Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents
Phase: NA
Conditions: Suicide
Sponsor: University of North Carolina, Chapel Hill

 
Practice Experiences for School Reintegration: An Immersive Virtual 
Reality Program to Enhance Skill Development of Hospitalized 
Adolescents 
 
 
NCT number NCT05934396 
Document Date 07/16/2025 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
1 
Template Version  1.0            2021-09-09 
 
Master Protocol Document 
 
Title 
Practice Experiences for School Reintegration 
 
Sub-Title 
 
An Immersive Virtual Reality Program to Enhance Skill Development of 
Hospitalized Adolescents 
 
Principal Investigator 
Marisa Marraccini, School of Education 
919-843-5099 
Co-Investigators 
 
Not applicable 
Statistical 
Consultant1 
Leslie Brick, PhD 
Research Sites 
UNC Adolescent Psychiatry Inpatient Unit 
University of North Carolina at Chapel Hill School of Medicine 
 
Version Number 1.10 
16 JULY 2025    
 
 
 
 
I have read, understood, and approved this version of the protocol.   [electronic signatures accepted]  
 
Principal Investigator:     Marisa Marraccini 
Date: 7/16/25 
 
Statistical Co-investigator:     Leslie A. Brick 
Date: 7/16/25 
 
 
 
Statement of Confidentiality and Nondisclosure     This document is a confidential communication.  Acceptance of this document 
constitutes agreement by the recipient that no unpublished information contained herein will be published or disclosed without 
prior written approval of the Principal Investigator or other participating study leadership, except that this document may be 
disclosed in any medium to appropriate investigators, Institutional Review Boards, Scientific Review Committees, and others who 
are directly involved in the study specified herein under the condition that they keep the information confidential. 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
2 
Template Version  1.0            2021-09-09 
Table of Version Changes 
 
 
 
Previous 
Version No. 
Affected 
Sections 
Summary of the Changes 
to the Protocol 
Reason for Changes 
1.1 
1, 2.3, 3, 4, 4.5, 
4.6, 4.7, 4.8, 5.5, 
7, 9, 12.5, 13.1.1 
• Due to limited power, the exploratory aim was 
revised to remove exploration of possible 
impact and utility of the intervention and 
instead address assessment of candidate 
intermediary and outcome measures 
(addressed throughout and in statistical plan, 
section 9); 
• Clarification of what is considered success for 
Aims 1-2 (i.e., minimum recruitment rate, 
average completion times, average ratings, see 
4.8) 
• Change in stopping rules for study 
discontinuation and closure based on DSMB 
recommendations (now using SUDS to assess 
safety instead of CSSRS; see 4.5 and 12.5) 
• Clarification of intervention design based on 
developed feedback and final prototype (see 
4.6, 6) 
• Removal of stratification procedures for 
gender due to pilot nature of trial (see 4.7, 5.5) 
• Addition of missing measures collected (see 
Figure 2, Table 1, section 7) 
• Included list of IRB approved consent/assent 
documents (13.1.1) 
• Addition of Electronic Signatures 
Meeting with statistician 
concerning power of 
analyses, sample size 
implications for 
stratification, and 
improving specificity of 
measures for Aims 1-2;  
 
Meeting with DSMB 
about improving 
assessment of safety; 
 
Final review to correct 
errors or add any missing 
information related to 
number formatting, 
acronyms, and specific 
information related to 
intervention components 
(Intro to CBT was 
previously missing) and 
procedures based on final 
prototype and meeting 
with hospital. 
1.2 
4.8 
8.3 
12.1.1 
1 
4.6 
4.7 
6 
11.4 
• 
The specific primary outcomes and candidate 
exploratory outcomes were added to the 
statistical analysis section to ensure 
consistency across the document; 
• 
The appendices listing consent and assent 
documents were removed since 
clinicaltrials.gov requires final consent 
uploaded at the completion of the trial. 
• 
We have clarified that the worksheets are 
provided by the researchers to all participants 
and that participants receiving the 
intervention will also receive additional 
worksheets part of a workbook aligned to the 
intervention. 
• 
We have removed the virtual reality Intro to 
CBT module as we were unable to include 
this in the final intervention. 
• 
Based on previous DSMB review, we revised 
our safety protocol in 11.4 (these changes 
were made in version 1.2; however, we 
missed one instance in 11.4 and corrected it 
for 1.3): Previously, we indicated that 
intensity of suicidal thoughts would be 
Finalization of 
clinicaltrials.gov 
submission and review 
provided by UNC office 
of clinical trials. 
 
Final development and 
selection of worksheets 
and intervention 
workbook. 
 
We were not able to 
include the Intro to CBT 
VR lesson due to 
limitations of the VR 
device and time 
constraints. 
 
Previous DSMB review 
of safety protocols  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
3 
Template Version  1.0            2021-09-09 
monitored pre and post intervention 
completion; instead we will monitor using the 
SUDS scale (distress level) pre and post 
intervention.  
1.3 
TABLE OF 
ABBREVIATIONS 
4.7 
4.8 
7.1 
8.2 
12.1 
12.1.2 
 
• 
We removed a placeholder in the table of 
abbreviations that was part of the template  
• 
Relaxation was changed to Affect Regulation  
• 
The Authoritative School Climate Survey 
(ACS) and School Connectedness Scale 
(SCS) were removed from post-intervention 
assessment  
• 
Qualtrics was added as an additional option 
for obtaining parent permission virtually 
The placeholder was 
removed for readability 
 
Relaxation was changed 
to Affect Regulation to 
ensure consistency of 
wording throughout the 
intervention  
 
ACS and SCS were only 
meant to be completed 
once during baseline 
given they measure 
perceptions on school and 
participants remain in 
hospital throughout 
baseline 
 
Both Qualtrics and 
REDCap are approved 
data collection tools in the 
study IRB 
1.4 
4.8 
7.1 
 
• 
We amended timepoints for when medical 
records will be collected 
• 
Admission and discharge date were added to 
information collected from medical record 
Medical records will be 
collected during baseline 
and again at 3-months to 
ensure consistency and 
accuracy 
 
Admission and discharge 
date were added to 
consider length of 
hospitalization as a 
covariate and to facilitate 
follow-up appointments 
1.5 
4 
4.7 
 
7 
7.4 
• 
We corrected an error in which the protocol 
stated the 3-month follow-up assessments 
were anchored to discharge, but they are 
anchored to school re-entry. 
 
• 
We have allowed post-intervention 
assessments to be completed following 
discharge as needed. 
The full protocol anchors 
follow-up appointments to 
school re-entry (not 
discharge) and this was 
inconsistent with the other 
aspects of the protocol. 
 
Hospital discharge can 
occur very last minute, 
and it is not always 
possible for us to 
complete post-
intervention assessments 
prior to discharge. 
Although we will 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
4 
Template Version  1.0            2021-09-09 
continue to prioritize 
completing assessments 
prior to discharge, we are 
revising the protocol to 
allow to complete 
assessments following 
discharge as needed. 
1.6 
4.5 
11.5 
 
7 
• 
We identified an error in study suspension 
procedures (a 3-point increase pre/post VR 
on the 0-10 distress scale was meant to signal 
concern, and the protocol mistakenly reports 
this as a 30% increase when it is actually a 
300% increase. 
• 
The abbreviated feedback form completed by 
adolescent participants was moved to the 
correct place in the table  
This was a percentage 
calculation error, as a 
30% increase would be a 
much too small threshold 
and a 300% increase is 
considered appropriate. 
Approval for this 
correction was confirmed 
by the DSMB on 
01/23/2024. 
 
The abbreviated feedback 
form completed by 
adolescent participants 
was mistakenly placed 
with the clinician 
feedback 
1.7 
5.1 
• 
We noted that hospital professionals can be 
recruited from one of two hospitals and that 
1-2 UNC hospitals will be used for patient 
recruitment 
We are adding a new site 
to the trial (UNC Youth 
Behavioral Health) 
1.8 
12.9 
• 
Reporting procedures for protocol deviations 
corrected. 
Reporting procedures for 
protocol deviations were 
clarified to align with 
policies and procedures of 
funding agency and 
institutional review board. 
1.9 
1, 5.2 
• 
Eligibility for adolescent patients 
participating with a hospital professional (not 
part of the randomized trial) was clarified and 
revised 
Hospital professional 
participants have been 
supporting decisions 
around appropriateness of 
intervention and many 
patients without expected 
return to school have been 
considered appropriate; 
given the open trial does 
not follow outcomes, but 
rather, aims to inform 
implementation, we have 
revised eligibility criteria 
for these patients. Note 
that the randomized trial 
eligibility remains the 
same. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
5 
Template Version  1.0            2021-09-09 
1.10 
4.8 
• 
Amended Table 2 to correct 
occasions of retention rates 
measurements 
• 
Corrected minor typos throughout 
Correcting information 
for readability and clarity, 
including addressing 
errors in tables. 
 
 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
6 
Template Version  1.0            2021-09-09 
Table of Contents 
Table of Version Changes ............................................................................................................. 2 
Statement of Compliance ............................................................................................................... 8 
Table of Abbreviations ................................................................................................................... 9 
1. 
Protocol Synopsis .............................................................................................................. 10 
2. 
Introduction ....................................................................................................................... 13 
2.1  Background Information..................................................................................................... 13 
2.2 
Scientific Rationale ......................................................................................................... 14 
3. 
Specific Aims ...................................................................................................................... 15 
3.1 
Aim 1 ............................................................................................................................... 15 
3.2 
Aim 2 ............................................................................................................................... 15 
3.3 
Exploratory Aim .............................................................................................................. 15 
Because this study is a treatment development study, an exploratory aim is to calculate descriptive 
statistics for candidate outcome variables to inform power for a future study that examines efficacy of 
the intervention. ......................................................................................................................... 15 
4 
Study Design ...................................................................................................................... 15 
4.1 End-of-Study Definition ...................................................................................................... 16 
4.2 Discontinuation of Study Intervention/Experimental Manipulation ................................... 16 
4.3 Participant Discontinuation/Withdrawal from the Study .................................................... 16 
4.4 Lost to Follow-Up ............................................................................................................... 16 
4.5 Study Discontinuation and Closure ................................................................................................. 16 
4.6 
Intervention Design ........................................................................................................ 17 
4.7 Experimental Design ............................................................................................................ 18 
4.8  Measurement Design .......................................................................................................... 20 
5. Study Participants ................................................................................................................... 25 
5.1 
Numbers of Participants ................................................................................................. 25 
5.2 
Eligibility Criteria ........................................................................................................... 26 
5.3 Enrollment/Selection Strategies .......................................................................................... 27 
5.4 Strategies for Retention ....................................................................................................... 27 
5.5 
Matching and Stratification ............................................................................................ 27 
5.6 
Randomization and Concealment ................................................................................... 28 
5.7 
Blinding .......................................................................................................................... 28 
6 
Treatment Design: Procedures ....................................................................................... 29 
7 
Schedule of Activities and Procedures ........................................................................... 29 
7.1 
Table of Events ............................................................................................................... 29 
7.2 Screening ............................................................................................................................. 32 
7.3 Enrollment ........................................................................................................................... 32 
7.4 Study Visits ......................................................................................................................... 32 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
7 
Template Version  1.0            2021-09-09 
7.5 Final Visit ............................................................................................................................ 32 
7.6  Phone Contacts ................................................................................................................... 32 
7.8  Follow-Up Contact ............................................................................................................. 33 
7.9  Early Discontinuations ....................................................................................................... 33 
7.10 Enrollees May Drop Out ................................................................................................... 33 
8 
Statistical Analysis Plans ................................................................................................. 33 
8.1 Strategies that Apply to all the Aims ................................................................................... 33 
8.2  Sample Description ............................................................................................................ 33 
8.3  Aim-Specific Plans ............................................................................................................. 34 
8.4  Planned Interim Analyses ................................................................................................... 35 
9 
Sample Size Rationale ...................................................................................................... 36 
10 
Data Capture and Database Management ..................................................................... 36 
10.1 Software for Data Capture .............................................................................................. 36 
10.2 Responsibilities for Data Capture and Database Management ...................................... 36 
10.3 Study Records Retention ................................................................................................ 36 
11 
Safety Monitoring and Management .............................................................................. 37 
11.1 Risk / Benefit Assessment .............................................................................................. 37 
11.2 Assessment of Safety ...................................................................................................... 37 
11.3 Unanticipated Problems, Adverse Events, Serious Adverse Events .............................. 38 
11.4 Safety Monitoring ........................................................................................................... 39 
11.5 Study Suspension / Early Termination of the Study ...................................................... 40 
12 
Regulatory, Ethical, and Study Oversight Specifications ............................................ 40 
12.1 Informed Consent Process .............................................................................................. 40 
12.2 Study Discontinuation and Closure ................................................................................ 41 
12.3 Confidentiality and Privacy ............................................................................................ 41 
12.4 Future Use of Stored Specimens and Data ..................................................................... 42 
12.5 Key Roles and Study Governance .................................................................................. 43 
12.6 Safety Oversight ............................................................................................................. 43 
12.7 Clinical Monitoring Plan (CMP) .................................................................................... 43 
12.8 Quality Assurance and Quality Control ......................................................................... 44 
12.9 Protocol Deviations ........................................................................................................ 44 
12.10 Publication and Data Sharing Policy .............................................................................. 44 
12.11 Conflict of Interest Policy .............................................................................................. 45 
13 
References ......................................................................................................................... 46 
 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
8 
Template Version  1.0            2021-09-09 
Statement of Compliance 
This study will be conducted as specified in the protocol and in accordance with the International Conference on 
Harmonization Guidelines for Good Clinical Practice (ICH E6) and the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46).  
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent form 
must be obtained before any participant is enrolled.  Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented into the study.  In addition, all changes to the consent 
form 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. 
If required by the IRB, the master protocol document, informed consent form(s), recruitment materials, and all 
participant materials will be submitted to the Scientific Review Committee (SRC) prior to IRB review 
(research.unc.edu/clinical-trials/src). 
The statistical analysis plans will be consistent with guidance in CONSORT Statement [1] or STROBE Statement 
[2], ICMJE recommendations [3], the 2016 and 2019 statements of the American Statistical Association [4,5], and 
recommendations in Nature [6,7].*  
All personnel involved in the conduct of this study have completed human subjects protection training. 
 
