Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)
Phase: NA
Conditions: Suicide
Sponsor: San Diego State University

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Suicide Prevention for Sexual and Gender 
Minority Youth 
  
Protocol Number: HS-2020-0076 
 
National Clinical Trial (NCT) Identified Number: NCT04757649 (Case 
Series), NCT05087966 (Open Trial) 
 
Principal Investigators: Drs. Aaron Blashill and Kristen Wells 
 
Sponsor: San Diego State University 
 
Grant Title: Suicide Prevention for Sexual and Gender Minority Youth 
 
Grant Number: 1R61MH120236-01A1 
 
Funded by: National Institute of Mental Health 
 
Version Number:  1.5; 11.30.2021 
 

Suicide Prevention for Gender and Sexual Minority Youth                          Version 1.5 
Protocol HS-2020-0076                                                                                30 November 2021 
 
 
Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
6.6.4 
Removal of guidelines for suicidality-
related clinical worsening in the 
context of adverse event reporting. 
We removed specific guidelines for 
determining suicidality-related clinical 
worsening following the recommendations 
from the DSMB. These will be added to the 
study MOP. 
 
 
 
 
 
 
 

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Table of Contents 
STATEMENT OF COMPLIANCE .............................................................................................. 1 
INVESTIGATOR’S SIGNATURE ............................................................................................... 2 
1 
PROTOCOL SUMMARY .................................................................................................. 3 
1.1 
Synopsis ..................................................................................................................... 3 
1.2 
Schema ...................................................................................................................... 5 
1.3 
Schedule of Activities ............................................................................................... 7 
2 
INTRODUCTION ............................................................................................................... 9 
2.1 
Study Rationale ......................................................................................................... 9 
2.2 
Background .............................................................................................................. 10 
2.3 
Risk/Benefit .............................................................................................................. 13 
2.3.1 
Known Potential Risks ........................................................................... 13 
2.3.2 
Known Potential Benefits ...................................................................... 13 
2.3.3 
Assessment of Potential Risks and Benefits ..................................... 14 
3 
STUDY DESIGN .............................................................................................................. 15 
3.1 
Overall Design ......................................................................................................... 15 
3.2 
Justification for Intervention .................................................................................. 18 
3.3 
End-of-Study Definition .......................................................................................... 19 
4 
STUDY POPULATION .................................................................................................... 19 
4.1 
Inclusion Criteria ..................................................................................................... 19 
4.2 
Exclusion Criteria .................................................................................................... 19 
4.3 
Screen Failures ....................................................................................................... 20 
4.4 
Strategies for Recruitment and Retention ........................................................... 20 
5 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............... 22 
5.1 
Study Intervention(s) or Experimental Manipulation(s) Administration .......... 22 
5.1.1 
Administration and/or Dosing ............................................................... 22 
5.2 
Fidelity ...................................................................................................................... 22 
5.2.1 
Interventionist Training and Tracking .................................................. 22 
5.3 
Study Intervention/Experimental Manipulation Adherence .............................. 23 
6 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL .......... 24 
6.1 
Discontinuation of Study Intervention/Experimental Manipulation .................. 24 
6.2 
Participant Discontinuation/Withdrawal from the Study .................................... 24 
6.3 
Lost to Follow-Up .................................................................................................... 24 
6.4 
Endpoint and Other Non-Safety Assessments .................................................. 25 
6.5 
Safety Assessments ............................................................................................... 31 
6.6 
Adverse Events and Serious Adverse Events ................................................... 33 
6.6.1 
Definition of Adverse Events ................................................................ 33 
6.6.2 
Definition of Serious Adverse Events .................................................. 33 
6.6.3 
Classification of an Adverse Event ...................................................... 34 
6.6.4 
Time Period and Frequency for Event Assessment and Follow-Up
 
36 
6.6.5 
Adverse Event Reporting ...................................................................... 37 
6.6.6 
Serious Adverse Event Reporting ....................................................... 37 
6.7 
Unanticipated Problems ......................................................................................... 37 
6.7.1 
Definition of Unanticipated Problems .................................................. 37 

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6.7.2 
Unanticipated Problems Reporting ...................................................... 38 
6.7.3 
Reporting Unanticipated Problems to Participants ........................... 38 
7 
STATISTICAL CONSIDERATIONS .............................................................................. 38 
7.1 
Statistical Hypotheses ............................................................................................ 38 
7.2 
Sample Size Determination ................................................................................... 38 
7.3 
Populations for Analyses ....................................................................................... 39 
7.4 
Statistical Analyses ................................................................................................. 39 
7.4.1 
General Approach .................................................................................. 39 
7.4.2 
Analysis of the Primary Endpoint(s) .................................................... 39 
7.4.3 
Baseline Descriptive Statistics ............................................................. 40 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS . 40 
8.1 
Regulatory, Ethical, and Study Oversight Considerations ............................... 40 
8.1.1 
Informed Consent Process ................................................................... 40 
8.1.2 
Study Discontinuation and Closure ..................................................... 41 
8.1.3 
Confidentiality and Privacy ................................................................... 41 
8.1.4 
Future Use of Stored Specimens and Data ....................................... 43 
8.1.5 
Key Roles and Study Governance ...................................................... 43 
8.1.6 
Safety Oversight ..................................................................................... 43 
8.1.7 
Quality Assurance and Quality Control ............................................... 44 
8.1.8 
Data Handling and Record Keeping .................................................... 46 
8.1.9 
Protocol Deviations ................................................................................ 47 
8.1.10 
Publication and Data Sharing Policy ................................................... 47 
8.1.11 
Conflict of Interest Policy ...................................................................... 48 
8.2 
Abbreviations and Special Terms ........................................................................ 48 
9 
REFERENCES ................................................................................................................. 49 
 

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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. 
 
Principal Investigator or Clinical Site Investigator: 
 
 
Signed: 
 
Date: 
11/30/2021 
 
Name: Aaron Blashill, PhD 
 
Title: 
Professor 
 
Investigator Contact Information 
Affiliation: Department of Psychology, San Diego State University 
Address: 6363 Alvarado Ct., Ste. 103, San Diego, CA 92120 
Telephone: 619-594-2245 
Email: ajblashill@sdsu.edu 
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Suicide Prevention for Sexual and Gender Minority Youth 
  
Grant Number: 
1R61MH120236-01A1 
  
Study Description: 
In the case series, participants will be screened for eligibility 
and then complete the initial baseline assessment. During the 
baseline appointment, participants will receive the first module 
of the Patient Navigator+Safety Planning Intervention 
(PN+SPI), consisting of the intake, introduction to navigation, 
and the SPI. Participants will then receive PN services for a 
period of three months. At three-months, participants will 
complete a final follow-up assessment. There are no formal 
hypotheses associated with the case series.  
 
In the open trial, participants will be screened for eligibility and 
then complete the initial baseline assessment. During the 
baseline appointment, participants will receive the first module 
of the PN+SPI intervention, consisting of the intake, introduction 
to navigation, and the SPI. Participants will then receive PN 
services for a period of six months. Participants will complete a 
three-month follow-up assessment and a six-month follow-up 
assessment. For the open trial, it is hypothesized that PN+SPI 
participants will display decreases in thwarted belongingness 
and increases in suicide-related coping skills (the hypothesized 
mechanistic targets of the intervention). We will also assess the 
feasibility and acceptability of the PN+SPI intervention during 
the open trial.    
 
The R61 phase (e.g., case series and open trial) precedes a 
potential R33 phase, in which the theoretical targets of the 
intervention will be further tested in a RCT (PN+ SPI vs. SPI 
alone).  
 
A detailed schematic describing all visits and a schedule of 
assessments is included in Section 1.2, Schema and Section 
1.3, Schedule of Activities. 
 
Objectives/Endpoints: 
 
The primary objective of the case series is to obtain feedback 
on study procedures and the PN+SPI intervention. The primary 
objective of the open trial is to assess the acceptability and 
feasibility of the PN+SPI intervention, as well as the preliminary 
impact on the purported mechanisms of action of the PN+SPI 
intervention (e.g. decreasing thwarted belongingness, 
increasing suicide-related coping skills). There are no 
secondary objectives in either the case series or open trial. 
  

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Study Population: 
The case series will consist of up to 10 sexual and gender 
minority participants, aged 15-29, located in San Diego. The 
open trial will consist of 30 sexual and gender minority 
participants, aged 15-29, located in San Diego. The participants 
in both the case series and open trial are generally physically 
healthy but are currently experiencing suicidal ideation and 
have attempted suicide in the past.   
  
Description of 
Sites/Facilities Enrolling 
Participants: 
 
San Diego State University (SDSU) is the only site enrolling 
participants for both the case series and open trial. 
 
Description of Study 
Intervention/Experimental 
Manipulation: 
 
The study intervention integrates a brief (30 minute), empirically 
supported, single-session suicide prevention intervention 
(Safety Planning Intervention; SPI) with patient navigation (PN) 
services (PN+SPI). Intervention dose will vary by participant 
based on their individual needs. All PN+SPI intervention 
sessions will be administered individually. The first PN+SPI 
intervention session will occur either remotely or in-person. 
After the initial session, the remaining intervention sessions will 
occur according to the participant’s preferred contact method 
(e.g., Zoom-based, over the phone).  
 
 
Study Duration: 
The estimated time from when the study opens to enrollment 
until completion of data collection is five months for the case 
series and fifteen months for the open trial.  
  
Participant Duration: 
 
  
In the case series, it will take three months for each individual 
participant to complete all study related tasks. In the open trial, 
it will take six months for each individual participant to complete 
all study-related tasks. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

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1.2 
SCHEMA 
 
Case Series Flow Diagram  
 
Total N = 10 
 
 
Pre-Screening 
 
 
 
 
 
Visit 1 
<Day 1> 
 
 
 
 
 
 
 
<Day 1 – 
 Day 91 > 
 
 
 
 
 
 
Visit 2 
< Day 91 ± 31> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-screen potential participants by inclusion and exclusion criteria; 
schedule Visit 1. 
Conduct informed consent process. Perform baseline assessments. 
Administer first PN+SPI intervention session 
 
Refer to Section 1.3, Schedule of Activities 
Final Assessment (Three-
Month Follow-Up) 
 
Refer to Section 1.3, 
Schedule of Activities 
Administer remaining patient navigator intervention sessions 

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Open Trial Flow Diagram 
 
Total N = 30 
 
 
Pre-Screening 
 
 
 
 
Visit 1 
<Day 1> 
 
 
 
 
 
 
<Day 1  
– Day 90 > 
 
 
 
Visit 2 
< Day 91 
 ± 31> 
 
 
 
 
<Day 91 
 ± 183> 
 
 
Visit 3 
<Day 183 
 ± 214>  
 
 
 
 
 
 
Pre-screen potential participants by inclusion and exclusion criteria; 
schedule Visit 1. 
Conduct informed consent process. Perform baseline assessments. 
Administer first PN+SPI intervention session. 
 
Refer to Section 1.3, Schedule of Activities 
Final Assessment (Six-
Month Follow-Up) 
 
Refer to Section 1.3, 
Schedule of Activities 
Administer patient navigation intervention sessions 
 
Administer patient navigation intervention sessions 
Three-Month Follow-Up Assessment 
 
Refer to Section 1.3, Schedule of Activities 

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1.3 
SCHEDULE OF ACTIVITIES 
 
Case Series Schedule of Activities 
 
 
Phone 
Screening 
Baseline 
<Day 1> 
Intervention 
Sessions 
<Day 1 – 90> 
Three-Month 
Follow-Up 
<Day 91 ±31> 
Verbal Phone 
Screen Consent 
X 
 
 
 
Phone Screener 
X 
 
 
 
Informed 
Consent 
 
X 
 
 
Demographics 
 
X 
 
 
Psychiatric 
Diagnoses 
 
X 
 
 
Suicidality 
Assessment 
(Columbia-
Suicide Severity 
Rating Scale) 
 
X 
X 
X 
Other clinician--
administered 
assessments 
(including 
Medical Care 
and Conditions) 
 
X 
 
X 
Other self-report 
questionnaires 
 
X 
 
X 
PN+SPI 
Intervention  
 
X 
X 
 
PN Intervention 
Encounter Data 
Collection 
 
X 
X 
 
Study + 
Intervention 
Feedback (Open 
Ended Survey + 
Interview 
Questions) 
 
 
 
X 
Adverse Events 
Reporting 
 
X 
X 
X 
 
 

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Open Trial Schedule of Activities 
 
 
Phone 
Screening 
Baseline 
<Day 1> 
Intervention 
Sessions 
<Day 1 – 
90> 
Three-
Month 
Follow-
Up  <Day 
91 ± 31> 
Intervention 
Sessions 
<Day 91 ± 
183> 
Six-
Month 
Follow-
Up 
<Day 
183 ± 
214> 
Verbal Phone 
Screen 
Consent 
X 
 
 
 
 
 
Phone 
Screener 
X 
 
 
 
 
 
Informed 
Consent 
 
X 
 
 
 
 
Demographics 
 
X 
 
 
 
 
Psychiatric 
Diagnoses 
 
X 
 
 
 
 
Suicidality 
Assessment 
(Columbia-
Suicide 
Severity 
Rating Scale) 
 
X 
X 
X 
X 
X 
Other 
clinician-
administered 
assessments 
(including 
Medical Care 
and 
Conditions) 
 
X 
 
X 
 
X 
Other self-
report 
questionnaires 
 
X 
 
X 
 
X 
Outcome 
Evaluation 
 
 
 
 
 
 
Thwarted 
Belongingness 
(Interpersonal 
Needs 
Questionnaire) 
 
X 
 
X 
 
X 

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Suicide-
Related 
Coping Skills 
(Suicide-
Related 
Coping Skills 
Scale) 
 
