Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD
Phase: NA
Conditions: Autism Spectrum Disorder, Autism
Sponsor: Children's Hospital of Philadelphia

 
 
Title: 
Immersive Virtual Reality as a Tool to Improve Police Safety in 
Adolescents and Adults with ASD 
Short Title 
VR Intervention to Improve Police Safety 
Drug or Device 
Name(s): 
Floreo’s VR Police Safety Module 
FDA IND 
N/A 
Regulatory Sponsor: 
N/A 
eIRB Number: 
17-14387 
Protocol Date: 
November 13, 2017 
Amendment 1 Date: October 1, 2018 
 Amendment 4 Date: March 23, 2020 
Amendment 2 Date: March 13, 2019 
Amendment 3 Date: June 24, 2020 
Amendment 5 Date: October 15, 2020 
 
 
Study Principal Investigator  
Julia Parish-Morris, Ph.D.  
Roberts Center for Pediatric Research 
2716 South Street, Office 5363 (5th Floor) 
Philadelphia, PA 19146-2305 
Phone 267-425-1175 
email: parishmorrisj@email.chop.edu 
 
 
 

  
 
 
 
 
 
 
 
ii 
TABLE OF CONTENTS 
Table of Contents .......................................................................................................... ii 
Abbreviations and Definitions of Terms ..................................................................... iv 
Abstract ......................................................................................................................... v 
Table 1: Schedule of Study Procedures ........................................................................ vi 
1 
BACKGROUND INFORMATION AND RATIONALE .................................................................... 7 
1.1 
INTRODUCTION ......................................................................................................................................7 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ......................................7 
1.3 
RELEVANT LITERATURE AND DATA .......................................................................................................7 
1.4 
COMPLIANCE STATEMENT .....................................................................................................................9 
2 
STUDY OBJECTIVES ....................................................................................................................... 9 
2.1 
PRIMARY OBJECTIVE (OR AIM) ..............................................................................................................9 
2.2 
SECONDARY OBJECTIVES (OR AIM) ......................................................................................................10 
3 
INVESTIGATIONAL PLAN ........................................................................................................... 10 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ..................................................................................................10 
3.1.1 
Screening Phase .............................................................................................................................10 
3.1.2 
Cycle A – Laboratory-Based Efficacy Study ................................................................................10 
3.1.3 
Cycle B – Virtually-Based Efficacy Study ....................................................................................10 
3.2 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ...................................................................11 
3.2.1 
Duration of Study Participation ...................................................................................................11 
3.2.2 
Total Number of Study Sites/Total Number of Subjects Projected ............................................11 
3.3 
STUDY POPULATION ............................................................................................................................11 
3.3.1 
Inclusion Criteria ..........................................................................................................................11 
3.3.2 
Exclusion Criteria ..........................................................................................................................11 
4 
STUDY PROCEDURES ................................................................................................................... 12 
4.1 
SCREENING INTERVIEW .......................................................................................................................12 
4.2 
CHARACTERIZATION VISITS .................................................................................................................12 
4.3 
INTERVENTION VISITS .........................................................................................................................12 
4.4 
FOLLOW-UP VISITS .............................................................................................................................12 
4.4.1 
4 weeks post-intervention (Cycle B only) ...................................................................................12 
4.5 
UNSCHEDULED VISITS ..........................................................................................................................12 
4.6 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................13 
5 
STUDY EVALUATIONS AND MEASUREMENTS ........................................................................ 13 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ..................................................13 
5.1.1 
Medical or Research Record Review ...........................................................................................13 
5.1.2 
IQ testing .......................................................................................................................................13 
5.1.3 
Clinician Observed Autism Symptoms ........................................................................................13 
5.1.4 
Autism Screening ..........................................................................................................................14 
5.1.5 
Other Measures and Questionnaires ............................................................................................14 
5.2 
INTERVENTION: VIRTUAL REALITY SESSIONS .......................................................................................15 
5.3 
CONTROL CONDITIONS ........................................................................................................................15 
5.3.1 
Cycle A: Video Modeling ..............................................................................................................15 
5.3.2 
Cycle B: Treatment-as-usual .........................................................................................................16 

 
 
 
 
 
 
 
 
iii 
5.4 
EFFICACY EVALUATIONS .....................................................................................................................16 
5.4.1 
Baseline Assessment ......................................................................................................................16 
5.4.2 
Police Interaction Assessments ....................................................................................................16 
5.4.3 
Police Knowledge Questionnaire .................................................................................................18 
5.4.4 
Floreo Feedback Questionnaire ....................................................................................................18 
5.5 
VIDEO/AUDIO RECORDING ..................................................................................................................18 
5.6 
SAFETY EVALUATION ...........................................................................................................................19 
6 
STATISTICAL CONSIDERATIONS ............................................................................................... 19 
6.1 
PRIMARY ENDPOINTS ..........................................................................................................................19 
6.2 
SECONDARY ENDPOINTS ......................................................................................................................19 
6.3 
STATISTICAL METHODS .......................................................................................................................19 
6.3.1 
Baseline Data .................................................................................................................................19 
6.3.2 
Efficacy Analysis ...........................................................................................................................19 
6.3.3 
Safety Analysis ...............................................................................................................................20 
6.4 
SAMPLE SIZE AND POWER ...................................................................................................................20 
7 
STUDY INTERVENTION ............................................................................................................... 21 
7.1 
VIRTUAL REALITY INTERVENTION .......................................................................................................21 
7.2 
VIDEO MODELING INTERVENTION ......................................................................................................21 
8 
SAFETY MANAGEMENT .............................................................................................................. 21 
8.1 
CLINICAL ADVERSE EVENTS .................................................................................................................21 
8.2 
ADVERSE EVENT REPORTING ...............................................................................................................22 
9 
STUDY ADMINISTRATION .......................................................................................................... 22 
9.1 
TREATMENT ASSIGNMENT METHODS ..................................................................................................22 
9.1.1 
Randomization ..............................................................................................................................22 
9.1.2 
Blinding .........................................................................................................................................22 
9.2 
DATA COLLECTION AND MANAGEMENT ..............................................................................................22 
9.3 
CONFIDENTIALITY ...............................................................................................................................23 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS ...................................................................................24 
9.4.1 
Data and Safety Monitoring Plan .................................................................................................24 
9.4.2 
Risk Assessment ............................................................................................................................24 
9.4.3 
Potential Benefits of Trial Participation ......................................................................................26 
9.4.4 
Risk-Benefit Assessment ...............................................................................................................26 
9.5 
RECRUITMENT STRATEGY ....................................................................................................................26 
9.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION .............................................................27 
9.6.1 
Assessment of the Capacity to Consent .......................................................................................28 
9.6.2 
Waiver of Assent ...........................................................................................................................28 
9.7 
PAYMENT TO SUBJECTS/FAMILIES ........................................................................................................28 
10 
PUBLICATION ............................................................................................................................... 29 
11 
REFERENCES ................................................................................................................................. 29 
Appendix ..................................................................................................................... 30 
 

  
 
 
 
 
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
ASD 
CAR 
PSM 
VR 
 
Adverse event 
Autism Spectrum Disorder 
Center for Autism Research 
Police Safety Module 
Virtual Reality 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
v 
ABSTRACT 
Context:  (Background) 
Individuals with autism spectrum disorder (ASD) have core impairments in social 
communication skills that typically persist into adulthood and result in challenges related to 
independence, employment, and emotional wellbeing.  Given the increased prevalence of 
ASD diagnoses in childhood and the noted challenges with community living skills seen in 
adults with ASD, it is critical to develop effective and easily accessible programs to support 
social skills in adolescents and adults with ASD.  Advances in virtual reality (VR) 
technology offer new opportunities to design interventions targeting the core deficits 
associated with ASD and promote acquisition of skills necessary for effective navigation of 
challenging social situations, such as engagement with law enforcement. 
Objectives: (primary and important secondary objectives) 
The primary objective of this study is to demonstrate the efficacy of Floreo’s PSM in 
adolescents and adults with ASD by assessing improvement in police interaction skills as 
compared to a video modeling intervention in a laboratory setting.  A secondary objective is 
to demonstrate the virtual-based efficacy of Floreo’s PSM in adolescents and adults with 
ASD by assessing improvement in police interaction skills as compared to a treatment-as-
usual condition, in virtual video conferencing settings using CHOP-based staff as treatment 
implementers. 
 
