Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
Phase: NA
Conditions: Depression, Adolescent Behavior
Sponsor: University of Washington

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APPLICATION IRB Protocol 
 
 
The Human Subjects Division (HSD) strives to ensure that people with disabilities have access to all services and content. If you 
experience any accessibility-related issues with this form or any aspect of the application process, email 
hsdinfo@uw.edu for assistance. 
INSTRUCTIONS 
• 
This form is only for studies that will be reviewed by the UW IRB. Before completing this form, check HSD’s website to confirm 
that this should not be reviewed by an external (non-UW) IRB. 
• 
If you are requesting a determination about whether the planned activity is human subjects research or qualifies for exempt 
status, you may skip all questions except those marked with [DETERMINATION] For example 1.1. [DETERMINATION] must be 
answered. Do not upload consent materials for determinations in Zipline as HSD does not review or approve them. 
• 
Answer all questions. If a question is not applicable to the research or if you believe you have already answered a question 
elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the information). If you do 
not answer a question, the IRB does not know whether the question was overlooked or whether it is not applicable. This may 
result in unnecessary “back and forth” for clarification. Use non-technical language as much as possible.  
• 
For collaborative or multi-site research, describe only the UW activities unless you are requesting that the UW IRB provide the 
review and oversight for non-UW collaborators or co-investigators as well.  
• 
You may reference other documents (such as a grant application) if they provide the requested information in non-technical 
language. Be sure to provide the document name, page(s), and specific sections, and upload it to Zipline. Also, describe any 
changes that may have occurred since the document was written (for example, changes that you’ve made during or after the 
grant review process). In some cases, you may need to provide additional details in the answer space as well as referencing a 
document.  
• 
NOTE: Do not convert this Word document to PDF. The ability to use “tracked changes” is required in order to modify your 
study and respond to screening requests 
INDEX 
1. Overview 
2. Participants 
3. Non-UW Research Setting 
4. Recruiting and Screening Participants 
5. Procedures 
6. Children (Minors) and Parental Permission 
7. Assent of Children (Minors) 
8. Consent of Adults 
9. Privacy and Confidentiality 
10. Risk / Benefit Assessment 
11. Economic Burden to Participants 
12. Resources 
13. Other Approvals, Permissions, and 
Regulatory Issues 
 
1. OVERVIEW 
Study Title:  
 
Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed 
Adolescents  

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1.1. [DETERMINATION]  Home institution. Identify the institution through which the lead researcher listed on the IRB 
application will conduct the research. Provide any helpful explanatory information. 
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers them to be a paid 
employee, or (2) at which the researcher is a matriculated student. Scholars, faculty, fellows, and students who are visiting the 
UW and who are the lead researcher: identify your home institution and describe the purpose and duration of your UW visit, as 
well as the UW department/center with which you are affiliated while at the UW. 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the SOP Use of the 
UW IRB. 
University of Washington 
1.2. [DETERMINATION]  Consultation history. Has there been any consultation with someone at HSD about this study? 
It is not necessary to obtain advance consultation. However, if advance consultation was obtained, answering this question will 
help ensure that the IRB is aware of and considers the advice and guidance provided in that consultation. 
☒ No 
☐ Yes → Briefly describe the consultation: approximate date, with whom, and method (e.g., by email, phone call, 
in-person meeting). 
Click or tap here to enter text. 
1.3. [DETERMINATION]  Similar and/or related studies. Are there any related IRB applications that provide context for the 
proposed activities? 
Examples of studies for which there is likely to be a related IRB application: Using samples or data collected by another study; 
recruiting subjects from a registry established by a colleague’s research activity; conducting Phase 2 of a multi-part project or 
conducting a continuation of another study; serving as the data coordinating center for a multi-site study that includes a UW site. 
Providing this information (if relevant) may significantly improve the efficiency and consistency of the IRB’s review. 
☐ No 
☒ Yes → Briefly describe the other studies or applications and how they relate to the proposed activities. If the other 
applications were reviewed by the UW IRB, please also provide: the UW IRB number, the study title, and 
the lead researcher’s name. 
Our team has IRB approval related to conducting a series of design, development and usability studies 
related to our digital mental health support tool for adolescent depression care, ActivaTeen 
(STUDY00002824; Designing for Adolescent Health). These studies have assisted us discovering target 
user needs, evaluation of proposed digital tool designs and user testing in mock scenarios with target 
users. The finalized ActivaTeen tool will be utilized in the present study as part of a pilot randomized 
clinical trial (RCT) to better understand feasibility, usability, acceptability, and engagement of the tool 
when used alongside behavioral activation (BA) for adolescent depression care. Both the usability and 
RCT lead researchers are Drs. Jenness and Kientz. 
1.4. [DETERMINATION]  Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or 
urgency that affect the proposed activity? 