X 
 
X 
 
X 
PN+SPI 
Intervention  
 
X 
X 
 
X 
 
PN 
Intervention 
Encounter 
Data 
Collection 
 
X 
X 
 
X 
 
Key Informant 
Interview 
 
 
 
 
 
X 
Satisfaction 
with Mental 
Health 
Services 
(Client 
Satisfaction 
Questionnaire-
8) 
 
 
 
X 
 
X 
Satisfaction 
with 
Interpersonal 
Relationship 
with PN 
 
 
 
X 
 
X 
Study 
Satisfaction 
(Open Ended 
Survey 
Questions) 
 
 
 
X 
 
X 
Adverse 
Events 
Reporting 
 
X 
X 
X 
X 
X 
 
 
 
2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
 
Death by suicide is one of the leading causes of mortality in the United States. One group that is 
at a particularly heightened risk of suicide are sexual and gender minorities (SGMs). SGM is an 
umbrella term to describe individuals who: 1) identify as non-exclusively heterosexual (e.g. gay, 

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lesbian, bisexual, pansexual, asexual, queer); and/or 2) report same-gender attraction; and/or 3) 
identify as a gender different than their birth sex (e.g. transgender, gender non-binary, 
genderqueer). Despite the fact that SGMs are at a high risk of suicide attempts and death by 
suicide, no known suicide prevention programs exist for this vulnerable population. Therefore, the 
purpose of the present study is to develop and test a novel suicide prevention intervention 
designed to reduce suicide attempts among SGM youth and emerging adults. The proposed 
intervention will integrate a single-session, empirically supported suicide prevention intervention 
(Safety Planning Intervention; SPI) with patient navigation (PN) services (PN+SPI). PN may be 
particularly well suited to address the needs to young SGMs at risk of suicide, given its focus on 
cultural sensitivity and its high level of flexibility to address patients’ specific needs. Patient 
navigators work with the individual patient, the patient’s significant others, the health care system, 
and community services to improve adherence to recommended health care and healthy 
behaviors. The SPI is a 30-minute behavioral intervention to reduce suicide attempts by providing 
individuals with specific actionable behaviors they can engage in to reduce the likelihood of acting 
on suicidal urges, including: 1) identification of suicidality warning signs; 2) implementing personal 
coping strategies; 3) connecting with mental health professionals; 4) connecting with friends 
and/or family for support; 5) connecting with mental health professionals; and 6) reducing access 
to means of completing suicide. Patient navigators will deliver the SPI and continue frequent 
contact for the purpose of providing motivational enhancement, problem-solving, reinforcing 
coping strategies, and connecting participants to social support and mental health resources (e.g. 
SGM-specific support groups from the community). The aims of this R61 phase are to refine the 
PN+SPI intervention content and procedures, assess acceptability and feasibility, and test if the 
intervention impacts propertied targets (i.e. thwarted belongingness and suicide-related coping 
skills). The first phase of the R61 study is to conduct a case series and the second phase is to 
conduct an open-phase trial.  The case series will be used to obtain participant feedback on study 
procedures and the PN+SPI intervention for the purpose of improving approaches for the open-
phase trial. Thus, it has no hypotheses. Based on the minority stress model and the interpersonal 
theory of suicide, in the open-phase trial, we hypothesize that the PN+SPI intervention will reduce 
suicide attempts through 2 proposed targets: 1) decreasing thwarted belongingness (e.g. through 
interactions with the PN and connection with SGM-specific support groups) and 2) increasing 
suicide-related coping skills. The PN+SPI overtly develops with participants both internal and 
external coping skills to rely on during suicidal crises. For example, internal coping skills refers to 
distraction from suicidal thoughts and urges, whereas external coping skills refers to means 
restricting (i.e. restricting access to lethal means to act on suicidal urges) in addition to reaching 
out to others (e.g. friends, family, PN, mental health provider) when in crisis. Therefore, the clinical 
outcome of interest are effect size estimates of changes in thwarted belongingness and suicide-
related coping. 
 
 
2.2 
BACKGROUND  
 
Death by suicide is a leading cause of mortality in the United States1. Indeed, among the entire 
U.S. population, suicide is the 10th leading cause of death1. Death by suicide accounts for even 
more premature mortality among youth and emerging adults. For instance, suicide is the 2nd 
leading cause of death among individuals between the ages of 15 and 341. Moreover, among the 
U.S. population, there is an increasing trend in the incidence of suicide attempts2 and death by 
suicide3. This trend has also been found among youth and emerging adults4,5. In addition to the 
prevalence and increasing incidence in the U.S., the psychological and financial burden of suicide 
is immense. Not only does suicide lead to substantial distress among family and friends of people 
who died by suicide6-8, the economic impact is striking. In 2013, it was estimated that suicide 

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attempts and death by suicide cost $93.5 billion in the U.S.9. Additionally, there are specific 
vulnerable populations that experience disproportionate rates of suicide. 
 
Sexual and gender minorities (SGMs) are a vulnerable population, for which substantial mental 
health disparities have been demonstrated10-16. Further, SGM youth also are at a substantial risk 
for suicidality, with 23% of sexual minority youth reporting one or more suicide attempts (in the 
past 12 months) versus 5.4% of heterosexual youth17. Meta-analytic findings have also echoed 
these results, with sexual minority adolescents and emerging adults reporting 2.26 increased 
odds of suicide attempts compared to their heterosexual counterparts18. Gender minorities are 
also at substantially elevated risk compared to the general population, with 45% of 18-24-year-
old transgender individuals reporting history of one or more suicide attempts19. However, to date, 
no known suicide prevention programs have been developed and tested among SGM, a notable 
gap in the literature, given the substantial suicide disparities noted among this vulnerable 
population. Therefore, the purpose of this study is to adapt and test a patient navigation (PN) 
intervention for SGM youth/emerging adults designed to reduce suicide attempts among SGM 
youth. 
 
One of the leading models of suicide behaviors is the interpersonal theory of suicide20-23. The core 
tenants of the interpersonal theory of suicide include the constructs of thwarted belongingness, 
perceived burdensomeness, and capability for suicide. Together, these constructs are meant to 
explain variance in the ideation-to-action framework – that is, illuminating pathways from suicidal 
desire to suicidal behavior (i.e., fatal and non-fatal suicide attempts). Thwarted belongingness 
denotes an unmet need to belong socially, which includes components of loneliness, having few 
friends, social withdrawal, and/or interpersonal conflict. Perceived burdensomeness is defined as 
an internal miscalculation that one’s death would be more valuable to others than their life would 
be. Capability for suicide includes a genetic predisposition and a learned lowering of one’s fear of 
death and increasing pain tolerance through repeated exposures to painful events. This model 
suggests that the interaction amongst thwarted belongingness, perceived burdensomeness, and 
capability for suicide, synergistically places individuals are increased risk for suicide attempts. 
Empirically, recent meta-analytic findings have supported this model, noting significant main 
effects of thwarted belongingness, perceived burdensomeness, and capability for suicide on 
suicide attempts and risk (i.e. attempts in the context of current ideation)20. Of note, significant 2-
way interactions with thwarted belongingness and perceived burdensomeness (and 3-way 
interactions with all variables) were significant in predicting suicide attempts and suicide risk, with 
thwarted belonginess demonstrated an r = .33 main effect with suicide risk. 
 
The leading theoretical model to explain health disparities, including suicide attempts, among 
SGMs, is the minority stress theory24-27. The minority stress theory posits that in addition to 
general stressors, distal minority stressors (e.g. discrimination, prejudice, and victimization 
towards SGMs) and proximal minority stressors (e.g. discrimination, prejudice, and victimization 
towards SGMs) and proximal minority stressors (e.g. internalization of anti-SGM messages, 
concealment of one’s identity, and expectations of rejection) lead to poor mental health outcomes 
and suicide attempts. Critically, variables have also been identified which buffer the effects of 
these stressors on negative mental health outcomes, namely social support (broadly, and specific 
to other SGM members) and coping skills11,28-31. Integrating minority stress theory with the 
interpersonal theory of suicide provides a strong conceptual model for understanding suicide risk 
amongst SGM youth. Both models highlight modifiable buffering variables, that if addressed, 
would theoretically allay suicide attempts. For example, the minority stress theory posits that 
increasing social support (broadly, and specifically from other SGMs) and coping skills, attenuates 
the association of minority stressors to negative mental health outcomes (e.g. suicide attempts). 

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Social support from minority stress theory conceptually overlaps greatly with thwarted 
belongingness from the interpersonal theory of suicide. Here too, the model implies, and its 
authors have provided compelling arguments, that reducing thwarted belongingness (such as 
through fostering interpersonal connectedness related to social support) would also attenuate the 
associations between perceived burdensomeness and capability for suicide with suicide attempts 
and risk.  
 
Thus, the proposed brief and scalable PN+SPI does not aim to directly target upstream minority 
stressors, or general stressors, or address perceived burdensomeness or capability for suicide. 
Rather, the PN+SPI aims to modulate two theoretical targets to suicide attempts among SGMs – 
poor coping skills and thwarted belongingness. If the PN+SPI increases coping skills, a 
subsequent reduction in suicide attempts is expected, both through adaptive coping skills (e.g. 
suicide means restriction, distraction skills) and also through attenuating the association between 
stressors and suicide attempts. Similarly, if the intervention decreases thwarted belongingness, 
a subsequent reduction in suicide attempts is expected, both through an increased sense of 
belonging (e.g. through general and SGM-specific social support) and also through attenuating 
the associations between: 1) perceived burdensomeness; 2) capability for suicide; and 3) 
stressors, on suicide attempts. 
 
PN may be particularly well suited to address the needs to young SGMs at risk of suicide, given 
its focus on cultural sensitivity and its high level of flexibility to address patients’ specific needs. 
Patient navigators work with the individual patient, the patient’s significant others, the health care 
system, and community services to improve adherence to recommended health care and healthy 
behaviors. There have been few PN interventions developed or tested to assist patients 
experiencing mental health or developmental conditions. Research indicates that the PN 
approach has been used to assist patients with serious mental illness32-35, depression36,37, autism 
spectrum disorder38-40, and traumatic brain injuries. Existing studies of PN applied to mental health 
conditions have several limitations. For example, no known study has evaluated whether PN can 
assist patients with suicide risk. In fact, most studies have excluded patients who expressed 
suicidal ideation, leading to significant gaps in knowledge regarding the best ways to assist 
suicidal populations. 
 
The SPI41 is a 30-minute behavioral intervention to reduce suicide attempts by providing 
individuals with specific actionable behaviors they can engage in to reduce the likelihood of acting 
on suicidal urges, including: 1) identification of suicidality warning signs; 2) implementing personal 
coping strategies; 3) connecting with mental health professionals; 4) connecting with friends 
and/or family for support; 5) connecting with mental health professionals; and 6) reducing access 
to means of completing suicide. In a recent trial of the SPI, 1,640 patients with suicide risk 
received either the SPI or usual care and were followed for six months. Results indicated that 
participants who received the SPI significantly reduced suicidal behaviors compared to the 
comparison condition, with 45% fewer suicide attempts noted among the SPI participants 
compared to usual care42. 
 
 The PN+SPI intervention is a multi-level intervention and will target several hypothesized 
mechanistic targets that theoretically underlie the impact of the PN+SPI on reduction in suicide 
attempts. One proposed target of the intervention is decreased thwarted belongingness (e.g. 
through interactions with the PN and connection with SGM-specific support groups). For example, 
in a recent meta-analysis of over 100 unique samples, thwarted belongingness was significantly 
associated with increased suicide risk (r = .33)20. Additionally, among a sample of sexual minority 
and heterosexuals, the association between thwarted belongingness and suicide ideation was 

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stronger amongst SMs and SM participants with a history of suicide attempts reported 
substantially higher thwarted belongingness compared to SMs with no history of suicide attempts 
(d = .54)43. SMs also report greater thwarted belongingness compared to their heterosexual peers 
(d range from .80 to .97)44. Related, thwarted belongingness has also been found to predict 
suicide attempts among gender minority youth (Odds Ration [OR] = 2.88)20,44,45.  
 
Another set of hypothesized targets are suicide-related coping skills. The PN+SPI overtly 
develops with participants both internal and external coping skills to rely on during suicidal crisis. 
For example, internal coping skills refers to distraction from suicidal thoughts and urges, whereas 
external coping skills refers to means restriction (i.e. restricting access to lethal means to act on 
suicidal urges) in addition to reaching out to others (e.g. friends, family, PN, mental health 
provider) when in crisis46. Means restriction has previously been shown to reduce suicide attempts 
at both the population and individual level47,48. Indeed, recent meta-analytic data underscore the 
efficacy of means restriction and lower odds of death by suicide49. Further, greater use of internal 
and external suicide-related coping skills have both been significantly associated with lowered 
suicidal ideation intensity, severity, and lower likelihood of suicide attempts46.  
 
Positive results from this project would elucidate pathways in which brief suicide prevention 
programs may confer reduction in suicide attempts among vulnerable populations. Negative 
results would also confer crucial information on theoretically informed pathways which may not 
be active in prevention programs, which subsequently may encourage researchers to postulate 
alternative targets as brief suicide prevention programs are created and refined. We anticipate 
that decreasing thwarted belongingness, and increasing internal and external coping, will have 
significant clinical meaningfulness as all three targets will subsequently reduce suicidal behavior. 
There are currently no known existing suicide prevention approaches designed for SGM and none 
that has utilized PN, thus the proposed study is likely to have a significant clinical benefit and 
impact on the field of suicide prevention research. 
 
 
2.3 
RISK/BENEFIT  
2.3.1 KNOWN POTENTIAL RISKS  
 
Case Series and Open Trial Potential Risks: 
 
It is unlikely that participants will be at any risk for physical harm as a result of study participation. 
Participants may reflect on unpleasant memories or talk about certain things that they may find 
distressing and may experience anxiety as a result. As with any study of participants with suicidal 
ideation, there is always the risk of symptoms worsening and the possibility of suicide attempts. 
Other potential risks include the possibility that confidentiality could be breached, as well as 
possible discomfort about treatment sessions and assessments being audio-recorded for 
supervision and treatment adherence checks.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Case Series and Open Trial Potential Benefits: 
 
All participants will have the opportunity to participate in a suicide prevention program. Each 
participant will receive the SPI which is the ‘gold-standard’ intervention for suicide prevention. 