Study Design:  
This is a randomized control trial in which an immersive VR module is intervention being 
evaluated.   
Setting/Participants: 
Cycle A of the study will be conducted at the Center for Autism Research at CHOP.  Cycle 
B of the study will be conducted virtually using CHOP approved, HIPPA compliant video 
conferencing software. Subjects aged 12 to 60 years with ASD are eligible to participate. 
Study Interventions and Measures:  
The study intervention is an immersive VR police safety module.  The main outcome 
measures are a police interaction assessment and a police knowledge assessment.   
 
 

 
vi  
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
 
 
Study Phase 
Screening 
Cycle A 
Cycle B 
 
Visit Number 
 
1 
2 
3 
1 
2  
3 
4 
 
 
 
 
 
 
 
 
4 weeks 
post-
intervention 
Informed Consent/Assent 
X 
X 
 
 
X 
 
 
 
Review Inclusion/Exclusion 
Criteria 
X 
X 
 
 
X 
 
 
 
Screening Interview 
X 
 
 
 
 
 
 
 
IQ Testing 
 
X 
 
 
X 
 
 
 
Behavioural Testing and 
Questionnaires 
 
X 
X 
X 
X 
X 
X 
X 
Baseline Assessment 
 
X 
 
 
X 
 
 
 
Virtual Reality Sessions 
 
X 
X 
X 
X 
X 
X 
X 
Police Interaction Assessment 
 
 
 
X 
 
 
X 
X 
 
.

 
7  
 
 
 
 
 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Individuals with autism spectrum disorder (ASD) have core impairments in social 
communication skills that typically persist into adulthood and result in challenges related to 
independence, employment, and emotional wellbeing. ASD prevalence is rising, with recent 
estimates in studies from the Centers for Disease Control and Prevention ranging from 14.6 per 
1000 children aged 8 years (Centers for Disease Control and Prevention 
[CDC], 2016) to 2.24% in children aged 3 to 17 years (Zablotsky et al., 2015). Given the 
increased prevalence of ASD diagnoses in childhood and the noted challenges with community 
living skills seen in adults with ASD, it is critical to develop effective and easily accessible 
programs to support social skills in adolescents and adults with ASD. 
 
Advances in virtual reality (VR) technology offer new opportunities to design interventions 
targeting the core deficits associated with ASD and promote acquisition of skills necessary for 
effective navigation of challenging social situations, such as engagement with law enforcement. 
Researchers have explored the potential of virtual reality technology in targeting autism-related 
deficits (Parsons and Cobb, 2011), but at this time there are no evidence-based VR interventions 
for ASD. While most research labelled VR for the purposes of therapy has not been immersive, 
in recent years, the commercial introduction of head-mounted displays (HMD) and lower cost of 
virtual reality technology have led to greater interest in therapeutic applications of VR. As part of 
a mission to develop VR products for individuals with ASD, we will collaborate with a 
commercial tech start-up company, Floreo Technology, to study a mobile VR module for police 
safety skills.   The project will evaluate the safety and feasibility of the mobile VR police safety 
module (PSM) and the effectiveness of the module in improving police interaction skills in 
adolescents and adults with ASD with mid-range to high-functioning intellectual abilities. 
 
1.2 Name and Description of Investigational Product or Intervention 
Floreo’s virtual reality (VR) application provides immersive and engaging therapy intended to 
help individuals with ASD build real world skills. If proven effective, the application would be 
an affordable supplement to traditional therapy that is fun and engaging for the user, while 
allowing a supervising adult to monitor and guide the activities.   
 
Floreo’s Police Safety Module (PSM) will offer a supervised VR experience for individuals with 
ASD. The software will be a downloadable application that provides a three-dimensional 
immersive scene for headset-compatible smartphones and a supervisory overview that can run on 
smartphones or tablets. The individual with ASD will use a smartphone capable of running the 
application with a dedicated headset providing the virtual environment.  
 
1.3 Relevant Literature and Data 
Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with lifelong 
impact. ASD is characterized by variable degrees of impairment in social communication and 

 
8  
 
 
 
 
 
 
 
restricted and repetitive patterns of behavior (American Psychiatric Association, 2013). 
Prevalence has been rising, with recent estimates in studies from the Centers for Disease Control 
and Prevention ranging from 14.6 per 1000 children aged 8 years (Centers for Disease Control 
and Prevention [CDC], 2016) to 2.24% in children aged 3 to 17 years (Zablotsky et al., 2015).  
While much attention has been paid to the pathogenesis and diagnosis of ASD, there remains a 
clear need for effective treatments for the core symptoms. ASD is a lifelong disorder, persisting 
into adulthood and resulting in significant challenges for affected individuals. 
 
Adults with ASD experience significant social challenges that impact functional living skills and 
emotional well-being. Families of young adults initially diagnosed with ASD as preschoolers 
have noted the persistence of unmet social needs (Eaves and Ho, 2008). A more recent survey of 
young adults with ASD found that 24% reported social isolation, as well as high rates of anxiety, 
depression, and attention deficit hyperactivity disorder. In addition, 4 in 10 young adults with 
ASD were described as disconnected from work and continued education through their late teens 
and early twenties. Less than 20% of young adults with ASD lived independently (Roux et al., 
2015). Researchers have also described age-related declines in social communication (Wallace et 
al., 2016) and adaptive functioning skills (Pugliese et al., 2015).  
 
Individuals with social communication disabilities like ASD may be particularly susceptible to 
poor police interaction outcomes due to difficulty reading social cues (American Psychiatric 
Association, 2013), variable verbal ability (Tager-Flusberg & Kasari, 2013), heightened anxiety 
(Sukhodolsky et al., 2008), and reduced executive control (Blijd-Hoogewys et al., 2014). The 
presence of intellectual disability (ID) is associated with greater risk of injury during police 
interactions (Perry & Carter-Long, 2016), and approximately 30% of individuals with ASD also 
have ID (CDC, 2012). Rava et al. (2017) reported that elevated externalizing behaviors in U.S. 
teens with ASD are associated with police contact. Similarly, Tint et al. (2017) reported that 
instances of aggressive behavior are the most common cause of contact between police and 
Canadian adults with ASD. 
 
Existing intervention approaches relevant to interactions with law enforcement for individuals 
with ASD have not been shown to be effective. The effort to promote optimal social and 
community living skills in young adults with ASD has led researchers to investigate strategies 
such as story-based interventions and video modeling. Social StoriesTM is the most well-known 
story-based intervention. While a systematic review of Social StoriesTM found positive benefits 
for various social outcomes (Karkhaneh et al., 2010), a meta-analysis found Social StoriesTM to 
be of limited effectiveness in addressing social difficulties (Kokina and Kern, 2010). 
 
Video modeling intervention was found to be moderately effective (Hong et al., 2016) and 
described as an evidence-based practice for daily living skills (Hong et al., 2015) for individuals 
with ASD. BE SAFE The Movie uses a video modeling approach to support more effective 
interactions between individuals with ASD and law enforcement officers. This program has been 
used in communities across the country and is featured as a safety resource by Autism Speaks.  
However, the efficacy and effectiveness of the BE SAFE intervention have not yet been 
experimentally examined and there are currently no evidence-based programs specifically 
designed to train police safety skills in individuals with ASD. 
 

 
9  
 
 
 
 
 
 
 
New VR technology is promising. Researchers have explored the potential of VR technology in 
targeting ASD-related deficits (Parsons and Cobb, 2011). However, most research labelled VR 
for the purposes of therapy has not been immersive (Lahiri et al., 2015; Didehbani et al., 2016; 
Josman et al., 2008). An immersive VR experience gives the user the feeling of being inside a 
virtual world, and offers an environment in which users can try out experiences that are hard to 
stage or replicate in real life. In recent years, the commercial introduction of head-mounted 
displays (HMD) and lower cost of VR technology have led to increased use by the public as well 
as greater interest in therapeutic applications of VR. These new advances in VR technology offer 
opportunities to design interventions targeting the core deficits associated with ASD and promote 
progress toward optimal functional outcomes. Given the increasing prevalence of ASD in the 
population, and the impact of persisting deficits in social communication and daily living skills 
in adults with 
ASD, it is critical to develop innovative means of providing support to individuals with ASD. 
Consistent with this, the most recent National Standards Project from the National Autism 
Center, released in 2015, describes “Technology-based Intervention” as an Emerging 
intervention, warranting additional research (National Autism Center, 2015). 
  
