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To adequately evaluate the primary endpoints, we need precise estimates of acceptability, appropriateness, 
and feasibility. We calculated our sample size based on our primary outcomes, a 5% error rate, and best 
practices for feasibility studies.104-111 The median number of teachers at each MetroWest Region high school is 
n=86. With 4 schools in our sample, we anticipate inviting a total ≥344 school staff to participate in the pilot 
study. Assuming 50% agree to participate, 50% of participants are in the PLANTS study arm, and 75% of 
PLANTS participants complete the follow-up survey (reduced n=65), we can estimate 95% CI widths ≤0.33 for 
AIM, IAM, and (based on the largest upper CI limit of the AIM, IAM, and FIM standard deviations89,112) and 
≤10.1 for SUS.113,114 Such precision levels are sufficient.  
Secondary Endpoints 
We anticipate inviting at least 344 school staff to participate in the pilot study, and assuming 5% type I error 
rate, we will be able to estimate a 95% confidence interval width of no more than 0.11 for the participation rate. 
Assuming a participation rate of 50% (n=172), we will be able to estimate a 95% confidence interval width of 
no more than 0.15 for the attrition rate. Assuming half of the consenting participants are in the intervention arm 
(n=86), we will be able to estimate 95% confidence interval widths of no more than 0.21 for the proportion of 
school staff who adhere to the PLANTS intervention and for the proportion of school staff who report adverse 
events. 
Qualitative Endpoints 
For qualitative interviews, we aim to interview people with a diversity of intervention fidelity, acceptability, 
usability, feasibility, and appropriateness. This is an exploratory interview study in nature, so idea generation 
and exploration are the goals (not thematic saturation). We aim to interview PLANTS (n=20-30) and EMAILS 
(n=10-20) participants, and these sample sizes will provide us with ample information about the CFIR domains. 
9.3 
Populations for Analyses 
We will analyze data from the following populations: 
• 
PLANTS Primary Endpoint Population: This includes all participants who were in the PLANTS study 
arm and have AIM, IAM, or FIM data as reported in the follow-up survey. 
• 
Intention-to-Treat (ITT) Analysis Population: This includes all staff participants who enroll in the study. 
• 
Per-Protocol Analysis Population: This includes all staff participants who enroll in the study. 
• 
PLANTS Condition Population: Staff participants in the PLANTS arm. 
• 
EMAILS Condition Population: Staff participants in the PLANTS arm. 
• 
Qualitative Interview Population: Staff who participate in interviews. 
9.4 
Statistical Analyses 
 
9.4.1 General Approach 
With the ITT Analysis Population, we will calculate baseline descriptive statistics by study arm using means 
and standard deviations for continuous variables, and frequencies and percentages for categorical variables. 
We will test for differences in potential confounders between intervention and control arms using baseline staff-
and school-level data with Rao-Scott chi-square tests for categorical variables and linear mixed models (with a 
random effect for school) for continuous variables (models adjusting for the clustering of staff within schools). 
Secondary analyses will adjust for imbalances between arms. For previously validated scales, we will report 