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Additionally, each participant will receive the services of a patient navigator who will help them 
connect to resources in the community, problem-solve barriers to treatment, and reinforce coping 
skills. Lastly, all participants, regardless of eligibility status, will be provided with referrals to local 
mental health providers, and local/national suicide crisis hotlines, including The Trevor Project, 
which specializes in suicide prevention for sexual and gender minority youth/emerging adults.  
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Case Series and Open Trial Assessment of Potential Risks and Benefits: 
 
As stated above, participants may reflect on unpleasant memories or talk about certain things that 
they may find distressing and may experience anxiety as a result. However, it is necessary that 
we ask these potentially emotionally upsetting items in order to adequately evaluate the PN+SPI 
intervention. Participants will be advised during the informed consent process and throughout the 
study that they may decline to answer any study questions, that participation is voluntary, and 
that they may withdraw from the study at any time. 
 
To partially address participants’ risk of distress and potential breaches of confidentiality, we have 
obtained a waiver of parental consent from the IRB and an approval of minor’s (age 15 to 17) 
ability to self-consent, which is consistent with the U.S. Department of Health and Human 
Services Office of Human Research Protections guidelines: 
 
An IRB may waive the requirements for obtaining parental or guardian permission if it 
makes and documents the findings under either 45 CFR 46.116(c) or (d). In addition to 
the provisions for waiver contained in 45 CFR 46.116(c) or (d), if the IRB determines that 
a research protocol is designed to study conditions in children or a subject population for 
which parental or guardian permission is not a reasonable requirement to protect the 
subjects (for example, neglected or abused children), it may waive the parental permission 
requirements provided that an appropriate mechanism is in place to protect the children, 
and provided that the waiver is not inconsistent with federal, state, or local law (45 CFR 
46.408(c)). 
 
Per Fisher, Arbeit, Dumont, Macapagal, and Mustanski50, failure of IRBs to approve these 
requests represents a significant barrier to sexual and gender minority youth engagement in 
research protocols due to fear of being stigmatized and/or victimized if guardian permission leads 
to disclosure of their sexual orientation or gender identity51-53. The results of IRBs’ failure to 
approve these requests can subsequently result in more limited and unrepresentative samples54, 
which may bias results which undermine the generalizability of findings to sexual and gender 
minority youth who live in a non-accepting familial environment. Indeed, results from a sample of 
60, 14-17 year-old sexual and gender minority youth indicated that the vast majority reported that 
requiring parental consent for research studies would prevent them from participating. 
Additionally, participants demonstrated strong knowledge of the informed consent process, 
including risks/benefits, random assignment, and confidence in dissenting to research practices 
with which they did not feel comfortable50. 
 
Given that we have obtained a waiver of parental consent for the reasons described above, we 
do not plan to alert parents/caregivers if a minor enrolled in the study reports immediate suicidal 
intent. Rather, we will require all participants at baseline to identify at least one trusted adult whom 
the study staff would contact in case of a psychiatric emergency or difficulty in contacting the 

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participant. If study staff were to alert parents/caregivers, it could potentially be detrimental to the 
participant’s well-being, particularly in the context of a suicidal crisis, if the family member(s) were 
not aware of, and/or supportive of, the participant’s sexual or gender identity.  
  
The patient navigation procedures will facilitate receipt of high-quality mental health care. The 
intervention will be implemented by a social work navigator who will be under the supervision of 
Dr. Blashill, a licensed clinical psychologist, and Dr. Wells, a trained clinical psychologist. The 
assessment of intervention fidelity will also help to ensure that clinical protocols are being 
implemented as designed. Study navigators will also have ready access to the Principal 
Investigators, as well as their direct supervisor at the Family Health Centers of San Diego 
(FHCSD). In all cases, participant health and safety have priority over study protocol. Study 
procedures do not preclude participant referral for additional care and treatment.  
 
Other potential risks include the possibility that confidentiality could be breached, as well as 
possible discomfort about treatment sessions and assessments being audio-recorded for 
supervision and treatment adherence checks. Participants will be advised that they can refuse to 
be audio-recorded. All data will be kept confidential, under lock-and-key, or electronically and 
password protected, accessible only to trained study staff. Participants’ data will be identified by 
an ID number only, and a link between names and ID numbers will be kept separately under lock-
and-key or electronically and password protected, again accessible only to trained study staff. All 
digital audio recordings of sessions will be uploaded to the study computer immediately post-
session and the file deleted from the digital recorder. Computer files will be secured by password 
and will be accessed only by authorized study personnel. These procedures will be implemented 
to provide study participants with the assurance of confidentiality around very sensitive and 
personal information.  
 
The purpose of the study is to develop and test a PN+SPI prevention program for SGM youth and 
young adults. Despite the vulnerability of these populations to suicide, there are currently no 
known suicide prevention programs for them. Results from the study will provide important 
information which could reduce the mortality of these populations. 
 
 
3 
STUDY DESIGN 
3.1 
OVERALL DESIGN 
 
There are no hypotheses associated with the case series given that the purpose of the case series 
is to obtain feedback on study procedures and the PN+SPI intervention. For the open trial, we 
hypothesize that PN+SPI participants will display decreases in thwarted belongingness and 
increases in suicide-related coping skills (the hypothesized mechanistic targets of the 
intervention). We will also assess the feasibility and acceptability of the PN+SPI intervention 
during the open trial.  
 
As stated, the case series (up to 10 participants) will be conducted to refine study procedures and 
the PN+SPI intervention. In terms of trial type, the open phase trial is a within-subjects trial. All 
participants in the case series and open trial will be assigned to the PN+SPI intervention. 
Therefore, no randomization or control group will be used. 
 
The case series (N = 10) is a one group, one arm study. Participants in the case series will 
receive up to three months of the patient navigation plus safety planning intervention, at which 

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point they will complete a three-month follow-up assessment. The open phase trial (N = 30) is 
also a one group, one arm study and will follow the same approach; however, there will be both 
a three-month and six-month follow-up assessment, and intervention services will be provided 
for six months. The R61 phase (e.g., case series and open trial) precedes a potential R33 
phase, in which the theoretical targets of the intervention will be further testes in a RCT.  
 
The study intervention includes patient navigation (PN) for SGM youth/emerging adults designed 
to target mechanisms (i.e. decreasing thwarted belongingness and increasing suicide-related 
coping skills) that theoretically underlie suicide. The study intervention integrates a single-session, 
empirically supported, suicide prevention intervention (Safety Planning Intervention41; SPI) with 
PN services (PN+SPI).  
 
During the first PN+SPI session, the patient navigator will deliver the SPI and assess barriers to 
accessing mental health care services and SGM social support services. After the initial session, 
the patient navigator will continue frequent contact for the purpose of providing motivational 
enhancement, problem-solving, reinforcing coping strategies, and connecting participants to 
social support and mental health resources (e.g. SGM-specific support groups within the 
community). The planned PN content is described in Table 1 (see below) and includes 7 modules 
that can be delivered using a flexible approach. In other words, patient navigators will deliver the 
modules based on the particular concerns and needs of each participant, and modules can be 
repeated. 
 
Table 1:  
  
Module 
Construct 
Content 
1. Introduction to patient 
navigation 
• Understanding of the 
patient navigation 
intervention and role of 
the patient navigator  
• Conducting a patient navigation 
intake assessment 
• Explaining the navigation 
intervention and the role of the 
navigator 
2. Psychoeducation on 
minority stress and 
how it can lead to 
self-harm behaviors 
• Minority stress (e.g., 
internalized 
homophobia, 
internalized 
transphobia) 
• Perceived 
burdensomeness 
• Introduction to minority stressors 
• Exploration of the influence of 
minority stressors on 
participants’ day-to-day lives 
• Identify how minority stress 
triggers risk of self-harm 
3. Assessing and 
addressing barriers to 
SGM-affirming mental 
health services 
• Access to mental 
health services 
• Thwarted 
belongingness  
• Coping skills (e.g. 
reaching out to others) 
• Systematically assessing 
barriers to mental health 
services on an ongoing basis 
(i.e., insurance, transportation, 
unsure how to find a provider, 
substance use, violence 
victimization) and generating 
possible solutions 
• Providing a list of SGM-affirming 
mental health services and 
assisting participant with 
identifying a service that best 
meets their needs 

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• Developing resources to 
address specific barriers 
• Identifying and implementing 
actions to assist the participant 
in implementing barrier-reducing 
strategies 
• Assessing whether action(s) 
reduced barrier(s) 
• Problem solving for seeking 
affirming mental health care and 
generating possible solutions 
• Role playing activities for 
practicing communication 
4. Assessing and 
addressing barriers to 
local SGM support 
resources  
• Minority stress (e.g., 
concealment, rejection 
sensitivity) 
• Thwarted 
belongingness 
• Systematically assessing 
barriers to SGM-specific support 
resources on an ongoing basis 
(i.e., financial, transportation, 
unsure how to find resources, 
substance use, violence 
victimization) and generating 
possible solutions 
• Providing a list of SGM-specific 
support resources and assisting 
participant with identifying a 
resource that best meets their 
needs 
• Developing resources to 
address specific barriers 
• Identifying and implementing 
actions to assist the participant 
in implementing barrier-reducing 
strategies 
• Assessing whether action(s) 
reduced barrier(s) 
• Problem solving for seeking 
SGM support resources and 
generating possible solutions.  
• Role playing activities for 
practicing communication 
5. Decision Making 
Support 
• Coping skills 
• Means restriction 
• Access to mental 
health services 
• Minority stress (e.g., 
concealment, rejection 
sensitivity) 
• Thwarted 
belongingness 
• Decisional balance sheets re 
seeking SGM-affirming mental 
health services and SGM 
support resources 
• Motivational enhancement and 
goal setting for seeking SGM-
affirming mental health services 
and SGM support resources  

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6. Suicidal Crisis 
Management 
 
• Coping skills 
• Means restriction 
• Access to mental 
health services 
• Assessing the participant’s 
suicide risk 
• Reviewing and reinforcing the 
participant’s Safety Plan 
• Providing other patient 
navigation services if warranted 
• Providing emergency services if 
necessary 
• Assisting participants in 
obtaining a higher level of 
mental health care if necessary 
7. PN intervention 
review and wrap-up 
• Coping skills 
• Means restriction 
• Reinforcing lessons learned 
during the intervention related to 
minority stress and its impact on 
risk of self-harm 
• Reviewing, reinforcing, and 
updating the coping strategies 
plan in the SPI 
• Reviewing, reinforcing, and 
updating the means restriction 
plan in the SPI 
• Identifying problems which may 
occur in the future and 
generating solutions for seeking 
help and support 
 
To develop the content described in Table 1, the research team will hold a series of meetings 
with a participatory planning group (PPG) and conduct the following steps specified in Intervention 
Mapping:55 1) reviewing various PN interventions developed by Dr. Wells along with the SPI; 2) 
creating a logic model of the health problem (e.g. suicide); 3) creating a logic model of the 
integrated PN+SPI; 4) assessing intervention fit and planning adaptations; and 5) making 
adaptations. The Intervention Mapping approach guides the adaptation process, including 
delivery fit, design features, and cultural (i.e. SGM) relevance. The research team will develop 
and initial draft of patient-focused materials, along with a manual for the patient navigators with 
the SPI plus PN modules. In subsequent meetings, drafted materials and protocols will be revised 
based on PPG feedback. The PPG will review the final draft of the intervention prior to its 
production for use in the open trial.  It is anticipated that only two rounds will be needed to refine 
the SPI+PN intervention and study procedures in preparation for the open trial. 
 
 
3.2 
JUSTIFICATION FOR INTERVENTION 
PN interventions are flexible by design to address participant’s unique barriers to care; the content 
and pace of the intervention is delivered according to the needs and concerns of the participant. 
All participants will receive the SPI during the first intervention session. At this time, the patient 
navigator will also assess barriers to accessing mental health care services and SGM social 
support services. After the initial session, the patient navigator will contact participants using their 
preferred method (e.g. over the phone) one time per week (at minimum) for the next seven weeks 

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and then monthly (at minimum) for the remainder of the intervention period. It is possible that 
some participants will require additional assistance from the patient navigator. As a result, the 
length, number, and frequency of intervention contacts will vary based on the participants’ needs.  
 
The minimum-acceptable participation in the intervention is the completion of the first session of 
PN+SPI, which is the intake, introduction to navigation, and the SPI. Please see Section 2.2 for 
more information about the justification for the intervention. 
 
 
3.3 
END-OF-STUDY DEFINITION 
 
In the case series, a participant is considered to have completed the study if they have completed 
the baseline assessment, at least 1 intervention session, and the 3-month follow-up assessment. 
In the open trial, a participant is considered to have completed the study if they have completed 
the baseline assessment, at least 1 intervention session, and the 3-month and 6-month follow-up 
assessments. 
 
 
 
4 
STUDY POPULATION 
4.1 
INCLUSION CRITERIA 
 
Case Series and Open Trial Eligibility Criteria: 
 
In order to be eligible to participant in this study, an individual must meet all of the following 
criteria: 
1. Provision of signed and dated informed consent form  
2. Stated willingness to comply with all study procedures and availability for the duration of 
the study 
3. Age 15 to 29 years 
4. Identifies as gay, lesbian, bisexual, transgender, genderqueer, asexual, pansexual, non-
binary, or another non-exclusively heterosexual or cisgender identity, and/or reports 
same-gender romantic attraction, and/or reports same-gender sexual behavior in the 
past 12 months 
5. Resides in San Diego County, California 
6. Speaks English 
7. Reports suicidal ideation over the past two weeks during phone screen, as indicated by 
the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline 
version 
8. Reports a lifetime history of one or more suicide attempts (i.e., actual and interrupted 
suicide attempts, not aborted attempts) 
 
 
4.2 
EXCLUSION CRITERIA 
 
Case Series and Open Trial Exclusion Criteria: 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 

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1. Reports immediate (i.e., within 10 days) intention and plan to attempt suicide based on PI 
evaluation (as guided by responses to the C-SSRS). This may include past-two-week 
intent and plan. 
 