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and HIPAA. All episodes of noncompliance will be 
documented. 
The investigators will perform the study in accordance with this protocol, will obtain consent and 
assent (unless a waiver is granted), and will report unanticipated problems involving risks to 
subjects or others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and after the 
study.  
2 
STUDY OBJECTIVES 
The overall objective of the proposed project is to demonstrate a satisfactory safety profile, 
feasibility, and efficacy of a unique mobile VR application for police safety skills in adolescents 
and adults with ASD. Safety and feasibility was found to be acceptable under a separate protocol 
(#14194), while this phase of the project will involve ongoing research and development 
including laboratory-based efficacy and virtually-based efficacy studies. This study will involve 
further development of the PSM, including greater complexity of the virtual environment and 
greater diversity of police interaction options. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to demonstrate the efficacy of Floreo’s PSM in adolescents 
and adults with ASD by assessing improvement in police interaction skills as compared to a 
video modeling intervention and a treatment-as-usual condition.  
 

 
10  
 
 
 
 
 
 
 
2.2 Secondary Objectives (or Aim) 
The secondary objective is to demonstrate the efficacy of Floreo’s PSM in adolescents and adults 
with ASD by assessing improvement in police interaction skills as compared to a treatment-as-
usual condition under virtual implementation. 
 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design  
3.1.1 Screening Phase 
Potential subjects will be screened using a screening interview that reviews the protocol’s 
requirements, and inclusion/exclusion criteria.  Questions about level of functioning will be 
included to provide an estimate of IQ. In the case of a reported grade level discrepancy greater 
than one year, potential subjects will be asked to provide the most recent IEP evaluation in order 
to review IQ scores and estimate current IQ. Medical and/or research records will be reviewed to 
document ASD diagnosis.   
Informed consent (if adult) or parental/guardian permission (if child or adult with diminished 
capacity) and, if applicable, assent, will be obtained prior to any study related procedures being 
performed, including IQ testing to confirm that subjects meet this inclusion criterion.  
3.1.2 Cycle A – Laboratory-Based Efficacy Study 
In the first year of the study, an efficacy study will be conducted at the Center for Autism 
Research.  Subjects will be randomized to the VR intervention or to the video modeling control 
condition (with stratification, see Study Procedure).  Subjects in each condition will undergo a 
baseline assessment of police interaction skills via a live role play with a study staff member and 
three sessions of their assigned intervention within an approximately six-week period.  At the 
end of Visit 3, subjects’ police interaction skills will be assessed via a live interaction with a 
police officer.     
3.1.3 Cycle B – Virtually-Based Efficacy Study  
In the second year (after the completion of Cycle A), a virtually-based efficacy trial will be 
conducted by CHOP staff via videoconference.  Subjects will be randomized to the VR 
intervention or to the treatment-as-usual condition (with stratification, see Study Procedure).  
Subjects in each condition will undergo a baseline assessment of police interaction skills via a 
novel pre-/post-intervention assessment and three sessions within an approximately six-week 
period. At the end of Visit 3, subjects’ police interaction skills will be assessed. There will be an 
additional follow-up visit approximately 4 weeks post-training, for all participants, to re-
administer outcome measures, as an assessment of maintenance of learning.   

 
11  
 
 
 
 
 
 
 
3.2 Study Duration, Enrollment and Number of Sites 
3.2.1 Duration of Study Participation 
In the first year of the study (Cycle A), the study duration per subject will be up to 3 visits over 
approximately 6 weeks. In Cycle B, the study duration per subject will be up to 4 virtual sessions 
over approximately 10 weeks. 
3.2.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately two investigative sites in the United States.  Cycle 
A of the study will be conducted at the Center for Autism Research at CHOP, while Cycle B will 
be conducted virtually using CHOP approved, HIPPA compliant video conferencing software.  
Recruitment will stop when approximately 48 evaluable subjects complete each phase of the 
study.  It is expected that approximately 400 subjects will be enrolled to produce 96 evaluable 
subjects.  
3.3 Study Population   
3.3.1 Inclusion Criteria 
1) Males or females age 12 to 60 years  
2) Documented ASD diagnosis 
3) Verbal and overall IQ ≥ 75 (Cycle A)/Verbal and overall IQ ≥ 80 (Cycle B) 
4) Informed consent (if adult) or parental/guardian permission (if child or adult with diminished 
capacity) and, if applicable, assent 
3.3.2 Exclusion Criteria 
1) Participation in Phase I (IRB# 14194) 
2) Personal or family history of seizures or a seizure disorder, subject to review on a case by 
case basis by medical professionals at Floreo  
3) Primary sensory impairment (e.g., blindness, deafness) 
4) Personal history of migraines, subject to review on a case by case basis by medical 
professionals at Floreo  
5) History of vertigo 
6) Diagnosis of a known genetic syndrome (e.g., Down syndrome, Fragile X syndrome)  
7) History of a medical condition which has affected/affects cognitive, sensory, or motor 
functioning (e.g., Fetal Alcohol Syndrome, brain injury, stroke, brain tumor)  
8) Non-English speaking 

 
12  
 
 
 
 
 
 
 
9) Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant 
with study schedules or procedures 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of 
these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 Screening Interview 
• Informed Consent 
• Screening Questionnaire 
• Medical or Research Record Review 
4.2 Characterization Visits 
• Informed Consent, and assent if appropriate 
• IQ testing (completed at first visit) 
• ASD diagnostic testing (completed at any of the 3 intervention study visits in Cycle A 
only)  
• Self-report measures 
• Parent-report questionnaires 
• Stratified randomization to either the VR intervention or to the video modeling control 
condition 
• Medical or Research Record Review 
4.3 Intervention Visits 
• Baseline Assessment 
• VR or video modeling session 
• Pre and post-intervention Police Knowledge Assessment 
• Police Interaction Assessment at the end of Visit 3 
• Floreo Feedback Questionnaire following the Police Interaction Assessment (Cycle B)  
• Debriefing 
4.4 Follow-Up Visits  
4.4.1 4 weeks post-intervention (Cycle B only) 
• Police Interaction Assessment 
• Police Knowledge Assessment   
• Debriefing  
4.5 Unscheduled Visits 
No unscheduled visits are anticipated.   

 
13  
 
 
 
 
 
 
 
4.6 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They may 
also be discontinued from the study at the discretion of the Investigator for lack of adherence to 
study visit schedules or procedures.  The Investigator may also withdraw subjects who violate 
the study plan, or to protect the subject for reasons of safety or for administrative reasons.  It will 
be documented whether or not each subject completes the pilot study. If the Investigator 
becomes aware of any serious, related adverse events after the subject completes or withdraws 
from the study, they will be recorded in the source documents and on the CRF.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical or Research Record Review 
For subjects who have participated in a study at the Center for Autism Research, their ASD 
diagnosis will be confirmed using previously collected information.  The electronic medical 
records of subjects who receive care at CHOP may also be reviewed to confirm diagnosis.  
Finally, records supporting their ASD diagnosis will be requested from subjects who are not 
affiliated with CHOP. For subjects enrolled in Cycle B, research staff will review relevant 
records to confirm ASD status. 
5.1.2 IQ testing 
Cognitive function, including verbal and non-verbal intelligence, will be assessed using the 
Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II; Wechsler & Hsiao-pin, 
2011) or other equivalent IQ test.  Subjects with a verbal and overall IQ greater than or equal to 
75 (Cycle A), or 80 (Cycle B) will continue with the study. 
5.1.3 Clinician Observed Autism Symptoms  
Autism Diagnostic Observational Schedule - 2nd Edition (Lord, Rutter, DiLavore, Risi, Gotham, 
& Bishop, 2012). The ADOS-2 is a semi-structured standardized assessment using 
developmentally appropriate social interactions in a 30-45 minute evaluation session. The 
ADOS-2 consists of five different modules, each directed at a particular level of language ability. 
The ADOS-2 has been carefully psychometrically validated across a wide range of ages and 
severity levels in autism, and it is widely considered the single best gold standard diagnostic 
instrument.  The ADOS will be administered onsite at CHOP during Cycle A. Feedback will be 
provided to participants in person or over the phone as needed, based on conversations between 
participating families and the study clinician. Participants who have completed an ADOS at the 
Center for Autism Research or a comparable organization within one year of participation in this 
study will not need to complete it again. 
The ADOS will be audio and video recorded in accordance with CHOP Policy RI-2-03 
(Recording or Filming of Patients). Audio and video recordings may be used for clinical 
supervision, training, educational, or research purposes. 