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internal consistency via Cronbach’s alpha for continuous scales. For newly created items, we will conduct 
exploratory factor analyses to examine the dimensions of our outcomes as well as internal consistency using 
baseline surveys. We will use the most recent version of Stata. All tests are two-tailed and α=0.05. Given the 
small sample size and pilot nature of these analyses, we will not perform any corrections for multiple tests. 
Regarding qualitative analyses, we will transcribe, de-identify, and quality check all data.115-118 We will perform 
qualitative analyses in Dedoose.119 We will use CFIR as a guiding framework. Two qualitative coders will 
independently read interviews and compare coding until they agree they are on the same page. Once the 
coders, we will create a final codebook with definitions, rules, and examples for each code.117,118 Two coders 
will then recode all data using the final codes. We will calculate inter-rater reliability (i.e., Kappa statistic) to 
examine code application between coders.120 Coders will discuss any discrepancies until they reach 
agreement; Dr. Coulter will resolve disagreements.117,118 We will use either a qualitative descriptive coding 
approach121 (wherein we describe and count the number of code applications) or axial coding122 (wherein we 
combine inductive codes into broader categories to define emerging patterns or themes). We will identify and 
interpret patterns in the data using a thematic analytic approach.123 
9.4.2 Analysis of the Primary Endpoints 
To answer our primary research question, we use best practices for pilot/feasibility studies.104-111 Thus, we will 
analyze our primary outcomes using descriptive statistics.104-111 We will not correct for multiple tests.104-111 AIM, 
IAM, and FIM are calculated as an average of their 4 respective items in the follow-up survey. We will calculate 
SUS as recommended. Among people in the PLANTS primary endpoint population, we will calculate means 
and 95% CIs for participants’ responses to the FIM, AIM, IAM, and SUS.89 Our benchmarks of success are 
means > 3.75 out of 5 for AIM, IAM, FIM and scores > 75 out of 100 for SUS.  
9.4.3 Analysis of the Secondary Endpoints 
Hypothesis: School staff will have high participation rates in the study (≥50% consent). 
The Participation Rate equals the number of school staff who consent to participate divided by the total number 
of school staff who are invited. We will calculate an overall participation rate with a 95% confidence interval. 
Hypothesis: School staff will have a low attrition rate for the follow-up survey (≤25% drop-out). 
The Attrition Rate equals the number of school staff who failed to complete the follow-up survey divided by the 
total number of school staff who were consented. We will calculate an overall rate with a 95% confidence 
interval. 
Hypothesis: High school staff in the PLANTS arm will have high intervention demand (≥75% of enrolled 
participants will adhere to the PLANTS intervention). 
Intervention Demand will be a variable ranging from 0-100%. Investigators assess PLANTS adherence, which 
is a composite variable ranging from 0% to 100%, comprised of 55% for module completion (based on the 
number of completed items divided by the total number of items offered) and 45% for Live Zoom Event 
attendance (where each event is 15%). These proportions are based on approximate time allocations. 
Adherence is reflected by a score of 100%. We will calculate an overall adherence rate among PLANTS 
participants with a 95% confidence interval. 
 

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Hypothesis: High school staff participants in the PLANTS arm will report pre-post improvements in active-
empathic listening, self-efficacy for supporting, affirming, and protecting sexual and gender minority youths, 
and positive bystander intervention behaviors for bullying. 
To examine the pre-post changes in high school staff outcomes, investigators will first use descriptive 
statistics, such as means and percentages at each timepoint within arms. To test for within-arm statistical 
significance, investigators will use linear mixed models for continuous outcomes and generalized linear mixed 
models for binary outcomes, which account for within-school and within-person clustering using random 
effects. Investigators will estimate the intraclass correlations for within-school and within-person effects. These 
models will adjust for school size (a priori design variable). 
Hypothesis: Participants in PLANTS will report greater active-empathic listening, greater self-efficacy for 
supporting, affirming, and protecting SGMY, and greater positive bystander intervention behaviors for bullying 
in follow-up surveys than participants in the active control arm. 
We will use linear mixed models for continuous outcomes and generalized linear mixed models for binary 
outcomes—which account for within-school and within-person clustering effects (using random effects). We will 
estimate the intraclass correlations for within-school and within-person effects. Regression models will include 
a fixed term for school size (a priori design variable), intervention group (intervention or control), time (baseline 
or follow-up), and the interaction of intervention group × time (our variable of interest). The test of intervention 
effects on secondary outcomes will be primarily based on intent-to-treat estimates. We will estimate per-
protocol effects in secondary models. If there are differences in potential confounders by intervention group, 
we will adjust for them in secondary multivariable analyses. 
Additional Analyses 
Participant bias assessment will compare staff participants’ demographics (at baseline) to publicly available 
school-level data. We will report significant differences as potential validity threats. 
Attrition bias assessment will compare staff respondents who completed follow-up surveys versus those who 
did not by baseline demographics and outcomes. 
9.4.4 Safety Analyses 
Hypothesis: High school staff in the PLANTS arm will have low adverse event prevalence (≤20% of PLANTS 
participants will report adverse events). 
We will estimate the prevalence of adverse events by calculating the percentage and 95% confidence interval 
of school staff that reported adverse events experienced any time after PLANTS deployment and use.  
Additional Analyses 
We will report overall frequency (adding together all the adverse events reported) of adverse events by study 
arm, followed by the frequency of all types of adverse events by study arm. We will also report the total number 
of adverse events by severity and average duration, overall and by arm. We will also examine the frequency 
and percentage of school staff reporting adverse events (which will be counted once only for a given 
participant). We will also calculate adverse events by school level. We will report study arm-specific 
percentages of schools that had staff who reported any adverse event and by each type of adverse event.  
9.4.5 Baseline Descriptive Statistics 