 
4.3 
SCREEN FAILURES 
 
Screen failures in both the case series and open trial are defined as participants who consent to 
participate in this study but are not subsequently entered in the study. To verify if participants 
meet the past-two-week suicidal ideation criterion assessed during phone screen, participants’ 
past-month suicidal ideation will be evaluated during the baseline assessment, creating overlap 
between reference periods and reducing the number of screen failures. Some individuals who do 
not meet the inclusion criteria or do meet the exclusion criterion for participation in this trial (screen 
failure) may be rescreened if their response to the criterion or criteria that excluded them from the 
study changes over time. Examples include a participant who did not have suicidal ideation during 
the initial telephone screening, but at a subsequent screening reports suicidal ideation. 
Rescreened participants will be assigned the same participant number as for the initial screening. 
 
 
4.4 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
We do not have an anticipated number to be screened in order to reach the target enrollment size 
for the case series. We will use data collected as part of the case series to help us determine the 
anticipated number to be screened in order to reach the target enrollment size in the open trial.  
 
The anticipated accrual rate over the course of the case series is five participants per month over 
two months (total N = 10). The anticipated accrual rate over the course of the open trial is five 
participants per month over six months (total N = 30).  
 
A broad recruitment strategy will be used to recruit diverse participants within the greater San 
Diego area via a variety of methods, including FHCSD outreach programs, support groups, 
flyering local LGBT community centers, gay-identified/friendly coffee shops, gyms, and bars. We 
will also utilize online recruitment methods, including targeted ads through Facebook/Instagram, 
and use of geolocation social networking mobile applications tailored to SGM (e.g. Grindr, Scruff, 
Jacked). Finally, we will also recruit from the BISH Lab registry, a database of diverse SGM 
community members who are willing to be contacted for research projects. This multi-method 
approach has been in our current and previous studies sampling SGM, is a frequently used 
method among researchers studying SGM56 and is cost-effective57. We already have developed 
several recruitment flyers and ads for other studies that can be modified to recruit participants 
that reflect the ethnic and racial diversity of San Diego County. We have also budgeted funding 
for the expenses related to study recruitment to help ensure our success. 
 
An electronic tracking system will be developed for use by the project director and outcome 
assessors that will track participants in order to schedule and complete follow-up assessments. 
This system will provide the outcome assessors with a calendar of participants to contact for 
follow-up visits within one month of each’s participant’s next scheduled follow-up appointment (if 
they are unable to schedule the follow-up appointment at the time of the previous appointment). 
The outcome assessors will be responsible for documenting both baseline and each follow-up 
data collection encounter in the system. At the baseline assessment participants will complete a 
locator form which asks permission for study staff to contact participants via phone, text, email, 

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social media (Facebook) and mail. We also ask participants for their preferred contact method, 
although we will use multiple methods of contacting participants, as necessary. Additionally, we 
ask participants for the name and contact information of close friends/family member whom the 
study could contact in the event that staff are unable to connect with the participant. We also 
provide evening and weekend appointments to accommodate participants’ schedules. Further, 
we provide phone/text reminders regarding study appointments and confirm appointments with 
participants several times in advance. Participants will be provided with incentives (compensation 
via gift cards) to participate in each data collection session. These incentives will be provided in 
recognition of the time and effort the participant is providing to the study team, as well as costs 
for travel. The study team will meet weekly to discuss study enrollment and retention rates, as 
well as challenges faced in both recruitment and retention. These challenges, as well as the steps 
taken to overcome them, will be part of the feasibility data collected by the study team. However, 
it is expected that these strategies will prove successful based on our previous history using them. 
For example, in Dr. Blashill’s and Wells’ ongoing R34 HIV prevention trial sampling young sexual 
minority men in the San Diego area, the project team has retained 100% of our sample 6 months 
post-baseline. 
 
This grant is focused on recruiting and retaining participants from historically under-represented 
populations. We will be using strategies for recruitment and retention which have been optimized 
in other studies (described above).  
 
Furthermore, the PN+SPI intervention and subsequent intervention materials will be developed 
with the assistance of the PPG, consisting of mental health providers at FHCSD, potential 
program implementers, young SGMs, and community members who interact with or deliver 
services to people who may benefit from the intervention. This will help ensure that the PN+SPI 
intervention approach focuses on the needs of the population, as well as utilizes intervention 
materials that are acceptable from the population. Lastly, study staff are well-trained to be strong 
at being able to communicate and work with the communities that we serve. 
 
The age range for this study is restricted to ages 15-29. The lower bound age of 15 was selected 
as epidemiological research has identified age 15+ as a critical period for suicide risk. Additionally, 
there are developmental, ethical, and legal aspects to consider in suicide prevention work with 
children. Further, our upper age limit of 29 years was chosen given this encapsulates the 
developmental period of emerging adulthood, another critical period of lifespan development and 
suicide risk.  
 
Potential participants are requested to contact study personnel via email, telephone, or by 
completing a brief Qualtrics survey. A trained member of the study team will contact each 
interested participant to explain the study, obtain verbal consent for pre-enrollment screening, 
and conduct the screening process. Those who meet screening criteria will be scheduled for the 
enrollment (baseline) study visit. At the time of the enrollment appointment, a trained member of 
the study team will provide more information about the study and engage in an informed consent 
process for the purpose of study participation. Individuals who provide written informed consent 
will be asked to complete baseline surveys, which, together with the clinical interview, will be 
reviewed to confirm whether the participants meet criteria to participate. To verify if participants 
meet the past-two-week suicidal ideation criterion assessed during phone screen, participants’ 
past-month suicidal ideation will be evaluated during the baseline assessment, creating overlap 
between reference periods and reducing the number of screen failures. Reasons for non-
participation of potential participants will be documented. 
 

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As mentioned above, participants will be compensated for study participation. Specifically, 
participants will receive a $75 gift card after completing the initial baseline assessment and a $50 
gift card after completing each follow-up assessment. Case series participants can earn a total of 
$125 in gift cards if they complete both data collection sessions (baseline and three-month follow-
up). Open trial participants can earn a total of $175 in gift cards if they complete all three data 
collection sessions (baseline, three-month, and six-month follow-up). As mentioned, these 
incentives will be provided in recognition of the time and effort the participant is providing to the 
study, as well as costs for travel. The amount that participants will be compensated ($75 for 
baseline, $50 for follow-ups) has been deemed appropriate in Southern California for the amount 
of time, effect, and travel required to complete study assessments. All incentives will be given 
directly to the participants, including those who are minors. 
 
 
5 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
5.1 
STUDY 
INTERVENTION(S) 
OR 
EXPERIMENTAL 
MANIPULATION(S) 
ADMINISTRATION 
5.1.1 ADMINISTRATION AND/OR DOSING 
 
All PN+SPI intervention sessions will be conducted by social work navigators who will be hired by 
our clinical partner, Family Health Centers of San Diego, based on their familiarity with the 
intended audience, young SGMs. The first intervention session will be held immediately following 
study enrollment (i.e. during the baseline assessment). While the COVID-19 outbreak is on-going, 
this session will be conducted online via Zoom (a secured video calling platform with audio and 
video capabilities) instead of in-person to ensure proper care and safety of participants and study 
staff. All participants will receive the SPI during this first intervention session. Additionally, the 
patient navigator will assess barriers to accessing mental health care services and SGM social 
support services at this time. 
 
Given that PN interventions are flexible by design in order to address participants’ unique barriers 
to care, the PN+SPI intervention will not be administered according to any predetermined 
frequency or schedule. At minimum, the patient navigator will contact participants using their 
preferred method (e.g., over the phone) one time per week for the next seven weeks and then 
monthly for the remainder of the intervention period. However, some participants may require 
additional assistance from the patient navigator. Therefore, the patient navigator will deliver the 
intervention modules based on the particular concerns and needs of each participant, repeating 
modules as needed. As a result, there is no predetermined number of intervention sessions 
constituting a complete or “full-dose” intervention. We will monitor the dose of patient navigation 
(as measured by the quantitative variables of frequency of service delivery, amount of time spent 
with participants, and actions taken) by utilizing a PN encounter form. Lastly, participants will not 
interact with other participants or with a shared interventionist throughout the duration of the study. 
 
 
5.2 
FIDELITY 
5.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
The patient navigators, who will be social workers, will be extensively trained (e.g., through 
didactics and role playing) by the study team using training manuals developed in collaboration 

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with the PPG and via the Patient Navigation Research Program (PNRP)58 training approach. 
Patient navigators will be trained on all SOPs that are relevant to their work (i.e., child and elder 
and dependent adult abuse and neglect) and will have significant training in safety monitoring. 
This training will include didactic approaches as well as active learning, such as role playing with 
the investigative team and community members. General PN training will focus on the history of 
PN, establishing rapport, professionalism in PN, and documenting the PN services provided. In 
addition, more specific training will be provided in how to administer the SPI content of the 
integrated intervention, as well as the 7 PN intervention modules, one of which includes 
addressing suicidal crises. Based on prior PN studies, it is anticipated that training will last at least 
2-3 weeks to allow the patient navigators adequate time to practice delivering intervention 
modules, documenting care provided, and following study data collection protocols. However, 
training may be extended depending on each navigator’s needs. All staff who will be interacting 
with participants will be trained in the techniques of the UWRAP as it pertains to their role in the 
project. 
 
Intervention fidelity will be assessed via audio-recordings and observation conducted by the study 
project director. Audio-recordings, considered the gold standard in treatment fidelity59, will be 
evaluated by the trained project director who will code the recordings using a checklist to track 
whether the interventionists delivered PN+SPI according to the manual. Using an approach 
developed by the PNRP, patient navigators will record process data related to the PN services 
provided, including: 1) number of encounters, 2) length of time of each encounter; 3) barriers 
experienced by patients; and 4) actions taken to reduce barriers. Patient navigators will keep 
copies of the participants’ safety plans and the SPI suicide risk curve. The patient navigators will 
also be asked to keep detailed qualitative notes regarding telephone, text, and in-person 
encounters with participants, including participants’ progress in obtaining mental health services, 
successes in implementing the PN intervention, and challenges in implementing the PN 
intervention. A Research Program Manager at FHCSD will provide day-to-day supervision of the 
patient navigators and will meet with the navigators weekly and document successes and 
challenges to PN intervention implementation through a weekly written report. Dr. Blashill, a 
licensed psychologist, and Dr. Wells will also provide the patient navigators with weekly, and as 
needed clinical supervision.  
 
5.3 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
We will track participants’ attendance at intervention sessions and exposure to intervention 
materials by utilizing a PN encounter form. Here, patient navigators will record process data 
related to the PN services provided, including: 1) number of encounters, 2) length of time of each 
encounter; 3) barriers experienced by patients; and 4) actions taken to reduce barriers. This 
information will be recorded using the PN encounter form. Patient navigators will keep copies of 
the participants’ safety plans and the SPI suicide risk curve. The patient navigators will also keep 
detailed qualitative notes regarding telephone, text, and in-person encounters with participants, 
including participants’ progress in obtaining mental health services, successes in implementing 
the PN intervention, and challenges in implementing the PN intervention.  
 
We will examine intervention adherence during the case series and open trial by calculating the 
number of PN encounters, number of intervention modules delivered, and how often each module 
is delivered. We will also review the progress notes to determine if participants carried out plans 
described in the progress notes (i.e., contact a mental health provider, enroll in a support group). 
 
 

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6 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
6.1 
DISCONTINUATION 
OF 
STUDY 
INTERVENTION/EXPERIMENTAL 
MANIPULATION 
 
If a subject chooses to discontinue from PN+SPI intervention but agrees to remain in the study, 
remaining study procedures (assessments) will be completed as indicated by the study protocol.  
 
The data to be collected at the time of study intervention discontinuation will include the following: 
• The reason(s) for discontinuing the participant from the intervention, and methods for 
determining the need to discontinue 
• If the participant is due to complete assessments within 2 weeks of being discontinued from 
the study intervention, those assessments will be administered at the time of discontinuation; 
if the next scheduled assessments are more than 2 weeks from the discontinuation date, the 
discontinued participant will wait for the next scheduled assessment. Thereafter, the 
participant will be included in all future scheduled assessments, even though not participating 
in the intervention. 
 
 
6.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
In both the case series and open trial, 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: 
• 
The participant can no longer participate in the remainder of the study (e.g. long-term 
prison sentence, long-term hospitalization); or 
• 
The participant loses their legal right to provide consent to participate for the remainder of 
the study. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded in an 
electronic system of tracking developed by the research team. Subjects who sign the informed 
consent form and receive the study intervention, and subsequently withdraw, or are discontinued 
from the study will not be replaced. 
 
 
6.3 
LOST TO FOLLOW-UP 
 
For the case series, a participant will be considered lost to follow-up only if they fail to complete 
the three-month follow-up assessment within 31 days of when it was scheduled to be completed. 
For the open trial, a participant will be considered lost to follow-up only if they fail to complete the 
six-month follow-up assessment within 31 days of when it was scheduled to be completed. 
Otherwise, study staff will continue to attempt to contact the participant, unless the participant 
decides to withdraw from the study or 31 days has passed following the last scheduled follow-up. 
 