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HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To ensure fairness, it is HSD 
policy to review applications in the order in which they are received. However, HSD will assign a higher priority to research with 
externally-imposed urgency that is beyond the control of the researcher. Researchers are encouraged to communicate as soon as 
possible with their HSD staff contact person when there is an urgent situation (in other words, before submitting the IRB 
application). Examples: a researcher plans to test an experimental vaccine that has just been developed for a newly emerging 
epidemic; a researcher has an unexpected opportunity to collect data from students when the end of the school year is only four 
weeks away.  
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be requested to compensate for 
a researcher’s failure to prepare an IRB application in a timely manner. Note that IRB review requires a certain minimum amount 
of time; without sufficient time, the IRB may not be able to review and approve an application by a deadline. 
☒ No 
☐ Yes → Briefly describe the urgency or deadline as well as the reason for it. 
Click or tap here to enter text. 
1.5. [DETERMINATION]  Objectives. Using lay language, describe the purpose, specific aims, or objectives that will be met 
by this specific project. If hypotheses are being tested, describe them. You will be asked to describe the specific 
procedures in a later section. 
If this application involves the use of a HUD “humanitarian” device: describe whether the use is for “on-label” 
clinical patient care, “off-label” clinical patient care, and/or research (collecting safety and/or effectiveness data). 
The purpose of this project is to test the feasibility and acceptability a digital health intervention for both 1) 
clinicians delivering the intervention and 2) teenagers with depression (ages 13-19) receiving the intervention. 
The intervention is an add-on component to an established depression protocol called behavioral activation (BA). 
All patient participants will receive BA, either in-person or via telehealth. Half of the patients will be randomized 
to additionally receive the digital support tool, ActivaTeen, which is a type of asynchronous remote community 
(ARC). ActivaTeen is a digital support tool that is delivered on a platform (Microsoft Teams) that is HIPAA-
compliant, accessible at all times, and allows patients to connect with other patient participants as well as with 
the clinicians who are delivering the intervention.  Therefore, this study will compare clinical and implementation 
outcomes between the BA-Only and ActivaTeen+BA groups across the following specific aims: 
 
1) Test the feasibility, usability, appropriateness, engagement, and acceptability of delivering 
ActivaTeen+BA compared to BA alone for clinicians  
2) Test the feasibility, usability, appropriateness, engagement, and acceptability (i.e., implementation 
outcomes) of receiving ActivaTeen+BA compared to BA alone for patients  
a. Explore the effect of ActivaTeen+BA compared to BA alone on depression and anxiety as well as 
functional impairment (i.e., clinical outcomes)   
b. Explore the association of specific components of ActivaTeen with hypothesized treatment 
mechanisms including therapist alliance, timeliness of intervention, treatment efficiency, and 
social belongingness 
c. Explore race and ethnicity as moderators of implementation and clinical outcomes linked to 
ActivaTeen+BA  
 
1.6. [DETERMINATION]  Study design. Provide a one-sentence description of the general study design and/or type of 
methodology. 

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Your answer will help HSD in assigning applications to reviewers and in managing workload. Examples: a longitudinal 
observational study; a double-blind, placebo-controlled randomized study; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinating center for a multi-site study. 
This is a 2-arm pilot randomized controlled trial of the acceptability of a remote digital health intervention for 
teenagers (ActivaTeen), ages 13-19, with depression (n=70), in which the clinicians delivering the intervention 
(n=10) will also be enrolled in the research to provide feedback on the acceptability of using ActivaTeen to 
support care.  
1.7. [DETERMINATION]  Intent. Check all the descriptors that apply to your study. You must check at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each option carefully. 
Check all 
that apply 
Descriptor 
☐ 
Class project or other activity whose purpose is to provide an educational experience for the 
researcher (for example, to learn about the process or methods of doing research). 
☐ 
Part of an institution, organization, or program’s own internal operational monitoring. 
☐ 
Improve the quality of service provided by a specific institution, organization, or program. 
☒ 
Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, 
and produce results that: 
• 
Are expected to apply to a larger population beyond the site of data collection or the 
specific subjects studied, or 
• 
Are intended to be used to develop, test, or support theories, principles, and statements 
of relationships, or to inform policy beyond the study. 
☐ 
Focus directly on the specific individuals about whom the information or biospecimens are 
collected through oral history, journalism, biography, or historical scholarship activities, to provide 
an accurate and evidence-based portrayal of the individuals. 
☐ 
A quality improvement or program improvement activity conducted to improve the 
implementation (delivery or quality) of an accepted practice, or to collect data about the 
implementation of the practice for clinical, practical, or administrative purposes. This does not 
include the evaluation of the efficacy of different accepted practices, or a comparison of their 
efficacy. 
☐ 
Public health surveillance activities conducted, requested, or authorized by a public health 
authority for the sole purpose of identifying or investigating potential public health signals or 
timely awareness and priority setting during a situation that threatens public health. 
☒ 
Preliminary, exploratory or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire). 
☐ 
Expanded access use of a drug or device not yet approved for this purpose. 