 
 
 
 
 
 
 
 
 
*  [1]   www.consort-statement.org  
   [2]  www.strobe-statement.org  
   [3]  www.icmje.org  
   [4]  Wasserstein RL, et al. (2016), The ASA's Statement on p-Values, The American Statistician, 70:2, 129-133  
   [5]  Wasserstein RL, et al. (2019), Moving to a World Beyond p < 0.05, The American Statistician, 73:sup1, 1-19  
   [6]  Amrhein, et al. (2019) Scientists rise up against statistical significance, Nature 567, 305-307  
   [7]  Editorial (2019) It’s time to talk about ditching statistical significance: Looking beyond a much used and abused measure 
          would make science harder, but better. Nature 567, 283-283. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
9 
Template Version  1.0            2021-09-09 
Table of Abbreviations 
AE / SAE 
Adverse Event / Serious Adverse Event 
ASCS 
Authoritative School Climate Survey 
ATQ 
Automatic Thoughts Questionnaire 
BHS 
Beck Hopelessness Scale 
CASI 
Child Anxiety Sensitivity Index 
CBT 
Cognitive Behavioral Therapy 
CBTSQ 
Cognitive-Behavior Therapy Skills Questionnaire 
CFR 
U.S. Code of Federal Regulations (www.eCFR.gov) 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical Sciences (cioms.ch) 
CoC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials (www.consort-statement.org) 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CSCC 
UNC Collaborative Studies Coordinating Center (sites.cscc.unc.edu/cscc) 
CSSRS 
Columbia Suicide Severity Rating Scale 
CT.gov 
ClinicalTrials.gov website 
CTAS 
Cognitive Therapy Awareness Scale 
DCC 
Data Coordinating Center 
DSMB 
Data and Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
eCTD 
Electronic Common Technical Document 
ESE 
Emotional Self-Efficacy Measure 
FDA 
U.S. Food and Drug Administration (www.fda.gov) 
GCP 
Good Clinical Practice 
HIPAA 
U.S. Health Insurance Portability and Accountability Act (www.hhs.gov/hipaa) 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization (www.ich.org) 
ICMJE 
International Committee of Medical Journal Editors (www.icmje.org) 
IDE 
Investigational Device Exemption 
IDS 
UNC Investigational Drug Services (uncids.web.unc.edu) 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
MAR 
Missing at Random Criterion 
MCAR 
Missing Completely at Random Criterion 
MNAR 
Missing Not at Random Criterion 
MICE 
Multiple Imputation by Chained Equations 
MSSQ 
Motion Sickness Susceptibility Questionnaire  
MOP 
Manual of Procedures 
MOST 
Multiphasic Optimization Strategy 
MPD 
Master Protocol Document 
N 
Number of Enrolled Participants 
NDA 
New Drug Application 
OCT 
UNC Office of Clinical Trials (research.unc.edu/clinical-trials) 
OHRP 
Office for Human Research Protections 
PCTS 
Performance of Cognitive Therapy Strategies  
PHI 
Protected Health Information 
PI 
Principal Investigator 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
10 
Template Version  1.0            2021-09-09 
PRC 
UNC Oncology Protocol Review Committee (UNClineberger.org/protocol review) 
PrESR 
Practice Experiences for School Reintegration 
PROMIS 
Patient-Reported Outcomes Measurement Information System -Pediatric Self Report 
QA 
Quality Assurance 
RCT 
Randomized Controlled Trial 
REDCap 
Research Electronic Data Capture system 
SCS 
School Connectedness Scale 
SD 
Standard Deviation 
SE 
Standard Error 
SITB 
Self-Injurious Thoughts and Behaviors Interview 
SoCT 
Skills of Cognitive Therapy 
SOP 
Standard Operating Procedures 
SRC 
UNC Scientific Review Committee (research.unc.edu/clinical-trials/src) 
SSQ 
Simulator Sickness Questionnaire 
STROBE 
Strengthening Reporting of Observational Studies in Epidemiology (www.strobe-
statement.org) 
SUDS 
Subjective Units of Distress Scale 
TraCS 
N.C. Translational and Clinical Sciences Institute (tracs.unc.edu) 
UNC 
The University of North Carolina 
UNCH 
UNC Hospitals 
VR 
Virtual Reality 
 
1. Protocol Synopsis 
 
 
Title 
Practice Experiences for School Reintegration: An Immersive 
Virtual Reality Program to Enhance Skill Development of 
Hospitalized Adolescents 
 
Study Description 
This study is developing and refining a novel Virtual Reality (VR) 
supplement for inpatient treatment: the Practice Experiences for School 
Reintegration (PrESR) program. The PrESR will provide immersive 
school experiences for inpatient adolescents (with suicidal-related 
admissions) to practice skills in real-world settings with the guidance of 
a trained clinician within the confines of a hospital. This pilot study 
follows a Multiphasic Optimization Strategy (MOST) to conduct a pilot 
optimization trial of the PrESR to inform the feasibility of training 
clinicians, the ability to recruit adolescent inpatient participants, and 
management of experimental conditions. This study is not powered to 
test hypotheses; however, in addition to assessing feasibility and 
acceptability, this pilot trial will assess candidate intermediary and 
outcome measures. 
 
Specific Aims 
(objectives) 
 
Aims for the pilot optimization component of the MOST preparation 
phase are: 
 
Aim 1.  Conduct a pilot optimization trial of the PrESR to examine 
feasibility and acceptability of identifying, enrolling, and retaining 
participants at the hospital.  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
11 
Template Version  1.0            2021-09-09 
 
Aim 2: Conduct a pilot optimization trial of the PrESR to examine 
feasibility and acceptability of implementing assessment protocols 
(including motion sickness screening), fidelity of the intervention 
delivery (including applying the PrESR to existing hospital Cognitive 
Behavioral Therapy (CBT) protocols), candidate intermediary variables 
(i.e., threat habitation, cognition), and candidate outcomes (psychological 
distress, self-efficacy, suicidal thoughts and behaviors, and 
rehospitalization). 
 
 
 
Exploratory Aim: Because this study is a treatment development study, 
an exploratory aim is to calculate descriptive statistics for candidate 
proximal outcome variables to inform power for a future study that 
examines efficacy of the intervention. 
 
 
Target Population 
This study recruits a prospective sample of youth hospitalized for suicide-
related crises. Based on hospitalization data, adolescents are expected to 
be 65% female, 15% Hispanic or Latino, 65% Caucasian and 30% 
minority across all aims. 
 
Adolescent Inclusion Criteria: 1) current hospitalization for suicidal 
thoughts and behaviors, 2) ages 13-18; 3) expected return to school 
following discharge, 4) ability to speak, read, and understand English 
sufficiently to complete study procedures, 5) consent of a parent/legal 
guardian (in English or Spanish), and 6) adolescent assent. 
 
Adolescent Exclusion Criteria:  1) evidence of active psychosis; 2) 
evidence of intellectual disability; 3) Cybersickness (50th percentile as 
measured on the Motion Sickness Susceptibility Questionnaire). 
 
Hospital Professional Inclusion Criteria: A clinician at the treatment 
site(s) who delivers treatment (potentially including CBT) to hospitalized 
adolescents. Hospitalized adolescent patients working with hospital 
professionals have the same eligibility criteria as listed as above, with 
the exception of inclusion criteria #3 (“expected return to school 
following discharge”) and may be included irrespective of school status.  
Numbers of Enrollees 
 
Adolescent Participants 
Target sample size is N = 48 enrolled adolescents. 
 
Recruitment will continue until N = 48 individuals have completed all 
aspects of the protocol and have complete data or until the study end 
date. We anticipate 20% of attrition; however, the purpose of this study 
is to explore feasibility and acceptability of intervention and study 
protocols, with true estimates of attrition unknown (attrition rate is 
considered to be an estimand of the study). 
 
                                                                                                                       
 
Up to 1,000 individuals will be recruited and screened.   

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
12 
Template Version  1.0            2021-09-09 
 
Hospital Professional Participants 
Target sample size is N=5, with a minimum of 2 considered adequate. Up 
to 12 individuals will be recruited. 
 
Interventions 
The PrESR VR supplement will focus on increasing acquisition and 
utilization of critical cognitive-behavioral skills for treating adolescents 
with suicidal thoughts and behaviors. All participants will receive 
treatment as usual during inpatient and all adolescents will receive 
research-related worksheets instructing them on target cognitive 
behavioral skills (introduction to cognitive behavioral therapy, cognitive 
restructuring, problem solving, and affect regulation) aligning to 
worksheets used as part of typical hospital protocol. Adolescents 
receiving the intervention will practice skills using the PrESR, which will 
provide clinical guidance and feedback. Following a similar format to 
other therapeutic VR programs, a research clinician will observe 
adolescents wearing standard headsets as they learn and practice coping 
strategies in immersive experiences designed to mimic real life (school) 
stressors. At the end of the program, the adolescent and research clinician 
will develop a safety plan designed to address the return to school, based 
on these in vivo sessions and, when possible, in collaboration with the 
school. CBT skills provided through worksheets will follow a standard 
format across participants, with VR enhanced CBT skills based on 
randomization to intervention component.   
 
Outcome Measures 
 
For Aim 1. Feasibility and acceptability of identifying, enrolling, and 
retaining participants at the hospital will be assessed with: (1) rates of 
recruitment (proportion of >50th percentile as measured on the Motion 
Sickness Susceptibility Questionnaire); (2) rates of retention (and reasons 
participants cite for withdrawing from the study). 
 
For Aim 2. Feasibility and acceptability of implementing assessment 
protocols (including motion sickness screening) and intervention delivery 
(including applying the PrESR to existing hospital CBT protocols) will be 
assessed in four ways: (1) time to complete assessments; (2) time to 
complete the intervention; (3) ability of research staff to deliver 
intervention with fidelity; (4) adolescent participant feedback about the 
intervention (exit interview and feedback form); and (5) professional 
feedback about the intervention (focus group interviews or one-on-one 
interviews, feedback questionnaire).  
 
Exploratory Aim: Because this study is a treatment development study, 
candidate proximal outcomes of psychological distress (as measured by 
the Child Anxiety Sensitivity Index [CASI]; Beck Hopelessness Scale 
[BHS]; Emotional Distress-Anxiety/Depression - Pediatric Short Form 
[PROMIS]) and self-efficacy (as measured by the Emotional Self-
Efficacy Measure [ESE]) will be collected to provide an assessment of 
candidate proximal outcome variables.  
 
 
Statistical Analysis Plans  
for Each Aim  
Feasibility and Acceptability 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
13 
Template Version  1.0            2021-09-09 
The feasibility of the intervention for Aims 1 and 2 will be assessed via 
rates of recruitment and retention, ability of staff to deliver the 
intervention with fidelity, time involved in completing assessments, time 
involved in the intervention, and participant/staff feedback about the 
intervention. Acceptability is assessed qualitatively via interviews, and 
quantitatively via feedback forms. As such, feasibility and acceptability 
data are descriptive and qualitative and do not require null hypothesis 
significance testing analyses. 
 
Exploratory Aim: Assessment of Candidate Proximal Outcomes  
The pilot optimization trial was designed to use a balanced 2x2x2 full 
factorial to examine each component (VR enhanced cognitive 
restructuring, problem-solving, and affect regulation) across treatment 
level (standard vs. standard + PRESR). All participants will receive 
standard treatment, as well as researcher provided worksheets addressing 
introduction to cognitive behavioral therapy, cognitive restructuring, 
problem-solving, and affect regulation aligned to standard procedures, but 
the experimental conditions will vary according to VR enhancement of 
each skill. With this design, primary focus will be on calculating key 
statistics (means, standard deviations [SDs], correlations) and 
distributional properties of candidate proximal outcome variables based 
on condition of skill use (n=24 per group for each of the skills assessed) 
to provide an assessment of these variables. 
 
Study Duration 
2 years  
 
Participation Duration 
4-6 months, depending on participant discharge date and school re-
entry date  
Enrollment Duration 
24 months 
 
2. Introduction 
2.1  Background Information 
Rates of suicide and suicide-related thoughts and behaviors increased among adolescents over the decade prior to 
COVID-19. Based on data collected as part of the national Youth Risk Behavior Survey (YRBS), 13.8% of 
adolescents reported seriously considering attempting suicide in 2009, compared to 18.8% in 2019; 6.3% reported 
having attempted suicide in 2009, compared to 8.9% in 2019 (CDC, 2019). Since the onset of COVID-19, there has 
been a significant increase in concerns for depression and suicide-related risk within pediatric primary care settings 
for adolescent girls (Mayne et al., 2021). Moreover, rates of hospitalization for a suspected suicide attempt were 
significantly higher in the winter of 2021 compared to the previous year (Yard et al., 2021).  More generally, 
suicidal thoughts and behaviors are a primary reason for psychiatric hospitalization for nearly 50% of hospitalized 
adolescents (Peterson et al., 1996; Tossone et al., 2014). Therefore, this intervention targets adolescents 
hospitalized for suicide-related crises. 
 
Although the effectiveness of psychiatric hospitalization for individuals in crisis is highly debated (Jobes, 2017; 
Jobes et al., 2008), it remains standard practice for most individuals at high-risk for making a suicide attempt (Kidd 
et al., 2014). Inpatient treatment appears most effective when it involves cognitive behavioral therapy (CBT) based 
problem-solving skills (Blanz & Schmidt, 2000; Frazier et al., 2016; Green et al., 2007). CBT is well suited for 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
14 
Template Version  1.0            2021-09-09 
acute treatment of adolescents in crisis because it is an evidence-based, transdiagnostic intervention for reducing 
self-harm behaviors, appropriate for the multidetermined risk of suicide (Alavi et al., 2013; Esposito-Smythers et 
al., 2011; Ghahramanlou-Holloway et al., 2015; Ougrin et al., 2015). Unfortunately, a key mechanism of CBT skill 
learning is practicing skills in real life (Kazantzis et al., 2000; Stanley et al., 2009), something that is not typically 
possible during hospitalization. 
 
Following discharge, youth are at increased risk for subsequent suicide attempts or re-hospitalization and require 
ongoing treatment (Brent et al., 1993; Chung et al., 2017; Goldston et al., 1999, 2001; Horwitz et al., 2015; James 
et al., 2010; Stensland et al., 2012; Wolff et al., 2017). Multiple studies underscore the importance of immediate, 
intensive interventions focused on relapse prevention, followed-up with close monitoring of adolescents after 
discharge (Goldston et al., 1998, 1999, 2001, 2009; Kelley et al., 1996; Prinstein et al., 2008). Yet, post-hospital 
treatment utilization remains low, with many adolescents receiving inadequate or no ongoing treatment (Brown & 
Jager-Hyman, 2014; James et al., 2010; Spirito et al., 2010). Many adolescents return to school at high-risk for 
making a suicide attempt without ongoing treatment in place (Brown & Jager-Hyman, 2014; Daniel et al., 2009).  
Moreover, adolescents report distinct concerns about returning to school following hospitalization, including 
ongoing management of symptoms, social stressors, and academic concerns  (M. Marraccini & PIttleman, 2022; 
Preyde et al., 2018). 
 
Immersive Virtual Reality (VR) is a novel way to enhance treatments applicable to lived settings. VR integrates 
computer graphics, body tracing, and sensory inputs to simulate life-like experiences (Lewis et al., 2018). By 
facilitating human-computer interactions, VR-based applications provide systematic training and practice in 
settings that mirror the real-world (Hubal & Parsons, 2017). Decades of research and development support the VR 
as a novel tool for training and practice conditions to promote skill development (Hubal, 2008; Hubal & Parsons, 
2017). Increasing the ecological validity of assessments, virtual school environments can measure attention and 
cognition (Parsons, 2015; Rizzo et al., 2009) and students’ tendency towards risky behavior (Hubal et al., 2015; 
Hubal & Parsons, 2017). Evidence supporting VR therapeutically demonstrates that VR exposure therapy has 
comparable effects to lived exposure therapy for real-life anxiety reduction (Carl et al., 2019; Morina et al., 2015). 
 
