BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
Phase: NA
Conditions: Depression, Suicidal Ideation
Sponsor: University of Pittsburgh

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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Study Protocol 
 
 
 
 
Official Title: BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk 
Teens) 
 
 
 
ClinicalTrials.gov ID (NCT number): NCT04000399 
 
 
 
Protocol Date: 04/30/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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PROTOCOL TITLE: 
The Center for Enhancing Treatment & Utilization for Depression and Emergent 
Suicidality Phase 1b-Study 3-BRITEPath 
 
PRINCIPAL INVESTIGATOR: 
Stephanie Stepp, PhD 
Department of Psychiatry 
Telephone Number: 412-383-5051 
Email Address: steppsd@upmc.edu  
VERSION NUMBER/DATE: 
Version 1/ 4/30/2020 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Background* ............................................................................................................ 6 
4.0 
Study Endpoints* ..................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 7 
6.0 
Procedures Involved* ............................................................................................... 8 
7.0 
Data and Specimen Banking* ................................................................................ 11 
8.0 
Sharing of Results with Subjects* ......................................................................... 11 
9.0 
Study Timelines* ................................................................................................... 12 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 13 
11.0 Vulnerable Populations* ........................................................................................ 14 
12.0 Local Number of Subjects ..................................................................................... 14 
13.0 Recruitment Methods ............................................................................................. 14 
14.0 Withdrawal of Subjects* ........................................................................................ 14 
15.0 Risks to Subjects* .................................................................................................. 15 
16.0 Potential Benefits to Subjects* .............................................................................. 17 
17.0 Data Management* and Confidentiality ................................................................ 17 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 19 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
20.0 Compensation for Research-Related Injury ........................................................... 20 
21.0 Economic Burden to Subjects ................................................................................ 20 
22.0 Consent Process ..................................................................................................... 20 
23.0 Process to Document Consent in Writing .............................................................. 22 
24.0 Setting .................................................................................................................... 22 
25.0 Resources Available ............................................................................................... 22 
26.0 Multi-Site Research* ............................................................................................. 22 
 
 
 
 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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1.0 
Study Summary 
 
Study Title 
BRITEPath-ETUDES Phase 1b 
Study Design 
Stepped wedge randomization; We will evaluate 
BRITEPath’s feasibility and efficacy compared to treatment 
as usual care (TAU) across sites. 
Primary Objective 
We will create and rapidly iterate user interfaces to develop 
the three components of BRITEPath: (1.) Guide2BRITE, an 
electronic guide for mental health clinicians providing step-
by-step instructions in the onboarding of the safety plan, 
emotion regulation, and distress tolerance skills for (2.) the 
BRITE app, a personalized and interactive safety plan and 
self-monitoring tool for the adolescent; and (3.) the clinician 
dashboard, BRITEBoard, to track adolescents’ app use, 
distress, and treatment progress as well as to promote 
communication and collaboration among mental health and 
primary care providers. 
Secondary 
Objective(s) 
We will test BRITEPath's impact compared to TAU utilizing 
a stepped wedge design and a RE-AIM framework. 
BRITEPath focuses on novel approaches to support 
treatment and management of adolescent depression and 
suicidality in pediatric primary care and community mental 
health settings. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Mobile App based intervention 
IND/IDE #  
n/a 
Study Population 
12-26 yo patients seeking mental health treatment 
Sample Size 
50 
Study Duration for 
individual 
participants 
12 weeks 
Study Specific 
Abbreviations/ 
Definitions  
BRITEPath=BP 
Guide2BRITE=G2B 
BRITE=app used on participant 
Mental health=MH 
Behavioral health=BH 
 
 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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2.0 
Objectives* 
Suicide and suicidal behavior are leading causes of adolescent mortality and morbidity. 
Suicide ideation is one of the strongest predictors of imminent suicide or suicide attempt. 
Among common psychiatric disorders, depression has the strongest association with 
suicide ideation and attempt, but anxiety, substance abuse, and disruptive disorders also 
elevate risk. Therefore, to identify adolescents at high suicidal risk, it makes sense to 
screen for depression AND for suicidal ideation, regardless of diagnosis. There is some 
evidence, mostly in adults, that brief interventions can reduce risk for suicidal behavior, 
whether through improved connection with services, increased sense of connection and 
social support, or via systematic follow-up, and while some brief interventions aimed at 
safety planning have been advanced, there are no brief interventions for adolescents. 
Furthermore, insufficient resources are available to guide clinicians in suicide risk 
assessment and management. In fact, a review of the literature for suicide prevention 
apps shows that of 123 available smartphone apps, none are geared to providing guidance 
for clinicians treating adolescents. This lack of resources is especially problematic 
because as primary care clinics implement depression screening for adolescents and 
enhance collaborative mental health (MH) care as recommended by the United States 
Preventive Services Task Force (USPSTF), more youth with depression AND those with 
acute suicide risk will be identified. Adolescents receiving treatment from an embedded 
MH provider may also result in the identification of even more adolescents with acute 
suicide risk. Enhancing mental health screening and providing embedded mental health 
treatment in primary care may have the unintended negative consequence of increasing 
emergency referrals and hospitalizations, which reflect the absence of current suicide risk 
management practices in primary care. Emergency department (ED) referrals for further 
evaluation are among those least favored by suicidal patients and may inadvertently 
decrease patients’ motivation to access and engage in follow-up treatment. Thus, there is 
urgent need to equip primary care with the capacity to assess and stabilize depressed and 
suicidal adolescents, in order to avoid unnecessary ED referrals and hospitalizations and 
ultimately, to reduce suicidal behavior upon follow-up. 
We will develop an app-based intervention, BRITEPath that enhances the 
capacity of pediatric primary care to effectively manage depressed and suicidal 
adolescents by referral to embedded MH services. BRITEPath includes three 
components delivered by MH clinicians, including (1.) an electronic on-boarding 
procedure tool that supports MH clinicians, Guide2Brite; (2.) the adolescents’ 
safety planning app, BRITE; and (3.) the clinician dashboard, BRITEBoard, to 
facilitate treatment planning and communication with other primary care 
providers.  
 