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The following actions will be taken to minimize loss to follow-up and missing data: 
• 
At the baseline assessment, participants will complete a locator form, which asks 
permission for study staff to contact participants via phone, text, email, and mail. We also 
ask participants for their preferred contact method, and for the name and contact 
information of close friends/family member whom the study could contact in the event that 
staff are unable to connect with the participant. Study staff will utilize these multiple contact 
methods to schedule, or re-schedule, follow-up assessments as necessary. 
• 
Study staff will contact participants on multiple days and times. 
• 
Participants will be given multiple appointment reminders and study staff will confirm the 
scheduled appointment with the participant multiple times. 
• 
Study staff will contact participants to schedule follow-up appointments within a month of 
each participant’s next scheduled follow-up appointment (if they are unable to schedule 
the follow-up appointment at the time of the previous appointment). 
• 
Upon rescheduling follow-up assessments, study staff will counsel the participant on the 
importance of maintaining the assigned visit schedule and ascertain if the participant 
wishes to continue in the study. 
• 
The study team will meet weekly to discuss challenges faced in contacting participants 
and completing follow-up assessments and how to potentially overcome them.  
 
 
6.4 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Case Series: 
 
Participants will complete the initial baseline assessment to confirm eligibility. Prior to beginning 
the baseline assessment procedures, a trained member of the study team will obtain informed 
consent. If the participant consents to participate in the study, the baseline assessment will be 
performed. Participants will complete self-report questionnaires (see below), clinician-based 
interviews (see below), and the first SPI+PN session (intake, introduction to navigation, and the 
SPI). 
 
Post-baseline, participants will receive PN services for a period of three-months. Patient 
navigators will record PN intervention encounter data (see below). Participants will then complete 
a three-month follow-up assessment, consisting of clinician-based interviews (see below) and 
providing study and intervention feedback through open-ended survey questions (see below).  
 
• 
Administration of self-report questionnaires:  
o Participants will complete self-report questionnaires in Qualtrics (either done 
remotely from their homes, or on a computer within the lab). 
o Self-report questionnaires include: 
§ 
Demographics survey 
• 
Assesses demographic items (e.g. age, race, ethnicity, sex 
assigned at birth, gender identity, sexual orientation, relationship 
status, country of origin, U.S. citizen status, primary language, 
current grade in school or education level, health insurance status, 
employment status, income (if applicable)) 
§ 
Interpersonal Needs Questionnaire-15 (INQ-15)63,64  
• 
Assesses thwarted belongingness and perceived burdensomeness 

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o INQ-15 has good structural validity, internal consistency, 
and concurrent validity  
§ 
Suicide-Related Coping Scale (SRCS)65  
• 
Assesses external coping and internal coping 
o SRCS has good structural validity, internal consistency, 
sensitivity to change, and concurrent validity  
§ 
Acquired Capability for Suicide Scale – Fearlessness about Death (ACSS-
FAD)66 
• 
Assesses capability for suicide 
o ACSS-FAD has strong psychometric properties 
§ 
Minority Stressors self-report questionnaires 
• 
Heterosexist Harassment and Rejection Scale (HHRDS)67 
• 
Internalized Homophobia Scale (IHP)68 
• 
Sexual Orientation Concealment Scale (SOCS)69 
• 
Gay-Related Rejection Sensitivity Scale (GRS)70 
• 
Sexual Minority Women Rejection Sensitivity Scale (SMW-RSS)71 
• 
Gender Minority Stress and Resilience Measure (GMSR)72 
o Assess distal minority stress (e.g., victimization, rejection, 
and discrimination) and proximal minority stress (e.g., non-
disclosure and internalized transphobia) 
§ 
Intersectional Discrimination Index (InDI)73  
• 
Assesses intersectional discrimination 
§ 
Social support self-report questionnaires 
• 
Patient-Reported Outcome Measurement Information System 
(PROMIS) Emotional Support Scale – Short Form 8a74 
• 
Patient-Reported Outcome Measurement Information System 
(PROMIS) Informational Support Scale – Short Form 8a74 
• 
Patient-Report 
Outcome 
Measurement 
Information 
System 
(PROMIS) Instrumental Support Scale – Short Form 8a74 
§ 
Hurt, Insult, Threaten Screen (HITS)75 
• 
Assesses intimate partner violence 
§ 
McLean Screening Instrument for Borderline Personality Disorder (MSI-
BPD)76 
• 
Assesses borderline personality disorder symptomology 
§ 
Client Satisfaction Questionnaire-8 (CSQ-8)77  
• 
Assesses satisfaction with mental health care services received 
o CSQ-8 has high internal consistency 
§ 
Satisfaction with Interpersonal Relationship with PN78 
• 
Assesses satisfaction with care provided by a patient navigator 
o Satisfaction with Interpersonal Relationship with PN has 
high internal consistency 
§ 
Dysmorphic Concern Questionnaire (DCQ)79 
• 
Assesses dysmorphic symptoms 
• 
Adapted with modified instructions to better capture the Body 
Dysphoric Disorder phenotype and identify participants whose 
concerns were due to an objective disfigurement caused by a 
medical condition or injury80 
§ 
Eating Disorder Examination-Questionnaire (EDE-Q)81 
• 
Assesses eating disorder pathology 

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• 
Adapted with modified instructions to improve the measure’s utility 
when evaluating objective binge eating in patients with Binge Eating 
Disorder82 
§ 
Adult ADHD Self-Report Screening Scale for DSM-5 (ASRS-5)83 
• 
Assesses ADHD symptomatology 
§ 
Satisfaction with Mental Health Care 
• 
Three open-ended questions created by investigative team 
§ 
Open-ended survey questions  
• 
Used to obtain study and intervention feedback 
• 
Clinician-administered interviews 
o Columbia-Suicide Severity Rating Scale (C-SSRS)60  
§ 
Assesses suicidal ideation, intent, plan, and behaviors 
§ 
C-SSRS has strong psychometric properties (i.e. evidence of internal 
consistency, construct validity, predictive validity, incremental validity, and 
sensitivity to change) 
o Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive and Related 
Neuropsychiatric Disorders (DIAMOND)61 
§ 
Semi-structured diagnostic interview  
§ 
Assesses psychiatric diagnoses among adults (aged 18+) 
• 
DIAMOND has very good inter-rater reliability, test-retest reliability, 
and convergent and divergent validity  
§ 
Modules regarding the following disorders will be administered depending 
on responses to screening questions: Anxiety and Mood Disorders, 
Trauma and Stressor-Related Disorders, and Psychotic Disorders 
o Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-
SADS)62 
§ 
Computer-administered diagnostic interview 
§ 
Assess psychiatric diagnoses among children (aged 15-17 in this study) 
§ 
Modules regarding the following disorders will be administered depending 
on responses to screening questions: Anxiety and Mood Disorders, 
Trauma and Stressor-Related Disorders, and Psychotic Disorders 
o Cornell Services Index (Psychological Services section)84 - Adapted 
§ 
Assesses the type(s) of psychological services obtained, the type of 
provider, the site of service, the reason for the visit, the frequency of 
service, and the number of minutes per visit during the past three months 
§ 
Has good re-test and interrater reliability 
§ 
Adapted by the study team to also collect data on: 
• 
Comorbid medical conditions  
• 
Medications prescribed 
• 
Date participant attended first mental health appointment following 
study enrollment 
• 
Number of mental health appointments attended following study 
enrollment 
• 
Types of mental health providers who treated the participant 
following study enrollment 
o Addiction Severity Index - Lite Version (ASI-Lite)85 
§ 
Assesses substance use 
o Interview questions to obtain feedback on the study and the intervention. 
• 
Patient Navigator Data Collection 
o Patient navigators will audio-record PN sessions  

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o Patient navigators will record process data related to the PN provided, including: 
§ 
Number of encounters 
§ 
Length of time of each encounter 
§ 
Barriers experienced by patients 
§ 
Actions taken to reduce barriers 
o Patient navigators will keep detailed qualitative notes regarding telephone, text, 
and in-person encounters with participants, including participants’ progress in 
obtain mental health services, successes in implementing the PN intervention, and 
challenges in implementing the PN intervention 
o Patient navigators will keep copies of the participants’ safety plans and the SPI 
suicide risk curve 
 
Open Trial: 
 
Participants will complete the initial baseline assessment to confirm eligibility. Prior to beginning 
the baseline assessment procedures, a trained member of the study team will obtain informed 
consent. If the participant consents to participate in the study, the baseline assessment will be 
performed. Participants will complete self-report questionnaires (see below), clinician-based 
interviews (see below), and the first SPI+PN session (intake, introduction to navigation, and the 
SPI). 
 
Post-baseline, participants will receive PN services for a period of six-months. Patient navigators 
will record PN intervention encounter data (see below). Participants will complete a three-month 
follow-up assessment, consisting of self-report questionnaires (see below) and clinician-based 
interviews (see below). Finally, participants will complete a six-month follow-up assessment, 
consisting of self-report questionnaires (see below), clinician-based interviews (see below), and 
a key informant interview.  
 
• 
Administration of self-report questionnaires:  
o Participants will complete self-report questionnaires in Qualtrics (either done 
remotely from their homes, or on a computer within the lab). 
o Self-report questionnaires include: 
§ 
Demographics survey 
• 
Assesses demographic items (e.g. age, race, ethnicity, sex 
assigned at birth, gender identity, sexual orientation, relationship 
status, country of origin, U.S. citizen status, primary language, 
current grade in school or education level, health insurance status, 
employment status, income (if applicable)) 
§ 
Interpersonal Needs Questionnaire-15 (INQ-15)63,64  
• 
Assesses thwarted belongingness and perceived burdensomeness 
o INQ-15 has good structural validity, internal consistency, 
and concurrent validity  
§ 
Suicide-Related Coping Scale (SRCS)65  
• 
Assesses external coping and internal coping 
o SRCS has good structural validity, internal consistency, 
sensitivity to change, and concurrent validity  
§ 
Acquired Capability for Suicide Scale – Fearlessness about Death (ACSS-
FAD)66 

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• 
Assesses capability for suicide 
o ACSS-FAD has strong psychometric properties 
§ 
Minority Stressors self-report questionnaires 
• 
Heterosexist Harassment and Rejection Scale (HHRDS)67 
• 
Internalized Homophobia Scale (IHP)68 
• 
Sexual Orientation Concealment Scale (SOCS)69 
• 
Gay-Related Rejection Sensitivity Scale (GRS)70 
• 
Sexual Minority Women Rejection Sensitivity Scale (SMW-RSS)71 
• 
Gender Minority Stress and Resilience Measure (GMSR)72 
o Assess distal minority stress (e.g., victimization, rejection, 
and discrimination) and proximal minority stress (e.g., non-
disclosure and internalized transphobia) 
§ 
Intersectional Discrimination Index (InDI)73  
• 
Assesses intersectional discrimination 
§ 
Social support self-report questionnaires 
• 
Patient-Reported Outcome Measurement Information System 
(PROMIS) Emotional Support Scale – Short Form 8a74 
• 
Patient-Reported Outcome Measurement Information System 
(PROMIS) Informational Support Scale – Short Form 8a74 
• 
Patient-Report 
Outcome 
Measurement 
Information 
System 
(PROMIS) Instrumental Support Scale – Short Form 8a74 
§ 
Hurt, Insult, Threaten Screen (HITS)75 
• 
Assesses intimate partner violence 
§ 
McLean Screening Instrument for Borderline Personality Disorder (MSI-
BPD)76 
• 
Assesses borderline personality disorder symptomology 
§ 
Client Satisfaction Questionnaire-8 (CSQ-8)77 
• 
Assesses satisfaction with mental health care services received 
o CSQ-8 has high internal consistency 
• 
Adapted by the study team to assess for satisfaction with patient 
navigation services received in addition to assessing for satisfaction 
with mental health care services received 
§ 
Satisfaction with Interpersonal Relationship with PN78 
• 
Assesses satisfaction with care provided by a patient navigator 
o Satisfaction with Interpersonal Relationship with PN has 
high internal consistency 
§ 
Dysmorphic Concern Questionnaire (DCQ)79 
• 
Assesses dysmorphic symptoms 
• 
Adapted with modified instructions to better capture the Body 
Dysphoric Disorder phenotype and identify participants whose 
concerns were due to an objective disfigurement caused by a 
medical condition or injury80 
§ 
Eating Disorder Examination-Questionnaire (EDE-Q)81 
• 
Assesses eating disorder pathology 
• 
Adapted with modified instructions to improve the measure’s utility 
when evaluating objective binge eating in patients with Binge Eating 
Disorder82 
§ 
Adult ADHD Self-Report Screening Scale for DSM-5 (ASRS-5)83 
• 
Assesses ADHD symptomatology 

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§ 
Difficulties in Emotion Regulation Scale-1686 
• 
Assesses emotion regulation 
§ 
Satisfaction with Mental Health Care 
• 
Three open-ended questions created by investigative team 
• 
Clinician-administered interviews 
o Columbia-Suicide Severity Rating Scale (C-SSRS)60  
§ 
Assesses suicidal ideation, intent, plan, and behaviors 
§ 
C-SSRS has strong psychometric properties (i.e. evidence of internal 
consistency, construct validity, predictive validity, incremental validity, and 
sensitivity to change) 
o Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive and Related 
Neuropsychiatric Disorders (DIAMOND)61  
§ 
Semi-structured diagnostic interview  
§ 
Assesses psychiatric diagnoses among adults (aged 18+) 
• 
DIAMOND has very good inter-rater reliability, test-retest reliability, 
and convergent and divergent validity  
§ 
Modules regarding the following disorders will be administered depending 
on responses to screening questions: Anxiety and Mood Disorders, 
Trauma and Stressor-Related Disorders, and Psychotic Disorders 
o Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-
SADS)62 
§ 
Computer-administered diagnostic interview 
§ 
Assess psychiatric diagnoses among children (aged 15-17 in this study) 
§ 
Modules regarding the following disorders will be administered depending 
on responses to screening questions: Anxiety and Mood Disorders, 
Trauma and Stressor-Related Disorders, and Psychotic Disorders 
o Cornell Services Index (Psychological Services section)84 - Adapted 
§ 
Assesses the type(s) of psychological services obtained, the type of 
provider, the site of service, the reason for the visit, the frequency of 
service, and the number of minutes per visit during the past three months 
§ 
Has good re-test and interrater reliability 
§ 
Adapted by the study team to also collect data on: 
• 
Comorbid medical conditions  
• 
Medications prescribed 
• 
Date participant attended first mental health appointment following 
study enrollment 
• 
Number of mental health appointments attended following study 
enrollment 
• 
Types of mental health providers who treated the participant 
following study enrollment 
o Addiction Severity Index - Lite Version (ASI-Lite)85 
§ 
Assesses substance use 
• 
Patient Navigator Data Collection 
o Patient navigators will audio-record PN sessions  
o Patient navigators will record process data related to the PN provided, including: 
§ 
Number of encounters 
§ 
Length of time of each encounter 
§ 
Barriers experienced by patients 
§ 
Actions taken to reduce barriers 