 
14  
 
 
 
 
 
 
 
5.1.4 Autism Screening 
Social Communication Questionnaire (SCQ; Rutter, Bailey, & Lord, 2003). The SCQ is a parent 
report screening measure for ASD that has been validated for identifying children displaying 
autism symptoms.  The SCQ will be completed by parents of participants.  
Autism-Spectrum Quotient (AQ; (Ruzich et al., 2015)). The AQ is a widely used, 50-item self-
report questionnaire designed to measure reciprocal behavior, social use of language, and other 
behaviors characteristic of ASD. Total AQ score and 5 subscales (communication, social skills, 
imagination, attention to detail, attention switching) are normally distributed, demonstrate good 
test-retest reliability, and have medium-to-high internal consistency (Baron-Cohen, 
Wheelwright, Skinner, Martin, & Clubley, 2001).   
5.1.5 Other Measures and Questionnaires 
Adult/Adolescent Sensory Profile (Brown, et al., 2001).  The Adolescent/Adult Sensory Profile is 
designed as a trait measure of sensory processing patterns and effects on functional performance. 
An individual answers questions regarding how he or she generally responds to sensations, as 
opposed to how he or she responds at any given time. This enables the instrument to capture the 
more stable and enduring sensory processing preferences of an individual. 
Child Behavior Checklist (CBCL) OR Adult Behavior Checklist, (T. Achenbach & Rescorla, 
2001). The CBCL is a 118-item checklist completed by parents regarding a broad range of 
behavioral and emotional problems. Statements are rated from 0 to 2 based on how well the 
statement describes the youth: 0 (not true), 1 (somewhat or sometimes true) and 2 (very often 
true).  Scores are reported for both internalizing and externalizing scales including the following 
subscales: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problem, 
Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. The 
Adult Behavior Checklist is a parent-report extension of the CBCL intended for adults aged 18-
59.  The Adult Self-Report is the self-report extension of the CBCL intended for adults aged 18-
59.      
Social Responsiveness Scale – Second Edition (SRS-2; Constantino, 2012).  The SRS-2 
distinguishes autism spectrum conditions from other psychiatric conditions by identifying 
presence and extent of autistic social impairment. The SRS-2 is a 65-item quantitative measure 
of autistic traits ranging continuously from significantly impaired to above average. Familial 
correlations of sub-clinical features of autism can be measured by the SRS-2, which is consistent 
with the potential for heritability of a broad autism phenotype in family members. Parents will 
complete the SRS-II or the SRS-ARV, as appropriate to the participant’s age, as the measure of 
autistic traits in non-ASD and ASD participants.  The SRS-2 will be completed by parents of 
subjects age 12-17.   
Demographic and Medical History Form (all ages). Information about participant family, 
medical and diagnostic history, race/ethnicity, household income, and educational level will be 
collected from parents/adult participants. This information will be used to understand participant 
diagnostic history, control bias, and will be entered as covariates to statistical analyses when 
groups are not matched on critical features.   

 
15  
 
 
 
 
 
 
 
Police Knowledge Assessment.  This measure has been created by study investigators to measure 
prior police interaction experience and feelings about interacting with police. 
Police Interaction Behavior Checklist. This checklist has been created by study investigators as a 
learning tool to be given to all participants prior to beginning the first trial of the PSM. The 
Police Interaction Behavior Checklist describes how to appropriately behave while interacting 
with a police officer. The participant and the moderator can refer to this checklist as needed 
while progressing through the VR trials to aid in learning.  
Floreo Feedback Questionnaire. This questionnaire has been created by study investigators to 
measure how the participants felt about the VR and to get feedback on how the VR can be 
modified to better suit people with different backgrounds.  
5.2 Intervention: Virtual Reality Sessions 
Each subject assigned to the PSM intervention will undergo three sessions over an approximately 
six week period (at least 24 hours between sessions). At the beginning of each session, research 
personnel will preview the VR session experience with the subject and a parent or caregiver as 
appropriate. The VR experience preparation will include screening of subject’s health status and 
adjustment of the headset to fit the subject. The VR session will consist of multiple scenes in 
which the subject is approached and engaged by police officers in the virtual environment. Some 
police officer avatars in the virtual environment will be wearing facemasks to accurately reflect 
real-world masking behaviors in Cycle B. VR scenes will be presented via the Floreo application 
downloaded onto an iPhone worn by the participant in a lightweight, inexpensive VR headset. 
The VR interaction will be controlled and operated via linked iPad by a research staff member 
sitting with the subject at CAR in Cycle A, or via tele-administration in Cycle B. Subjects in the 
VR environment will receive live feedback from research staff members about police officer 
interaction expectations and safety in accordance with individual scene scripts and prompts. 
Each VR session should encompass four VR trials, each involving a non-identical police safety 
scene. The subject will take a break from the VR environment in between each trial. 
 
5.3 Control Conditions  
5.3.1 Cycle A: Video Modeling  
Subjects assigned to the comparison video modeling interaction will undergo three sessions over 
a period of six weeks that will consist of BE SAFE The Movie Curriculum Lessons 1-4 
(https://besafethemovie.com/curriculum/). The BE SAFE The Movie Curriculum consists of 
video-based instruction on police officer interaction expectations and safety. These include 
Lesson 1: Laws Help us BE SAFE; 2: Law Enforcement Officers Help Us BE SAFE; 3: 
Uniforms and Safety Tools; 4: Stay Calm When You Meet the Police; within each of these 
lessons, participants will be shown videos, and then complete additional engaging video-based 
activities and short movie scenarios to video model.  The lessons will be presented by research 
staff member sitting with the subject at CAR. Video observation, activities, and modeling 
sessions will be structured to correspond with VR session duration and total number. Participants 
in the video modeling interaction arm will be screened for subject health status in preparation for 
their sessions. 

 
16  
 
 
 
 
 
 
 
5.3.2 Cycle B: Treatment-as-usual 
Subjects assigned to the control condition will not receive any training with PSM, but will 
engage with the software for their assessments, and will continue their other treatments as usual. 
Participants in the treatment-as-usual arm will be screened for subject health status in preparation 
for their sessions. 
 
 
5.4 Efficacy Evaluations 
5.4.1 Baseline Assessment 
5.4.1.1 Cycle A 
Before beginning the first VR or video modeling intervention session, all participants will 
complete a baseline assessment of police interactions skills via a live role play of a police 
interaction with a study staff member. These interactions are designed to measure each 
participant’s ability to interact with a police officer prior to completing either intervention. The 
study staff member will be provided with a semi-structured set of prompts to use when 
interacting with the participant. The interaction is designed with guidance from law enforcement 
officers with particular experience working with individuals with intellectual and developmental 
disabilities. The live interaction will be video-recorded via a videoconference platform. These 
recordings will be coded for a set of behaviors that would encourage successful police 
interactions (i.e.: making appropriate eye contact, etc.)  
5.4.1.2 Cycle B 
Before beginning the first VR or video modeling intervention session, all participants will 
complete a baseline novel remote assessment of police interactions skills. These interactions are 
designed to measure each participant’s ability to interact with a virtual police officer prior to 
completing either intervention. This assessment will include coded video recordings of 
participants wearing the VR headset while engaging in a standardized experience. The behaviors 
of the participant inside the virtual environment will also be coded. The interaction is designed 
with guidance from law enforcement officers with particular experience working with 
individuals with intellectual and developmental disabilities. The live interaction will be video-
recorded via a CHOP-approved, HIPPA compliant videoconference platform. These recordings 
will be coded for a set of behaviors that would encourage successful police interactions (i.e.: 
making appropriate eye contact, etc.)  
5.4.2 Police Interaction Assessments 
5.4.2.1 Cycle A: Live Police Interaction Assessment  
After the final VR or video modeling intervention session, all participants will be assessed via a 
live semi-structured interaction with a police or security officer. These interactions are 
specifically designed to serve as an index of behaviorally defined skills associated with effective 
interactions with a police officer. The police officer will be provided with a semi-structured set 
of prompts to use when interacting with the participant, and will rate the participant’s responses. 
The interaction is designed with guidance from law enforcement officers with particular 
experience working with individuals with intellectual and developmental disabilities. The live 

 
17  
 
 
 
 
 
 
 
interaction will be video-recorded. These recordings will be coded for a set of behaviors that 
would encourage successful police interactions (i.e. making appropriate eye contact, etc.).   
 