2.2 The aims and hypotheses related to this specific protocol and submission are 
below for Phase 1b. Aims of the previous phase are in a University of Pittsburgh 
OSIRIS IRB protocol submission (#PRO18050281) entitled ETUDES Phase 1a-
qualitative. Aims of later phases described briefly will be submitted in subsequent 
protocols. 
 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
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We will test the feasibility of using BRITEPath in community & pediatric 
practices using a stepped wedge design. We hypothesize that participants, parents, 
and clinicians will find the intervention usable and feasible to deploy. We will 
assess the impact of BRITEPath alone (compared to its impact as part of iCHART 
in later phases of the ETUDES Center, by obtaining follow-up phone assessments 
on suicidality, depression, and functional status at 4 and 12 weeks after intake. 
 
Aim 1b (Phase 1b, Feasibility). We will pilot BRITEPath in sites using a stepped 
wedge design (50 adolescents aged 12-26 yo). Hypothesis 1b: The use of 
BRITEPath will decrease depressive symptoms, distress, and suicidality (any self-
injurious ideation, urges, or behavior) as well as improve overall functioning 
compared to TAU.  
 
Criterion for success: 75% of adolescents who receive BRITEPath will use it, and 
75% of MH clinicians will use Guide2BRITE and BRITEBoard. 
 
3.0 
Background* 
Drs. Stepp (PI) and Brent (Co-PI) are have expertise with all aspects of the 
proposed study: developing psychosocial interventions targeting suicide, 
partnering with private companies to create smartphone apps to monitor suicide 
and other high risk behaviors in daily life as well as analyzing the intensive 
longitudinal data resulting from such research protocols, conducting randomized 
controlled trials of psychosocial interventions for suicidal adolescents, and 
evaluating long-term outcomes from longitudinal studies of high risk adolescents 
and families with excellent retention. 
 
In a previous study, Dr. Brent and colleagues developed a brief, inpatient- based, 
novel intervention with an accompanying safety planning app (BRITE) for 
psychiatrically hospitalized, suicidal adolescents. In a pilot RCT with 66 
adolescents, this app-supported intervention cut the incidence of recurrent suicide 
attempts by half (Incidence rate ration [IRR] for attempts=0.47, 95%CI 0.12-1.56, 
p=0.18), with a stronger effect in the 80% of adolescents with a previous history 
of a suicide attempt (IRR=0.23, 95% CI, 0.05-1.09). The app was accessed an 
average of 29 times over a 6-month period, 45.5% accessed the safety plan, and 
the more frequently the app was used, the greater the decline in suicidal ideation 
and increase in reasons for living (rho=0.36, p’s=0.08). Participants rated BRITE 
high on usability using the Post-Study Satisfaction and Usability Questionnaire 
(lower score indicates greater satisfaction, range 10-70, mean scores 17.6-18.4). 
Moreover, clinicians who implanted the interventions wanted the app to guide 
them in formulating the safety plan and populating the app for use by the 
adolescent. These data provide preliminary support for the clinical utility of an 
app-supported intervention to reduce suicide risk in adolescents. An important 
next step is to further develop BRITE for use in pediatric care clinics by 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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developing a virtual treatment manual designed to guide clinicians in delivering 
the intervention and a clinician dashboard to monitor symptoms and treatment 
progress. 
 
 
4.0 
Study Endpoints* 
At anytime, the primary investigators may discontinue a participant's participation 
in this study. The PI may decide to remove a participant off this study if their 
health or safety may be at risk; if they have not been following study instructions 
or because of a study administrative decision by the PI. 
 
5.0 
Study Intervention/Investigational Agent 
Overview of the BRITEPath intervention 
There are three components of the BRITEPath intervention, each of which will be 
described: 1) BRITE, 2) GUIDE2BRITE and 3) BRITEBoard.  All participants assigned 
to the intervention components will receive each of these 3 components. 
 
BRITE 
BRITE is a tool for self-monitoring and self-management that is not targeting any 
specific diagnosis or medical condition.  BRITE includes monitoring of distress on a 
daily basis paired with content targeting skill targeting emotion regulation, distress 
tolerance, social support, and reasons for living.  Content will take the form of clinician-
recommended videos, photos, and websites, as well as personalized content that has 
salience to the adolescent that they may add onto their app.  In this way, the app is 
customizable to uniquely meet the adolescents' needs and preferences.  Adolescents will 
be encouraged to use the skills on the app on a daily basis. Additionally, the BRITE app 
will include an electronic version of a safety plan that will be developed in collaboration 
with the youth's therapist.  Safety plans, which contain coping strategies, social supports, 
and crisis contacts are used as a standard of care in the treatment of suicidal youth.  
Finally, on each screen of the app, there is a link to crisis contacts that will be 
programmed onto the app with the assistance of their therapist. 
 
GUIDE2BRITE 
Embedded mental health providers, who will treat youth who have access to the BRITE 
app, will use GUIDE2BRITE to facilitate the process of orienting youth to the 
app.  GUIDE2BRITE will be an interactive website that leads the clinician 
through the process of developing a safety plan and identifying appropriate 
content for the BRITE app with their adolescent patient.  During this process, 
providers will orient patients on the purpose and function of the app, 
demonstrating and practicing skills they will use as part of the app-based 
intervention. Guide2BRITE supports clinicians in the delivery of an intervention 
designed to: (a) identify likely triggers of suicidal and self-harm urges; assess 
lethality and restricting access to means; (b) teach skills via modeling and role-
play to cope with suicidal and self-harm urges and (c) identify professional 
resources to access in a crisis should others means of coping fail.  A mock-up that 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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shows the integration between BRITE and GUIDE2BRITE is provided within 
question 2. 
 
BRITEBOARD 
BRITEBOARD is a web-based portal that tracks participants use of the app, e.g. tracking 
distress ratings and times in which they added/removed content, as well as changes in 
patient outcomes over time, e.g. depression ratings collected as part of the study.  In order 
to facilitate effective communication within the participant's clinical team, information on 
this portal will be shared among the adolescents' providers within their practice, including 
the embedded therapist, their primary care provider, and other providers within the office 
that are designated as part of the adolescents' care team. 
 