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Check all 
that apply 
Descriptor 
☐ 
Use of a Humanitarian Use Device. 
☐ 
Other. Explain: 
 
Click or tap here to enter text. 
1.8. Background, experience, and preliminary work. Answer this question only if the proposed activity has one or more 
of the following characteristics. The purpose of this question is to provide the IRB with information that is relevant 
to its risk/benefit analysis. 
• 
Involves more than minimal risk (physical or non-physical) 
• 
Is a clinical trial, or 
• 
Involves having the subjects use a drug, biological, botanical, nutritional supplement, or medical device. 
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or 
tests. 
1.8.a. Background. Provide the rationale and the scientific or scholarly background for the proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that the project is 
intended to address. 
This should be a plain language description. Do not provide scholarly citations. Limit your answer to less than one page 
or refer to an attached document with background information that is no more than three pages long. 
About 3.1 million adolescents are diagnosed with depression (MDD) each year and adolescent-onset MDD 
is associated with chronic physical, mental, and psychosocial disability. However, over 60% of adolescents 
with MDD do not receive mental health care, and there is low treatment engagement among those who 
do. Further, as the world has rapidly embraced the use of digitally delivered evidence-based psychosocial 
interventions (EBPIs) due to the COVID-19 pandemic, this new intervention landscape provides an 
opportunity and need to improve digital tools to support mental health care. This project addresses the 
need to develop innovative tools to improve access, engagement, and usability of current EBPIs. 
  
Given their ubiquitous access to and use of mobile technologies, adolescents may be better reached and 
engaged through technology platforms that leverage social media and mobile technology approaches. 
Asynchronous Remote Communities (ARCs) are a promising technology-based approach for engaging 
adolescents in mental health care that capitalizes on the reach and scalability of technology while also 
providing support, peer-to-peer social interactions, clinician-to-patient support and motivation to engage. 
ARCs use private online platforms (e.g., Slack, Microsoft Teams) to deliver and gather information from 
adolescents in a format that is lightweight, accessible, usable, and low burden.  
 
The ARC designed by our team, called ActivaTeen, aims to support adolescents with MDD who are 
completing an EBPI known as behavioral activation (BA). The BA model proposes: 1) stressors lead to 
increased punishment and decreased reward in the environment, which triggers 2) negative emotions like 
sadness, irritability, or hopelessness and prompt 3) anhedonic symptoms like avoidant behaviors and 

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social withdrawal. Avoidant behaviors have negative consequences such as losing friendships, lowered 
grades, and conflicts that feed back into stress, negative emotions, and more avoidant behaviors, which 
perpetuates a “downward spiral” of depression. BA attempts to reverse this process through a number of 
behavioral strategies (e.g., mood-activity tracking, goal-setting, problem-solving barriers) with the ultimate 
goal of (1) increasing rewarding experiences to help improve mood and (2) decreasing avoidance of 
potentially rewarding activities, which may serve to reinforce MDD symptoms. Importantly, the BA 
approach is individually tailored to fit each individual’s personal values and goals. 
 
There are several core components of ARC-supported BA that may improve patient engagement and, 
ultimately, mental health and functional outcomes. ARC platforms allow for 1) asynchronous therapist 
coaching through direct messaging; 2) between-session therapy homework and goal completion support 
through interactive chatbots, reminders, and access to online worksheets; 3) ecological momentary 
assessment (EMA) tracking and visualizations of symptoms and behavior that can been viewed and shared 
by both patient and clinician; and 4) scaffolded peer communities that collectively respond to moderated 
engagement prompts to share homework goals and challenges, provide asynchronous peer coaching, and 
general peer support. 
 