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Study arms will be compared on baseline characteristics (e.g., demographics) using descriptive statistics. We 
will test for differences in potential confounders between intervention and control arms using baseline staff- 
and school-level data with Rao-Scott chi-square tests for categorical variables and linear mixed models (with a 
random effect for school) for continuous variables (models adjusting for the clustering of staff within schools). 
9.4.6 Planned Interim Analyses  
N/A 
9.4.7 Sub-Group Analyses 
Primary endpoints will be analyzed based on gender, sexual identity, race/ethnicity, intrinsic religiosity, 
religious attendance, religious activity, and role in school. Average score differences will be estimated using 
mixed models with demographic characteristics as predictors and the primary endpoints as outcomes, 
adjusting for school clustering. 
Secondary endpoints of PLANTS efficacy will be analyzed based on gender, sexual identity, race/ethnicity, 
intrinsic religiosity, religious attendance, religious activity, and role in school (i.e., effect modifiers). 
Multivariable models will contain the 3-way interaction term, all 2-way interaction terms, main effects of time, 
study arm, the potential effect modifier, and any variables that meaningfully differ between study arms at 
baseline. We will conduct both intent-to-treat and per-protocol analyses. A significant 3-way interaction 
suggests the presence of intervention effect heterogeneity. Following the approach of Kraemer124,125 to focus 
on effect size derivation, we will use Stata’s postestimation “margins” command to probe the 3-way interaction 
terms to provide simpler meaningful results.  
9.4.8 Tabulation of Individual Participant Data 
Individual participant data will be examined and presented in ways that fully protect participants’ privacy and 
anonymity.SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.5 
Regulatory, Ethical, and Study Oversight Considerations 
 
9.5.1 Informed Consent Process 
9.5.1.1 Consent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. The following consent materials are submitted with this protocol: 
• 
Screener Consent  
• 
Informed Consent for Trial Participation 
• 
Interview Consent 
9.5.1.2 Consent Procedures and Documentation 
Informed consent will be self-administered in REDCap using the e-Consent module. Informed consent is only 
offered in English because school staff are required to read English.  

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9.5.2 Study Discontinuation and Closure 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to study participants and funding agency, and regulatory authorities. If the 
study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the Institutional Review Board (IRB), and sponsor/funding agency and will provide the reason(s) 
for the termination or suspension. Study participants will be contacted, as applicable, and be informed of 
changes to the study’s schedule of activities. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies. 
9.5.3 Confidentiality and Privacy  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, the 
safety and oversight monitor, and the sponsor and funding agency. This confidentiality is extended to the data 
being collected as part of this study. Data that could be used to identify a specific study participant will be held 
in strict confidence within the research team. No personally identifiable information from the study will be 
released to any unauthorized third party without prior written approval of the sponsor/funding agency.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of the 
Institutional Review Board (IRB), regulatory agencies or representatives from companies or organizations 
supplying the product, may inspect all documents and records required to be maintained by the investigator. 
The study site will permit access to such records. 
The study participant’s contact information will be securely stored for internal use during the study. At the end 
of the study, all records will continue to be kept in a secure location for as long a period as dictated by the 
reviewing IRB, Institutional policies, or sponsor/funding agency requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored in Pitt’s OneDrive. This will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by sites and their research 
staff will be secured and password protected. At the end of the study, all study databases will be de-identified 
and archived via University of Pittsburgh regulations and policies. 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies: It is NIH policy 
that the results and accomplishments of the activities that it funds should be made available to the public 
(see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to share data will 
include proper plans and safeguards for the protection of privacy, confidentiality, and security for data 
dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific 

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study participant). Plans for archiving and long-term preservation of the data will be implemented, as 
appropriate.  
Certificate of Confidentiality: To further protect the privacy of study participants, the Secretary, Health and 
Human Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers engaged in 
biomedical, behavioral, clinical or other human subjects research funded wholly or in part by the federal 
government. Recipients of NIH funding for human subjects research are required to protect identifiable 
research information from forced disclosure per the terms of the NIH Policy (see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, 
recipients conducting NIH-supported research covered by this Policy are required to establish and maintain 
effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is 
managed in compliance with Federal statutes, regulations, and the terms and conditions of award. It is the NIH 
policy that investigators and others who have access to research records will not disclose identifying 
information except when the participant consents or in certain instances when federal, state, or local law or 
regulation requires disclosure. NIH expects investigators to inform research participants of the protections and 
the limits to protections provided by a Certificate issued by this Policy. 
9.5.4 Future Use of Stored Data  
Data collected for this study will be analyzed and stored at the University of Pittsburgh. After the study is 
completed, the de-identified, archived data will be stored at the University of Pittsburgh, for use by other 
researchers including those outside of the study via request.  
9.5.5 Key Roles and Study Governance 
Principal Investigator 
Robert W.S. Coulter, PhD, MPH, Assistant Professor 
University of Pittsburgh  
130 DeSoto Street, Pittsburgh, PA 15261 
1-412-624-0647 
Robert.ws.coulter@pitt.edu  
The Executive Committee consists of Dr. Robert Coulter (PI), Dr. Elizabeth Miller (Co-Investigator, pediatrician 
scientist) and Dr. Kaleab Abebe (Co-Investigator, biostatistician).  
9.5.6 Safety Oversight 
There are low risks associated with participation in the proposed study. We include an Internal Safety 
Executive Committee. Safety oversight will be under the direction of the Safety Executive Committee 
composed of individuals with the appropriate expertise, including LGBTQ+ health, biostatistics, and pediatrics. 