Individuals with and without ASD both experience a degree of stress/anxiety when interacting 
with Police Officers.  Police Officers also have particular characteristics, training, and 
expectations which make their approaches to members of the community unique. Furthermore, 
Police Officer approaches and interaction are very often unexpected.  Yet, Police Officer 
approaches to civilians are common, every day occurrences, including for individuals with ASD.  
As a result of these factors, it is critical that experimental measurement of effective versus 
ineffective interaction with Police Officers in the current study are implemented using real Police 
or Security Officers.   
 
While it is important that our research participants are approached by actual Police Officers, it is 
also critical that risks for stress/distress and other harms are minimized.  To this end, the Police 
Officer will be instructed to take a casual, non-accusatory approach to questioning the 
participant, but to otherwise follow their standard procedures in the type of scenario where they 
need to inquire with an individual but where that individual is not a suspect.  In addition, 
although the Police Officers will be blinded to the experimental treatment condition of the 
participant, all Police Officers will be made aware that the participants may have ASD, and will 
be given basic information and have opportunity to ask questions and learn about what it means 
for someone to have ASD. 
 
Consistent with ethical standards in psychological research, all participants will be de-briefed 
immediately following the Live Interaction Assessment with the Police Officer. The researcher 
and the Police Officer will both remind the research participant that the Police Officer’s 
approach to them was conducted as part of the study.  The researcher and Police Officer will 
further explain to the research participant that they are not in trouble and that the Police Officer 
is not upset with them.  The research participant will be offered the opportunity to ask questions, 
and to provide their thoughts and feedback on the study procedures and practices.  Research 
participants will also be asked to rate their experience with the Live Police Interaction, as well as 
the study process and procedures overall, in a formal questionnaire.  Information gathered from 
both the interview and the questionnaire will be used to inform the researchers of how the 
practice is affecting research participants.   
 
5.4.2.2 Cycle B: Virtual Police Interaction Assessment 
After the final VR intervention session, all participants will be assessed via a remote semi-
structured interaction with a police or security officer avatar. Approximately 4weeks after the 
final VR intervention session, participants in Cycle B will be assessed once again via a remote 
interaction with a police or security officer. These interactions are specifically designed to serve 
as an index of behaviorally defined skills associated with effective interactions with a police 
officer. The police officer will be programmed with a semi-structured set of prompts to use when 
interacting with the participant, and will rate the participant’s responses. The interaction is 
designed with guidance from law enforcement officers with particular experience working with 
individuals with intellectual and developmental disabilities. We will use video recordings of both 
the participant wearing the headset and behaviors while in the VR experience to code behaviors. 
These recordings will be coded for a set of both virtual and real-world behaviors that would 

 
18  
 
 
 
 
 
 
 
encourage successful police interactions (i.e. making appropriate eye contact, orienting to the 
virtual officer, etc.).   
 
 
While it is important that our research participants are approached by simulated Police Officers, 
it is also critical that risks for stress/distress and other harms are minimized.  To this end, the 
virtual reality Police Officer will take a casual, non-accusatory approach to questioning the 
participant, and will follow their standard procedures in the type of scenario where they need to 
inquire with an individual but where that individual is not a suspect.   
 
Consistent with ethical standards in psychological research, all participants will be de-briefed 
immediately following the Remote Interaction Assessment. The research participant will be 
offered the opportunity to ask questions, and to provide their thoughts and feedback on the study 
procedures and practices.  Research participants will also be asked to rate their experience with 
the remote Police Interaction, as well as the study process and procedures overall, in a formal 
questionnaire.  Information gathered from both the interview and the questionnaire will be used 
to inform the researchers of how the practice is affecting research participants.   
 
 
5.4.3 Police Knowledge Questionnaire    
This questionnaire has been developed by the study team as a measure of knowledge of officer 
expectations for interaction and will be administered to all participants both pre-treatment and 
post-treatment, as well as during the follow-up visit for Cycle B. 
5.4.4 Floreo Feedback Questionnaire  
This questionnaire has been developed by the study team as a measure of how well the VR 
simulated a real police interaction and will be administered to all participants post treatment.  
5.5 Video/Audio Recording 
Virtual and in person clinical testing will be audio and video recorded in accordance with CHOP 
Policy RI-2-03 (Recording or Filming of Patients). Audio and video recordings may be used for 
clinical supervision, training, educational, or research purposes. 
The VR sessions may be recorded for research, accuracy, and safety purposes.  Video recording 
will not be mandatory; permission to record these sessions will be obtained in the consent form.  
The VR sessions will be recorded to capture any adverse effects of the VR, which may help 
prevent such effects in future visits.  It would also be helpful to have a video record of the 
session to determine how the gyroscopic effects in the VR module correspond to the subjects’ 
movements. Video modeling sessions may also be recorded for comparison purposes. 
The Baseline Assessment as well as Virtual and Live Police Interactions will be recorded for 
research purposes.  The interactions will be coded for a set of behaviors that would encourage 
successful police interactions (i.e. making appropriate eye-contact, orienting to the virtual 
officer, etc.). All recordings will be stored on a secure CHOP-approved server.  If conducted via 
videoconference, they will be recorded through the CHOP- approved platform used. 

 
19  
 
 
 
 
 
 
 
5.6 Safety Evaluation 
Immediately after completing each intervention session, research staff will ask subjects about 
any side effects experienced during the session. Research staff will also document the subject’s 
overall perceived mood and emotional state. 
 
6 
STATISTICAL CONSIDERATIONS  
6.1 Primary Endpoints 
The primary efficacy endpoints will be the change in post-treatment Live and Virtual Police 
Interaction Assessment Scores between the Virtual Reality Intervention and treatment-as-usual 
groups, and the change in scores between the Baseline Assessment and Virtual Police Interaction 
Assessment.  
6.2 Secondary Endpoints 
Secondary endpoints will include the following: 
• The changes in Police Interaction Knowledge Questionnaire Scores from Pre-Treatment 
to Post-Treatment for the Virtual Reality Intervention and BE SAFE Video-Based 
intervention or treatment-as-usual;  
• The maintenance of learned skill improvements, indexed via the 4-week (Cycle B) 
Follow-Up administration of the Virtual Police Interaction Assessment. 
6.3 Statistical Methods 
6.3.1 Baseline Data 
Baseline and demographic characteristics will be summarized by standard descriptive summaries 
(e.g., means and standard deviations for continuous variables such as age and percentages for 
categorical variables such as gender).  Statistical analyses will be conducted to compare groups 
on each of the measures.  Any baseline characteristics which exhibit statistically significant 
group differences despite stratified random assignment will be utilized as co-variates in both 
Primary and Secondary statistical analyses of intervention effects. 
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach and will include all subjects 
randomized at Visit 1.   
The primary efficacy endpoint will be the change in post-treatment Live Police Interaction 
Assessment Scores between the Virtual Reality Intervention and BE SAFE Video-Based 
intervention and the change in scores between the Baseline Assessment and Live Police 
Interaction Assessment. In the case of Cycle 2, the Baseline Assessment will be compared to the 
Virtual Police Interaction Assessment between the Virtual Reality Intervention and treatment-as-
usual groups. The study hypothesis is that participants randomly assigned to the Virtual Reality 
Intervention will perform better on the post-treatment Live or Virtual Police Interaction 
Assessment than will participants randomly assigned to the BE SAFE Video-Based intervention 
or treatment-as-usual condition. 