This research focuses on helping solve the significant gap between rates of adolescent depression and 
access to and engagement in high-quality EBPIs. ARC platforms capitalize on several key factors to close 
this gap, including 1) widespread use of scalable technology solutions by adolescents and 2) peer 
communities that provide social connection and engagement. Using ARC platforms as a delivery model for 
treatment is an innovative way to increase access to EBPIs through remote and asynchronously delivered 
content while simultaneously supporting synchronous therapy interactions through technology-based data 
collection, homework completion, and monitoring. ARC platforms provide an unparalleled opportunity for 
more precise characterization of symptoms and behavioral engagement via tools that support EMA. 
Inclusion of peer communities may boost treatment response via several proposed mechanisms including 
increased engagement with the EBPI content, increased social connection, and decreased stigma 
associated with mental health diagnoses. Improved engagement and effectiveness of EBPIs is essential for 
improving the significant morbidity and mortality associated with MDD, particularly in adolescents. 
 
 
1.8.b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you, 
your team, or your collaborators/co-investigators have that supports the feasibility and/or safety of this 
study. 
It is not necessary to summarize all the discussion that has led to the development of the study protocol. The IRB is 
interested only in short summaries about experiences or preliminary work that suggest the study is feasible and that risks 
are reasonable relative to the benefits. Examples: Your team has already conducted a Phase 1 study of an experimental 
drug which supports the Phase 2 study being proposed in this application; your team has already done a small pilot study 
showing that the reading skills intervention described in this application is feasible in an after-school program with 
classroom aides; your team has experience with the type of surgery that is required to implant the study device; the 
study coordinator is experienced in working with subjects who have significant cognitive impairment. 
In our NIMH R03-funded pilot work with a similarly-composed investigative team, we successfully built a 
preliminary prototype of the intervention being studied in this project. The prototype was considered to 
be acceptable, usable, and engaging to depressed adolescents and to mental health clinicians. This 
feedback was incorporated into the design and development of the full BA+ActivaTeen.  

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1.8.c. Subject matter expertise. Is the study a clinical trial and/or does the study involve use of a drug, biologic, 
botanical, nutritional supplement and/or is the study otherwise considered to be greater than minimal risk to 
subjects? 
☒ No  →   Answering this question is optional. 
☐ Yes →   Provide the name, degree(s), and contact information (e.g., email, phone number) of someone 
with appropriate expertise in the subject matter described in the objectives and design of this 
study. The individual should be unaffiliated with the study and have no other apparent conflict of 
interest. The individual may be associated with the UW or external to the University. Ensure the 
individual is aware they may be contacted by HSD. 
Provision of this information is required for all clinical trials, for studies involving the use of a drug, biologic, botanical, 
nutritional supplement and for studies involving greater than minimal risk. For all other studies, the information is 
optional, though HSD reserves the right to request researcher assistance in providing a consultant if necessary to 
complete review of the study.  
For the consultant, the request involves a brief email or phone call with targeted questions that usually can be responded 
to in 30 minutes or less. 
Click or tap here to enter text. 
1.9. Supplements. Check all boxes that apply, to identify relevant SUPPLEMENTS that should be completed and 
uploaded to Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this IRB Protocol form that 
you will need to provide in these Supplements. 
Check all 
that apply 
Type of Research 
Supplement Name and 
Link 
☐ 
Department of Defense 
The research involves Department of Defense funding, facilities, data, 
or personnel. 
SUPPLEMENT Department 
of Defense 
☐ 
Department of Energy 
The research involves Department of Energy funding, facilities, data, 
or personnel. 
SUPPLEMENT Department 
of Energy 
☐ 
Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of the proposed 
research. 
SUPPLEMENT Drugs 
☐ 
Emergency exception to informed consent 
Research that requires this special consent waiver for research 
involving more than minimal risk. 
SUPPLEMENT Exception 
from Informed Consent for 
Emergency Research (EFIC) 

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Check all 
that apply 
Type of Research 
Supplement Name and 
Link 
☐ 
Genomic data sharing 
Genomic data are being collected and will be deposited in an external 
database (such as the NIH dbGaP database) for sharing with other 
researchers, and the UW is being asked to provide the required 
certification or to ensure that the consent forms can be certified. 
SUPPLEMENT Genomic Data 
Sharing 
☐ 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of the proposed research, except when the device is 
FDA-approved and is being used through a clinical facility in the 
manner for which it is approved. 
SUPPLEMENT Devices 
☒ 
Multi-site or collaborative study 
The UW IRB is being asked to review on behalf of one or more non-
UW institutions in a multi-site or collaborative study. 
SUPPLEMENT Multi-site or 
Collaborative Research 
☐ 
Non-UW Individual Investigators 
The UW IRB is being asked to review on behalf of one or more non-
UW individuals who are not affiliated with another organization for 
the purpose of the research. 
SUPPLEMENT Non-UW 
Individual Investigators 
☐ 
Other REDCap Installation Attestation for Electronic Consent 
The research will use a non-UW installation of REDCap for conducting 
and/or documenting informed consent. 
SUPPLEMENT Other REDCap 
Installation 
☐ 
None of the above. 
 