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o Patient navigators will keep detailed qualitative notes regarding telephone, text, 
and in-person encounters with participants, including participants’ progress in 
obtain mental health services, successes in implementing the PN intervention, and 
challenges in implementing the PN intervention 
o Patient navigators will keep copies of the participants’ safety plans and the SPI 
suicide risk curve 
• 
Key informant interview 
 
 
6.5 
SAFETY ASSESSMENTS 
 
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used by the trained telephone 
screeners, assessors, and patient navigators to assess participant safety throughout both the 
case series and open trial. The Principal Investigators will train all personnel to use the C-SSRS 
and will be providing ongoing supervision. The C-SSRS is a clinician-based interview that 
assesses five types of suicidal ideation of increasing severity and four types of suicidal behavior, 
as well as the intensity of suicidal ideation. During the phone screen, items from the C-SSRS will 
be administered to determine participant eligibility, as well as assess participant safety. The C-
SSRS will be administered during the baseline assessment to confirm participant eligibility, as 
well as assess participant safety. The C-SSRS will additionally be administered during each major 
assessment sessions and at the beginning of each intervention session.   
Preliminary verification of eligibility will be completed (over the phone) in advance of the full 
baseline assessment visit. To manage suicide risk during the telephone screening or 
assessments (completed in person or remotely), the University of Washington Risk Assessment 
Protocol (UWRAP)87 will be used. Those who have enrolled in the study will receive additional 
support from their navigators following all assessments.  A summary of how the UWRAP will be 
administered is as follows: 
Phone Screen:  
1. Administer the introductory language and then administer and obtain verbal consent for 
telephone screening. 
2. Administer the location/emergency contact items. 
3. Administer the demographic inclusion criteria questions. 
4. Administer items from the University of Washington Risk Assessment Protocol (UWRAP) 
regarding impairment as a result of substance use and the pre-assessment risk protocol 
(1: stress level; 2: urge to harm oneself; 3: intent to kill oneself; 4: urge to use 
substances) on a 1-7 point scale. 
5. Administer items 1-3 from the UWRAP mood improvement protocol. 
6. Administer phone screening items adapted from the Columbia-Suicide Severity Rating 
Scale. 
7. Administer the UWRAP debrief checklist item 1 (obtain feedback on the telephone 
screening) plus items regarding re-assessment of risk (1: stress level; 2: urge to harm 
oneself; 3: intent to kill oneself; 4: urge to use substances) on a 1-7 point scale. 
8. Administer the UWRAP debrief checklist items 5 and 6 (i.e., coping with negative 
feelings and suicidal ideation and description of fun activities planned for the day). 
9. If potential participant has no suicidal intent and plan, engage in chit-chat and/or suggest 

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that they engage in the other activities in the UWRAP mood induction protocol item 4 
before returning to their daily activities (for example, listen to music) 
10. If a potential participant has suicidal intent and/or plan, administer the UWRAP debrief 
checklist items 8 and 9 (strategies to reduce suicide risk) and then UWRAP mood 
induction protocol item 4. The person conducting the phone screening should stay on 
the telephone with the potential participant while they do their activity or chat). After the 
potential participant has completed their mood induction activity, the phone screener 
should administer item 5 on UWRAP mood induction protocol (i.e., rating the effect of 
the activity on their mood). 
11. Consult with the clinician “on call” for those with suicidal intent and plan who are unable 
to guarantee that they will use behavior strategies (for example, to keep themselves safe 
for 24 hours) who may then contact emergency services.  
12. The Principal Investigators should be contacted when any participant expresses suicidal 
intent and/or plan, based on their responses to the Columbia-Suicide Severity Rating 
Scale. 
Baseline Assessment: 
1. Administer the introductory language and then engage in the informed consent 
procedures for the study.  
2. Administer the location/emergency contact items. 
3. Administer three items from the University of Washington Risk Assessment Protocol 
(UWRAP) regarding impairment as a result of substance use and the pre-assessment 
risk protocol (1: stress level; 2: urge to harm oneself; 3: intent to kill oneself; 4: urge to 
use substances) on a 1-7 point scale. 
4. Administer items 1-3 from the UWRAP mood improvement protocol. 
5. Complete the baseline assessment.  
6. Administer the UWRAP debrief checklist item 1 (obtain feedback on the telephone 
screening) plus items regarding re-assessment of risk (1: stress level; 2: urge to harm 
oneself; 3: intent to kill oneself; 4: urge to use substances) on a 1-7 point scale. 
7. Administer the UWRAP debrief checklist items 5 and 6 (i.e., coping with negative 
feelings and suicidal ideation and description of fun activities planned for the day). 
8. If participant has no suicidal intent and plan, engage in chit-chat and/or suggest that they 
engage in the other activities in the UWRAP mood induction protocol item 4 before 
returning to their daily activities (for example, listen to music) 
9. If the participant remains distressed, administer the UWRAP mood induction protocol 
item 4. Stay on the videoconference/or with the potential participant while they do their 
activity or chat. After the participant has completed their mood induction activity, 
administer item 5 on UWRAP mood induction protocol (i.e., rating the effect of the 
activity on their mood). 
10. Consult with the clinician “on call” for those with suicidal intent and plan who are unable 
to guarantee that they will use behavior strategies (for example, to keep themselves safe 
for 24 hours) who may then contact emergency services.  
11. The Principal Investigators should be contacted when any participant expresses suicidal 
intent and/or plan, based on their responses to the Columbia-Suicide Severity Rating 
Scale.  
12. Transfer participant to the patient navigator. The patient navigator will implement the 
intake session of the patient navigation intervention, which includes the Safety Planning 
Intervention.  
Follow-up Assessment: 

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1. Administer the introductory language and the location/emergency contact items. 
2. Administer three items from the University of Washington Risk Assessment Protocol 
(UWRAP) regarding impairment as a result of substance use and the pre-assessment 
risk protocol (1: stress level; 2: urge to harm oneself; 3: intent to kill oneself; 4: urge to 
use substances) on a 1-7 point scale. 
3. Administer items 1-3 from the UWRAP mood improvement protocol. 
4. Complete the follow-up assessment.  
5. Assessor administer the UWRAP debrief checklist item 1 (obtain feedback on the 
telephone screening) plus items regarding re-assessment of risk (1: stress level; 2: urge 
to harm oneself; 3: intent to kill oneself; 4: urge to use substances) on a 1-7 point scale. 
6. Assessor administer the UWRAP debrief checklist items 5 and 6 (i.e., coping with 
negative feelings and suicidal ideation and description of fun activities planned for the 
day). 
7. If participant has no suicidal intent and plan, the assessor should engage in chit-chat 
and/or suggest that they engage in the other activities in the UWRAP mood induction 
protocol item 4 before returning to their daily activities (for example, listen to music) 
8. If the participant remains distressed, the assessor should administer the UWRAP mood 
induction protocol item 4. The assessor should stay on the videoconference/or with the 
potential participant while they do their activity or chat. After the participant has 
completed their mood induction activity, the assessor should administer item 5 on 
UWRAP mood induction protocol (i.e., rating the effect of the activity on their mood). 
9. Consult with the clinician “on call” for those with suicidal intent and plan who are unable 
to guarantee that they will use behavior strategies (for example, to keep themselves safe 
for 24 hours) who may then contact emergency services.  
10. The Principal Investigators should be contacted when any participant expresses suicidal 
intent and/or plan, based on their responses to the Columbia-Suicide Severity Rating 
Scale. 
11. Transfer participant with suicidal intent and plan to the patient navigator. The patient 
navigator will go over the safety plan with the participant and will administer PN module 
6: Suicidal Crisis Management.  
 
 
6.6 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
6.6.1 DEFINITION OF ADVERSE EVENTS 
 
The National Institutes of Health follows OHRP guidance on the definitions of adverse events 
and the associated reporting expectations. Thus, an adverse event is defined as any untoward 
or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, 
or disease, temporally associated w/ subject’s participation in research, whether or not 
considered related to subject’s participation in the research; encompasses both physical and 
psychological harm. This study will also capture non-medical events that may be behavioral 
(i.e., self-harm) or social (e.g., child protective services involvement with the family).  
 
6.6.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
According to the SDSU Human Research Protection Program and OHRP guidance, (from 
SDSUHRPP Standards and Practices v. 02.13.19; also definition in OHRP guidance, 
which NIH follows), an adverse event is considered serious if it: 1) Results in death; 2) is life 

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threatening; 3) requires inpatient hospitalization; 4) results in persistent or significant disability or 
incapacity; 5) results in congenital anomaly or birth defect; or 6) risks the subject’s health and 
may require medical or surgical intervention to prevent one of the outcomes listed above.  For 
the purpose of this study, hospitalization is defined as an inpatient hospital stay equal to or 
greater than 24 hours (inclusive of ER visits of 24 hours or longer).  
 
6.6.3 CLASSIFICATION OF AN ADVERSE EVENT 
6.6.3.1 SEVERITY OF EVENT 
 
The Principal Investigators, in consultation with physician Co-Investigator Dr. Ramers and other 
Co-Investigator Dr. Weersing, if necessary, will assess the severity of adverse events as either: 
1) Grade 1: Mild; 2) Grade 2: Moderate; 3) Grade 3: Severe; 4) Grade 4: Life threatening; or 5) 
Grade 5: Death.  The following definitions will be used to assign a severity rating:  
1. Grade 1 Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; 
no intervention indicated. 
2. Grade 2 Moderate: minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activity of daily living. 
3. Grade 3 Severe or medically significant but not immediately life-threatening: 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily living. 
4. Grade 4 Life-threatening consequences: urgent intervention indicated. 
5. Grade 5 Death related to adverse event. 
Because the study focuses on suicide prevention, adverse events related to suicidal ideation, 
suicidal behaviors, and other types of self-harm will be graded for severity using the following 
guidelines: 
 
Grade 1:  
1. Worsening of suicidal ideation from baseline or last assessment 
Grade 2:  
1. Development of new suicide intention or plan 
2. Engaging in self-harm behaviors which do not require hospitalization 
3. Engaging in self-harm behaviors which require an ER visit but not inpatient 
hospitalization 
 
Grade 3:  
1. Suicide attempt or other type of self-harm which requires hospitalization but is not 
immediately life threatening. 
2. Suicide attempt or other type of self-harm which is disabling 
3. Suicide attempt or other type of self-harm which limits self-care activities of daily living 
Grade 4: 
1. Suicide attempt or other type of self-harm which is life threatening and requires urgent 
intervention 

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Grade 5:  
1. Death by suicide 
2. Death from another type of self-harm 
3. Death from any cause 
 
6.6.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
Adverse events may be caused by one or more of the following: 
1. the procedures involved in the research; 
2. an underlying disease, disorder, or condition of the subject; or 
3. other circumstances unrelated to either the research or any underlying disease, disorder, 
or condition of the subject.  
In general, adverse events that are determined to be at least partially caused by (1) would be 
considered related to participation in the research, whereas adverse events determined to be 
solely caused by (2) or (3) would be considered unrelated to participation in the research.  
 
All adverse events will be rated by the Principal Investigators (in consultation with physician 
study Co-Investigator Dr. Ramers and other Co-Investigator Dr. Weersing, if necessary) on the 
degree to which they are related to the study intervention using the following attribution scale 
and definitions: 
 
1. Not related: The adverse event is clearly not related to the study intervention. 
2. Unlikely related: The adverse event is doubtfully related to the study intervention. 
3. Possibly related: The adverse event may be related to the study intervention. 
4. Probably related: The adverse event is likely related to the study intervention. 
5. Definitely related: The adverse event is clearly related to the study intervention. 
 
In considering the degree to which the adverse event is related to the intervention, the Principal 
Investigators and Co-Investigators will consider:  
 
1. Whether the adverse event is a known reaction of the intervention? 
2. Whether the adverse event is similar to other adverse events listed in the study protocol 
and consent documents?  
3. Whether the adverse events occurred before in this study?  
4. Whether the adverse event is reasonably temporally related to the intervention?  
5. Whether the adverse event was present at the baseline assessment of the participant?  
6. Whether the adverse event can be reasonably explained by the participant’s clinical 
disease status? 
7. Whether there are any other potential causes for the adverse event? 
 