6.0 
Procedures Involved* 
We will develop an app-based intervention, BRITEPath that enhances the 
capacity of pediatric primary care to effectively manage depressed and suicidal 
adolescents by referral to embedded MH services. BRITEPath includes three 
components delivered by MH clinicians, (as described previously in this protocol) 
including (1.) an electronic on-boarding procedure to that supports MH clinicians, 
Guide2Brite; (2.) the adolescents’ safety planning app, BRITE; and (3.) the 
clinician dashboard, BRITEBoard, to facilitate treatment planning and 
communication with other primary care providers. Increasing pediatric primary 
care’s ability to effectively intervene with these mental health problems is likely 
to lead to reductions in 1) adolescent distress, 2) suicidal and self-harm urges, 
thoughts, and behaviors, depressive symptoms, and 3) improvements in 
functioning.  Although primary care practices following USPTF 
recommendations to integrate depression screening and embed MH clinicians into 
routine care will also inevitability increase detection of depressed and suicidal 
youth, no effective intervention for the pediatric primary care setting exists to 
treat and manage these mental health problems. We propose to address this gap in 
services by developing and pilot testing a novel app-based intervention, 
BRITEPath, optimized for delivery by embedded MH clinicians to adolescents 
with depression and suicidality in pediatric primary care.  
BRITEPath will include several highly innovative features that are responsive to 
the needs of both the MH clinician and the adolescent, including (1) brevity of 
BRITE onboarding (30 minutes); (2) low provider training costs (4 hours); (3) 
immediate service delivery upon initiation of treatment for depression or 
suicidality; and (4) provision of services in pediatric primary care clinics where 
the majority of adolescents are served. Furthermore, the Guide2BRITE 
component is innovative because, to our knowledge, it is the only safety planning 
app aimed at helping clinicians deliver an empirically-supported intervention. 
Guide2BRITE could serve as a paradigm for electronic guides for managing a 
wide array of mental health problems and emergencies. 
This study has the potential to improve treatment outcomes by assisting MH 
clinicians in creating an individualized safety plan, monitoring symptoms and 
skills use, and facilitating shared decision making between clinicians and with 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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parents and patients. The simplicity and flexibility of BRITEPath would allow for 
its dissemination to reach beyond specialty MH clinics and is consistent with the 
NIMH 2015 Strategic Plan emphasizing the need for individualized strategies to 
improve patient outcomes. 
It is impractical for MH clinicians to offer BRITEPath only sometimes and to 
some patients and not others. Although a cluster randomized trial could address 
this issue, this design is not feasible for a pilot study. Thus, we will utilize a 
stepped wedge design in which all practices start with Treatment As Usual (TAU) 
initially and are randomly chosen to transition to BRITEPath at different times. 
All clinics will be initially monitored for at least two months during TAU for the 
main outcomes of fidelity to delivery of the intervention. This will be followed by 
a staggered adoption of BRITEPath. At each time period, a new clinic will begin 
implementing the intervention. Block randomization determines the order each 
clinic begins BRITEPath. Each time period (approximately 3 months), a web-
based system will be used to assign the next clinic to begin using BRITEPath. 
We recognize the limitations of the proposed stepped wedge study design for 
evaluating the effectiveness of BRITEPath, once a practice enters their 
intervention phase, assignment to BRITEPath cannot be concealed. This concern 
is somewhat mitigated by blind follow-up assessors. Alternative study designs 
(e.g., randomized control trial) pose significant implementation challenges. 
Clinicians may be hesitant to deliver TAU once the BRITEPath intervention is 
known, which could lead to study condition contamination (e.g.,BRITEPath 
strategies introduced into TAU condition) and nonrandom patient assignment to 
condition (e.g., more high acuity patients referred to BRITEPath). In a stepped 
wedge design these feasibility concerns are addressed by the eventual assignment 
of all participating practices to the intervention condition and BRITEPath can be 
offered to all patients moving forward. Additionally, these designs are consistent 
with our broader goal of enhancing participant and community stakeholder 
engagement with the ETUDES Center. Results from this pilot trial will allow us 
to estimate the effect size of the BRITEPath intervention compared to TAU for 
reducing suicide risk in pediatric primary care. If our initial results show promise, 
these effect size estimates would be used to design a larger and adequately 
powered randomized control trial of BRITEPath. 
 
SCREENING 
Trained research staff or site staff will determine appropriate potential participants 
to refer and either refer via email, phone, or in person when staff person is on site. 
Site staff will review medical record or be made aware of the potential 
participant’s chief complaint at presentation to the clinical setting to determine 
eligibility.  At the time of identifying an eligible participant, trained research staff 
will complete verbal eligibility screen (with parent if a minor participant is 
involved or with adult participant).  Upon eligibility, trained research site staff 
will enter participant contact information and date of birth into University of 
Pittsburgh secure webapp saved behind a firewall.  This will create an “ID” which 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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will communicate with the electronic Guide2Brite to create a profile for the 
participant in the secure BRITEPath web app. 
 