2. PARTICIPANTS 
2.1. [DETERMINATION]  Participants. Describe the general characteristics of the subject populations or groups, including 
age range, gender, health status, and any other relevant characteristics. 
Clinician participants will be licensed mental health practitioners in the state of Washington or clinical psychology 
trainees supervised by a licensed mental health practitioner within the state of WA. In order to engage with the 
ARC platform, they must be proficient speaking English. To enroll in the study, clinician participants must 
complete BA certification with Drs. Jenness or McCauley.  
 
Patient participants will be English-speaking teenagers (ages 13-19) who have a primary psychiatric diagnosis of 
current MDD. Patients will have been referred to Seattle Children’s Hospital outpatient behavioral medicine clinic, 
and must have a PHQ-8 score of 8 or greater, indicating moderate or above depression. All patient participants will 
be screened for developmental disabilities and severe psychiatric comorbidities, for example active suicidality 
requiring a higher level of care or psychosis.  
2.2. [DETERMINATION]  Inclusion and exclusion criteria. 
2.2.a. Inclusion criteria. Describe the specific criteria that will be used to decide who will be included in the research 
from among interested or potential subjects. Define any technical terms in lay language. 

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Clinicians:  
Inclusion criteria:  
1) Licensed mental health clinician in the state of Washington OR clinical psychology trainees 
supervised by a licensed mental health clinician within the state of WA 
2) English-speaking 
3) Completion of behavioral activation certification training 
 
Patients:  
Inclusion criteria:  
1) Aged 13-19  
2) Referred for MDD treatment  
3) Clinically assessed diagnosis of current MDD based on caregiver or patient report or a PHQ-8 total 
of 8 or greater (moderate MDD)  
4) MDD clinically determined to be the primary diagnosis  
5) English-speaking 
6) Access to a smartphone device. 
 
Caregivers: 
Inclusion criteria:  
1) Primary caregiver of a patient who is enrolled in the study 
2) English-speaking 
 
 
2.2.b. Exclusion criteria. Describe the specific criteria that will be used to decide which of the subjects who meet the 
inclusion criteria listed above will be excluded from the research. Define any technical terms in lay language. 
Clinicians:  
Exclusion criteria:  
1) Failure to meet satisfactory BA fidelity for role play during certification training (i.e., completing <80% 
of required BA components on the BA fidelity checklist as measured by Drs. Jenness or McCauley);  
2) Missing 3 consecutive supervision meetings once enrolled as a clinician participant 
 
Patients:  
Exclusion criteria:  
1) Developmental disability (e.g., intellectual disability, autism spectrum disorder) 
2) Severe psychiatric comorbidity (e.g., active suicidality requiring higher level of care; psychosis or 
substance use, bipolar, or conduct disorder) 
3) Previously completed a full course of evidence based psychosocial intervention for depression  
 
Caregivers: 
Exclusion criteria:  
1) Unwilling or unable to complete study procedures  
2.3. [DETERMINATION]  Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners 
are not an intended target population. 
Is the research likely to have subjects who become prisoners while participating in the study? 
For example, a longitudinal study of youth with drug problems is likely to have subjects who will be prisoners at some point 
during the study. 