6.6.3.3 EXPECTEDNESS  
 
The Principal Investigators (in consultation with physician study Co-Investigator Dr. Ramers and 
other Co-Investigator Dr. Weersing, if necessary) will be responsible for determining whether an 

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adverse event (AE) is expected or unexpected. The following definition will be used to determine 
the expectedness of the AE: 
 
OHRP defines unexpected adverse event as any adverse event occurring in one or more 
subjects participating in a research protocol, the nature, severity, or frequency of which is not 
consistent with either: 
1. the known or foreseeable risk of adverse events associated with the procedures involved 
in the research that are described in (a) the protocol-related documents, such as the 
IRB-approved research protocol, any applicable investigator brochure, and the current 
IRB-approved informed consent document, and (b) other relevant sources of 
information, such as product labeling and package inserts; or 
2. the expected natural progression of any underlying disease, disorder, or condition of the 
subject(s) experiencing the adverse event and the subject’s predisposing risk factor 
profile for the adverse event. 
According to OHRP’s unanticipated problems involving risks and adverse events guidance 
(2007)88, the vast majority of adverse events occurring in the context of research are expected 
in light of (1) the known toxicities and side effects of the research procedures; (2) the expected 
natural progression of subjects’ underlying diseases, disorders, and conditions; and (3) subjects’ 
predisposing risk factor profiles for the adverse events. 
 
By the definition above, the following adverse events are expected for the study: non-suicidal 
self-injury, suicidal ideation, suicidal intent, suicidal plan, suicide attempts, hospitalization 
related to suicide attempt or self-harm, and death from suicide or self-harm. Additionally, given 
that SGM youth (particularly those with a history of suicide attempts and ideation) experience 
elevated health disparities compared to the general population on many mental 
health/substance use markers, we also expect significant comorbidities, including psychiatric 
and substance use disorders, to be reported over the course of the study.  
 
All adverse events will be rated on whether or not they were expected (Yes, No) according to 
OHRP criteria and in consideration of the adverse events expected for this study.   
 
6.6.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-
UP 
 
Adverse events will be ascertained by the following methods: 1) spontaneously reported 
symptoms; 2) observed symptoms and signs; 3) other people’s reports (e.g., parent, guardian, 
health care provider, child protective services, trusted adult); and through 4) regular 
assessments using validated questionnaires. The University of Washington Risk Assessment 
Protocol (UWRAP) will be administered during each major assessment session (Case Series: 
baseline, 3-month follow-up; Open Trial: baseline, 3-month follow-up, 6-month follow-up). The 
Columbia-Suicide Severity Rating Scale (C-SSRS) will also be administered during each major 
assessment session and at the beginning of each virtual, phone, or in person intervention 
session, to assess suicidal ideation, intent, plans, and behaviors. The UWRAP and C-SSRS are 
being utilized to identify suicide-related AEs and SAEs. All staff interacting with study 
participants will be trained to observe participants for signs of injury or illness during virtual and 
in person assessments. If any injury or illness appears to be related to child abuse and neglect, 
study staff will also follow the standard of practice for child abuse and neglect, in addition to 

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documenting an adverse event.  Study staff will also be trained to document spontaneously 
reported symptoms or other information about adverse events when reported by a participant or 
another person. If the adverse event is reported to the study team by another person, a member 
of the study team will attempt to verify the adverse event by contacting the study participant. 
Suicidality-related clinical worsening is not solely defined by increases in C-SSRS scores. 
Clinical worsening is determined on a case-by-case basis by the Principal Investigators, if 
needed in consultation with Drs. Ramers and Weersing.  
6.6.5 ADVERSE EVENT REPORTING  
 
The Principal Investigators are responsible for reporting adverse events to the SDSU IRB 
according to the timelines established in the IRBs reporting policies and will be assisted in 
submitting reports by the research coordinator.  For all adverse events that are deemed 
expected and/or unrelated to the study, a summary should be submitted to the NIMH PO with 
the annual progress report. Adverse events that are not SAEs will be included in the DSMB full 
data report that is submitted once a year. 
 
6.6.6 
SERIOUS ADVERSE EVENT REPORTING  
 
The Principal Investigators are responsible for reporting serious adverse events to the SDSU 
IRB according to the timelines specified by the IRBs reporting policies and will be assisted in 
submitting reports by the research coordinator.  According to SDSU IRB policy, all study-related 
serious adverse events must be reported to SDSU IRB within 24 hours. A summary of serious 
adverse events that are deemed expected and/or unrelated to the study will be submitted to the 
NIMH PO with the annual progress report. Unexpected Serious Adverse Events related to study 
participation will be reported to the NIMH PO within 10 business days of the study team 
becoming aware of the serious adverse event.  SAEs will be reported to the DSMB in the data 
reports submitted three times a year. Expedited reporting will be provided to the Board for all 
deaths and unexpected and related SAEs.  For deaths, the report will be submitted within 5 
business days, and for unexpected and related SAEs, the report will be submitted within 10 
business days.   
 
 
6.7 
UNANTICIPATED PROBLEMS 
6.7.1 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, in general, to include any incident, experience, or 
outcome that meets all of the following criteria: 
1. unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the characteristics 
of the subject population being studied; 
2. related or possibly related to participation in the research (in this guidance document, 
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 

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3. suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
Unanticipated problems can include experiences such as protocol deviations, data breaches, 
having study-related data or documentation unsecured and stolen.  
 
6.7.2  UNANTICIPATED PROBLEMS REPORTING 
 
Unanticipated problems that are serious adverse events (SAEs) will be reported by the 
investigator to the SDSU IRB within 24 hours. Unanticipated problems which can cause serious 
risks to others are reported to the NIMH PO and the DSMB within 10 business days of the 
investigator learning of the event. Any other unanticipated problem will be reported by the 
investigator to the SDSU IRB, the NIMH PO, and the NIMH DSMB within 10 business days. 
 
The unanticipated problem report will include the following information: 
• 
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 unanticipated problem 
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the unanticipated problem 
 
6.7.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Participants will be informed individually about unanticipated problems which may impact their 
current and future health and privacy via their preferred method of communication (e.g. phone, 
text, mail). 
 
 
7 
STATISTICAL CONSIDERATIONS  
7.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Endpoint(s):  
 
The purpose of the case series is to obtain feedback on study procedures and the PN+SPI 
intervention. Therefore, there are no formal hypotheses associated with the case series. Only 
descriptive statistics will be calculated. 
 
For the open trial, it is hypothesized that PN+SPI participants will display decreases in thwarted 
belongingness and increases in suicide-related coping skills (the hypothesized mechanistic 
targets of the intervention). We will also assess the feasibility and acceptability of the PN+SPI 
intervention during the open trial.    
 
 
7.2 
SAMPLE SIZE DETERMINATION 
 

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For the open pilot, N = 30 was selected based on recommendations in the field which specify 15 
to 30 participants per condition are satisfactory for pilot trials. Given the open pilot includes a 
single condition, we planned for the upper limit sample size based on these recommendations89.  
 
 
7.3 
POPULATIONS FOR ANALYSES 
 
There are no quantitative analyses for the case series. For the open pilot, the analysis population 
will include any participant who participated in one or more intervention sessions. Given that the 
first intervention session occurs during the initial baseline appointment, this means that all 
participants should be included in the analyses. 
 
 
7.4 
STATISTICAL ANALYSES 
7.4.1 GENERAL APPROACH 
 
In the case series and open trial, descriptive statistics will be presented as frequencies and 
percentages (for binary and categorical variables), means with standard deviations, and range 
(for continuous variables).  
 
In the open trial, qualitative data will be saved in a text file to import into NVivo90 for analysis. Drs. 
Wells and Blashill will review the qualitative data using a content analysis technique, which 
identifies emergent themes occurring during discussion. Code mapping91 will be used to develop 
a preliminary set of codes (themes) corresponding to each potential strength of the PN+SPI as 
well as every potential aspect for improvement. Then, Drs. Wells and Blashill will independently 
code the remaining data and meet to discuss coding. Once coded, the data will be summarized 
by theme.  
 
Inferential tests and checks of assumptions underlying statistical procedures will not be performed 
in either the case series or open trial. No corrective procedures will be applied. 
 
7.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
As the purpose of the case series is to obtain feedback on study procedures and the PN+SPI 
intervention, no statistical analyses will be conducted.  
 
In the open trial, the feasibility and acceptability of the PN+SPI intervention will be assessed 
descriptively and therefore will not involve any statistical analyses. However, we will examine the 
preliminary impact of the PN+SPI intervention on the purported mechanisms of action (e.g. 
decreasing thwarted belongingness, increasing suicide-related coping skills). This will be done by 
testing within-person changes in thwarted belongingness and suicide-related coping skills by 
calculating Cohen’s d.  If missing data are minimal (e.g. 5% or less) available item analysis will 
be conducted. If greater than 5% of data are missing, multiple imputation will be conducted. 
Outliers will be defined as ± 3.3 standard deviations from the mean and will be Windsorized to 
the next highest non-outlier value. This approach retains the rank order of the outlier, without the 
outlier exerting a disproportionate effect on the sample. 
 
 

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7.4.3 BASELINE DESCRIPTIVE STATISTICS 
 
In both the case series and open trial, baseline descriptive statistics will be used to describe the 
sample in terms of sociodemographics and psychiatric diagnoses. There is only one treatment 
group (PN+SPI) so intervention groups cannot be compared. Inferential statistics will not be used. 
 
 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
8.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
8.1.1 INFORMED CONSENT PROCESS 
8.1.1.1 CONSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
For both the case series and open trial, participants will initially be screened for eligibility via a 
phone screen conducted by a trained member of the study team. Prior to beginning the phone 
screen, a trained member of the study team will obtain verbal consent for pre-enrollment 
screening. The IRB-approved verbal informed consent form will be read verbatim to all study 
participants over the phone. It describes in detail the phone screening procedure and associated 
risks. During the COVID-19 pandemic, all study procedures, including consenting, will be 
conducted virtually.  
 
Those who meet the screening criteria will be scheduled for an initial baseline appointment. At 
the time of the baseline appointment, a trained member will engage in a discussion with all 
participants and using a written/digital informed consent form that describes in detail the study 
intervention, study procedures, information about potential risks and benefits of participation, and 
information regarding whom they can contact if they have any further questions. It will also state 
that participation is voluntary, that participants can refuse to answer any question, they can 
withdraw from the study at any time, and that study participation is in no way related to 
participating in other studies at San Diego State University. Written/digital documentation of 
informed consent will be completed prior to starting the intervention. The following consent 
materials are submitted with this protocol: 
 
1. Telephone Screening Consent (see attachment 6) 
2. Informed Consent Case Series (see attachment 7) 
3. Informed Consent Open Trial (see attachment 8) 
 
8.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
The verbal informed consent for the phone screen will be administered by a trained member of 
the study team. Prior to beginning the phone screen, the study team member will read the verbal 
informed consent verbatim to the participant and answer any questions that they may have. The 
study team member will then ask if they would like to take part in the screening process today. If 
the participant provides their verbal consent to participate, the study team member administering 
the informed consent will document that the participant provided their consent to answer the 
screening questions. This will be done by having the study team member sign the telephone 
screening consent form. 
 

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The informed consent for the case series, as well as open trial, will be administered by a trained 
member of the study team. This will be done at the beginning of the baseline assessment prior to 
beginning study procedures. At this time, the study team member will verbally go through the 
informed consent with the participant and answer the participant’s questions. The study team 
member will then give the participant time to review the consent form at their own pace and 
answer any further questions that they may have. The study team member will then ask the 
participant if they would like to take part in the study. If the participant does wish to participate, 
the study team member will have the participant sign the informed consent form. The study team 
member will then sign the informed consent form themselves and provide the participant with a 
copy of the informed consent form.  
 
Given that we have obtained a waiver of parental consent form from the IRB and an approval of 
minor’s ability to self-consent, the procedure for administering informed consent for minors in the 
case series, as well as open trial, will be the same as for adults. These consent procedures use 
eight-grade verbiage to facilitate comprehension by both minors and adults. We will not re-
consent children who become adults or are emancipated during the study. 
 
We will not obtain consent from speakers of language other than English, as the ability to speak 
English is one of the inclusion criteria required for study enrollment. We will assess competency 
and comprehension/understanding through discussing the informed consent with the participant. 
Similarly, we will not obtain surrogate consent for those unable to consent on their own behalf, as 
the ability to provide informed consent is one of the inclusion criteria required for study enrollment.  
 
8.1.2 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, 
investigator, sponsor/funding agency (NIMH), and regulatory authorities (OHRP, DSMB). If the 
study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform 
study participants, the SDSU Institutional Review Board (IRB), the DSMB, funding agency 
(NIMH), and OHRP and will provide the reason(s) for the termination or suspension. Study 
participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
 
If suspended, the study may resume once concerns about safety, protocol compliance, and data 
quality are addressed, and satisfy the sponsor/funding agency (NIMH), IRB, or other relevant 
regulatory or oversight bodies (OHRP, DSMB). 
 
8.1.3 CONFIDENTIALITY AND PRIVACY  
 
All data will be kept confidential, under lock-and-key, or electronically and password protected, 
accessible only to trained study staff. All participants will be assigned a four-digit ID number (e.g. 
“1001”) upon scheduling the initial baseline assessment. Participants’ data will be identified by 

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this ID number only, and a link between names and ID number will be kept separately in a 
password protected participant contact electronic file, accessible only to study staff. 
 
Research files (for example, surveys, interviews, audio files) will be kept at SDSU. All research 
data collected from participants will be stored in a separate password protected file in a separate 
electronic drive. All digital audio recordings of sessions will be uploaded to the study computer 
immediately post session and the file deleted from the original recorder. Physical copies of some 
data (e.g. clinician-based assessments) will only include participant IDs, and will be stored in a 
locked filing cabinet, within a locked room, in a locked suite. Only trained study staff will have 
access to electronic and physical data. 
 
All research activities will be conducted in as private a setting as possible. 
 
The computers where study data will be stored may be connected to the internet. Study data may 
be stored on a university-managed Google drive which can only be accessed using a password-
protected login. The study Google drive follows university IT security procedures. Access to the 
study Google drive will be limited to study staff. Some of the study data will be collected using the 
Qualtrics survey system. Qualtrics uses Transport Layer Security (TLS) encryption (also known 
as HTTPS) for all transmitted data. Access to the study survey and data will be limited to study 
staff who must use a password to access study surveys and data.  
 