STUDY INTERVENTION 
Following informed consent discussion in the site’s clinical setting, trained 
research clinical staff will implement BRITEPath intervention (described above), 
help participant download app, and schedule a follow up visit with the participant.  
Pittsburgh/ETUDES Center research staff will follow up with site clinicians or a 
designated primary care provider if safety issues emerge during the research 
phone calls following management of imminent safety/risk.   
PITTSBURGH/ETUDES CENTER RESEARCH PHONE CALLS & EMR 
DATA 
During 3 follow research phone calls the measures the research study will collect 
include: sociodemographic questions, the CSSRS scale & suicide scales, quality 
of life ratings, treatment history, barriers to treatment, readiness for treatment, 
attitudes toward seeking psychological help, anxiety & mania adaptive scales via 
the K-CAT mental health adaptive screen, substance use, depression history, 
treatment preferences, and if there's a family history of bipolar disorder that 
impacts the youth's risk for mental health problems. A waiver of HIPAA 
authorization to collect permission verbally over the phone will be used to access 
and collect medical record data. Electronic medical record information will be 
used to supplement treatment and service utilization and uptake of the BRITEPath 
intervention via the RE-AIM framework described in statistical analysis. Parents 
will respond to questions about their child, not themselves and youth will answer 
about themselves. Phone calls will take about 30-60 minutes.  Once a participant 
is completed with the research study follow up period, they will NOT lose access 
to the BRITE app.  They will have access to it as long as they keep it installed on 
their device.   
Only medical information that is necessary to conduct the study intervention will 
be collected. This will include diagnostic records, referral information, dates, 
times, outcomes of patient appointments, notes pertaining to patient appointments, 
who in the EMR prescribed/referred patients to use the intervention, PHQ-9 
responses & scores, Service utilization (# visits-PCP, Mental Health specialty, 
ER, hospitalizations); pharmacotherapy; medical/psychiatric comorbidity; 
insurance coverage, matching referrals provided by PCP to expert opinion, Use of 
technical components of interventions & webportals, # of providers engaging in 
training/intervention, % representation at practice site, # practices who deliver 
intervention, and any other information needed for cost analysis purposes. 
As with the informed consent & assent, it is not practical for researchers to 
conduct any ETUDES research activities, including the HIPAA authorization for 
BRITEPath on site due to the time and work flow constraints that emerged from 
formative qualitative data collection prior to this trial. The providers identified the 
time constraint of about 5 minutes of patient interaction that would be allowed for 

PROTOCOL TITLE: The Center for Enhancing Treatment & Utilization for Depression 
and Emergent Suicidality Phase 1b-Study 3-BRITEPath 
 
 
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researchers to implement eligibility screening only. Thus the BRITEPath 
intervention, including informed consent and obtaining any necessary HIPAA 
authorization, was developed based on pilot focus groups and Phase 1a focus 
groups & interviews to be implemented without impacting the clinical work 
flows.  
Further, the vast majority of participants recruited across sites are not near the 
research offices in Pittsburgh.  It would put undue burden on the research 
participants to complete in-person consent, baseline, & follow up assessment 
visits to ask them to come to instead of using verbal consent in their "real world" 
setting (especially due to telehealth activities since the COVID-19 pandemic). 
A cost analysis is a core piece of the practicality of implementing the BRITEPath 
intervention within the real world setting of pediatric primary care, thus access to 
the electronic medical record is required. The intervention being tested as part of 
the study requires an understanding of the diagnosis, health service utilization, 
comorbidity, insurance coverage, medication usage, and any other information 
needed to conduct a cost analysis. The intervention results will include a cost 
analysis of the service utilization and outcomes of diseases and comorbidity. The 
results will require information on how many individuals used the intervention 
and the impact on their service utilization and disease. 
Note-full set of data collection measures will be provided upon request.  A data 
use agreement will be developed with site in the event that site investigators plan 
to collaborate on publications and will have access to de-identified data to 
conduct analyses.  Both the site and Pittsburgh will have access to identifiable 
data as they are managing participant information/patient records to recruit 
subjects. 
PROCEDURES FOR MANAGING SUICIDAL RISK AT Multi-SITE Location 
In the event that an adolescent is not able to commit to a safety plan or if the 
clinician feels concerned that the patient is at high imminent risk, the clinician 
will follow their standard care procedures.  Standard care involves careful 
assessment to identify the presence of imminent risk. If the clinician and their 
supporting clinical team determine the adolescent is in imminent risk, they will 
communicate the level of risk to the parent/guardian. Additionally, Drs. Brent, 
Goldstein, or Stepp will also be available as needed. Depending on the level of 
clinical severity, the MH clinician has the option to call the phone crisis network 
either for phone support or to request a mobile crisis team, or to refer the 
adolescent directly to a local psychiatric emergency to be assessed for inpatient 
hospitalization. 
 
 
7.0 
Data and Specimen Banking* 
During the data cleaning period at the end and following conclusion of the study, the data 
will be thoroughly searched for any identifiers, so that data storage on a long-term basis, 
will be stripped of identifiers.  

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Identifiable data collected by the study will be contained in secure, firewall-protected 
servers managed by Pitt/CSSD-NOC and will only be accessible by the research team. 
 
We assure that the private information gathered as part of this study will not be reused or 
disclosed to any other person or entity, except when required by law, for authorized 
oversight of the study, or for other research for which the IRB has granted a waiver of 
written HIPAA authorization. 
 
At the request of another researcher, we will provide de-identified data sets only via 
encrypted documents. The research statistical coordinator and data manager will keep a 
log of data shared. 
 
Sharing Data with Kaiser Permanente: 
Data from the CASA, Child and Adolescent Services Assessment and E-HR will be 
collected in order to meet the study aims of conducting cost analyses on ETUDES center 
research pilot studies, including BRITEPath. We are sending a limited set. 
 
Data we are sharing includes responses from the Child and Adolescent Services 
Assessment (CASA) that is administered to both parent and child participants at baseline 
and all follow up visits. A limited data set of the CASA will be shared including all 
service utilization fields except names of facilities/providers. We also recode any date 
into “days since baseline.” The investigators will collect electronic health record data 
including:  
1) Service Utilization: # Visits (PCP, MH specialty, ER, hospitalizations); 
pharmacotherapy; medical/psychiatric comorbidity; Insurance coverage;  
2) Personalized referral: Match to Screening Wizard & expert opinion;  
3) Application utilization: Use of technical components of interventions & web portals 
(Text2Conect, BritePath);  
4) Provider uptake: # Providers engaging in training/intervention % Representation at 
practice site; and  
5) Practice uptake: # Practices who deliver intervention. 
 
8.0 
Sharing of Results with Subjects* 
Upon publication of primary outcome paper, participants will be informed through a 
preferred contact method of the publication.  No subjects will be identified without 
explicit and written consent in any publications that come from this project.   
 
9.0 
Study Timelines* 
The duration of an individual subject’s participation in the study is 12 
weeks. 
The duration anticipated to enroll all study subjects will be from 
8/2019-2/2020. 