In order to enhance clinical treatment of adolescents with suicide-related risk, this study is conducting a pilot 
optimization trial of a novel intervention to supplement inpatient treatment, the Practice Experiences for School 
Reintegration (PrESR) program. During its development, we have sought feedback from school professionals, 
hospital clinicians, and adolescents previously hospitalized for a suicide-related crises. Difficult school scenarios 
are based on this expert feedback, and also built from our previous work identifying adolescent, parent, school 
professional, and hospital professional perceptions of school-related influences of suicide-related risk (M. E. 
Marraccini, Pittleman, et al., 2022). 
 
2.2  Scientific Rationale 
This pilot optimization trial will be used to prepare for a fully powered optimization trial and RCT by investigating 
acceptability and feasibility of study procedures, assessment protocols, intervention delivery, candidate 
intermediary variables, and candidate outcomes with the PrESR intervention with a sample of 48 hospitalized 
adolescents randomized to VR conditions (using a balanced 2x2x2 full factorial).  
 
The inclusion criteria are based on the target population (i.e., adolescents hospitalized for suicide-related risk), with 
specific exclusions (i.e., active psychosis, intellectual disability) based on expert feedback during model 
development (unpublished data collected from earlier phases of the study). 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
15 
Template Version  1.0            2021-09-09 
The specific skills taught, and length of virtual experiences were selected based on previous research (Blanz & 
Schmidt, 2000; Frazier et al., 2016; Green et al., 2007)  and expert feedback during the development phase 
(Marraccini et al., 2024). 
The approach of adding the research intervention to usual care ensures that no youth will receive less than what is 
typically considered to be the standard of care in these facilities.  
3. Specific Aims 
 
The larger study involves several aspects of preparation of the MOST phase, specifically involving developing, 
refining, and pilot testing the intervention. Aims for the pilot optimization component of the MOST preparation 
phase addressed in this protocol are: 
 
3.1 Aim 1 
Conduct a pilot optimization trial of the PrESR to examine feasibility and acceptability of identifying, 
enrolling, and retaining participants at the hospital.  
 
3.2 Aim 2 
Conduct a pilot optimization trial of the PrESR to examine feasibility and acceptability of implementing 
assessment protocols (including motion sickness screening), fidelity of the intervention delivery (including 
applying the PrESR to existing hospital CBT protocols), measuring candidate intermediary variables (i.e., 
threat habitation, cognition), and measuring candidate outcomes (psychological distress, self-efficacy, 
suicidal thoughts and behaviors, and rehospitalization). 
 
3.3 Exploratory Aim 
Because this study is a treatment development study, an exploratory aim is to calculate descriptive statistics 
for candidate outcome variables to inform power for a future study that examines efficacy of the 
intervention. 
 
4 Study Design 
 
This Stage I Behavioral Intervention Development study follows a multiphasic optimization (MOST) research 
design to prepare for a subsequent fully powered optimization trial and RCT; this clinical trial is considered to be a 
pilot optimization component of the MOST framework. MOST is a comprehensive framework for optimizing and 
evaluating multi-component behavioral interventions. MOST has three phases: preparation, optimization, and 
evaluation (Collins & Kugler, 2018), with the optimization trial typically following a factorial design.  
 
For the present study, a prospective sample of adolescents (N= 48) hospitalized for suicidal thoughts and behaviors 
will be randomly selected into one of 8 experimental conditions (N=5-6 per group) adhering to the “intent to treat” 
principle.  
 
Adolescents will be invited to participate based on pre-screening of medical records to identify eligible participants. 
Prior to or immediately following consent/permission/assent procedures, adolescent participants will complete a 
motion sickness susceptibility questionnaire. Adolescents at risk for developing Cybersickness (Kidd et al., 2014), 
which is defined as 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire (Golding, 
1998), will be excluded from the study based on screen failure. 
 
The intervention will be tested during the participant’s index hospitalization, with data collection at baseline, over 
the 2-week period post-school re-entry, at 2-weeks post-school re-entry, and 3-months post-school re-entry 
(longitudinal). Participation is expected to take approximately 12 hours, and include consent/assent (30 min.), 3-7 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
16 
Template Version  1.0            2021-09-09 
intervention sessions (up to 50 min. each), and assessment procedures at all time points (90 min. each; see Figure 1 
in Marraccini et al., 2025). 
 
As part of training in the new research intervention, research staff are being trained to provide validation of any 
difficulties and coping strategies reduce distress. In addition, participants are informed that participation in this 
study is voluntary and that they can withdraw without penalty. If participants become distressed when completing 
assessments, or are too distressed to complete assessments, research staff can discontinue or delay the assessments 
at that point.  
 
Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this 
study will also aim to recruit 2-5 clinicians to deliver the intervention to inform acceptability and feasibility of the 
intervention within their clinical workflow. 
4.1 End-of-Study Definition 
Participants are considered to have completed the study if they contribute data during hospitalization and then 
participate in the three-month follow-up assessment.  
4.2 Discontinuation of Study Intervention/Experimental Manipulation 
The study intervention or assessments may be discontinued if, in the judgment of direct care and clinical staff at the 
psychiatric facility, youths' clinical situation (e.g., their level of agitation) appears to be worsening as a result of 
continuing efforts to implement the intervention or conduct assessments. A participant may also be withdrawn if 
s/he is declining to complete the assessments for the study.  
4.3 Participant Discontinuation/Withdrawal from the Study 
Participation in this study is completely voluntary and participants (youth or guardians) are free to withdraw 
consent/assent at any time without penalty. The reason for participant discontinuation or withdrawal, if given, will 
be recorded.  Participant discontinuation or withdrawal will be recorded on case report forms.  
4.4 Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she fails to complete the follow-up assessment(s) and 
study staff are unable to contact the participant after at least three attempts. Before a participant is deemed lost to 
follow-up, the investigator or designee will make every effort to regain contact with the participant, including, at a 
minimum, three phone calls to the respective participant’s family whose contact information will be obtained 
during consent/assent.  
4.5 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 the funding agency, regulatory authorities, and any youth and family already in the follow-up 
phase of the study.  If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and will 
provide the reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
1. Determination of unexpected, significant, or unacceptable risk to participants: If 10 Serious Adverse Events 
occur in 10 subjects during baseline procedures or if 10 number of subjects have a 300% increase in distress 
(as measured by SUDS captured before and immediately following a practice experience in PrESR, averaged 
across practice sessions), the study will be suspended  
2. Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
3. Data that are not sufficiently complete and/or evaluable 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed and satisfy 
the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies (DSMB). 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
17 
Template Version  1.0            2021-09-09 
 
 
4.6 Intervention Design 
The PrESR intervention will focus on increasing acquisition and utilization of critical cognitive-behavioral skills 
for treating adolescents with suicidal thoughts and behaviors. Inpatient clinicians will provide standard treatment 
and adolescents will receive researcher provided worksheets instructing them on target cognitive behavioral skills 
(introduction to cognitive behavioral therapy, cognitive restructuring, problem solving, and affect regulation) 
aligning to worksheets used as part of typical hospital protocol. Adolescents will practice skills using the PrESR 
with clinical guidance and feedback. Sessions begin with an overview of the skill to be practiced, followed by a 
brief immersive experience using virtual reality designed to mimic difficult school experiences in which 
adolescents are able to practice the learned skill. Participants receiving the intervention will also be provided with a 
workbook used during sessions that align to their lessons and practices in PrESR. 
  
Following a similar format to other therapeutic VR programs, research clinicians will observe adolescents wearing 
standard headsets as they practice coping strategies. At the end of the program, the adolescent and clinician will 
develop a safety plan designed to address the return to school, based on these in vivo sessions and, if possible, in 
collaboration with the school. Selection of individual VR scenarios and number of lessons delivered to teach each 
CBT skill is determined based on the needs of individual patients, with the goal of providing at least two practice 
opportunities per skill. Note that although participants are randomized based on skill components (affect regulation, 
cognitive restructuring, problem solving), all participants receiving at least one component of the intervention will 
also collaborate on a safety plan. 
 
This specific sequence was selected to allow individuals to become habituated to anxiety or distress provoking 
situations, and to use coping skills accordingly. The conceptual model (shown in Figure 1 in Marraccini et al., 
2025) posits two mechanisms for change that lead to skill mastery and application: (1) habituation to fear based on 
inhibitory learning; and (2) cognitive shifts in beliefs and appraisals. As adolescents begin to increase their 
tolerance to these difficult experiences and shift away from faulty thinking and towards acceptance, they are able to 
build and apply skills in low-risk settings initially (i.e., mixed reality settings during hospitalization) and extend 
them into higher risk settings (i.e., in school post-discharge). 
 
Inhibitory learning with exposure increases fear tolerance by building new (secondary) non-threat based 
associations (i.e., school experiences and skill use) with the original threat-based associations (i.e., school 
experiences and psychological distress) remaining intact (Kidd et al., 2014). Because habituation is understood as 
dynamic throughout exposure, in that it can deescalate and escalate in accordance with the intensity of exposure 
(Jobes, 2017), it will be measured with a Subjective Units of Distress Scale (SUDS) provided by researchers before, 
between, and following VR sessions to measure self-reported levels of distress. Note, however, that the PrESR 
differs from classic exposure therapy in that it is active, as opposed to passive. Where habituation during exposure 
discourages the use of skills such as cognitive restructuring, relaxation techniques, and distraction, because they are 
posited to interfere with habituation (Jobes, 2017), the PrESR proposes to enhance skill development through 
applied practice in in vivo like experiences. Thus, in addition to tolerance of fear, improvements in outcomes are 
also expected to be mediated by changes in cognition. Cognitive shifts in thinking are accomplished via the PrESR 
by providing data to challenge faulty thinking and appraisals, reciprocally reinforced by and reinforcing increased 
fear tolerance. 
 
These initial increases in fear tolerance and positive changes in cognitions are expected to lead to both reduced 
psychological distress and increased emotional self-efficacy in school, which ultimately will reduce rates of re-
hospitalization and subsequent suicidal thoughts and behaviors.  
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
18 
Template Version  1.0            2021-09-09 
4.7 Experimental Design    
A prospective sample of adolescents (N= 48) hospitalized for suicidal thoughts and behaviors will be recruited from 
a psychiatric inpatient unit. An even number of participants will be assigned into one of eight conditions (see Table 
shown in Figure 2) in block sizes of 8, 16, or 24 to ensure equal assignment and avoid selection bias. As described 
in previous sections, treatment conditions are informed by a MOST framework, with conditions varying based on 
participation in the PrESR for specific skills or enhanced treatment as usual (i.e., provision of worksheets teaching 
CBT skills). Because this is a pilot trial, randomization will not be stratified; however, because gender identity may 
be an important stratification variable in a future, fully powered trial, we will collect information related to gender 
identity to inform stratification procedures in the future. A biostatistician with no other study responsibilities will 
set up randomization tables for use in REDCap (a secure web-based service for building and managing online 
surveys and databases), and other research staff will not have access to the tables. Participants will be randomized 
following the baseline assessment using the randomize feature in REDCap. This ensures allocation concealment. 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
19 
Template Version  1.0            2021-09-09 
Figure 2.  Randomized MOST pilot trial of PrESR.  
 
  
Recruitment 
and Screening 
 
 
 
 
 
 
Verification of Eligibility 
and Enrollment 
 
 
 
Baseline 
Assessments 
(during 
Hospitalization) 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
(during  
hospitalization) 
 
 
23 Factorial Experimental Design for Optimization Trial 
Exp. Condition 
A. 
Cognitive 
Restructuring 
B. 
Problem-
Solving 
C. 
Affect 
Regulation 
n 
1 
Yes 
Yes 
Yes 
4-6 
2 
Yes 
Yes 
Yes + PrESR 
4-6 
3 
Yes 
Yes + PrESR 
Yes 
4-6 
4 
Yes 
Yes + PrESR 
Yes + PrESR 
4-6 
5 
Yes + PrESR 
Yes 
Yes 
4-6 
6 
Yes + PrESR 
Yes 
Yes + PrESR 
4-6 
7 
Yes + PrESR 
Yes + PrESR 
Yes 
4-6 
8 
Yes + PrESR 
Yes + PrESR 
Yes + PrESR 
4-6 
Review medical records to identify eligible participants. 
Obtain informed consent (permission, assent, and/or consent).   
Obtain screening data, clinician approval, and screening data (MSSQ). 
Apply inclusion and exclusion criteria.  
Begin intervention components A, B, C 
 
Randomization into one of eight conditions 
Enrollment of Eligible 
Patients 
Perform additional baseline assessments (adolescent self-report version of 
SoCT, SITB, CSSRS, CTAS, CBTSQ, CASI, BHS, PROMIS, ASCS, SCS, 
ATQ, ESE, demographics).  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
20 
Template Version  1.0            2021-09-09 
 
 
 
  
 
 
 
Intervention 
Assessments 
(during  
hospitalization) 
 
 
 
Daily Assessments 
(2-week period 
following school 
reintegration) 
  
 
 
 
2-week assessment 
(2-weeks 
following school 
reintegration) 
  
 
 
3-month assessment 
(3-months 
post school re-entry) 
  
 
4.8  Measurement Design 
Feasibility and acceptability 
For Aim 1 (examine feasibility and acceptability of identifying, enrolling, and retaining participants at the 
hospital), the following measures will be administered/collected:  
1. 
Proportion of patients in the target population who agree to participate 
a) Rate of Recruitment, with a minimum of 80% considered adequate 
b) [Time Frame: Baseline] 
2. 
Proportion of patients in the target population excluded due to motion sickness screening 
a) Rate of recruitment related to motion sickness, with participant scores greater or equal than 
50th percentile on motion sickness susceptibility questionnaire excluded 
b) [Time Frame: Baseline] 
3. 
Proportion of participants who complete all study procedures, including reasons participants cite 
for withdrawing from the study. 
Follow-up assessments of candidate intermediaries, candidate outcome measures, and 
safety (SoCT, PCTS, SUDS, SSQ, SITB, CSSRS, CTAS, CBTSQ, CASI, BHS, PROMIS, 
ASCS, SCS, ATQ, ESE, feedback form, qualitative interview).  
Daily assessments of candidate outcome measures. 
2-week follow-up assessments of candidate outcome measures (SoCT, 
SITB, CSSRS, CTAS, CBTSQ, CASI, BHS, PROMIS, ASCS, SCS, 
ATQ, ESE, demographics, feedback form). 
Final 3-month follow-up assessments of candidate outcome measures 
(SoCT, SITB, CSSRS, CTAS, CBTSQ, CASI, BHS, PROMIS, ASCS, 
SCS, ATQ, ESE, demographics).  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
21 
Template Version  1.0            2021-09-09 
a) Rate of Retention 
b) [Time Frame: up to 3-months following school re-entry] 
 
 
For Aim 2 (examine feasibility and acceptability of implementing assessment protocols [including motion sickness 
screening], fidelity of the intervention delivery [including applying the PrESR to existing hospital CBT protocols], 
candidate intermediary variables (i.e., threat habitation, cognition), and candidate proximal and distal outcomes 
[psychological distress, self-efficacy, suicidal thoughts and behaviors, and rehospitalization]), the following 
measures will be administered/collected:  
 