Physical copies of data will be retained for seven years after the completion of the study. After 
seven years, identifiable computer files will be erased and the paper surveys will be shredded. 
Audio recordings will be retained for three years after the completion of the study. After three 
years, the audio files will be erased. Permission will not be required to destroy physical copies of 
data or audio recordings. 
 
The investigative team will work with the Institutional Review Board that regulates the study, as 
well as Family Health Centers of San Diego, to coordinate the data sharing process. Any 
information that could potentially identify a participant will be removed prior to distributing the data. 
All investigators funded under this funding opportunity announcement are expected to share data 
collected as part of an award. Thus, in accordance with National Institute of Mental Health policy, 
we will prepare and submit de-identified data to the National Data Archive (NDA). In addition, 
instructions for contacting the Multiple Principal Investigators will be placed on their lab websites 
so that researchers interested in using the data can contact them directly to obtain the de-
identified data. The research team will require that any recipients of the data execute a data 
sharing agreement with San Diego State University that will obligate recipients to: 1) use data 
only for research; 2) not identify an individual participant; 3) commit to securing data using 
appropriate computer technology; and 4) commit to destroying or returning data after analyses 
are completed or three years have passed 
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 

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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. 
 
8.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Biospecimens are not being collected for this study. Data collected will be analyzed and stored at 
San Diego State University. After the study is completed, the de-identified, archived data will be 
transmitted to and stored at the National Data Archive for use by other researchers including 
those outside of the study. Permission to transmit data to the NDA will be included in the informed 
consent.  
 
When the study is completed, access to the de-identified study data will be provided through the 
NDA. Researchers can also request the data directly from the Multiple Principal Investigators. 
 
Genetic testing will not be performed as part of the study. 
 
 
8.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator  
Principal Investigator 
Aaron 
Blashill, 
Ph.D., 
Professor 
Kristen Wells, Ph.D., MPH, 
Professor 
San Diego State University  
San Diego State University 
Department 
of 
Psychology, 
6363 Alvarado Ct., Ste. 103, 
San Diego, CA 92120 
Department of Psychology, 
6363 Alvarado Ct., Ste. 103, 
San Diego, CA 92120 
619-594-2245 
619-594-6780 
ajblashill@sdsu.edu 
kwells@sdsu.edu 
 
There are no study leadership committees or country-specific administrative requirements or 
functions that materially affect the conduct of the study for either the case series or open trial. 
 
8.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a NIMH Data and Safety Monitoring Board (DSMB) 
composed of individuals with the appropriate expertise, including, at minimum, one content-
related or therapeutic area expert and a biostatistician. Members of the DSMB will be independent 
from the study conduct and free of conflict of interest. The board will meet via teleconference 3 
times per year. The DSMB will operate under the rules of an approved charter that clearly outlines 
what data points will be monitored, how the data will be monitored, and the monitoring schedule. 
The DSMB review will include, at minimum: enrollment data, safety data, and data and protocol 

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integrity.   These will be provided to the Board for review in advance of each meeting.  Any DSMB 
member can request an additional meeting or additional information should they desire it. The 
DSMB will issue meeting minutes that will be provided to the Principal Investigators following each 
review/meeting. This report will include any significant actions taken and the final 
recommendations with regard to the study’s continuation. These reports will be submitted to the 
NIMH Program staff in the annual progress report. 
 
8.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Both the case series and open trial will have a written Manual of Procedures (MOP) detailing the 
study’s organization, operations, procedures, data collection, data management, and quality 
control. This MOP will be developed by the PIs in collaboration with study team members, and 
the MOP will be provided to research staff during their training. The MOP will be regularly 
reviewed by the Principal Investigators to ensure that the operating procedures described in the 
MOP are accurate. If any procedures have been changed or modified, the MOP will be updated 
and distributed to research staff. Each page of the MOP will be numbered and dated and contain 
a version number that will be updated with each revision to ensure that the correct version of the 
MOP is used by study staff. 
 
All essential documents pertaining to the conduct of the study will be contained in an electronic 
regulatory binder. This regulatory binder will be maintained by study staff and will contain the 
following documents: 
1. IRB-related documents 
○ All versions of IRB-approved protocols and amendments 
○ All versions of IRB-approved informed consent forms 
○ All versions of IRB-approved recruitment advertisements 
○ IRB continuing review submissions and approvals 
○ IRB compliance documentations  
2. DSMB-related documents 
○ DSMB reports and approvals 
○ DSMB charter 
3. NIMH-related documents 
○ Documents related to NIMH grants management (e.g. grant application, grant 
award, financial documents) 
○ NIMH progress report submissions and correspondence 
○ Reportable events 
4. Study staff training and qualifications documents 
○ Curriculum vitae (CV) for those listed on delegation of authority log 
○ Documentation of current licensure for PIs and all sub-investigators 
○ Documentation of human subjects protection training and GCP training 
○ Documentation of study-specific training 
5. Ongoing study operations documents 
○ Manual of Procedures (MOP) 
6. Study logs and templates documents 
○ Delegation of authority log 

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○ Subject screening and enrollment log template 
○ Confidential subject identification code template 
○ Protocol violations and deviations log 
○ Adverse event/serious adverse event log 
○ Sample source documents 
 
The study staff will be responsible for ensuring that all essential documents in the regulatory 
binder are complete and current. 
 
The research team will receive ongoing training and feedback via quality control checks. The 
following quality control (QC) procedures will be implemented in both the case series and open 
trial: 
  
Good Clinical Practice (GCP) - Study staff who directly interact with participants will complete 
GCP training requirements in accordance with the principles of the International Conference on 
Harmonisation (ICH) E6 (R2). Each staff member’s completion of GCP training requirements will 
be documented in a GCP training log created by the study team, as well as maintained in the 
regulatory binder. All other study staff is required to complete the CITI Human Subjects Research 
(HSR) – Social-Behavioral course required by SDSU. 
 
All study staff members are responsible for ensuring that their GCP and/or HSR training is up-to-
date. The Principal Investigators understand and accept responsibility for overseeing the conduct 
of the study in accordance with GCP. 
 
Safety Monitoring — Study staff will monitor whether documentation related to safety protocols 
indicates that safety protocols have been appropriately followed.  This will include SOPs for the 
telephone screening and all assessments as well as the patient navigation intervention Module 
10. Documentation will include forms completed for the screening, assessments, and intervention, 
along with the progress notes for the patient navigation intervention. 
 
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. Study staff will be responsible for updating 
the informed consent in the regulatory binder every time the IRB approves a new version. 
 
Source Document Verification (SDV) — Study staff will confirm that accurate, complete, and 
current source documentation is maintained. SDV will be ongoing. 
  
Data Integrity — Data collection will occur in the form of self-report questionnaires, clinician-
administered verbal assessments, logs of patient navigation encounters, observations of study 
team members, and key informant interviews. All study data will ultimately be entered into study 
databases. To ensure accuracy, trained study team members will regularly perform data 
verification and data cleaning procedures.  
  
Intervention Fidelity — Consistent delivery of the study interventions will be monitored 
throughout the intervention phase of the study.  
  
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 

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level of concern. All protocol deviations will be documented in a protocol deviation and violation 
tracking log created by the study team, as well as maintained in the regulatory binder. Protocol 
versions will be updated in a regulatory binder with each IRB-approved revision. 
 
8.1.8 DATA HANDLING AND RECORD KEEPING  
8.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the trained study team members under the supervision 
of the principal investigators. The investigators will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Source data will be recorded in either electronic or paper form. Source data includes self-report 
surveys, clinical interviews, key informant interviews, patient navigation encounter forms, and 
audio recordings of patient navigator sessions and interviews conducted as part of the study. All 
processing of source data will be ongoing.  
 
All paper source data (e.g. clinical interviews) will be entered into an electronic study database 
directly from the source documents to ensure that it is consistent with the data recorded on the 
source documents.  Additionally, double data entry will be performed by trained study team 
members. 
 
Most surveys will be completed by participants directly in Qualtrics, reducing the need for data 
entry. 
 
All audio files will be transcribed verbatim by a research assistant and verified by a second 
research assistant. 
 
Source data will may be stored on a university-managed Google drive which can only be accessed 
using a password-protected login. The study Google drive follows university IT security 
procedures. Access to the study Google drive will be limited to study staff. Some of the study data 
will be collected using the Qualtrics survey system. Qualtrics uses Transport Layer Security (TLS) 
encryption (also known as HTTPS) for all transmitted data.  
 
A study codebook will be developed for all survey and interview data.  
 
8.1.8.2 STUDY RECORDS RETENTION  
 
Physical copies of data will be retained for seven years after the completion of the study. After 
seven years, identifiable computer files will be erased and the paper surveys will be shredded. 
Audio recordings will be retained for three years after the completion of the study. After three 
years, the audio files will be erased. Permission will not be required to destroy physical copies of 

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data or audio recordings. Aggregated, de-identified data will be retained indefinitely for data 
sharing purposes, as required by NIMH. 
 
8.1.9 PROTOCOL DEVIATIONS   
 
According to the SDSU Human Research Protection Program, a protocol deviation is defined as 
when there is inconsistency between the procedures carried out in a study and the procedures 
stated in the research protocol, or when regulations regarding the manner in which research is 
being conducted are not being followed (from SDSUHRPP Standards and Practices v. 
02.13.19). 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. 
 
It will be the responsibility of the investigator to use continuous vigilance to identify and report 
deviations to the SDSU IRB within 5 days. All deviations will be addressed in study source 
documents, and reported to NIMH PO with the annual progress report.  All protocol deviations will 
also be reported to the DSMB annually in the full data report.  These reports should indicate that 
the monitoring entities (PI, IRB, DSMB) and appropriate regulatory entities have been notified in 
accordance with the approved monitoring plan and federal regulations.  
 
 
 
 
8.1.10 PUBLICATION AND DATA SHARING POLICY  
 
San Diego State University is committed to the principle of rapid data, model, and software release 
to the scientific community.  We will adhere to the Data Sharing Policy developed by the National 
Institutes of Health as well as specific policies of the National Institute of Mental Health.  
 
The goals for dissemination of our research are to directly share the study findings and materials: 
1) with the research community via scholarly publications in peer-reviewed public health, 
behavioral science, and medical journals and presentations at professional conferences; 2) with 
the community and public via a variety of channels, including presentations in the community and 
at FHCSD and; 3) with researchers and the public on websites, including the websites of the 
Multiple Principal Investigators, the SDSU HealthLINK Center, and the Center for Research on 
Sexuality and Sexual Health (SASH). Decisions regarding dissemination will be made by the 
research team in collaboration with the Participatory Planning Group.   
The study team will adhere to the 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. 
 
Publication of data shall occur during the project, if appropriate, or at the end of the project, 
consistent with normal scientific practices. Research data which documents, supports, and 
validates research findings will be made available after the main findings from the final research 
data set have been accepted for publication. Such research data will be de-identified to prevent 
the disclosure of personal identifiers. 
 

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8.1.11 CONFLICT OF INTEREST POLICY 
 
There are no conflicts of interest to report for either the case series or open trial. 
 
 
8.2 
ABBREVIATIONS AND SPECIAL TERMS 
 
ACSS-FAD 
Acquired Capability for Suicide Scale – Fearlessness about Death 
AE 
Adverse Event 
ASRS-5 
Adult ADHD Self-Reporting Screening Scale for DSM-5 
BISH 
Body Image, Sexuality, and Health  
CFR 
Code of Federal Regulations 
COC 
Certificate of Confidentiality 
COVID-19 
Coronavirus Disease 2019 
CSQ-8 
Client Satisfaction Questionnaire-8 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CV 
Curriculum Vitae  
DCQ 
Dysmorphic Concern Questionnaire 
DERS 
Difficulties in Emotion Regulation Scale 
DIAMOND 
Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive and Related 
Neuropsychiatric Disorders 
DSMB 
Data Safety Monitoring Board 
EDE-Q 
Eating Disorder Examination-Questionnaire 
ER 
Emergency Room 
FHCSD 
Family Health Centers of San Diego 
GCP 
Good Clinical Practice 
GRS 
Gay-Related Rejection Sensitivity Scale 
GMSR 
Gender Minority Stress and Resilience Measure 
HHRDS 
Heterosexist Harassment, Rejection, and Discrimination Scale 
HHS 
Secretary, Health and Human Services 
HIV 
Human Immunodeficiency Virus 
ICH GCP 
International Council on Harmonisation Good Clinical Practice 
IHP 
Internalized Homophobia Scale 
INQ-15 
Interpersonal Needs Questionnaire-15 
IRB 
Institutional Review Board 
IT 
Information Technology 
K-SADS 
Schedule for Affective Disorders and Schizophrenia for School-Aged Children 
LGBT 
Lesbian, Gay, Bisexual, Transgender 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NDA 
National Data Archive 
NIH  
National Institutes of Health 
NIHGPS 
National Institutes of Health Grants Policy Statement 
NIMH 
National Institute of Mental Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PN 
Patient Navigation 
PNRP 
Patient Navigation Research Program 

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PN+SPI 
Study Intervention Name  
PO 
Program Officer 
PPG 
Participatory Planning Group 
QC 
Quality Control 
RCT 
Randomized Control Trial 
SAE 
Serious Adverse Event 
SASH 
Center for Research on Sexuality and Sexual Health  
SDSU 
San Diego State University 
SDSUHRPP San Diego State University Human Research Protection Program 
SDV 
Source Document Verification 
SGM 
Sexual and Gender Minorities 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOCS 
Sexual Orientation Concealment Scale 
SOP 
Standard Operating Procedure 
SPI 
Safety Planning Intervention 
SRCS 
Suicide Related Coping Scale 
TLS 
Transfer Layer Security (also known as HTTPS) 
UP 
Unanticipated Problem 
US 
United States 
UWRAP 
University of Washington Risk Assessment Protocol 
 
 
9 
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