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The estimated date for the investigators to complete this study 
(complete primary analyses) is 4/2022. 
10.0 Inclusion and Exclusion Criteria* 
Individuals will be screened for eligibility via phone or after presenting to 
the site’s clinical setting with an eligibility script and inclusion/exclusion 
questions.  Reponses to the questions will be entered into a secure study 
database managed by the University of Pittsburgh housed on a secure, 
encrypted server behind University firewall.  Individual logins will be 
provided to research/site staff associated with this project.   
Inclusion Criteria: 
-Youth aged 12-26 yo 
-Own a device (e.g. smartphone, ipod, tablet) with capability to download 
BRITE app 
-Biological or adoptive parent is willing to provide informed consent for 
teen to participate 
-Youth speaks and understands English 
-Positive PHQ score or provider determines patient has depressive 
symptoms based on clinical interaction and refers youth to the study (in 
cases when PHQ is not available   OR  provider/parent have concern that 
youth/patient has a mood or behavioral problem   
-Family agrees to see a MH staff at the site 
Exclusion Criteria: 
-Non English speaking 
-No parent willing to provide informed consent for minors 
-No cell phone capability of downloading BRITE app 
-Is currently experiencing mania or psychosis symptoms that would 
prevent participant from understanding/participating 
-Evidence of an intellectual or developmental disorder (IDD) 
-Life threatening medical condition that requires immediate treatment 
(included emergent suicidality, homicidality, abuse/neglect, or other 
mental or physical condition) 
-Other cognitive or medical condition preventing youth from 
understanding study and/or participating. 
-Adults unable to consent 
-Pregnant women-not specifically included or excluded as intervention 
and research procedures conducted will not inquire if a woman is 
pregnant. 

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-Prisoners excluded 
11.0 Vulnerable Populations* 
Children ages 12-17 will be recruited through their parents and not directly advertised to 
with study information.  Legal guardians with proper court paperwork, biological and/or 
adoptive parents will provide permission for their child to participate.  The child will 
receive study information via email/mail and over the phone to aid in their understanding 
of the study procedures and trained clinical assessors will explain the procedures using 
language appropriate for their age/grade level.   See consent process for additional 
details. 
 
12.0 Local Number of Subjects 
We expect to recruit about 10 subjects locally at each site onboarded to 
BRITEPath study as eligible and completed informed consent, and intervention 
with site clinicians. 
13.0 Recruitment Methods 
Participants will be screened through site staff and clinicians under the direction 
of the site investigators.  Clinicians taking part in the research project will scan 
intakes via telehealth (or in person when the COVID-19 pandemic allows for in 
person procedures) appointments for eligibility by reviewing electronic medical 
record information and chief complaint for presenting to appointment.  At time of 
appointment, trained clinician/research site staff will discuss BRITEPath study 
option and complete eligibility screening questions.   
Flyers and informed consent fact sheets used to discuss procedures and 
risks/benefits may be emailed or mailed for the patient to view at any time. 
Participants are provided with the BRITE app during this appointment following 
completion of the intervention.  Upon responding to follow up phone calls made 
by Pittsburgh/ETUDES Center research staff, the participants will be paid up to 
$180 on a visa gift card type card and mailed to participants’ address. 
Baseline visit phone call after intervention completed at sitel: $40 
Week 4 Follow Up call: $60 
Week 12 Follow Up call: $80 
14.0 Withdrawal of Subjects* 
Youth and young adult participants and parents may be formally withdrawn by the PI's if 
they develop a condition that meets criteria for exclusion or if they show evidence of 
clinical deterioration that may require further hospitalization during the course of study 
participation. Participants who are at risk for suicide attempts may need to be 
psychiatrically hospitalized, and this may occur at any time during the course of the 
study. Participants will be referred to their primary care physician and further for 
hospitalization if their condition is unstable as manifested by suicidal ideation with the 
inability to voice that they can keep themselves safe, psychosis, current intoxication, 
mania, rapid cycling, or mixed state. With permission, the study team may consult an 

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outpatient clinician and/or the primary care physician responsible for the treatment of the 
youth if it is the clinical opinion of the study team that an emergency evaluation or 
referral for hospitalization is indicated. Participants will be encouraged to contact their 
PCP or outpatient provider with any concerns reported to the study team during phone 
assessments. In cases of severe adverse effects, patients may be instructed to go to the 
nearest emergency department. Adverse events will be reported to the IRB in accordance 
with current procedures. 
 
Research participants may also choose to voluntarily withdraw and should provide 
written notice to the PI of their decision.  Data collected up until the point of receiving 
this notice will still be included in the research study.  Participants may choose not to 
authorize HIPAA verbally for the researchers to collect medical record information and 
still participate in the remainder of study activities. 
 
15.0 Risks to Subjects* 
Protection against risk will begin with careful clinical management and education 
of patients and families. Informed consent will be obtained at the enrollment 
phone visit and include specific details of all risks, including consequences of 
psychiatric illnesses. 
 
Baseline & Follow Up Assessments conducted by Pittsburgh/ETUDES Center 
The risks due to phone interview assessments and self-reported questionnaires 
are: 1) discussion of potentially upsetting information, 2) loss of confidentiality, 
and 3) assessment burden. The interviewers will all be trained and skilled 
interviewers who can assess and monitor the reaction to questioning about 
sensitive topics; interviewees will be given the option of not responding or ending 
the interview. The assessment has been streamlined to limit assessment burden by 
using only a few measures per outcome domain. Each phone assessment should 
take about 30-60 minutes. Participants will be appropriately compensated for their 
time. Another potential risk is the disclosure of abuse. We are very familiar with 
assessment, management, and reporting of child maltreatment as this is 
considered part of standard clinical care in psychiatry and pediatric primary care. 
These incidents are common during trials, and we have standard for both 
managing and reporting these incidents. In all cases, state law is followed. Risk 
management procedures involved referral if symptoms do not improve or worsen 
and procedures to protect confidentiality are in place, as well as annual review of 
study progress by a Data Safety Monitoring Board. Risk management procedures 
are in place to involve communication between study staff and primary care 
physicians if there are indicators of clinical deterioration (e.g. suicidal thoughts 
emerge in youth interview and youth cannot contract for safety), to protect 
confidentiality. Every effort will be made to schedule assessments at times that 
are suitable for participants and families (after school or work) as needed in order 
to minimize negative impact on other important work, school, or social activities.  
 