 
4. 
Average number of hours to complete assessments at each time point 
a) Time to complete assessments, assessments are expected to last less than 4 hours, with average 
completion time less than 2 hours considered adequate  
b) [Time Frame: up to 3-months following school re-entry] 
5. 
Average number of minutes to complete each intervention session 
a) Time to complete intervention sessions, each session is expected to last less than 60 minutes, 
with average time to compete a session below 50 minutes considered adequate 
b) [Time Frame: Baseline] 
6. 
Average proportion of components of intervention fidelity checklist completed 
a) Fidelity of intervention delivery 
b) [Time Frame: Baseline] 
7. 
Adolescents' Mean Acceptability Scores (feedback form) 
a) Percent of adolescents with average acceptability Score less than or equal to 2), with ratings 
averaging to 2 (or “agree”) on a five-point scale from 1 (strongly agree) to 5 (strongly disagree) 
related to acceptability considered adequate.  
b) [Time Frame: Baseline] 
8. 
Professionals' Mean Acceptability Scores (feedback form) 
a) Percent of professionals with average acceptability score less than or equal to 2), with ratings 
averaging to 2 (or “agree”) on a five-point scale from 1 (strongly agree) to 5 (strongly disagree) 
related to acceptability considered adequate. 
b) [Time Frame: Baseline] 
9. 
Adolescents' Perceptions of Acceptability (audio recorded exit interviews) 
a) Qualitative feedback based on transcribed interviews. 
b) [Time Frame: Baseline] 
10. 
Professionals' Perceptions of Acceptability (audio recorded exit interviews) 
a) Qualitative feedback based on transcribed interviews. 
b) [Time Frame: Baseline] 
 
Exploratory Aim: Assessment of Candidate Proximal Outcomes  
As a treatment development study, this project is not powered to test hypotheses regarding efficacy. To demonstrate 
the potential viability of the approach, we will use this data to obtain precise enough estimate of these statistics in 
order to make reasonable guesses as to how to design the fully powered and definitive trial. Additionally, feasibility 
and acceptability of collecting other outcomes of interest (mechanisms and distal outcomes) require the following 
measures to be collected/administered (outcome measures are shown in Table 1): 
 
Exploratory Intermediary Variables: Threat habituation: Subjective Units of Distress Scale (SUDS); 
Cognition: Automatic Thoughts Questionnaire (ATQ-30);  
 
Exploratory Candidate Proximal Primary Outcomes: Psychological distress: Child Anxiety Sensitivity Index 
(CASI); Beck Hopelessness Scale (BHS); Emotional Distress-Anxiety/Depression - Pediatric Short Form 
(PROMIS). Self-efficacy: Emotional Self-Efficacy (ESE) measure.  
 

Practice E x perie nces f or Sc h o ol Rei nte grati o n  
  
Versi o n 1 .1 1  
U N C I R B Pr ot oc ol I D # 2 0 -3 4 3 6  
 
1 6 J U L Y 2 0 2 5  
I nter ve nti o nal or O bser vati o nal Pr ot oc ol                                                                                                                                                                                 Pa ge   
2 2  
T e m plate Versi o n  1. 0            2 0 2 1 -0 9 -0 9  
E x pl or at or y C a n di d ate Dist al Pri m ar y O utc o mes: S uici d al t h o u g hts a n d be h avi ors: Self -I nj uri o us T h o u g hts 
a n d Be ha vi ors I nter vie w ( SI T B); C ol u m bia S uici de S e verit y Rati n g S c ale  ( C S S R S). Re h os pit aliz ati o n: M e dic al 
Re c or d Re vie w.  
 
A d diti o n al E x pl or at or y C a n di d ate S ec o n d ar y O utc o mes:  S kill use a n d u n derst a n di n g: Perf or ma nc e of 
C o g niti ve T her a p y Strate gies ( P C T S) assess me nt; C o g niti ve -Be ha vi or T hera p y S kills Q uesti o n naire ( C B T S Q); 
C o g niti ve T her a p y A ware ness Sc ale ( C T A S); S kills of C o g niti ve T hera p y ( S o C T); Dail y diar y of diffic ult sc h o ol 
e x perie nc es, s uici dal t h o u g hts a n d be ha vi ors, s kill use, a n d safet y pla n use f or 2 -wee ks p ost sc h o ol re -e ntr y peri o d. 
S c h o ol e x perie n ces : A ut h oritati ve Sc h o ol Cli mate S ur ve y ( A S C S); S c h o ol C o n necte d ness S cale ( S C S). 
 
Assess m e nt of S er vic e Use F oll o wi n g Rele ase : W it h c o nse nt/asse nt of pare nts a n d a d olesce nts, we will o btai n 
a d olesce nts’ tr eat me nt rec or ds. Rec or ds will be use d t o verif y t he n u m ber, d urati o n, a n d fre q ue nc y of c o ntacts wit h 
me ntal he alt h pr o vi ders.  
 
Ta ble 1 . Ca n di date O utc o me Me as ures  
I nstr u m e nt or 
M e as ur e m e nt 
N a m e  
Ti me Fr a me  
Brief Desc ri pti o n  
S c ori n g  
M oti o n Sic k ness 
S usc e pti bilit y 
Q uesti o n nair e  
Pre -
e nr oll me nt 
A me as ure use d t o e val uate m oti o n 
sic k ness i n vari o us f or ms of 
tra ns p ort 
R a n ge :  
Eli gi bilit y S c ore: 
 5 0 %  
S elf -I nj uri o us 
T h o u g hts a n d 
Be ha vi ors  I nter vie w 
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit  
A str uct ure d i nter vie w t hat assesses 
t he prese nc e, fre q ue nc y ( n u m ber of 
e pis o des) a n d se verit y of a ra n ge of 
self-i nj uri o us t h o u g hts a n d be ha vi ors 
R a n ge: 0 -4  
Fr e q ue ncies  
C ol u m bia S uici de 
S e verit y Rati n g 
S c ale  
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit  
A me as ure use d t o i de ntif y a n d 
assess i n di vi d ual ris k f or s uici de  
R a n ge: 0 -5  
Fr e q ue ncies  
C o g niti ve T her a p y 
A ware ness Sc ale  
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit  
4 0 tr ue -false q uesti o ns a b o ut basic 
C B T c o nc e pts a n d met h o ds  
Tr u e/ F alse  
C o g niti ve -Be ha vi or 
T her a p y S kills 
Q uesti o n nair e  
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit  
1 6 ite m self -re p ort me as ure t o assess 
fre q ue nc y of be ha vi oral acti vati o n 
a n d c o g niti ve restr uct uri n g 
R a n ge:  5 -p oi nt scale (I d o n’t 
d o t his t o I al wa ys d o t his)  
C hil d A n xiet y 
S e nsiti vit y I n de x  
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit  
1 8 ite m self -re p ort me as ure t o assess 
h o w res p o nsi ve c hil dre n are t o 
vari o us s y m pt o ms of a n xiet y  
R a n ge: 3 -p oi nt scale ( N o ne, 
S o me, A L ot)  
Be c k H o peless ness 
S c ale  
H os pitalizati
o n, 2 -W ee k 
Visit, 3 
M o nt h Visit   
2 0 ite m self -re p ort me as ure t hat 
me as ures t hre e maj or as pe cts of 
h o peless ness: feeli n gs a b o ut t he 
f ut ure, l oss of m oti vati o n, a n d 
e x pe ctati o n  
Tr u e/ F alse  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
23 
Template Version  1.0            2021-09-09 
Emotional Distress-
Anxiety/Depression 
- Pediatric Short 
Form (PROMIS) 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit   
8 item self-report measure that 
assesses fear, anxious misery, 
hyperarousal, somatic symptoms 
related to arousal, negative mood, 
views of self, social cognition, as 
well as decreased positive affect and 
engagement 
Range: 5-point scale (Never 
to Always) 
Authoritative School 
Climate Survey 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit   
Survey to assess school climate and 
bullying in school settings 
Range: Variable by 
component (e.g., 1-4; 1-3) 
Frequencies 
School 
Connectedness 
Scale 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit   
54 item survey that reflects students’ 
belief that peers and adults in the 
school support, value, and care about 
their individual well-being as well as 
their academic progress 
Range: 5-point scale (Not at 
all true to Completely true) 
Automatic Thoughts 
Questionnaire 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit   
30 item questionnaire that measures 
the frequency of occurrence of 
automatic negative thoughts 
associated with depression 
Range: 5-point scale (Not at 
all to All the time) 
Emotional Self-
Efficacy Measure 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit   
7 item measure focused on the 
measurement of self-beliefs in 
relation to the management of 
emotions 
Range: 5-point scale (Not at 
all to Very well) 
Skills of Cognitive 
Therapy Strategies 
Hospitalizati
on, 2-Week 
Visit, 3 
Month Visit 
8 item self-report measure that assess 
understanding and use of basic 
cognitive therapy skills  
Range: 1-5 (Never to Always 
or When needed) 
Skills of Cognitive 
Therapy Strategies 
Hospitalizati
on 
8 item self-report measure that 
assesses understanding and use of 
basic cognitive therapy skills 
Range: Multiple Choice 
(Correct/Incorrect) 
 
Performance of 
Cognitive Therapy 
Strategies 
Hospitalizati
on 
15 item measure completed by a 
clinician to assess mastery and 
independent use of material covered 
in cognitive therapy 
Range: 0-6 
Subjective Units 
Distress Scale 
Hospitalizati
on 
Tool for measuring the intensity of 
your feelings and other internal 
experiences 
Range: 0-10 
Simulator Sickness 
Questionnaire 
Hospitalizati
on 
16 item questionnaire that assesses 
sickness levels before and after 
immersion in VR 
Range: 4-point scale (None 
to Severe) 
Daily diary of 
events, skill use, 
distress 
Over 2 
Weeks 
 
Range: Variable by skill 
(e.g., affect regulation, 
cognitive restructuring, 
problem solving) 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
24 
Template Version  1.0            2021-09-09 
Across aims, variables of interest are show in in Table 2. 
Table 2.  Variables of interest: Their occasions of evaluation, their uses for the aims, their roles in the study 
Variables within Domains 
Scale1 
Occasions2  Aims 
Main Roles3 
Identifiers 
 
 
 
 
Participant’s unique ID 
nominal 
all 
all 
identifier 
Experimental Condition (1-8) 
nominal 
E 
all 
identifier 
Feasibility and Acceptability Measures 
 
 
 
 
Rates of recruitment 
proportion 
0 
1 
Feasibility and 
Acceptability 
Rates of retention 
Proportion 
1, 2, 3, 4 
1 
Feasibility and 
Acceptability 
Time to complete assessments 
minutes 
All 
2 
Feasibility and 
Acceptability 
Assessment of intervention fidelity 
Checklist 
1 
2 
Feasibility and 
Acceptability 
Adolescent exit interview and feedback 
form 
Open text/response 
and ordinal 
1 
2 
Feasibility and 
Acceptability 
Professional exit interview and feedback 
form 
Open text/response 
and ordinal 
1 
2 
Feasibility and 
Acceptability 
Adolescent retrospective feedback form 
Open text/response 
and ordinal 
3 
2 
Feasibility and 
Acceptability 
Medical Records 
 
 
 
 
Reason for hospitalization 
categorical 
1, 4 
all 
Identifier 
primary outcome 
Admission Date 
date 
1, 4 
all 
covariate uses 
Discharge Date 
date 
1, 4 
all 
covariate uses 
Diagnosis 
categorical 
1, 4 
all 
Exploratory primary 
outcome 
screening 
Age 
decimal yrs 
1, 4 
all 
covariate uses 
Sex 
categorical 
1, 4 
all 
covariate uses 
Stressors 
Open text 
1, 4 
all 
covariate uses 
screening 
Medications 
Open text 
1, 4 
all 
covariate uses 
screening 
Treatment 
Open text 
1, 4 
all 
covariate uses 
Researcher Observation 
 
 
 
 
Skills of Cognitive Therapy Strategies 
Ordinal 
1 
All 
Exploratory candidate 
intermediary outcome 
Performance of Cognitive Therapy 
Strategies 
Ordinal 
1 
all 
Exploratory candidate 
intermediary outcome 
Patient-Reported Outcomes 
 
 
 
 
Self-report demographic information 
Ordinal 
1,3,4 
all 
Covariate 
Cognitive Therapy Awareness Scale 
Score 
1, 3,4 
all 
Exploratory candidate 
secondary  
Cognitive-Behavior Therapy Skills 
Questionnaire 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
secondary  
Skills of Cognitive Therapy 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
secondary  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
25 
Template Version  1.0            2021-09-09 
Child Anxiety Sensitivity Index 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
primary  
Beck Hopelessness Scale 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
primary  
Emotional Distress-Anxiety/Depression - 
Pediatric Short Form (PROMIS)  
Ordinal 
1, 3,4 
all 
Exploratory candidate 
primary  
Authoritative School Climate Survey 
Ordinal 
1, 3,4 
all 
Exploratory uses 
School Connectedness Scale 
Ordinal 
1, 3,4 
all 
Exploratory uses 
Subjective Units Distress Scale (SUDS) 
Ordinal 0-10 
1 
All 
Exploratory candidate 
intermediary 
Automatic Thoughts Questionnaire 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
intermediary 
Emotional Self-Efficacy Measure 
Ordinal 
1, 3,4 
all 
Exploratory candidate 
primary 
Daily diary of events, skill use, distress 
Multi-dim 
2 
All 
Exploratory candidate 
secondary  
Clinical Interviews 
 
 
 
 
Self-Injurious Thoughts and Behaviors 
continuous 
1, 3,4 
all 
Exploratory candidate 
primary  
Columbia Severity for Suicide Rating Scale 
continuous 
1, 3,4 
all 
Exploratory candidate 
primary  
Safety Monitoring 
 
 
 
 
AEs and SAEs documentation 
events 
1, 3,4 
all 
safety monitoring 
Simulation Sickness Questionnaire 
Ordinal 
1 
all 
safety monitoring 
Motion sickness susceptibility 
questionnaire 
Ordinal 
0 
N/A 
safety monitoring 
Feasibility and acceptability 
 
 
1 Units of measurement or the scale. 
 
 
2 Occasions of evaluation or retrieval:     O = screening, 1 = hospitalization, 2 = over 2 weeks,  
3 = 2-week visit, 4 = 3 month visit E = experimental 
condition 
 
3Main roles include: Feasibility and acceptability (the estimates of interest), Study Identifiers, Safety 
Monitoring, and Measures that are integrated as part of the protocol in order to inform 
feasibility and acceptability of study protocols (Primary Outcomes, Secondary Outcomes, 
Intermediaries) 
5. Study Participants 
5.1 Numbers of Participants 
 
5.1.1 Number to be screened:  n  1000 adolescents; n  12 hospital professionals. 
 
Adolescent Participants 
Initial screening will be based on medical chart records of patients hospitalized for a suicide-related billing code 
during hospitalization, and some may not be eligible for enrollment based on additional exclusion criteria.  
 
Hospital Professional Participants 
Hospital professional participants working on the adolescent inpatient unit at UNC Hospital and/or UNC Youth 
Behavioral Health will be invited to pilot the PrESR. 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
26 
Template Version  1.0            2021-09-09 
 
5.1.2 Number to be enrolled:   N = 48 adolescents; N = 2-5 hospital professionals (maximum of 
12). 
 
Recruitment will continue until N = 48 adolescent individuals have completed all aspects of the protocol and have 
complete data or the study end date. We anticipate approximately 20% attrition, with N = 35 a conservative lower 
limit. We also anticipate that more adolescents will be consented into the study and excluded due to screening 
procedures following consent (see exclusion criteria). 
 