 
20  
 
 
 
 
 
 
 
The secondary endpoint will include changes in Police Interaction Knowledge Questionnaire 
Scores from Pre-Treatment to Post-Treatment for the Virtual Reality Intervention and BE SAFE 
Video-Based intervention or treatment-as-usual. The study hypothesis is that participants 
randomly assigned to the Virtual Reality Intervention will exhibit significantly greater 
improvement from Pre-Treatment to Post-Treatment on Police Interaction Knowledge 
Questionnaire than will participants randomly assigned to the BE SAFE Video-Based 
intervention condition or the treatment-as-usual condition.  An additional Secondary endpoint is 
maintenance of learned skill improvements, indexed via the 4-week Follow-Up administration of 
the Virtual Police Interaction Assessment in Cycle B.  The study hypothesis is that participants 
randomly assigned to the Virtual Reality Intervention will exhibit significantly greater Live 
Police Interaction Assessment Scores and skill improvement/maintenance 4-week follow-up than 
will participants randomly assigned to the treatment-as-usual condition. 
6.3.3 Safety Analysis 
All subjects entered into the study at Visit 1 will be included in the safety analysis. The 
frequencies of AEs by type, body system, severity and relationship to study intervention type 
will be summarized. SAEs (if any) will be described in detail. 
AE incidence will be summarized along with the corresponding exact binomial 95% two-sided 
confidence intervals. 
6.4 Sample Size and Power 
This study will compare the PSM VR intervention to treatment-as-usual (TAU) in a total of 96 
adolescents and adults with ASD, in two separate studies (i.e., n=48 per study). The most 
relevant study to date (Didehbani, Allen, Kandalaft, Krawczyk, & Chapman, 2016) included 30 
7-16 year-olds with ASD in a pre/post virtual reality intervention to improve social cognitive 
skills. This study suggested a medium-to-large within-group effect of VR intervention on 
emotion recognition (Cohen’s d = .63), but did not compare two interventions. Sensitivity 
analysis using G*Power indicated that intervention differences using our proposed sample size 
(N=48 per group) will be detected with a critical t of 1.99, and that we will be able to detect 
differences with effect sizes of Cohen’s d = .74 or larger. Data will be behaviorally coded from 
video interactions and correct answers marked on knowledge tests. Scores will be summed, 
averaged, and examined for normality at the group level. Normally distributed data will be 
analyzed using parametric statistics (e.g., ANOVA, regression, Pearson correlation), and data 
that do not meet normality assumptions will either be transformed or will be analyzed using 
nonparametric statistical tests (e.g., Chi-square, Spearman correlation). Analyses will be 
corrected for comparisons. To compare PSM to BE SAFE, an Analysis of Variance (ANOVA) 
with Group (PSM VR Intervention, BE SAFE The Movie Video Modeling Intervention) as a 
Between-Subjects factor will be conducted for Live Interaction data. A separate ANOVA (or 
comparable statistical test) will be conducted for Questionnaire data. Relevant potential 
covariates include knowledge of police interactions at intake, sensory sensitivity scores, verbal 
abilities, and chronological age. 
 

 
21  
 
 
 
 
 
 
 
7 
STUDY INTERVENTION 
7.1 Virtual Reality Intervention 
Floreo’s Police Safety Module (PSM) will offer a supervised VR experience for individuals with 
ASD. The software will be a downloadable application that provides a three-dimensional 
immersive scene for headset-compatible smartphones and a supervisory overview that can run on 
smartphones or tablets. The individual with ASD will use a smartphone capable of running the 
application with a dedicated headset providing the virtual environment. 
 
1. Immersive story-based intervention. Floreo’s PSM provides a fully realized and intricately 
detailed urban environment (Appendix figure 1), designed to engage the user in a virtual 
encounter with law enforcement officers. The immersive VR environment engages the 
individual with ASD as an actor in a virtual narrative, incorporating strategies from both 
story-based intervention and video modeling. The opportunity to enter a virtual environment 
is likely to be appealing for adolescents with ASD. A law enforcement officer with extensive 
experience working with individuals with autism spectrum disorder along with members of 
the Philadelphia Police Department have provided ongoing input into content and 
environment design for this product. 
 
2. Video modeling. Floreo’s PSM provides video modeling to an individual with ASD.  The 
video demonstrates the approach and initial engagement efforts of various police officers in 
the virtual environment, from the perspective of the individual wearing the HMD (Appendix 
figure 2). 
 
3. Supervised Learning Environment. Floreo’s PSM allows a monitor to use a tablet or phone 
to supervise the individual’s virtual world. The devices used by individual with ASD and the 
monitor are communicatively paired together over a network connection (Appendix figure 3). 
 
7.2 Video Modeling Intervention 
The video modeling intervention consists of the first four BE SAFE The Movie Curriculum 
Lessons (https://besafethemovie.com/curriculum/). The BE SAFE The Movie Curriculum 
consists of video-based instruction on police officer interaction expectations and safety.  These 
include Lesson 1: Laws Help us BE SAFE; 2: Law Enforcement Officers Help Us BE SAFE; 3: 
Uniforms and Safety Tools; 4: Stay Calm When You Meet the Police; Participants will be shown 
videos from lessons, and then complete additional engaging video-based activities and short 
movie scenarios to video model.  
 
8 
SAFETY MANAGEMENT  
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  The PI and the research 
team will work together to minimize minor adverse events. This will be accomplished through 
systematic assessment for adverse events through active clinical observation and post-session 

 
22  
 
 
 
 
 
 
 
questionnaires. If adverse events occur, we will solicit direct guidance and feedback from 
CHOP’s IRB, and immediately implement safeguards to decrease or eliminate future risks. 
Minor AEs that are unrelated to study participation will be reported to CHOP’s IRB and the NIH 
program officer in a quarterly report.  
Safety research on Virtual Reality (VR) indicates that photosensitive seizures, headache, and 
vertigo are adverse events possibly related to VR use. Our study team will consider new onset 
seizure disorder, any seizure triggered during participation, and either headache or vertigo severe 
enough to result in an emergency room evaluation or hospitalization to be SAEs and respond 
accordingly.  
8.2 Adverse Event Reporting  
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen during 
the course of this study (including SAEs) they will be reported to the IRB in accordance with 
CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. AEs that are not 
serious but that are notable and could involve risks to subjects will be summarized in narrative or 
other format and submitted to the IRB at the time of continuing review.  
Dr. Julia Parish-Morris (PI) will be responsible for handling SAEs and AEs that may occur 
during this study. Taking NIMH guidelines into account, we will implement rigorous protocols 
at each site (CHOP) to ensure that SAEs and AEs are rapidly reported to Dr. Parish-Morris. All 
SAEs will be reported to Dr. Parish-Morris within 24 hours. At CHOP, SAEs will be reported 
directly to Dr. Parish-Morris by study staff. Dr. Parish-Morris will notify CHOP’s IRB and NIH 
program officer about SAEs within 72 hours. 
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
We will employ stratified random assignment using variables including developmental age and 
sex. Other participant variables that differ between our groups following this stratified 
randomized assignment will be accounted for statistically during our primary analyses.  
9.1.2 Blinding 
Study staff members and Police officers serving as confederates in the Baseline Assessment and 
Police Interaction Assessment and those that code the interactions will be blinded to intervention 
condition.     
9.2 Data Collection and Management 
Data collected as part of this study will be managed in strict accordance with CHOP’s secure 
confidentiality standards. Importantly, after consenting to participate, all participants will be 
assigned a unique, study-specific alphanumeric identifier (subject ID). This subject ID will be 
used to track all study data; although study staff will necessarily have access to identifiable 
participant information in order to contact participants and schedule visits, in no case will the 

 
23  
 
 
 
 
 