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Audio recording 
Measures will be taken to upload recordings to a secure network drive monitored 
by the University of Pittsburgh IT department and erased from the recording 
devise. 
 
BRITE Intervention: 
Risk management procedures involve referral if symptoms worsen or patients do 
not make significant gains and procedures to protect confidentiality are in place.  
Parents will be advised to monitor their youth's phone/device to avoid their access 
of explicit or unwanted material, as they typically would with any device intended 
for their child's personal use. Additionally, study PI & CO-I will be available to 
consult with clinical staff about the intervention in cases where the intervention 
may not be providing any gain to the patient or if symptoms worsen.  If a mental 
health staff identifies that their patient is at imminent risk for suicidal behavior, 
they will follow their usual standard of care in managing these symptoms.  The 
BRITEPath intervention will in no way interfere with the usual standard of care 
practices of managing imminent risk in pediatric primary care.   
The app is meant to measure distress, not suicidality, so there is no time in which 
it will trigger response from providers in real-time or outside of work hours.  The 
app will direct patients to deploy their safety plan if they are in crisis, which 
includes numbers for 24-hour crisis hotlines.  The contents of the participant’s 
safety plan will be available, even when the participant does not have access to 
wifi/data.  Some portions of the app, e.g. portions that link to websites or youtube 
videos, will not be available without internet connection.  Warnings are 
programmed within the app to notify participants when a poor connection is in 
place that may limit their access to certain parts of the app.  
Minimizing Risk of Suicidal Behavior 
Since participants may be eligible who exhibit current suicidal ideation, the 
biggest risk for these participants is their risk for suicidal ideation, behavior, or 
even suicide.  In relation to assessment, there is now clear evidence that asking 
about suicidal ideation and behavior will not increase the risk for such behavior. 
Further, through repeated assessments of psychopathology, suicidal ideation, and 
behavior, we provide an additional safety net for the participants and their 
families beyond that which would occur in clinical care. As noted above, the 
research team will be appropriately trained in clinical management of adolescent 
suicidal ideation and behavior. Both the Pittsburgh research team and local site 
will manage suicidal risk using suicide prevention procedures established by the 
American Academy of Child and Adolescent Psychiatry (AACAP) Practice 
Parameters on Suicidal Behavior. These include risk assessment, 
identification/modification of precipitants, and safety planning. Suicide risk will 
be managed within the primary care setting for youth in both the TAU and 
intervention group.  

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The ETUDES Center will generate “protocol alerts” for the Pittsburgh/ETUDES 
clinical assessors to assist with the detection and management of suicidality 
among adolescents. If suicidal ideation or behavior is endorsed at follow-up 
phone visits, trained clinical interviewers will engage in assessment of the 
adolescent's risk of attempt. A safety plan will be developed with youth 
expressing any suicidal ideation, if he or she does not already have one. The 
parent will be notified and the clinical interviewer will make a decision as to 
whether the patient is at imminent risk or not. Assuming that the patient can 
commit to a safety plan and the parent is agreeable, we already have obtained 
consent to notify the pediatrician and we will obtain permission to contact their 
therapist if they are in treatment. If the patient cannot commit to a safety plan 
and/or the clinical interviewer is concerned that the patient is at high imminent 
risk, this will be discussed with the parent, and the clinician will set up a 
conference call with a crisis hot line to further evaluate the patient.  If the patient 
refuses or hangs up, then the crisis team will be contacted who will help 
determine further action. Outside of Allegheny County/Pittsburgh, PA, the crisis 
line is the National Suicide Prevention Lifeline, which can provide on-phone 
support, and can access emergency visits to the home based on local resources. If 
the assessor is uncertain about assessment of suicidal risk, he or she will contact 
one of the Center on-call clinicians to either consult or speak directly with the 
patient and family. Similar procedures have been operative in studies of Dr. 
Brent’s including the Familial Pathways study (R01 MH056612), which assessed 
youth with parental loading of depression and suicide attempt and the EDSTARS 
study (U01 MH104311), which assessed adolescent’s suicide risk within pediatric 
EDs. If the interviewer is uncertain about how to proceed, the PI, Dr. Stepp or Co-
I, Dr. Brent, will be available as a back up. 
All aspects of the research interaction with participants will be private. Research 
staff will complete the phone assessments in a private, confidential location. In 
addition, research staff will ask the parent and youth prior to the start of the phone 
assessment if they are in a private location where they feel comfortable reporting 
sensitive information to the interviewer. Additionally all identifiable information 
will be held either in a locked filing cabinet or in a secure online database with 
security and confidentiality measures implemented and maintained by the 
University of Pittsburgh IT department. 
In the event that additional risks are found out, participants will be notified 
immediately of any risk it may pose to them. A copy of the verbal consent script 
will be provided to participants in the form they request (i.e. mailed, emailed). 
16.0 Potential Benefits to Subjects* 
This research project provides an immediate app-guided intervention to reduce suicidal 
distress.   
 
Participants may also derive a sense of accomplishment from participation in research 
and contributing to the knowledge of screening, triage, and management of 
adolescent/young adult depression and suicidal ideation and behavior. 

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17.0 Data Management* and Confidentiality 
 
A stepped wedge design was selected for both ethical considerations and feasibility. A stepped- wedge 
cluster randomized trial design involves the sequential random rollout of an intervention over multiple 
time periods following a “baseline” period when no cluster has been exposed. The crossover is typically in 
one direction, from control to intervention, and continues until all of the clusters receive the intervention 
with observations taken from every cluster and at each time period. All 3 studies in the ETUDES Center, 
and specifically, BRITEPath, will utilize this design. Prior to study start, each site will be randomly assigned 
to switch from. 
 
Treatment As Usual (TAU) to the intervention. In the proposed stepped wedge design, all practices start 
with TAU (i.e.,PCP referral to embedded MH care) and are randomized to transition to implement 
BRITEPath at different times. All clinics will be initially monitored for at least 2 months during TAU, 
followed by a staggered adoption of BRITEPath. During each time period, a new clinic will begin to use 
BRITEPath (order determined by block randomization. A webbased system will randomly assign the next 
clinic to begin. 
 