The pilot optimization trial will occur at 1-2 UNC Hospitals, well-known as a leading center for psychiatric care. 
UNC is well positioned to integrate the PrESR into their program given their clinical care’s emphasis on school 
readiness and use of CBT and skill-building tailored to individual needs.  
As described previously, participants will be randomized to 1 of 8 conditions. As shown in Figure 2, between 4-6 
participants will be enrolled one of the eight conditions. 
 
5.2 Eligibility Criteria 
 
Based on hospitalization data, adolescents are expected to be 65% female, 15% Hispanic or Latino, 65% 
Caucasian and 30% minority across all aims. 
Hospital professionals anticipated to include 2-5 participants may include any professionals providing 
services to hospitalized youth using CBT in their treatment, including any of the following: hospital 
teacher, attending physician, occupational therapist, recreational therapist, psychologist, trainee, or fellow.  
 
 
5.2.1. Inclusion Criteria  
Adolescent Participants 
To be eligible to participate in this study as an adolescent, an individual must meet all of the 
following criteria: 
• 
Current hospitalization for suicidal thoughts and behaviors based on medical chart review 
• 
Ages 13-18 based on medical chart review 
• 
Expected return to school following discharge based on self-report* 
• 
Approval of treating clinician 
• 
Ability to speak, read, and understand English sufficiently to complete study procedures based on 
medical chart review and self-report 
• 
Consent of a parent/legal guardian (in English or Spanish) 
• 
Adolescent assent 
 
*Adolescent patients receiving the intervention delivered by hospital professional participants may participate 
irrespective of school status (and do not need to be “expected to return to school following discharge”) 
 
Hospital Professional Participants 
To be eligible to participate in this study as a hospital professional, an individual must serve in a clinical 
role providing treatment to adolescents on the UNC inpatient unit. 
 
 
5.2.1. Exclusion Criteria  
 
Exclusion criteria was selected to maintain participant safety. 
Adolescent Exclusion Criteria 
Any individual who meets one or more of the following criteria will be excluded from participation: 
• 
Active psychosis based on medical chart review and/or clinician feedback 
• 
Intellectual disability based on medical chart review, self-report and/or clinician feedback 
• 
Risk for cybersickness based on score on Motion Sickness Susceptibility Questionnaire in combination 
with clinician feedback 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
27 
Template Version  1.0            2021-09-09 
Hospital Professional Exclusion Criteria 
N/A 
5.3 Enrollment/Selection Strategies 
 
5.3.1.  Prospective Recruitment    
A prospective sample of hospitalized adolescents will be recruited during their hospital stay. The study will use 
effective recruitment protocols involving approval from the treating clinician, screening via chart review, and 
approach and consent completed by way of family phone communication. 
 
The PI of the study has experience recruiting hospitalized adolescents with suicide-related risk in her role as a 
postdoctoral fellow on a federally funded grant and additional experience in recruiting adolescents with suicide-
related risk following hospitalization on several research studies as PI. 
 
Because this study focuses on adolescents, specific protections will be employed. Decisions regarding whether an 
adolescent will be invited to participate or not will be determined in collaboration with their attending physician. 
Adolescents will also be screened for risk of motion/cyber sickness. 
 
We will take precautions to minimize coercion to participate. We will emphasize the voluntary nature of the study 
and remind participants that they may discontinue at any time. Members of the research team will be trained to be 
respectful towards participants' preferences regarding participation. We will present information verbally and in 
writing on the consent form to ensure participants are aware of the voluntary nature of the study. The informed 
consent procedure will include a careful explanation of study procedures, risks, benefits, and alternatives. We have 
selected compensation rates that we believe will not be excessive or coercive for adolescents. All participating 
children will complete assent procedures after or simultaneously to when consent is given by parents. Children can 
refuse to answer individual questions or withdraw from the study at any time. 
 
 
 
5.3.2. Screen Failures    
We expect approximately 20% of consented individuals to be ineligible for the study following consent due to 
cybersickness. Accordingly, we will explain this exclusion criteria during the consent process. We do not expect 
individuals determined to be ineligible will be re-screened given the short-time frame available to complete study 
procedures during hospitalization. 
5.4 Strategies for Retention 
We will use effective strategies for retention used in previous studies, including collecting contact information from 
multiple members of the family (based on family preference to respect any privacy concerns related to eligibility 
for study) and providing study visit reminders. As needed, we will also develop protocols for follow-ups 
administered remotely in cases where transportation is difficult. 
5.5 Matching and Stratification 
Youth identifying as gender diverse at greater risk for suicide-related thoughts and behaviors compared to those 
identifying as cisgender (Marraccini, Ingram, et al., 2022). We will collect information about gender identity 
(cisgender boy, cisgender girl, or gender diverse [e.g., transgender or nonbinary]) based on participant self-report. 
Given the small sample size of this pilot study and the anticipated low frequencies of some gender groups, we will 
not stratify by gender identity but will focus our efforts on capturing information on the distribution of gender that 
will inform a stratification procedure for a future, fully powered trial that will have large enough recruitment to 
target a balanced design. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
28 
Template Version  1.0            2021-09-09 
5.6 Randomization and Concealment 
A biostatistician with no other study responsibilities will set up randomization tables for use in REDCap (a 
secure web-based service for building and managing online surveys and databases), and other research staff 
will not have access to the tables. Participants will be randomized following the baseline assessment using the 
randomize feature in REDCap. This ensures allocation concealment. 
5.7  Blinding 
We will not use blinding procedures in this study. 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
29 
Template Version  1.0            2021-09-09 
6 Treatment Design: Procedures 
Description    
As shown in Table 10.1, there are 8 intervention conditions with 4-6 participants per condition. Each condition is 
based on whether or not the participant receives the virtual reality supplement (PrESR) to learning three skills: 
affect regulation, cognitive restructuring, problem solving. All three skills will be provided by way of worksheets 
provided by researchers to all participants (irrespective of condition assignment). For each skill, if participants 
receive the supplemental intervention, participants will be guided to learn and practice the skill in a virtual reality 
session under the supervision of a trained researcher. Skills are introduced, and then participants engage in an 
immersive school scenario that involves several difficult social interactions and/or academic stressors, in which the 
participant can pause and practice using the target skill. At the close of each session, participants will complete a 
debrief with the onsite researcher. If participants receive any component of the intervention (conditions 2-8), they 
will also collaborate on a safety plan at the conclusion of the intervention. 
 
Adherence Monitoring/Evaluations   Researchers will be observing participants during sessions to monitor 
participation in treatment.  
 
Concomitant Therapies   Youth receiving the new intervention will receive usual care as part of their 
hospitalization stay and also complete worksheets provided by researchers to teach each of the three CBT skills 
(affect regulation, cognitive restructuring, problem solving). Families will be provided an authorization to release 
information, and, with permission, information from the assessments collected as part of the study will be shared 
with clinical staff and with the evaluating clinician so they can better address the needs of youth who have been 
suicidal. Concomitant therapies will be assessed at the 2-week and 3-month follow-up assessments based on 
medical record review.  
7 Schedule of Activities and Procedures 
7.1 Table of Events 
Schedule of Activities 
 
Hospital Stay 
Post-Hospital Discharge 
 
Psychiatric 
Hospital 
Admission 
(Day 0) 
Hospital 
Stay 
(Days 1-
Discharge)1 
Two-Week 
Assessments 
(Days 1-14 
following return to 
school2) 
Two-Week 
Follow-Up 
Assessments 
(Day 15-35 
following 
return to 
school) 
Three-Month 
Follow-Up 
Assessments 
(Day 84-112 
following 
return to 
school) 
Pre-screening, Motion 
Sickness Susceptibility 
Questionnaire, and 
Consent/Assent 
X 
 
 
 
 
Baseline assessments  
 
 
 
 
 
Self-Injurious Thoughts and 
Behaviors Interview 
 
X 
 
 
 
Columbia Suicide Severity 
Rating Scale 
 
X 
 
 
 
Cognitive Therapy 
Awareness Scale 
 
X 
 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
30 
Template Version  1.0            2021-09-09 
Cognitive-Behavior 
Therapy Skills 
Questionnaire 
 
X 
 
 
 
Skills of Cognitive Therapy 
(self-report) 
 
X 
 
 
 
Child Anxiety Sensitivity 
Index 
 
X 
 
 
 
Beck Hopelessness Scale  
X 
 
 
 
Emotional Distress-
Anxiety/Depression - 
Pediatric Short Form 
(PROMIS)  
 
X 
 
 
 
Authoritative School 
Climate Survey 
 
X 
 
 
 
School Connectedness 
Scale 
 
X 
 
 
 
Automatic Thoughts 
Questionnaire 
 
X 
 
 
 
Emotional Self-Efficacy 
Measure 
 
X 
 
 
 
Medical Record  
X 
 
 
 
Interventions (Conditions 
1-8) 
 
 
 
 
 
Intervention assessments 
and safety monitoring 
 
 
 
 
 
Subjective Units Distress 
Scale 
 
X 
 
 
 
Simulator Sickness 
Questionnaire 
 
X 
 
 
 
Post-intervention 
assessment  
 
 
 
 
 
Self-Injurious Thoughts and 
Behaviors Interview 
 
X 
 
 
 
Columbia Suicide Severity 
Rating Scale 
 
X 
 
 
 
Cognitive Therapy 
Awareness Scale 
 
X 
 
 
 
Cognitive-Behavior 
Therapy Skills 
Questionnaire 
 
X 
 
 
 
Skills of Cognitive Therapy 
(self-report) 
 
X 
 
 
 
Skills of Cognitive Therapy 
(clinician-report) 
 
X 
 
 
 
Performance of Cognitive 
Therapy Strategies 
 
X 
 
 
 
Child Anxiety Sensitivity 
Index 
 
X 
 
 
 
Beck Hopelessness Scale  
X 
 
 
 
Emotional Distress-
Anxiety/Depression - 
Pediatric Short Form 
(PROMIS)  
 
X 
 
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
31 
Template Version  1.0            2021-09-09 
Automatic Thoughts 
Questionnaire 
 
X 
 
 
 
Emotional Self-Efficacy 
Measure 
 
X  
 
 
 
Exit interview and feedback 
forms 
 
X 
 
 
 
Abbreviated feedback form  
 
 
X 
 
At Home Assessments 
following return to school 
 
 
 
 
 
Daily diary of events, skill 
use, distress 
 
 
X 
 
 
Follow-up assessment with 
youth  
 
 
 
 
 
Self-Injurious Thoughts and 
Behaviors Interview 
 
 
 
X 
X 
Columbia Suicide Severity 
Rating Scale 
 
 
 
X 
X 
Cognitive Therapy 
Awareness Scale 
 
 
 
X 
X 
Cognitive-Behavior 
Therapy Skills 
Questionnaire 
 
 
 
X 
X 
Skills of Cognitive Therapy 
(self-report) 
 
 
 
X 
X 
Child Anxiety Sensitivity 
Index 
 
 
 
X 
X 
Beck Hopelessness Scale  
 
 
X 
X 
Emotional Distress-
Anxiety/Depression - 
Pediatric Short Form 
(PROMIS)  
 
 
 
X 
X 
Authoritative School 
Climate Survey 
 
 
 
X 
X 
School Connectedness 
Scale 
 
 
 
X 
X 
Automatic Thoughts 
Questionnaire 
 
 
 
X 
X 
Emotional Self-Efficacy 
Measure 
 
 
 
X 
X 
Medical Record  
 
 
 
X 
Exit interview and feedback 
forms for hospital 
professionals 
 
 
 
 
 
Feedback form  
X 
 
 
 
Interviews  
X 
 
 
 
1 
Should adolescents be discharged from the hospital prior to completion of baseline procedures, the 
adolescent will be invited to complete post-intervention assessments as soon as possible following 
discharge. 
2 
There may be a gap between hospital discharge and return to school. 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
32 
Template Version  1.0            2021-09-09 
7.2 Screening 
Screening will be conducted within 2 weeks of identification based on medical record review: Day 1 to Day 14.     
Screen assessments include: (1) review of medical record to confirm eligibility/exclusion; (2) approval from the 
treating clinician; (3) consent/assent of adolescent patient and parental permission (depending on age); (4) 
completion of motion sickness screening questionnaire. 
7.3 Enrollment  
Hospital Stay 
Psychiatric Hospital Admission (Days 0 to 14):  
• 
Verify inclusion/exclusion criteria 
• 
Consent/assent 
• 
Motion Sickness Screening Questionnaire 
     
7.4 Study Visits 
Hospital Stay 
Hospital Stay (Days 1-discharge):  
• 
Medical chart review 
• 
Complete baseline self-report questionnaires  
• 
Administer intervention and accompanying questionnaires/assessments/interviews (note that if participants 
are discharged prior to questionnaires/assessments/interviews, these will be conducted as soon as possible 
following discharge) 
• 
Record adverse events as reported by participant or observed by staff/investigator 
 
Post-Hospital Discharge and School Re-Entry 
Two-Week Assessments following return to school (Days 1-14): 
• 
Complete daily diary 
Two-weeks following return to school (Days 15-35): 
• 
Collect daily diary 
• 
Complete follow-up assessments and self-report questionnaires 
7.5 Final Visit 
Post-Hospital Discharge 
Three-months following return to school (Days 84-112): 
• 
Complete follow-up assessments and self-report questionnaires 
• 
Complete medical chart review 
7.6  Phone Contacts  
Participant and parent/guardian phone and email will be collected to support participant retention. Participants will 
be given scheduling and reminder calls and emails (depending on preference) prior to study visits.  
 