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☒ No 
☐ Yes → If a subject becomes a prisoner while participating in the study, will any study procedures and/or data 
collection related to the subject be continued while the subject is a prisoner? 
☐ No 
☐ Yes → Describe the procedures and/or data collection that will continue with prisoner subjects. 
Click or tap here to enter text. 
2.4. [DETERMINATION]  Will the proposed research recruit or obtain data from individuals that are known to be 
prisoners? 
For records reviews: if the records do not indicate prisoner status and prisoners are not a target population, select “No”. Review 
the guidance on Prisoners for the definition of “prisoner”, which is not necessarily tied to the type of facility in which a person is 
residing. 
☒ No 
☐ Yes → Answer the following questions (2.4.a. – 2.4.d.) 
2.4.a. Describe the type of prisoners, and their locations(s). 
Click or tap here to enter text. 
2.4.b. One concern about prisoner research is whether the effect of participation on prisoners’ general 
living conditions, medical care, quality of food, amenities, and/or opportunity for earnings in prison 
will be so great that it will make it difficult for prisoners to adequately consider the research risks. 
How will the chances of this be reduced? 
Click or tap here to enter text. 
2.4.c. Describe what will be done to make sure that (a) recruitment and subject selection procedures will 
be fair to all eligible prisoners and (b) prison authorities or other prisoners will not be able to 
arbitrarily prevent or require particular prisoners from participating. 
Click or tap here to enter text. 
2.4.d. If the research is funded by one of these federal departments and agencies (Health & Human 
Services; Energy; Defense; Homeland Security; CIA; Social Security Administration), and/or will 
involve prisoners in federal facilities or in state/local facilities outside of Washington State: check 
the box below to provide assurance that study team members will (a) not encourage or facilitate 
the use of a prisoner’s participation in the research to influence parole or pardon decisions, and (b) 
clearly inform each prisoner in advance (for example, in a consent form) that participation in the 
research will have no effect on his or her parole or pardon. 
☐ Confirmed 

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2.5. [DETERMINATION]  Protected populations. IRB approval is required for the use of the subject populations listed here. 
Check the boxes for any of these populations that will be purposefully included. (In other words, being a part of the 
populations is an inclusion criterion for the study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed and should not be submitted. 
Check all 
that apply 
Population 
Worksheet Name and Link 
☐ 
Fetuses in utero 
WORKSHEET Pregnant Women 
☐ 
Neonates of uncertain viability 
WORKSHEET Neonates 
☐ 
Non-viable neonates 
WORKSHEET Neonates 
☐ 
Pregnant women 
WORKSHEET Pregnant Women 
2.5.a. If you check any of the boxes above, use this space to provide any information that may be relevant for the 
IRB to consider. 
Click or tap here to enter text. 
2.6. [DETERMINATION]  Native Americans or non-U.S. indigenous populations. Will Native American or non-U.S. 
indigenous populations be actively recruited through a tribe, tribe-focused organization, or similar community-
based organization? 
Indigenous people are defined in international or national legislation as having a set of specific rights based on their historical 
ties to a particular territory and their cultural or historical distinctiveness from other populations that are often politically 
dominant. 
Examples: a reservation school or health clinic; recruiting during a tribal community gathering. 
☒ No 
☐ Yes → Name the tribe, tribal-focused organization, or similar community-based organization. The UW IRB 
expects that tribal/indigenous approval will be obtained before beginning the research. This may or may 
not involve approval from a tribal IRB. The study team and any collaborators/investigators are also 
responsible for identifying any tribal laws that may affect the research. 
Click or tap here to enter text. 
2.7. [DETERMINATION]  UW Medicine and UW Dentistry residents and fellows. Will the research involve UW Medicine 
or UW Dentistry residents or fellows as study subjects?  
If it will →  (1) Describe in the Recruiting section (4.1) and Risks section (10.1) how you will ensure that residents 
and fellows feel free to truly make a voluntary decision about participation (i.e., no negative 
consequences from supervisors for saying “no”) and how you will ensure that any research data will 
not be used in the residents’ and fellows’ supervisor or program evaluation of them; AND  
(2) You must inform the UW HR Labor Relations representative who negotiates with the resident’s and 
fellows’ union about the study before beginning it. This is currently Jennifer Mallahan mallaj@uw.edu .  