With regard to the stated hypothesis: We will perform multilevel modeling to explore time- and 
intervention-level factors associated with BRITEPath’s use. We will first conduct t-tests for continuous 
variables and chi-square tests for categorical variables to examine baseline differences in demographic 
and clinical variables. We will use generalized linear mixed models (nesting for site) to examine between 
intervention differences in readiness. Distinguishing characteristics will be included as covariates in 
models examining treatment effects. 
Due to the pilot nature of this study, sample size and power considerations center around the precision of 
confidence interval (CI) width estimation for feasibility outcomes. In this development phase (Aim 1), a 
sample size of 50 affords us a 95% CI width of no more than 0.28. 
 
We will evaluate uptake of BRITEPath by community pediatric clinics utilizing the RE-AIM framework and 
determine implementation outcomes as follows: Reach: Compare demographic and clinical characteristics 
of those patients who do versus do not (opt-out) get BRITEPath in practice for sample representativeness. 
Efficacy: Measure the percentage of patients for whom clinically significant reductions in depressive 
symptoms and suicidality as well marked improvements in functioning are obtained. Adoption: The 
percentage and characteristics of MH clinicians who participate in the BRITEPath study. Implementation: 
The percentage and characteristics of MH clinicians who follow through with BRITEPath use procedures 
(examining different components of app use). Maintenance: Extent BRITEPath is utilized and predictors of 
utilization after research support has been withdrawn.  
 
Identifiers that will be collected via electronic data management include:  name, email address, 
phone numbers, medical record numbers, and social security numbers for payment only.  We will 
be collecting location data (addresses), date information (Date of Birth, admission dates, etc), and 
sensitive data (such as protected health information, etc).   
 
The data will be collected on a web-based database.  Data will not be stored with participant 
identifiers and will be coded with a participant ID #.  Data may be stored on UPMC owned or 
University owned computers in research offices.  Documents containing data will be deidentified 
and encrypted with a password to which only the research staff have access.  The following 
storage devices will be used: 
 
- 
Google cloud storage will be used for deidentified summary data collected from 
NuRelm’s webportal only.  NuRelm is the app developer of BRITEPath suite of tools.   

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- 
University or UPMC owned laptops and desktops 
- 
Amazon Web services stores deidentified data of one of the measures University of 
Pittsburgh collects through the cat-mh.com adaptive measures.  Only deidentified data 
will be stored here. 
- 
UPMC MyCloud/One Drive will be used to release only identifiable data and deidentified 
data that is necessary for ceded/partner sites to complete data analysis per Data Use 
Agreements with the University of Pittsburgh 
- 
Pitt Box will be used to share data between investigators and will only contain 
deidentified data. 
- 
University of Pittsburgh CSSD Network Operations Center Managed Server:  Participant 
questionnaire data and interview data collected during baseline and follow up phone 
visits will be stored on the web database created by the Center for Clinical Trials Data 
Collection (CCDC) on the University of Pittsburgh managed server.  NuRelm will create 
the portal and application tables that store intervention data and communicate to the 
CCDC web database will be stored on this server.  Only authorized users to the tables and 
portals/websites developed and stored on this server have access with specific login and 
password information given to them by study administrators/PIs.  Only particular views 
to the data are given to particular individuals on the study.  Individuals are only given 
access to what they absolutely need to complete their role on the study. 
 
Any hard copy or paper data will be stored by ID # in a locked cabinet in a locked office to which 
research staff only have access. No research data will be stored with identifiers on it. The key/link 
between the ID# and participant identifiable information will be kept separately in locked cabinets in 
locked research offices or in encrypted electronic documents on a Pitt or UPMC owned computer 
behind the firewall. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
Data Safety Monitoring Plan 
The study is designed to carefully monitor patient and participant safety and the PI is ultimately responsible for 
ensuring the safety of participants enrolled. During weekly project meetings, the principal investigator and the project 
coordinator will meet with all staff associated with the research study to monitor reports of abuse, neglect, 
suicidality, data entry, safety and maintenance of confidentiality for all active participants, course of adverse events, 
and ongoing symptoms of suicidality. They will review participant enrollment, instrument completion and data 
collection and determine if any breaches of confidentiality have occurred, or if participants have disclosed concerns 
that have warranted referral for further assessment or treatment, or if participants have made any complaints related 
to the conduct of the study. The PI and Project Coordinator will review the appropriate procedures for further 
assessment and referral in cases where clinical issues have been identified. In the event of a breach of confidentiality, 
the principal investigator will inform the involved participant and his/her parents that the breach occurred. The 
affected participant will be assigned a new ID number. The staff involved will continue to be counseled by the 
principal investigator and retrained on confidentiality principles. Any breaches of confidentiality will be reported to 
the IRB by the principal investigator. All serious adverse events (SAEs) will be reported to the WPIC Institutional 
Review Board according to the regulations set forth by the IRB. As defined by the FDA, an SAE is any adverse 
experiencing occurring during the study or within 30 days from termination of the patient/participant from the study 
that results in the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation 
of existing hospitalization, persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, 
or based upon appropriate medical judgement, may jeopardize the participant's health and may require medical or 
surgical intervention to prevent one of the other outcomes listed in this definition. 
 
Data Safety Monitoring Board 
A DSMB committee will be formed to periodically (semi-annually) review data, management of data and patient 
safety, reporting procedures and any UAPs and SAEs that emerge from the research. All UAPs and SAEs will be 
documented and reported to the DSMB & Pitt IRB, once a participant’s immediate safety and welfare are addressed. 

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Board members will include at least 3 qualified MD's and/or PhD's experienced in clinical care and research in 
adolescent suicidal behavior and uptake of technological interventions to address management and treatment of 
suicidal and/or depressed adolescents, all of whom have been identified upon funding of the ETUDES Center grant. 
The DSMB will make final conclusions regarding changes to risk-benefit ratio of the study and final recommendations 
related to continuing, changing, or terminating the study at each of the semi-annual meetings. 
 