Two-Week Assessments (Days 1-14): 
• 
Reminder calls to complete daily diary (weekly, depending on participant preference) 
Two-weeks following return to school (Days 15-35): 
• 
Scheduling calls as needed, beginning day 1 of return to school (note that scheduling may occur during 
hospitalization, depending on participant availability) 
• 
Reminder calls, 3-5 days ahead of appointment and 1 day ahead of appointment 
Three-months following return to school (Days 84-112): 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
33 
Template Version  1.0            2021-09-09 
• 
Scheduling calls as needed, beginning day 70 of return to school  
• 
Reminder calls, approximately 3-5 days ahead of appointment and 1 day ahead of appointment 
 
   
7.8  Follow-Up Contact  
Follow-up appointments will collect information as outlined in schedule of activities and medical records will be 
reviewed for subsequent hospitalizations/evidence of suicidal thoughts and behaviors.        
7.9  Early Discontinuations 
Data to be Collected   
If a participant chooses to withdraw consent or chooses to discontinue the treatment that was being observed, or the 
investigator discontinues or modifies their treatment, the investigator will still collect medical records data for the 
duration of the study for follow-up purposes, even if the study intervention is discontinued.  
Criteria for Intervention Discontinuation   The study intervention or assessments may be discontinued if, in the 
judgment of direct care and clinical staff at the psychiatric facility, youths' clinical situation (e.g., their level of 
agitation) appears to be worsening because of continuing efforts to implement the intervention or conduct 
assessments. A participant may also be withdrawn if s/he is declining to complete the assessments for the study.  
7.10 Enrollees May Drop Out 
10 
Participation in this study is completely voluntary and participants (youth or caregivers) are free to withdraw 
consent/assent at any time without penalty. The reason for participant discontinuation or withdrawal, if given, 
will be recorded.  Participant discontinuation or withdrawal will be recorded on case report forms. 
Recruitment will continue until enrolled participants completing study procedures meet 48 participants or 
study end. 
8 Statistical Analysis Plans 
8.1 Strategies that Apply to all the Aims 
The analysis plans will include outcome-dependent exploratory analyses to generate new hypotheses. 
8.2  Sample Description 
Key statistics (means, SDs, correlations) and distributional properties of main outcomes will be calculated for each 
condition. It is noted that while randomization involves 4-6 individuals per 8 conditions, calculation of descriptive 
statistics and distributional properties of main outcomes will be based on approximately n=24 given that half of the 
48 participants receiving VR enhanced skills in each of the three components (A, B, and C; n=16-24 in each group); 
see Table 3 with highlighted rows showing 24 participants per intervention group for A, B, and C). Calculations 
will provide an assessment of candidate proximal outcome variables.  
Table 3. 
Factorial Experimental Design for Optimization Trial 
Exp. Condition 
A. Cognitive 
Restructuring 
B. Problem-
Solving 
C. Affect 
Regulation 
n 
1 
Yes 
Yes 
Yes 
4-6 
2 
Yes 
Yes 
Yes + PrESR 
4-6 
3 
Yes 
Yes + PrESR 
Yes 
4-6 
4 
Yes 
Yes + PrESR 
Yes + PrESR 
4-6 
5 
Yes + PrESR 
Yes 
Yes 
4-6 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
34 
Template Version  1.0            2021-09-09 
6 
Yes + PrESR 
Yes 
Yes + PrESR 
4-6 
7 
Yes + PrESR 
Yes + PrESR 
Yes 
4-6 
8 
Yes + PrESR 
Yes + PrESR 
Yes + PrESR 
4-6 
 
 
8.3  Aim-Specific Plans 
Feasibility and Acceptability 
 
The estimands of interest for Aim 1 are the following primary outcomes:  
 
1. 
Proportion of patients in the target population who agree to participate 
a) Rate of Recruitment, with a minimum of 80% considered adequate 
b) [Time Frame: Baseline] 
2. 
Proportion of patients in the target population excluded due to motion sickness screening 
a) Rate of recruitment related to motion sickness, with participant scores greater or equal than 
50th percentile on motion sickness susceptibility questionnaire excluded 
b) [Time Frame: Baseline] 
3. 
Proportion of participants who complete all study procedures, including reasons participants cite 
for withdrawing from the study. 
a) Rate of Retention 
b) [Time Frame: up to 3-months following school re-entry] 
 
The estimands of interest for Aim 2 are the following primary outcomes:  
 
 
4. 
Average number of hours to complete assessments at each time point 
a) Time to complete assessments, assessments are expected to last less than 4 hours, with average 
completion time less than 2 hours considered adequate  
b) [Time Frame: up to 3-months following school re-entry] 
5. 
Average number of minutes to complete each intervention session 
a) Time to complete intervention sessions, each session is expected to last less than 60 minutes, 
with average time to compete a session below 50 minutes considered adequate 
b) [Time Frame: Baseline] 
6. 
Average proportion of components of intervention fidelity checklist completed 
a) Fidelity of intervention delivery 
b) [Time Frame: Baseline] 
7. 
Adolescents' Mean Acceptability Scores (feedback form) 
a) Percent of adolescents with average acceptability Score less than or equal to 2), with ratings 
averaging to 2 (or “agree”) on a five-point scale from 1 (strongly agree) to 5 (strongly disagree) 
related to acceptability considered adequate.  
b) [Time Frame: Baseline] 
8. 
Professionals' Mean Acceptability Scores (feedback form) 
a) Percent of professionals with average acceptability score less than or equal to 2), with ratings 
averaging to 2 (or “agree”) on a five-point scale from 1 (strongly agree) to 5 (strongly disagree) 
related to acceptability considered adequate. 
b) [Time Frame: Baseline] 
9. 
Adolescents' Perceptions of Acceptability (audio recorded exit interviews) 
a) Qualitative feedback based on transcribed interviews. 
b) [Time Frame: Baseline] 
10. 
Professionals' Perceptions of Acceptability (audio recorded exit interviews) 
a) Qualitative feedback based on transcribed interviews. 
b) [Time Frame: Baseline] 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
35 
Template Version  1.0            2021-09-09 
 
Aims 1 and 2 are assessed qualitatively via transcribed audio recorded interviews, and quantitatively via feedback 
forms, rates of recruitment, retention, time to complete assessments and intervention, and monitoring of 
intervention fidelity. As such, feasibility, safety, and acceptability data are descriptive and qualitative and do not 
require null hypothesis significance testing analyses. 
 
Exploratory Aim: Assessment of Candidate Proximal Outcomes  
As a treatment development study, this project is not designed to test treatment efficacy. To demonstrate the 
potential viability of the approach, we will examine this data to estimate key statistics of our exploratory outcome 
variables (e.g., frequencies, distributional properties, standard deviations) and their correlations with key 
intermediary variables. The goal is to gain information that will inform the design of a fully powered and definitive 
phase III trial.  
 
The pilot optimization trial was designed to use a balanced 2x2x2 full factorial to examine each component (VR 
enhanced cognitive restructuring, problem-solving, and affect regulation) across treatment level (standard vs. 
standard + PRESR). All patients will receive standard treatment, and will receive worksheets about cognitive 
restructuring, problem-solving, and affect regulation aligned to standard procedures provided by researchers, but 
the experimental conditions will vary according to VR enhancement of each skill (involving a VR lesson and 
practice session). With this design, primary focus will be on the candidate proximal outcome variables based on 
skill condition. Specific analyses include exploring the distribution and degree of variability among variables, as 
well as preliminary indicators of change over time (e.g., via pre-post comparisons before and after the intervention 
using paired sample t-tests to gauge directionality; maintenance of change at 2-week and 3-month follow-up visits) 
in order to evaluate which candidate variables are most promising. 
 
As shown in Table 1, candidate outcomes include: 
 
Exploratory Intermediary Variables: Threat habituation: Subjective Units of Distress Scale (SUDS); 
Cognition: Automatic Thoughts Questionnaire (ATQ-30);  
 
Exploratory Candidate Proximal Primary Outcomes: Psychological distress: Child Anxiety Sensitivity Index 
(CASI); Beck Hopelessness Scale (BHS); Emotional Distress-Anxiety/Depression - Pediatric Short Form 
(PROMIS). Self-efficacy: Emotional Self-Efficacy (ESE) measure.  
 
Exploratory Candidate Distal Primary Outcomes: Suicidal thoughts and behaviors: Self-Injurious Thoughts 
and Behaviors Interview (SITB); Columbia Suicide Severity Rating Scale (CSSRS). Rehospitalization: Medical 
Record Review. 
 
Additional Exploratory Candidate Secondary Outcomes: Skill use and understanding: Performance of 
Cognitive Therapy Strategies (PCTS) assessment; Cognitive-Behavior Therapy Skills Questionnaire (CBTSQ); 
Cognitive Therapy Awareness Scale (CTAS); Skills of Cognitive Therapy (SoCT); Daily diary of difficult school 
experiences, suicidal thoughts and behaviors, skill use, and safety plan use for 2-weeks post school re-entry period. 
School experiences: Authoritative School Climate Survey (ASCS); School Connectedness Scale (SCS). 
 
Assessment of Service Use Following Release: With consent/assent of parents and adolescents, we will obtain 
adolescents’ treatment records. Records will be used to verify the number, duration, and frequency of contacts with 
mental health providers.  
 
8.4  Planned Interim Analyses 
No interim analyses will be performed.  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
36 
Template Version  1.0            2021-09-09 
9 Sample Size Rationale 
 
The focus of this pilot clinical trial is to develop tools, procedures, and knowledge to inform the design of a larger 
study and is not intended to assess efficacy. A sample size of 48 with anticipated attrition of 20% was selected to 
allow n=4-6 per condition in the 2x2x2 factorial design. A sample of n=4-6 per condition will allow the researchers 
to assess key estimates of feasibility and acceptability within each condition. Even though this pilot is not designed 
to test efficacy, the analytic plan for the exploratory aim will focus on estimation of key statistics (means, SDs, 
correlations) and distributional properties of candidate proximal outcomes that in preparation for the fully powered 
trial. Ultimately, completion of this pilot clinical trial will result in a proof-of-concept paper that outlines the utility, 
feasibility, and acceptability of the PrESR conceptual model and in preparation for the fully-powered optimization 
trial. 
10 Data Capture and Database Management 
10.1  Software for Data Capture 
The study data will be entered into a REDCap database developed by the study personnel.  REDCap is a data 
capture system provided by the NC TraCS Institute at UNC. The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate (note, however, that REDCap is not currently 21CFRPart11 compliant).  Study data will be entered 
directly from the source documents. Data may also be collected using paper questionnaires (e.g., during 
hospitalization, at home diaries) and entered directly into REDCap. 
10.2  Responsibilities for Data Capture and Database Management  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site investigator. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data.   
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for recording data 
for each participant enrolled in the study.  Data recorded in the electronic case report form (eCRF) derived from 
source documents should be consistent with the data recorded on the source documents.  
Clinical data (including adverse events (AEs)) will be entered into REDCap, a HIPAA-compliant data capture 
system provided by the UNC TrACS Institute. The data system includes password protection and internal quality 
checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical 
data will be entered directly from the source documents. 
Authorized representatives of the NIH, sponsor, and regulatory agencies are permitted to examine (and when 
permitted by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and 
evaluation of the study safety, progress, and data validity.  
 
10.3  Study Records Retention 
The study results will be retained in the participant’s research record for three years after the study is completed or 
until the youth participant reaches the age of 21, whichever is longer. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
37 
Template Version  1.0            2021-09-09 
11 Safety Monitoring and Management 
11.1  Risk / Benefit Assessment 
Potential Risks:   
The primary risks associated with the study are: (1) distress in relation to answering questions about their 
experiences or physical (e.g., motion sickness) or psychological discomfort in relation to viewing/participating in 
stressful experiences that mimic real life stressors in the intervention; (2) coercion to participate in the study; and 
(3) loss of privacy or confidentiality. In the following sections we outline a number of ways we protect against 
risks. 
Distress/Motion Sickness. Because the intervention provides an immersive experience that mimics real life 
stressors, it is possible that participants will feel distressed or uncomfortable during the intervention. Decisions 
regarding whether an adolescent will be invited to participate or not will be determined in collaboration with their 
attending physician. Additionally, adolescents at risk for developing cybersickness (50th percentile as measured on 
the Motion Sickness Susceptibility Questionnaire) will be excluded from the study. Staff will be trained to provide 
validation and reduce stress during interactions, and to monitor physical safety during participation. Participants 
and staff will be taught how to end the intervention should they feel too stressed or agitated. Participants will be 
reminded that they may pause or end the intervention at any time. All equipment will be thoroughly cleaned before 
and after use. 
Coercion: We will take precautions to minimize coercion to participate. We will emphasize the voluntary nature of 
the study and remind participants that they may discontinue at any time. Members of the research team will be 
trained to be respectful towards participants' preferences regarding participation. We will present information 
verbally and in writing on the consent form to ensure participants are aware of the voluntary nature of the study. 
The informed consent procedure will include a careful explanation of study procedures, risks, benefits, and 
alternatives. We have selected compensation rates that we believe will not be excessive or coercive for adolescents. 
Confidentiality or loss of privacy. The information we are collecting is considered potentially sensitive and as 
such participants could experience distress or increased psychological risk if information is improperly handled or 
released inappropriately. Potential risk from breach of confidentiality will be minimized by strict adherence to the 
guidelines for research outlined by UNC and HIPAA. Study data will only be identified by numeric ID and any 
other records that do contain potentially identifying information will be stored separate from all other research data. 
All electronic data will be stored on a secure server. Data will only be stored on password-protected computers and 
electronic transmission of identifying data will not be permitted. Team members accessing data and identifying 
information will be trained on the management of sensitive clinical information. All data will be considered 
confidential, and only trained research staff will have access to data. 
 
Potential Benefits:  
It is possible that adolescents receiving the PrESR intervention may benefit; however, the efficacy of the PrESR for 
reducing psychological distress and preventing suicide-related thoughts and behaviors is unknown. Additional 
benefits may involve increased monitoring of suicidal-thoughts and behaviors as part of follow-up procedures. 
 
11.2  Assessment of Safety 
Safety will be assessed throughout the intervention by monitoring participant responses and documentation of 
adverse events.  
 
Eligible participants will be recruited with permission of the treating clinician and screened for motion sickness 
using the following assessment protocols: 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
38 
Template Version  1.0            2021-09-09 
• 
Motion Sickness Susceptibility Questionnaire (MSSQ) 
 
Participants will be taught how to complete a SUDS scale and reminded of the potential risks of the intervention 
prior to beginning each session. Participants and clinicians will be taught how to immediately pause or end the 
intervention as needed, and clinicians will be trained to monitor participant safety during the intervention (i.e., 
watching where their body is at all times, validating and supporting their experiences). The intervention will be 
administered at the psychiatric hospital, with trained clinical staff available to support patients as needed. 
Participants are a vulnerable population (adolescents with a recent suicide-related crises) and the intervention is 
designed to supplement treatment as usual. Accordingly, all participants will receive treatment as usual and if 
randomized to participate in one of the conditions of the intervention will not disrupt other necessary treatments or 
interventions. 
11.3  Unanticipated Problems, Adverse Events, Serious Adverse Events 
Unanticipated Problems:    
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  An unanticipated problem is any incident, experience or outcome that meets all three 
OHRP criteria (1) unexpected (in severity, specificity, frequency, or nature), (2) related or possibly related to 
the research, and (3) suggests the research places participants or others at greater risk than previously known or 
recognized. Only a subset of adverse events will meet criteria for unanticipated problems.   
 
Adverse Event (AE) Definitions: This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any 
untoward medical occurrence associated with the use of an intervention in humans, whether or not considered 
intervention-related. 
 
Serious Adverse Events (SAE) Definition: A serious adverse event is an adverse event that results in death, is 
life-threatening, requires hospitalization, results in disability, is a congenital anomaly, or is a medically important 
event. 
 
 
Grading the Severity of Adverse Events and Events of ‘Special Interest’: For adverse events (AEs), the 
following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate 
events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other 
treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, the term “severe” 
does not necessarily equate to “serious”.] 
 
In this study, serious/severe adverse events include expected events such as suicide attempts, emergency 
department visits, and hospitalizations.   
 
Relatedness Definition: All adverse events (AEs) will have their relationship to study procedures, including the 
intervention, assessed by an appropriately trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility that the 
study procedures caused the AE, or there is a temporal relationship between the study procedures and the 
event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study 
procedures and the AE. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
39 
Template Version  1.0            2021-09-09 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, there is no 
temporal relationship between the study procedures and event onset, or an alternate etiology has been 
established. 
 
Expectedness Definition:  
A clinician with appropriate expertise in suicidal thoughts and behaviors and non-suicidal self-injury will be 
responsible for determining whether an adverse event (AE) is expected or unexpected. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk information previously 
described for the study procedures. 
 