 
 
participant's name or other identifying information appear with study data. We will keep a master 
list containing identifying information and subject ID number in a secure encrypted database 
(REDcap), separate from coded data forms, so that name-to-alphanumeric ID code 
correspondence cannot be deduced. Identifying information, including consent forms and 
information sent to us by participants or families, will be kept in a separate secure locked file 
only accessible to study staff. 
Online Data Collection: Online data collection will be facilitated by the Clinical and 
Translational Core (CTC) of the CHOP/Penn IDDRC.  The Core is comprised of CHOP staff 
only; no Penn staff are involved in data collection or management.  The CTC has negotiated 
contracts with publishers to allow the online administration of various questionnaires, and has 
standardized the data collection tools.  In return for these services, the de-identified data 
collected using CTC services will be stored in a registry, if participants agree to the future use of 
their data. 
Data Management. REDcap is a secure, password protected, encrypted web-based survey system 
based on a dedicated CHOP Research Information Systems server, and will be our primary 
tabular data management tool. Online questionnaires will be completed using REDcap, which 
will also store participants’ behavioral and clinical data coded by a unique alphanumeric 
identifier (subject ID) assigned after consenting to participate. Study staff at CHOP will be able 
to log in to REDcap via a separate interface that allows them to manually enter or update data. 
Data exported by CAR researchers for analysis will be blinded of all personally identifiable 
information (associated only with subject ID). A built-in audit trail records the identity of 
individuals that access and/or change data in the system. Data are backed up to time-stamped 
files daily by CHOP Research Information Systems using automated backup routines. Backup 
files are encrypted and transferred to a secure file server accessible only to designated personnel. 
In the event of data error, loss or corruption, research personnel will work with CHOP Research 
Information Systems to determine the most appropriate recovery strategy. As part of consent, 
participants will be asked if their coded data can be used in future studies, or for this study only, 
for which it will be retained indefinitely. Identifiable information will be retained if permission is 
given to re-contact the participant or family for future studies. Any identifiable information that 
is obtained will remain confidential per the protocol’s data management plan and will be 
disclosed only with participant/parental permission or as required by US or State law.  
Data Analysis. Primary tabular data analysis will be conducted on secure CHOP-imaged 
computers, and will not include personally identifiable information about participants. All data 
collected as part of this study will be analyzed at the group level; subjects will be identified only 
by ID number to protect their confidentiality. Primary data analysis will be conducted on secure 
CHOP-imaged computers, and will not include personally identifiable information about 
participants.  
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Investigator and other site personnel 
will not use such data and records for any purpose other than conducting the study.  

 
24  
 
 
 
 
 
 
 
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
The PI will periodically review the data collection and storage practices associated with this 
study and determine whether changes to enhance confidentiality and privacy are required. The PI 
will frequently monitor the quality control of the data with staff and research assistants.  Quality 
assurance will be monitored by the PI.   Compliance with the monitoring plan and requirements 
for reporting will be ensured through signed documentation acknowledging confidentiality and 
human subjects safeguards.  
This study will indirectly investigate adverse effects related to use of VR technology.   The 
project team will attempt to minimize these effects by familiarizing participants with the 
personnel and setting at each site, and closely monitoring them during the study. Tests are 
administered by well-trained and supervised personnel and participants are debriefed after each 
session. There may be discomfort associated with participation, but in our experience subjects 
who are well informed on the purpose of the study and who are accompanied throughout the 
procedures by a member of the research team tolerate this discomfort well and without 
complications. One approach the study team will take to protect against risks associated with VR 
use is to limit the duration of consecutive time participants spend in VR trials. Each participant 
will take a break in between each VR trial. If a participant who had not previously experienced 
adverse effects subsequently experiences an adverse effect, research staff will follow up with the 
participant or a caregiver in regard to any change in the participant’s medication regimen that 
might potentially impact tolerance of VR. A decision will then be made regarding ongoing 
participation in the study. 
A Data and Safety Monitoring Board will be established for this study, in accordance to the NIH 
policy for multisite studies.  The DSMB charter has been uploaded in the eIRB application. 
9.4.2 Risk Assessment 
Psychological Stress and Anxiety.  Due to the time associated with conducting the assessments, 
some subjects may experience fatigue, anxiety, or stress.  The Baseline Assessment and live 
police interactions may also produce these feelings.  Subjects will be allowed to take breaks and 
stop at any time. 
 
The study visits will be organized to involve breaks for the subject, and to allow the subject to 
rest between procedures.  Experienced clinicians will always be available to help in efforts to 
reduce anxiety.  Research staff working on the project all have experience working with 
adolescents and adults, and the PI and co-Investigators each have extensive experience working 
with individuals with ASD, and will therefore do everything possible to accommodate subjects.   
 
Risk of Seizures and Migraines.  There is a very low risk of seizures as a result of Virtual Reality 
technology, which is significantly increased for individuals with a history of seizures. There is 
also a low risk of migraines, which is significantly increased for individuals with a history of 
migraines. To reduce both of these risks we will screen all subjects for both a personal and 
family history of seizures and a personal history of migraines, and exclude any subject who 

 
25  
 
 
 
 
 
 
 
screens positive for either personal or family history of seizure activity of any type or personal 
history of any degree or migraines. 
 
There is also some evidence that sleep deprivation and recent alcohol use may increase risk for 
seizure activity during use of Virtual Reality or other technologies.  Therefore, we will 
encourage participants to reschedule in the event of night-before sleep deprivation or recent 
alcohol use, to avoid testing on days with either of these risks present. Finally, there is some 
evidence that extended playing time is associated with increased seizure risk.  Therefore, we 
include required breaks between trials in the Virtual Reality intervention, with approximately 20 
minutes of VR and 20 to 25 minutes of break time during the 45 minute VR intervention 
condition. 
 
Risk of Nausea and Eye Strain.  Use of Virtual Reality technology can be associated with nausea 
or eye strain. To reduce this risk, we include required breaks between the VR trials, as described 
above. The experimenters will also ask the subjects how they are feeling in between each trial. 
Finally, the researcher will be aware of the potential for nausea and eye strain and will observe 
the subject for signs of potential nausea and/or eye strain, including covering the eyes, putting 
one’s head down into their hands, holding one’s head or stomach, etc.  In cases where these 
potential indicators are observed, the experimenter will specifically ask how the subject is feeling 
and whether or not they are experiencing symptoms of nausea, eye strain, headache, or stomach 
pain or discomfort. If subjects report experiencing nausea or eye strain then the sessions will be 
stopped, in order to reduce risk of more serious adverse events such as migraines or seizures. 
 
Risk of Musculoskeletal Injury.  Use of virtual reality technology has potential to result in 
musculoskeletal injury. Specifically, as a result of differences in the virtual reality scene world 
and the real world, subjects may move in ways that do not match the real world with the risk of 
bumping into real world objects or falling.  To reduce this risk, the Virtual Reality Police 
Intervention platform does not allow for “walking” within any of the virtual reality scenes.  
Instead, even if the subject moves forward, backward, or to the side, the VR environment does 
not change.  As a result, movement of subjects is both discouraged and significantly reduced as a 
result of the virtual environment.  However, movements do occur, and subjects are able to 
“rotate” / “spin around” and look upwards and downwards within the virtual environment.  To 
further reduce the risk of musculoskeletal injury, subjects will use Virtual Reality in a central 
position of a room which is more than sufficient for the types of smaller-scale movements which 
are generally observed during this particular Virtual Reality Police Interaction training module. 
Furthermore, the experimenter will always be in the room with subject, and will monitor the 
subject’s movement within the room and intervene if at any time there is potential for the subject 
to move to a location where an injury could occur, such as a wall or piece of furniture. 
 
Sensorimotor Adaptations which Temporarily Affect Real World.  Use of virtual reality 
technology has potential to result in sensorimotor adaptations (e.g., eye-hand coordination) 
which may result in a brief period of disorientation and risk for musculoskeletal injury. 
Specifically, as a result of differences in the virtual reality scene world and the real world, 
subjects may have briefly altered sense of their sensorimotor functioning in the real world. To 
reduce the risk of injury as a result of any potential sensorimotor adaptations, we will implement 

 
26  
 
 
 
 
 
 
 
a brief post-intervention rest period during which the subject is encouraged to both sit and rest 
and then stand up and walk around in a safe open room space with the experimenter present until 
any potential sensorimotor adaptations have reversed to normal. 
 