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2.8. [DETERMINATION]  Third party subjects. Will the research collect private identifiable information about individuals 
other than the study subjects? Common examples include: collecting medical history information or contact 
information about family members, friends, co-workers. 
“Identifiable” means any direct or indirect identifier that, alone or in combination, would allow you or another member of the 
research team to readily identify the person. For example, suppose that the research is about immigration history. If subjects are 
asked questions about their grandparents but are not asked for names or other information that would allow easy identification 
of the grandparents, then private identifiable information is not being collected about the grandparents and the grandparents 
are not subjects. 
☐ No 
☒ Yes → These individuals are considered human subjects in the study. Describe them and what data will be 
collected about them. 
Caregivers of child patients will be recruited to be participants in the study. However, if a caregiver 
declines to participate but is willing to give permission for their child to participate, the caregiver will 
be a third-party subject. The contact information (phone number and email address) of the 
caregiver/legal guardian(s) of child patients enrolled in the study will be collected and stored with the 
identifiable child participant data. The first and last name of the legal guardian(s) and their relationship 
to the participant will be stored as well.  
2.9. Number of subjects. Is it possible to predict or describe the maximum number of subjects (or subject units) needed 
to complete the study, for each subject group? 
Subject units mean units within a group. For most research studies, a group will consist of individuals. However, the unit of 
interest in some research is not the individual. Examples: 
• 
Dyads such as caregiver-and-Alzheimer’s patient, or parent and child 
• 
Families 
• 
Other units, such as student-parent-teacher 
Subject group means categories of subjects that are meaningful for the specific study. Some research has only one subject group 
– for example, all UW students taking Introductory Psychology. Some common ways in which subjects are grouped include: 
• 
By intervention – for example, an intervention group, and a control group. 
• 
By subject population or setting – for example, urban versus rural families 
• 
By age – for example, children who are 6, 10, or 14 years old. 
The IRB reviews the number of subjects in the context of risks and benefits. Unless otherwise specified if the IRB determines that 
the research involves no more than minimal risk: there are no restrictions on the total number of subjects that may be enrolled. If 
the research involves more than minimal risk: The number of enrolled subjects must be limited to the number described in this 
application. If it is necessary later to increase the number of subjects, submit a Modification. Exceeding the IRB-approved 
number (over-enrollment) will be considered non-compliance. 
☐ No → Provide the rationale in the box below. Also, provide any other available information about the scope/size 
of the research. You do not need to complete the table. 
Example: It may not be possible to predict the number of subjects who will complete an online survey advertised 
through Craigslist, but you can state that the survey will be posted for two weeks and the number who respond is the 
number who will be in the study. 
Click or tap here to enter text. 

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☒ Yes → For each subject group, use the table below to provide the estimate of the maximum desired number of 
individuals (or other subject unit, such as families) who will complete the research. 
Group name/description 
Maximum desired number or individuals (or other 
subject unit) who will complete the research 
Provide numbers for the site(s) reviewed by the UW IRB 
and for the study-wide total number; example: 20/100 
Patient BA+ActivaTeen group 
40 
Patient BA only group 
40 
Clinician group 
10 
Caregiver Group 
80 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
3. NON-UW RESEARCH SETTINGS 
Complete this section only if UW investigators and people named in the SUPPLEMENT Non-UW Individual 
Investigators will conduct research procedures outside of UW and Harborview 
3.1. [DETERMINATION]  Research locations and rationale. Identify the locations where the research will be conducted 
and include a description of the reason(s) for choosing the locations. If the research will be conducted 
internationally, be sure to list all the countries where the research will take place. 
This is especially important when the research will occur in locations or with populations that may be vulnerable to exploitation. 
One of the three ethical principles the IRB must consider is Justice: ensuring that reasonable, non-exploitative, and well-
considered procedures are administered fairly, with a fair distribution of costs and potential benefits. 
Any recruitment and screening procedures that occur in-person are expected to take place at Seattle Children’s 
Hospital (SCH). The clinicians in the study will be professional clinicians at SCH outpatient mental health clinics.  
 
Seattle Children’s Hospital Psychiatry and Behavioral Medicine Outpatient Clinic:  
All in-person study procedures – which will entail the BA therapy sessions – will occur at SCH Psychiatry and 
Behavioral Medicine Outpatient Clinics. SCH Psychiatry and Behavioral Medicine is the premier children's mental 
health institute in a five-state region including Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI). The 
main campus facility houses the child and adolescent outpatient and inpatient clinics, the psychiatry consultation 
and liaison service, child psychiatry administration offices, and the Pediatric Clinical Research Center.  
 
SCH provides extensive support for clinical research, including outpatient space, free parking to patients, on-site 
and phone crisis support, research nursing services, laboratory and pharmacy services, and biostatistical 
consultation. BA psychotherapy is an evidence-based treatment used widely in the Mood and Anxiety Disorders 
Program (MAP) of Seattle Children’s Hospital. The MAP clinic has a strong reputation for training advanced clinical 
psychology students across, externship, internship and post-doctoral training levels.  
 

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The clinician participants will have a clinical appointment at SCH, conducting mood disorder treatment as part of 
their normal course of work.   
 
Clinicians may deliver BA treatment via SCH-provided telehealth software in accordance with their policies. 
 