AE and SAE Assessment, Follow-up Procedures: The occurrence of an adverse event (AE) or serious adverse 
event (SAE) may come to the attention of study personnel during study visits and interviews of a study participant.    
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form (CRF). 
Information to be collected includes event description, time of onset, clinician’s assessment of severity, relationship 
to study procedures (assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately regardless 
of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time during the 
study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each 
level of severity to be performed. Documentation of onset and duration of each episode will be maintained for AEs 
characterized as intermittent. 
 
Designated study personnel will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At each study 
visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events will be followed for 
outcome information until resolution or stabilization. 
 
Reporting and Documentation Procedures:  
Any unanticipated problems or serious and unexpected adverse events will be promptly reported by the principal 
investigator or designated member of the research team to the IRB, DSMB and sponsor or appropriate government 
agency if appropriate. 
 
Participant Notification of New Information:    
Participants will be informed of new information related to the study or intervention that might influence their 
interest/willingness to participate in the study. 
11.4  Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study participants. 
The principal investigator has extensive experience in overseeing research conducted with adolescents hospitalized 
or previously hospitalized for suicide-related crises and is a trained school psychologist and licensed psychologist. 
A Data Safety & Monitoring Board (DSMB) will be utilized, (see Section 16.6). Screening and assessment of 
motion sickness will be monitored and documented. Additionally, self-report measures of distress based on SUDS 
scales will be collected throughout the intervention; simulation sickness will be measured prior to and following the 
initial virtual reality session; and distress level will be measured pre- and post-intervention completion. 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
40 
Template Version  1.0            2021-09-09 
11.5  Study Suspension / Early Termination of the Study 
There is no interim analysis of the study so early termination is not expected; however, we are monitoring for 
safety as described elsewhere and we may stop based on an adverse event or accumulation of adverse events. If 
10 Serious Adverse Events occur in 10 subjects during baseline procedures or if 10 number of subjects have a 
300% increase in distress (as measured by SUDS captured before and immediately following a practice 
experience in PrESR, averaged across practice sessions), the study will be suspended 
12 Regulatory, Ethical, and Study Oversight Specifications 
 
12.1  Informed Consent Process 
 
Assent and consent forms describing in detail the study intervention, study procedures, and risks will be given to 
the participant and caregiver. Consent and assent will be obtained in-person using paper forms, or virtually using 
electronic capture with a REDCap or Qualtrics interface. Offering in-person and virtual permission for 
parent(s)/guardian(s) is necessary given the constraints of parents with hospitalized youth (e.g., families that live 
farther away from the hospital or with rigid work schedules may be unable to visit their child during 
hospitalization).  
 
 
 
12.1.1. 
Consent/Assent and Documents Provided to Participants 
Consent and assent forms describing in detail the study intervention, study procedures, and risks are provided to the 
participant and written documentation of informed consent is required prior to starting intervention/administering 
study intervention. Parent permission will also be available in Spanish, but adolescent participants will need 
proficiency in English to complete the intervention (which is only available in English). 
 
 
 
12.1.2. 
Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and 
continues throughout the individual’s study participation. Consent forms will be Institutional Review Board (IRB)-
approved and the participant will be asked to read and review the document. The investigator or research assistant 
will explain the research study to the parent/guardian and participant and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the participant’s comprehension of the purposes, procedures, 
and potential risks of the study and of their rights as research participants.  Participants (and their parents, if 
applicable) will have the opportunity to carefully review the written consent form and ask questions prior to 
signing. The participants will be provided the opportunity to discuss the study with their family or surrogates or 
think about it prior to agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. Permission and assent will be available in paper format and 
electronically via REDCap or Qualtrics in case parent(s)/guardian(s) are not available in-person. Participants must 
be informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records (either 
electronically or in paper format). The informed consent process will be conducted and documented in the source 
document (including the date), and the form signed, before the participant undergoes any study-specific procedures. 
The rights and welfare of the participants will be protected by emphasizing to them that the quality of their medical 
care will not be adversely affected if they decline to participate in this study. 
 
To ensure a standardized approach that ensures all elements of informed consent/assent are covered, we will 
develop a sample script for introducing the research study. Prior to the beginning of consent/assent procedures, we 
will role play administration of consent/assent with researchers providing consent and provide feedback.  
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
41 
Template Version  1.0            2021-09-09 
There is no requirement about whether the consent or assent should be obtained first. However, to participate in the 
study, both assent and consent will be required.  
 
In general, it should take no longer than 15 minutes to obtain consent/assent. However, as much time as needed will 
be allocated for answering any questions about the study.    
 
Participants and parent(s)/guardian(s) will be advised that if they have any questions about the research study, they 
can contact the principal investigators (for whom the appropriate telephone number is provided). Participants will 
also be informed that if they have any questions regarding their rights as research subjects, they may contact the 
Institutional Review Board at University of North Carolina at Chapel Hill.  
 
Youth who do not understand English will not be enrolled in the study.  Permission procedures will be made 
available for parent(s)/guardian(s) speaking Spanish. 
 
Participants will be notified that the UNC School of Medicine is not conducting this study. Participants will be 
apprised of the voluntariness of the research, and that the decision to participate or not will not have an impact on 
medical care or general conditions while in psychiatric care.   
 
Participants will be apprised that confidentiality will be broken if youth (a) indicate plans to harm themselves, (b) 
indicate plans to harm someone else, and/or (c) disclose previously unreported abuse according to the state of North 
Carolina. This information will be immediately reported to the adolescent’s treatment team or a caregiver during 
follow-up procedures. 
 
During follow-up procedures, adolescents who were previously a minority age who have since turned majority age 
will be re-consented into the study. 
 
12.2  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, the investigator, funding agency, and regulatory authorities.    
If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the Institutional Review Board (IRB), and sponsor 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. 
  
Examples of circumstances that may warrant termination or suspension of the study include: 
1. Criteria established in the MPD for early termination of the study have been satisfied 
2. Detection of an unexpected unacceptable level of risk to participants 
3. In preparatory (pilot) studies, futility due to insufficient adherence to protocol requirements 
4. Unexpected inability to recruit participants 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and satisfy the 
regulatory oversight (e.g., DSMB, sponsor, IRB, FDA). 
12.3  Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, the safety 
and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is extended to the data being 
collected as part of this study. Data that could be used to identify a specific study participant will be held in strict 
confidence within the research team. No personally identifiable information from the study will be released to any 
unauthorized third party without prior written approval of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
42 
Template Version  1.0            2021-09-09 
 
Study data will be entered into REDCap databases so there are minimal hard copies of data, reducing possibilities 
for breach of confidentiality. In data sets, participants will be identified by number only, with the subject's name 
and linked study number kept in a locked separate file in the office of the PI.   
  
Data gathered in the study will be protected in the following manner: participants will be identified by number 
only; data disks and study computers will be encrypted and kept in locked storage in locked rooms; data collected 
via paper at the psychiatric facilities will be entered into an encrypted REDCap Data Capture System maintained at 
UNC. The data set linking identifying information to subject numbers will be password protected/encrypted.  Data 
bases with identifying information (e.g., contact information) will not include de-identified data from the study. 
Conversely, data bases with de-identified data will not include identifying information but will be assigned a 
subject code.    
 
The study participant’s contact information will be securely stored at UNC for internal use during the study. At the 
end of the study, all records will continue to be kept in a secure location for as long a period as dictated by the 
reviewing IRB, Institutional policies, or sponsor/funding agency requirements. 
 
Authorized representatives of the sponsor or funding agency, and representatives of the Institutional Review Board 
(IRB), and other regulatory agencies may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital).  
 
We disclose the exceptions to confidentiality in this study in the informed consent/assent process. To further protect 
the privacy of study participants, the National Institute of Mental Health, has issued a Certificate of Confidentiality 
(CoC) to all researchers engaged in biomedical, behavioral, clinical, or other human subjects research funded 
wholly or in part by the federal government.  Recipients of NIH funding for human subjects research are required to 
protect identifiable research information from forced disclosure per the terms of the NIH Policy (see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, 
recipients conducting NIH-supported research covered by this Policy are required to establish and maintain 
effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is 
managed in compliance with Federal statutes, regulations, and the terms and conditions of award. It is the NIH 
policy that investigators and others who have access to research records will not disclose identifying information 
except when the participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to protections 
provided by a Certificate issued by this Policy.  
 
No reference to any individual participant will appear in reports, presentations, or publications that may arise from 
the study.  
 
 
 
12.3.1. 
Certificate of Confidentiality 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the National 
Institutes of Health (NIH).  This certificate protects identifiable research information from forced disclosure. It 
allows the investigator and others who have access to research records to refuse to disclose identifying information 
on research participation in any civil, criminal, administrative, legislative, or other proceeding, whether at the 
federal, state, or local level. By protecting researchers and institutions from being compelled to disclose 
information that would identify research participants, Certificates of Confidentiality help achieve the research 
objectives and promote participation in studies by helping assure confidentiality and privacy to participants. 
12.4  Future Use of Stored Specimens and Data 
 
Data collected for this study will be analyzed and stored in a secure, encrypted location following UNC and IRB 
guidelines. Transcriptions of audio recordings from interviews completed during baseline will be redacted of 
identifying information.  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
43 
Template Version  1.0            2021-09-09 
 
12.5 Key Roles and Study Governance 
[Provide the name and contact information of the Principal Investigator and the Medical Monitor.] 
Principal Investigator 
 
Marisa Marraccini, PhD, Assistant Professor 
 
University of North Carolina at Chapel Hill  
 
100 East Cameron Ave., Chapel Hill, NC 27599 
 
919-843-5099 
 
mmarracc@unc.edu 
 
 
In addition to the study PI, a mentorship team part of the K23 award is available for consult and support to the PI in 
determining conduct, management, and oversight. 
12.6  Safety Oversight 
 The principal investigator will be responsible for the overall monitoring of the data and safety of study participants.   
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB). The DSMB includes 
experts in scientific disciplines needed to monitor the data and ensure patient safety during the conduct of this 
study, a psychologist or psychiatrist, a clinical trials or mental health services expert who will chair the committee, 
a statistician, and a public member (e.g., school professional). No DSMB members will be directly involved in 
other aspects of the project or have a stake in its outcome. DSMB members have no association with the project 
investigators, and no conflicts of interest with study outcomes. The DSMB will meet by teleconference or in person 
on a twice yearly basis (unless there are compelling reasons to meet more often) to assess safety and data of the 
study.  
 
DSMB procedures conform with usual standards, including reviewing emerging trial data and maintaining 
confidentiality. The main responsibilities of the DSMB include, but are not limited to the following: (1) reviewing 
the research protocol, consent form(s) and plans for data and safety monitoring prior to the initiation of the study; 
(2) monitoring of the progress of the study, including data quality, timeliness, recruitment and retention of study 
participants, adverse events, serious adverse events (SAEs), reasons for participant withdrawal, adherence to the 
timeline of the study, protocol deviations, and factors that may affect the risks and benefits of the study such as 
emerging literature; and (3) making directives about the continuation, modification, or termination of the study, 
based on the balance of adverse events and beneficial outcomes. Throughout the study, notification of SAEs as well 
as any proposed investigator-initiated changes in the protocol will be submitted to the DSMB. Based on its review 
of the protocol, the DSMB will identify the data parameters and format of the information to be regularly reported. 
The DSMB may at any time request additional information from the Principal Investigators. 
 
12.7  Clinical Monitoring Plan (CMP) 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are protected, that 
the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with 
the currently approved protocol/amendment(s), with International Conference on Harmonization Good Clinical 
Practice (ICH GCP), and with applicable regulatory requirement(s).  
 
A. 
All SAEs and adverse events (AEs will only be reported to the DSMB annually) will be tabulated and 
submitted to the DSMB in the biannual DSMB data reports. Based on review of safety data, the DSMB will 
issue directives concerning the conduct of the study. Recommendation/directives made by the DSMB may 
include amending safety monitoring procedures, modifying the protocol or consent, terminating the study, 
or continuing the study as designed.  

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
44 
Template Version  1.0            2021-09-09 
B. 
Independent audits will not be conducted. 
12.8  Quality Assurance and Quality Control  
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as a 
percentage of the completed consent documents.  This review will evaluate compliance with GCP, accuracy, and 
completeness.  Feedback will be provided to the study team to ensure proper consenting procedures are followed.  
 
Electronic data --- When possible, data will be initially captured via a REDCap Electronic Data Capture system to 
minimize errors. Otherwise, paper data will be entered directly into REDCap. Electronic data will be reviewed 
regularly for errors, unusual patterns, and outliers that need to be checked.    
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study using a fidelity checklist.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will implement 
corrective actions when the quantity or nature of deviations are deemed to be at a level of concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor/funding agency, and 
inspection by local and regulatory authorities.  
12.9  Protocol Deviations 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, International 
Council on Harmonization Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions will be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3.  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1.  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report deviations 
within ten working days of identification of the protocol deviation, or within ten working days of the scheduled 
protocol-required activity. All deviations will be addressed in study source documents, reported to the National 
Institute of Mental Health when requested or as required by NIMH policies.  Protocol deviations will be sent to the 
reviewing Institutional Review Board (IRB) and/or documented per their policies. The site investigator will be 
responsible for knowing and adhering to the reviewing IRB requirements.  
12.10 Publication and Data Sharing Policy  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published 
results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise 
from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical 
Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
45 
Template Version  1.0            2021-09-09 
will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to 
ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.  Data from 
this study may be requested from other researchers five years after the completion of the primary endpoint by 
contacting Dr. Marraccini at University of North Carolina at Chapel Hill.   
12.11 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual conflict of 
interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be required to have 
such conflicts managed in a way that is appropriate to their participation in the design and conduct of this trial. The 
study leadership in conjunction with University of North Carolina at Chapel Hill and the National Institute of 
Mental Health have established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of interest.  
 