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This group will meet monthly and confer on an as-needed basis when adverse or difficult events occur (within 
48 hours). 
9.5.7 Clinical Monitoring 
N/A 
9.5.8 Quality Assurance and Quality Control 
Our team will perform internal quality management of study conduct, data collection, documentation, and 
completion. We will follow a common quality management plan. Quality control (QC) procedures will be 
implemented as follows: 
Informed consent: Study staff will review both the documentation of the consenting process as well as a 
percentage of the completed consent documents.  This review will evaluate compliance with GCP, accuracy, 
and completeness.  Feedback will be provided to the study team to ensure proper consenting procedures are 
followed.  
Source documents and the electronic data: Data will be initially captured in REDCap.  
Intervention Fidelity: Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  
Protocol Deviations: The study team will review protocol deviations on an ongoing basis and will implement 
corrective actions when the quantity or nature of deviations are deemed to be at a level of concern. 
9.5.9 Data Handling and Record Keeping  
9.5.9.1 Data Collection and Management Responsibilities  
Data collection will be the responsibility of the trial staff at the site under the supervision of the site investigator. 
The investigator will be responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. All data will be completed in REDCap in a neat, legible manner to ensure accurate interpretation 
of data. Clinical data (including adverse events) will be entered into REDCap, a 21 CFR Part 11-compliant data 
capture system provided by the University of Pittsburgh. The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, 
or inaccurate.  
9.5.9.2 Study Records Retention  
Study documents will be retained for a minimum of 2 years after the last approval of a marketing application in 
an International Council on Harmonisation (ICH) region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the formal discontinuation 
of clinical development of the study intervention. These documents should be retained for a longer period, 
however, if required by local regulations. No records will be destroyed without the written consent of the 
sponsor/funding agency, if applicable. It is the responsibility of the sponsor/funding agency to inform the 
investigator when these documents no longer need to be retained. 
9.5.10 Protocol Deviations   

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This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, International 
Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. 
The noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions will be developed by the site and implemented promptly. Some expected 
deviations, such as loss-to-follow-up or intervention nonadherence, will not be reported. 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
It will be the responsibility of the site investigator to use continuous vigilance to identify and report deviations 
within 3 working days of identification of the protocol deviation, or within 3 working days of the scheduled 
protocol-required activity. All deviations will be addressed in study source documents, reported to NIAAA 
Program Official. Protocol deviations will be sent to the reviewing Institutional Review Board (IRB) per their 
policies. The site investigator will be responsible for knowing and adhering to the reviewing IRB requirements. 
Further details about the handling of protocol deviations will be included in the MOP.  
9.5.11 Publication and Data Sharing Policy  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, 
this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to 
ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data 
from this study may be requested from other researchers by contacting the PI.  Considerations for ensuring 
confidentiality of these shared data are described in Section 10.1.3. 
9.5.12 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who have 
a perceived conflict of interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the design and conduct of this trial. The study leadership in conjunction with NIAAA has 
established policies and procedures for all study group members to disclose all conflicts of interest and will 
establish a mechanism for the management of all reported dualities of interest. 
9.6 
Additional Considerations 

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N/A 
9.7 
Abbreviations and Special Terms 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
COC 
Certificate of Confidentiality 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
EMAILS 
E-learning to Maximize Academic Inclusion of LGBTQ+ Students 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
LGBTQ+ 
Lesbian, Gay, Bisexual, Transgender, Queer, and More 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIAAA 
National Institute on Alcohol Abuse and Alcoholism 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PLANTS 
Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SGMY 
Sexual and gender minority youth 
TIDieR 
Template for intervention description and replication  
UP 
Unanticipated Problem 
US 
United States 
 
9.8 
Protocol Amendment History 
N/A 
 

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