Overall data monitoring will be the responsibility of the PIs. During the course of the study, the PIs will follow the 
progress of the clinical study and data entry to ensure utmost accuracy of the data and to detect any possible errors 
at an early timepoint. The study coordinators will generate weekly reports, which will include suicidality and adverse 
events for each subject for review during weekly project meetings as well as an ongoing CONSORT diagram. The data 
manager, the CCDC at University of Pittsburgh, will also compile DSMB reports, which will include recruitment data, 
demographic information, serious adverse events, early termination, and protocol deviations, as well as any other 
information requested by the DSMB. 
 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
 
Study procedures have been designed to protect the privacy and confidentiality of the research 
participants. Throughout the study all data, including that collected during the recruitment phase, will 
only be identified by a unique identification (ID) number and participant/subject codes using letters and 
numbers to protect against invasion of privacy. The data will be blinded correspondingly in all data 
analyses. Only authorized staff will have access to patient information. All study information containing 
identifying information will be stored separately from the study data and will be stored in a locked filing 
cabinet. On the other hand, we notify the patient at the beginning of the study if we detect information 
that could indicate that a participant's life or health is in danger, we will need to bring his/her parents 
and/or primary care physician and/or outpatient physical or mental health care provider into the 
discussion. 
 
20.0 Compensation for Research-Related Injury 
n/a 
 
21.0 Economic Burden to Subjects 
There are no costs to insurance or otherwise to participants if they choose to 
volunteer for this study. 
 
22.0 Consent Process 
INFORMED CONSENT/ Subjects who are not yet adults (infants, children, 
teenagers) 
 
Trained research/site staff will complete verbal informed consent with participant 
over the phone and provide a copy of the document via email or mail.  Upon 
obtaining informed consent, the site staff will initiate the BRITEPath intervention.  
Following the intervention, Pittsburgh/ETUDES Center research staff will follow 
up and complete research phone calls for which participants will be paid. 

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During the informed consent discussion, the site staff will speak with the parent to 
obtain permission to enroll the teen in this study and consent for her or his own 
participation. The staff will also speak with the adolescent to obtain her or his 
assent.  The assessor will ask the family to take the phone call in a private 
location to decrease confidentiality breaches and discomfort about talking about 
sensitive topics. 
During the consent process, research/site staff will make it clear that participation 
is voluntary to both the parent and child participants or adult participant if they 
are 18 at the time of enrollment. If a minor turns 18 years old during the course of 
the study an additional consent process will occur via the phone to ensure ongoing 
willingness to participate that Pittsburgh/ETUDES trained research staff will 
conduct. During each baseline and follow up phone call, Pittsburgh/ETUDES 
trained research staff will ascertain if the parent and child are still interested in 
participating in the study questions prior to collecting or updating data. Both the 
site staff and Pittsburgh/ETUDES trained research staff will make the family 
aware that they do not have to immediately make the decision to consent and can 
take the time to think and discuss participation after they receive all the necessary 
consent and risk information. The staff may also say that their participation will 
not influence their care or relationship with care providers. The staff will 
encourage the family to discuss their participation and provide several minutes for 
adequate reflection time. 
Staff from both Pittsburgh and multi-sites are trained to ascertain if a participant 
is adequately understanding what is being said during the informed consent 
discussion and the research questions. Staff will describe the study in wording to 
reflect appropriate literacy level of a teen and parent. Staff will ask if the family 
has questions throughout the process and provide responses to questions as they 
arise. 
 
Non-English Speaking Subjects 
n/a 
 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
The research involves minimal risk.  No changes will be made to the adolescents' 
standard clinical care.  The BRITEPath intervention and passive sensors augments 
their care.  Further, questions asked as part of study assessments are consistent 
with those asked at standard visits to their doctor. Project staff trained in the 
process of informed consent will obtain informed consent for study participation 
and document that they certify they gave informed consent.    
Due to the nature of research activities, which occur within a variety of sites 
across Western Pennsylvania, NY, Seattle, WA, and Dallas TX, and other states 

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in the United States, an investigator cannot practicably be available to participate 
in the consenting process of each subject. An investigator will be made available 
to those subjects who wish to speak to them. 
Research staff will inquire if a parent is biological or adoptive and it will be 
documented. Adults without this status must present paperwork to the research 
staff who will filter it to the respective IRBs and legal counsel for review and 
verify if an adult is legally able to consent for the child, if there is question over 
legal status. 
 
23.0 Process to Document Consent in Writing 
Research staff at the site will document the consent/assent response of each the 
parent and child during this process and the date and time it was obtained in the 
secure study database.  Please see attached “Fact Sheet” for minors and adult 
participants which will be emailed/mailed and read aloud to the participants over 
the phone. 
 
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
The setting where all research procedures will take place except screening 
and informed consent and the intervention will be at the University of 
Pittsburgh ETUDES phone center. 
Potential participants will be identified in the site’s  clinical settings via 
telehealth appointments (or in person if the COVID-19 pandemic permits).  
Trained clinicians will have access to a specific view in the 
CCDC/ETUDES database referenced in data management procedures to 
enter participant information to confirm eligibility and document 
date/time/response of participants during informed consent discussion. 
25.0 Resources Available 
25.1 Describe the resources available to conduct the research:  
 
During already scheduled appointments, clinicians trained at the site will 
approach and “pitch” the study to between 10-20 patients to pilot the 
BRITE app and suite of tools.  This will be done over the phone via 
telehealth appointments during the COVID-19 pandemic.   Site clinicians 
will be engaged in regular team meetings to review work and problem 
solve on the ground at their site. 
 
26.0 Multi-Site Research* 
26.1 
Study-Wide Number of Subjects: 50 

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26.2 
Study-Wide Recruitment Methods* 
All recruitment methods will be under the control of the local site. 
Specific clinicians who are trained at each site will ask patients on 
their own caseload at the time of scheduled appointments if they 
want to participate in using the app and the associated research 
phone calls.  Site clinicians may use BRITEPath advertising 
material to provide additional information to patients before they 
agree to answer screening questions and complete the informed 
consent over the phone.  No community sampling or other methods 
will be used to advertise for participants at the site. 
26.3 All participating sites will be engaged on bi-weekly team meeting 
conference calls to review procedures, problems, and enrollment 
targets.