 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
46 
Template Version  1.0            2021-09-09 
 
13 References 
 
Alavi, A., Sharifi, B., Ghanizadeh, A., & Dehbozorgi, G. (2013). Effectiveness of Cognitive-Behavioral 
Therapy in Decreasing Suicidal Ideation and Hopelessness of the Adolescents with Previous 
Suicidal Attempts. Iranian Journal of Pediatrics, 23(4), 467–472. 
Blanz, B., & Schmidt, M. H. (2000). Practitioner Review: Preconditions and Outcome of Inpatient 
Treatment in Child and Adolescent Psychiatry. The Journal of Child Psychology and Psychiatry 
and Allied Disciplines, 41(6), 703–712. https://doi.org/10.1111/1469-7610.00658 
Brent, D. A., Perper, J. A., Moritz, G., Allman, C., Friend, A., Roth, C., Schweers, J., Balach, L., & 
Baugher, M. (1993). Psychiatric Risk Factors for Adolescent Suicide: A Case-Control Study. 
Journal of the American Academy of Child & Adolescent Psychiatry, 32(3), 521–529. 
https://doi.org/10.1097/00004583-199305000-00006 
Brown, G. K., & Jager-Hyman, S. (2014). Evidence-Based Psychotherapies for Suicide Prevention: 
Future Directions. American Journal of Preventive Medicine, 47(3), S186–S194. 
https://doi.org/10.1016/j.amepre.2014.06.008 
Carl, E., Stein, A. T., Levihn-Coon, A., Pogue, J. R., Rothbaum, B., Emmelkamp, P., Asmundson, G. J. 
G., Carlbring, P., & Powers, M. B. (2019). Virtual reality exposure therapy for anxiety and related 
disorders: A meta-analysis of randomized controlled trials. Journal of Anxiety Disorders, 61, 27–
36. https://doi.org/10.1016/j.janxdis.2018.08.003 
CDC. (2019). Trends in the Prevalence of Suicide–Related Behaviors National YRBS: 1991—2019 | 
YRBSS | Adolescent and School Health | CDC. 
https://www.cdc.gov/healthyyouth/data/yrbs/factsheets/2019_suicide_trend_yrbs.htm 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
47 
Template Version  1.0            2021-09-09 
Chung, D. T., Ryan, C. J., Hadzi-Pavlovic, D., Singh, S. P., Stanton, C., & Large, M. M. (2017). Suicide 
Rates After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis. 
JAMA Psychiatry, 74(7), 694–702. https://doi.org/10.1001/jamapsychiatry.2017.1044 
Collins, L. M., & Kugler, K. C. (2018). Optimization of Behavioral, Biobehavioral, and Biomedical 
Interventions: The Multiphase Optimization Strategy (MOST). Springer International Publishing. 
https://doi.org/10.1007/978-3-319-72206-1 
Daniel, S. S., Goldston, D. B., Erkanli, A., Franklin, J. C., & Mayfield, A. M. (2009). Trait Anger, Anger 
Expression, and Suicide Attempts Among Adolescents and Young Adults: A Prospective Study. 
Journal of Clinical Child & Adolescent Psychology, 38(5), 661–671. 
https://doi.org/10.1080/15374410903103494 
Esposito-Smythers, C., Spirito, A., Kahler, C. W., Hunt, J., & Monti, P. (2011). Treatment of co-
occurring substance abuse and suicidality among adolescents: A randomized trial. Journal of 
Consulting and Clinical Psychology, 79, 728–739. https://doi.org/10.1037/a0026074 
Frazier, E., Thompson, A., Wolff, J., & Hunt, J. (2016, April 25). Implementing evidence‐based 
psychotherapy in an adolescent inpatient setting—Frazier—2016—The Brown University Child 
and Adolescent Behavior Letter—Wiley Online Library. 
https://onlinelibrary.wiley.com/doi/abs/10.1002/cbl.30121 
Ghahramanlou-Holloway, M., Neely, L. L., Tucker, J., Caffery, K., Colborn, V., & Koltko, V. (2015). 
Inpatient Cognitive Behavior Therapy Approaches for Suicide Prevention. Current Treatment 
Options in Psychiatry, 2(4), 371–382. https://doi.org/10.1007/s40501-015-0063-4 
Golding, J. F. (1998). Motion sickness susceptibility questionnaire revised and its relationship to other 
forms of sickness. Brain Research Bulletin, 47(5), 507–516. https://doi.org/10.1016/S0361-
9230(98)00091-4 
Goldston, D. B., Daniel, S. S., Erkanli, A., Reboussin, B. A., Mayfield, A., Frazier, P. H., & Treadway, S. 
L. (2009). Psychiatric diagnoses as contemporaneous risk factors for suicide attempts among 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
48 
Template Version  1.0            2021-09-09 
adolescents and young adults: Developmental changes. Journal of Consulting and Clinical 
Psychology, 77, 281–290. https://doi.org/10.1037/a0014732 
Goldston, D. B., Daniel, S. S., Reboussin, B. A., Reboussin, D. M., Frazier, P. H., & Harris, A. E. (2001). 
Cognitive Risk Factors and Suicide Attempts Among Formerly Hospitalized Adolescents: A 
Prospective Naturalistic Study. Journal of the American Academy of Child & Adolescent 
Psychiatry, 40(1), 91–99. https://doi.org/10.1097/00004583-200101000-00021 
Goldston, D. B., Daniel, S. S., Reboussin, B. A., Reboussin, D. M., Kelley, A. E., & Frazier, P. H. (1998). 
Psychiatric Diagnoses of Previous Suicide Attempters, First-Time Attempters, and Repeat 
Attempters on an Adolescent Inpatient Psychiatry Unit. Journal of the American Academy of 
Child & Adolescent Psychiatry, 37(9), 924–932. https://doi.org/10.1097/00004583-199809000-
00012 
Goldston, D. B., Daniel, S. S., Reboussin, D. M., Reboussin, B. A., Frazier, P. H., & Kelley, A. E. (1999). 
Suicide Attempts Among Formerly Hospitalized Adolescents: A Prospective Naturalistic Study of 
Risk During the First 5 Years After Discharge. Journal of the American Academy of Child & 
Adolescent Psychiatry, 38(6), 660–671. https://doi.org/10.1097/00004583-199906000-00012 
Green, J., Jacobs, B., Beecham, J., Dunn, G., Kroll, L., Tobias, C., & Briskman, J. (2007). Inpatient 
treatment in child and adolescent psychiatry – a prospective study of health gain and costs. 
Journal of Child Psychology and Psychiatry, 48(12), 1259–1267. https://doi.org/10.1111/j.1469-
7610.2007.01802.x 
Horwitz, A. G., Czyz, E. K., & King, C. A. (2015). Predicting Future Suicide Attempts Among 
Adolescent and Emerging Adult Psychiatric Emergency Patients. Journal of Clinical Child & 
Adolescent Psychology, 44(5), 751–761. https://doi.org/10.1080/15374416.2014.910789 
Hubal, R. (2008). Embodied Tutors for Interaction Skills Simulation Training. IJVR, 7, 1–8. 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
49 
Template Version  1.0            2021-09-09 
Hubal, R., Folsom-Kovarik, J., Woods, A., Jones, R., & Carbone, J. (2015). Patterns of life in the 
foreground and background: Practical approaches to enhancing simulation-based interaction 
skills training [Paper]. 
Hubal, R., & Parsons, T. (2017). Synthetic environments for skills training and practice. In The Sciences 
of Learning and Instructional Design. Routledge. 
James, S., Charlemagne, S. J., Gilman, A. B., Alemi, Q., Smith, R. L., Tharayil, P. R., & Freeman, K. 
(2010). Post-Discharge Services and Psychiatric Rehospitalization Among Children and Youth. 
Administration and Policy in Mental Health and Mental Health Services Research, 37(5), 433–
445. https://doi.org/10.1007/s10488-009-0263-6 
Jobes, D. A. (2017). Clinical assessment and treatment of suicidal risk: A critique of contemporary care 
and CAMS as a possible remedy. Practice Innovations, 2, 207–220. 
https://doi.org/10.1037/pri0000054 
Jobes, D. A., Rudd, M. D., Overholser, J. C., & Joiner Jr., T. E. (2008). Ethical and competent care of 
suicidal patients: Contemporary challenges, new developments, and considerations for clinical 
practice. Professional Psychology: Research and Practice, 39, 405–413. 
https://doi.org/10.1037/a0012896 
Kazantzis, N., Deane, F. P., & Ronan, K. R. (2000). Homework assignments in cognitive and behavioral 
therapy: A meta-analysis. Clinical Psychology: Science and Practice, 7, 189–202. 
https://doi.org/10.1093/clipsy.7.2.189 
Kelley, A., Goldston, D. B., Brunstetter, R., Daniel, S., Ievers, C., & Reboussin, D. M. (1996). First-Time 
Suicide Attempters, Repeat Attempters, and Previous Attempters on an Adolescent Inpatient 
Psychiatry Unit. Journal of the American Academy of Child & Adolescent Psychiatry, 35(5), 631–
639. https://doi.org/10.1097/00004583-199605000-00018 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
50 
Template Version  1.0            2021-09-09 
Kidd, S. A., McKenzie, K. J., & Virdee, G. (2014). Mental Health Reform at a Systems Level: Widening 
the Lens on Recovery-Oriented Care. The Canadian Journal of Psychiatry, 59(5), 243–249. 
https://doi.org/10.1177/070674371405900503 
Lewis, M., Wagner, L. K., Persky, S., Bordnick, P., & Riley, W. (2018). Using immersive virtual reality 
to study and change health-related behavior. https://www.rti.org/publication/using-immersive-
virtual-reality-study-and-change-health-related-behavior 
Marraccini, M., Anonick, R., Delgaty, L., Middleton, T., Toole, E., Ying, J., & Hubal, R. (2025). Practice 
Experiences for School Reintegration (PrESR): Iterative Development of a Virtual Reality 
Intervention to Supplement Cognitive Behavioral Therapy for Hospitalized Youth. Psychological 
Services, 22(1), 145–157. https://doi.org/10.1037/ser0000874 
Marraccini, M. E., Ingram, K. M., Naser, S. C., Grapin, S. L., Toole, E. N., O’Neill, J. C., Chin, A. J., 
Martinez, R. R., & Griffin, D. (2022). The roles of school in supporting LGBTQ+ youth: A 
systematic review and ecological framework for understanding risk for suicide-related thoughts 
and behaviors. Journal of School Psychology, 91, 27–49. https://doi.org/10.1016/j.jsp.2021.11.006 
Marraccini, M. E., Pittleman, C., Griffard, M., Tow, A. C., Vanderburg, J. L., & Cruz, C. M. (2022). 
Adolescent, parent, and provider perspectives on school-related influences of mental health in 
adolescents with suicide-related thoughts and behaviors. Journal of School Psychology, 93, 98–
118. https://doi.org/10.1016/j.jsp.2022.07.001 
Marraccini, M., & PIttleman, C. (2022). Returning to School Following Hospitalization for Suicide-
Related Behaviors: Recognizing Student Voices for Improving Practice. School Psychology 
Review, 51(3), 370–385. https://doi.org/10.1080/2372966X.2020.1862628 
Mayne, S. L., Hannan, C., Davis, M., Young, J. F., Kelly, M. K., Powell, M., Dalembert, G., McPeak, K. 
E., Jenssen, B. P., & Fiks, A. G. (2021). COVID-19 and Adolescent Depression and Suicide Risk 
Screening Outcomes. Pediatrics, 148(3), e2021051507. https://doi.org/10.1542/peds.2021-051507 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
51 
Template Version  1.0            2021-09-09 
Morina, N., Ijntema, H., Meyerbröker, K., & Emmelkamp, P. M. G. (2015). Can virtual reality exposure 
therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral 
assessments. Behaviour Research and Therapy, 74, 18–24. 
https://doi.org/10.1016/j.brat.2015.08.010 
Ougrin, D., Tranah, T., Stahl, D., Moran, P., & Asarnow, J. R. (2015). Therapeutic Interventions for 
Suicide Attempts and Self-Harm in Adolescents: Systematic Review and Meta-Analysis. Journal 
of the American Academy of Child & Adolescent Psychiatry, 54(2), 97-107.e2. 
https://doi.org/10.1016/j.jaac.2014.10.009 
Parsons, T. D. (2015). Virtual Reality for Enhanced Ecological Validity and Experimental Control in the 
Clinical, Affective and Social Neurosciences. Frontiers in Human Neuroscience, 9. 
https://www.frontiersin.org/articles/10.3389/fnhum.2015.00660 
Peterson, B. S., Zhang, H., Santa Lucia, R., King, R. A., & Lewis, M. (1996). Risk factors for presenting 
problems in child psychiatric emergencies. Journal of the American Academy of Child and 
Adolescent Psychiatry, 35(9), 1162–1173. https://doi.org/10.1097/00004583-199609000-00014 
Preyde, M., Parekh, S., & Heintzman, J. (2018). Youths’ experiences of school re-integration following 
psychiatric hospitalization. Journal of the Canadian Academy of Child and Adolescent Psychiatry, 
27(1), 22. 
Prinstein, M. J., Nock, M. K., Simon, V., Aikins, J. W., Cheah, C. S. L., & Spirito, A. (2008). 
Longitudinal trajectories and predictors of adolescent suicidal ideation and attempts following 
inpatient hospitalization. Journal of Consulting and Clinical Psychology, 76, 92–103. 
https://doi.org/10.1037/0022-006X.76.1.92 
Rizzo, A. A., Bowerly, T., Buckwalter, J. G., Klimchuk, D., Mitura, R., & Parsons, T. D. (2009). A 
Virtual Reality Scenario for All Seasons: The Virtual Classroom. CNS Spectrums, 11(1), 35–44. 
https://doi.org/10.1017/S1092852900024196 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
52 
Template Version  1.0            2021-09-09 
Spirito, A., Simon, V., Cancilliere, M. K., Stein, R., Norcott, C., Loranger, K., & Prinstein, M. J. (2010, 
April 19). Outpatient psychotherapy practice with adolescents following psychiatric 
hospitalization for suicide ideation or a suicide attempt—Anthony Spirito, Valerie Simon, Mary 
Kathryn Cancilliere, Rachel Stein, Candace Norcott, Katherine Loranger, Mitchell J. Prinstein, 
2011. https://journals.sagepub.com/doi/abs/10.1177/1359104509352893 
Stanley, B., Brown, G., Brent, D. A., Wells, K., Poling, K., Curry, J., Kennard, B. D., Wagner, A., Cwik, 
M. F., Klomek, A. B., Goldstein, T., Vitiello, B., Barnett, S., Daniel, S., & Hughes, J. (2009). 
Cognitive-Behavioral Therapy for Suicide Prevention (CBT-SP): Treatment Model, Feasibility, 
and Acceptability. Journal of the American Academy of Child & Adolescent Psychiatry, 48(10), 
1005–1013. https://doi.org/10.1097/CHI.0b013e3181b5dbfe 
Stensland, M., Watson, P. R., & Grazier, K. L. (2012). An Examination of Costs, Charges, and Payments 
for Inpatient Psychiatric Treatment in Community Hospitals. Psychiatric Services, 63(7), 666–
671. https://doi.org/10.1176/appi.ps.201100402 
Tossone, K., Jefferis, E., Bhatta, M. P., Bilge-Johnson, S., & Seifert, P. (2014). Risk factors for 
rehospitalization and inpatient care among pediatric psychiatric intake response center patients | 
SpringerLink. https://link.springer.com/article/10.1186/1753-2000-8-27 
Wolff, J. C., Davis, S., Liu, R. T., Cha, C. B., Cheek, S. M., Nestor, B. A., Frazier, E. A., Schaffer, M. M., 
& Spirito, A. (2017, March 27). Trajectories of Suicidal Ideation among Adolescents Following 
Psychiatric Hospitalization | SpringerLink. https://link.springer.com/article/10.1007/s10802-017-
0293-6 
Yard, E., Radhakrishnan, L., Ballesteros, M. F., Sheppard, M., Gates, A., Stein, Z., Hartnett, K., Kite-
Powell, A., Rodgers, L., Adjemian, J., Ehlman, D. C., Holland, K., Idaikkadar, N., Ivey-
Stephenson, A., Martinez, P., Law, R., & Stone, D. M. (2021). Emergency Department Visits for 
Suspected Suicide Attempts Among Persons Aged 12–25 Years Before and During the COVID-19 

Practice Experiences for School Reintegration 
  
Version 1.11 
UNC IRB Protocol ID #20-3436 
 
16 JULY 2025 
Interventional or Observational Protocol                                                                                                                                                                                 Page   
53 
Template Version  1.0            2021-09-09 
Pandemic—United States, January 2019–May 2021. Morbidity and Mortality Weekly Report, 
70(24), 888–894. https://doi.org/10.15585/mmwr.mm7024e1