Transmitted Diseases from Poor Hygiene.  Head-mounted immersive virtual reality requires re-
use of the same headset, earphones, and iPhone across subjects.  As a result, there is risk of 
diseases being transmitted from one subject to another as a result of poor hygiene.  To reduce the 
risk of disease transmission, the experimenters will wipe down all components of the physical 
setup using alcohol disinfectant wipes after each subject, as well as immediately prior to each 
new subject. 
 
Breach of Confidentiality.  To minimize this risk, all research records will be kept confidential 
and all research information will be associated with codes and not personal identifiers.  The 
investigators will not be able to identify subjects’ identities while working with the database 
created for this study. 
Risk of Audio and video recording: There is the possibility that participants’ audio-video 
recordings might be seen by someone outside of the study team. However, recordings will be 
kept on password-protected computers and DVDs/tapes will be kept in locked cabinets only 
accessible by the study team.  
9.4.3 Potential Benefits of Trial Participation 
No direct benefits are expected from this study.  The potential benefits of this project to society 
are considerable. There is limited evidence for effective interventions for social communication 
deficits in adolescents and adults with ASD. Demonstration of effectiveness of a mobile VR 
police safety module in adolescents and adults with ASD will provide support for a new pathway 
for social communication intervention in ASD. This study will provide insights that can guide 
further development of new tools to train a variety of social skills in adolescents and adults with 
ASD. Furthermore, the proposed effort will establish an infrastructure for future investigations to 
probe the role of VR technology in ASD intervention and treatment. 
 
Feedback will be provided to participants in person or over the phone as needed, based on 
conversations between participating families and the study clinician. 
 
9.4.4 Risk-Benefit Assessment 
While we cannot guarantee that subjects will receive any direct benefit from participation in 
this study it is hoped that the knowledge gained will benefit the subjects as well as the larger 
community of people with ASD. The risks of the study procedures are all considered minimal 
risk.  
9.5 Recruitment Strategy 
Each site will utilize the resources available to them for recruitment, and CHOP staff will 
support the other sites in their recruitment efforts.  Such resources may include previous 
participant/student lists, websites, and social media.  Colleagues of investigators or site directors 
who interact with individuals with ASD may refer their patients or students to study staff, with 

 
27  
 
 
 
 
 
 
 
appropriate permission. All recruitment materials will be submitted to the CHOP IRB for 
approval prior to being used. 
9.6 Informed Consent/Assent and HIPAA Authorization 
Potential subjects will be asked for their consent at several points of the study. Interested subjects 
will first contact study staff via phone or email for information about the study. Subjects will 
verbally provide HIPAA authorization over the phone before completing the screening 
procedures. Written informed consent for the study procedures will be obtained online prior to 
the first study visit.  The online consent forms will obtain valid electronic signatures, and consent 
responses will be tracked by parent or adult participant email.  Participants will also be able to 
print or save a copy of their consent form(s) through REDCap.       
 
Screening Phase. The HIPAA authorization form will describe the study details and HIPAA 
procedures that are in place to ensure privacy and confidentiality. It will also explain that all 
information collected will be kept strictly confidential and the nature of the risks and benefits of 
participating in the screening.   Subjects will then undergo the short screening interview over the 
phone to make sure that the subject is eligible to participate. Study staff will make it clear at the 
conclusion of the screening interview whether and why a subject is eligible to proceed. The 
specific inclusion or exclusion criteria in question will be described, and subjects will have an 
opportunity to ask questions.   
 
Cycle A and Cycle B will be two unique subject populations. Each group will have their own 
consent process and consent forms. 
 
In person visit (Cycle A). After the screening phase, subjects who are eligible and who are 
interested in proceeding will be scheduled for an in-person visit at CAR.  Consent to participate 
will be obtained online.  Eligible subjects or their parents will be emailed a link to access the 
consent form in REDCap.  The consent process will also be completed online, tracked by parent 
or adult participant e-mail address. The consent form will have contact information for the 
investigator and study staff if subjects or parents have questions about the consent form or about 
the study. The risks, benefits, financial considerations, and HIPAA procedures that are in place 
to ensure privacy and confidentiality will be highlighted on the consent page. Participants will be 
reminded that participation in the study is voluntary and can be terminated by the parent/legal 
guardian(s) (for participants under age 18 or adults with diminished capacity) or participant at 
any time with no obligations to continue and no penalties whatsoever. Refusal to participate will 
in no way influence the individual’s relationship with CHOP. Participants will have as much 
time as needed to make a decision regarding participation. Participants will be asked to indicate 
consent by checking a box at the bottom of the consent screen.  
Remote visit (Cycle B). After the screening phase, subjects who are eligible and who are 
interested in proceeding will be scheduled for a remote visit. Consent to participate will be 
obtained online.  Eligible subjects or their parents will be emailed a link to access the consent 
form in REDCap.  The consent process will also be completed online, tracked by parent or adult 
participant e-mail address. The consent form will have contact information for the investigator 
and study staff if subjects or parents have questions about the consent form or about the study. 
The risks, benefits, financial considerations, and HIPAA procedures that are in place to ensure 

 
28  
 
 
 
 
 
 
 
privacy and confidentiality will be highlighted on the consent page. Participants will be reminded 
that participation in the study is voluntary and can be terminated by the parent/legal guardian(s) 
(for participants under age 18 or adults with diminished capacity) or participant at any time with 
no obligations to continue and no penalties whatsoever. Refusal to participate will in no way 
influence the individual’s relationship with CHOP. Participants will have as much time as 
needed to make a decision regarding participation. Participants will be asked to indicate consent 
by checking a box at the bottom of the consent screen. All participants aged 12-17.99 and adults 
with diminished capacity will assent in the same manner (a note will encourage parents/legal 
guardians to read the directions at an appropriate level to participants). After 
consenting/assenting online, they will be offered the opportunity to print out a copy of the 
consent form with their name on it for their records. Participants can withdraw consent at any 
time.  
9.6.1 Assessment of the Capacity to Consent 
Adults who have a legally authorized representative (LAR) and/or may or may not have a 
diminished capacity to consent will be enrolled in the study.     
The capacity of prospective adult subjects with the potential for having a diminished ability to 
provide consent will be determined by the family, as all main study consent procedures will 
occur online.  If subject does not have the capacity to understand one or more of the required 
elements of consent, then the prospective subject will not be able to consent. The subject’s 
legally authorized representative must then provide informed consent on the subject’s behalf.  
Investigators will comply with CHOP Policy for Consent (RI-5-01) for identifying the individual 
who serves as the patient’s representative.  Adults who lack the capacity to consent will be 
required to provide assent.  Study staff will be available to prospective participants to address 
questions, if needed.  
9.6.2 Waiver of Assent 
A waiver of assent is requested for the screening phase of the study, as parents will likely be 
contacted when children are unavailable.  The research presents no more than minimal risk of 
harm to subjects and involves no procedures for which written consent is normally required 
outside of the research context.  The subjects' rights and welfare will not be adversely affected 
by the assent waiver because assent will be obtained before any of the main study (i.e. non-
screening) research procedures occur.     
9.7 Payment to Subjects/Families 
Participants at CHOP will be compensated $20 for each hour of participation (rounded up) and 
will be paid for each full hour of participation even if they fail to complete the hour.  Cycle A is 
expected to take 3 hours for questionnaires and clinical testing, 3 hours for VR or video-based 
intervention sessions, for a total of 6 hours ($120). Cycle B is expected to take 3 hours for 
questionnaires and clinical testing, 3 hours for VR or video-based intervention sessions, and 1 
hour for the 4-week follow-up, for a total of 7 hours ($140). 
 

 
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10 PUBLICATION 
At appropriate scientific junctures, results from these studies will be presented at scientific 
forums (e.g., national meetings).  Similarly, as results are achieved that deserve to be shared with 
the greater scientific community, they will be submitted for publication in appropriate peer 
review journals. They may also be presented in book chapters. 
 
11 REFERENCES 
Please see attached grant for references.  
 
 

 
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APPENDIX 
Figure 1 – Urban environment designed for Floreo’s mobile VR police safety module 
(PSM) 
 
 
Figure 2 – Police officer in virtual environment designed for Floreo’s mobile VR PSM 
 
 

 
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Figure 3 – Mobile VR application with smartphone and head mounted display paired with 
tablet