Recruitment flyers will be shared with adolescent outpatient primary care clinics and school-based mental health 
clinics in the community. However, no study-related procedures will occur at these locations.   
3.2. [DETERMINATION]  Local context. Culturally appropriate procedures and an understanding of local context are an 
important part of protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may 
affect the research, how it is conducted, or how consent is obtained or documented. 
Examples: It would be culturally inappropriate in some international settings for a woman to be directly contacted by a male 
researcher; instead, the researcher may need to ask a male family member for permission before the woman can be approached. 
It may be appropriate to obtain permission from community leaders prior to obtaining consent from individual members of a 
group. In some distinct cultural groups, signing forms may not be the norm. 
This federal site maintains an international list of human research standards and requirements: 
http://www.hhs.gov/ohrp/international/index.html 
We plan to apply to conduct recruitment at Odessa Brown Children’s Clinic (OBCC), a historic community pediatric 
clinic that offers care regardless of the patient’s ability to pay for treatment. The OBCC has strong ties to the Black 
and immigrant communities of the greater Seattle area. Given the historical exploitation of communities of color 
and immigrant people in the United States, both within and beyond academic research, our research team will 
devote extra attention to examining our implicit biases, using cultural humility practices to communicate with 
OBCC staff and patients, and adapting our procedures to minimize burden on OBCC as much as possible.  
3.3. [DETERMINATION]   Location-specific laws. Describe any local laws that may affect the research (especially the 
research design and consent procedures). The most common examples are laws about: 
• 
Specimens – for example, some countries will not allow biospecimens to be taken out of the country. 
• 
Age of consent – laws about when an individual is considered old enough to be able to provide consent vary 
across states, and countries. 
• 
Legally authorized representative – laws about who can serve as a legally authorized representative (and 
who has priority when more than one person is available) vary across states and countries. 
• 
Use of healthcare records – many states have laws that are similar to the federal HIPAA law but that have 
additional requirements. 
N/A 
3.4. [DETERMINATION]  Location specific administrative or ethical requirements. Describe local administrative or ethical 
requirements that affect the research. 
Example: A school district may require researchers to obtain permission from the head district office as well as school principals 
before approaching teachers or students; a factory in China may allow researchers to interview factory workers but not allow the 
workers to be paid for their participation. 
To engage in research recruitment at OBCC, a separate application is submitted and reviewed by staff and 
leadership at OBCC. We will only conduct recruitment at OBCC if our application is approved. For other primary 

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care recruitment or school-based recruitment, we will abide by any location-specific procedures related to 
recruiting for research.  
3.5. [DETERMINATION]  If the PI is a student: Does the research involve traveling outside of the U.S.? 
☐ No 
☐ Yes → Confirm by checking the box that (1) you will register with the UW Office of Global Affairs before traveling; 
(2) you will notify your advisor when the registration is complete; and (3) you will request a UW Travel 
Waiver if the research involves travel to the list of countries requiring a UW Travel Waiver.  
☐ Confirmed 
4. RECRUITING AND SCREENING PARTICIPANTS 
4.1. [DETERMINATION]  Recruiting and screening. Describe how subjects will be identified, recruited, and screened. 
Include information about: how, when, where, and in what setting. Identify who (by position or role, not name) will 
approach and recruit subjects, and who will screen them for eligibility. 
Note: Per UW Medicine policy, the UW Medicine eCare/MyChart system may not be used for research recruitment purposes. 
Additionally, researchers may not use UW Medicine’s Epic Care Everywhere data for research purposes unless the clinical data is 
necessary for patient/participant safety activities. This means Care Everywhere data cannot be used for recruitment, data 
abstraction, or any research activities other than those necessary for patient/participant safety. 
Patient participants will be identified from patients referred to SCH to receive treatment for major depressive 
disorder at SCH Psychiatry and Behavioral Medicine Outpatient Clinics. Research staff will screen the SCH 
electronic health record of patients who have been referred and are scheduled for a diagnostic interview.  
 
When research staff identify a patient as potentially eligible, based on age, reason for referral, and a lack of 
exclusion criteria, staff will alert the clinician assigned to conduct the patient’s clinical diagnostic interview to 
mention the research study to adult patients or to the parent/caregiver of child patients. Clinicians will also be 
asked to share the study flyer. The clinician will ask the patient or parent/caregiver if the research staff can contact 
the adult patient or the parent/caregiver of child patients to discuss the study in more detail. If the parent agrees, the 
clinician will send a secure message through the electronic health record to study staff letting them know the parent 
can be contacted for recruitment. 
 
Because the study intervention is a tool to support depression treatment, participants must begin the intervention as 
they are beginning their depression treatment. If a clinician forgets or otherwise fails to mention the study to a 
potentially eligible patient, the opportunity to enroll them may pass. Therefore, research staff will directly contact 
(cold contact) potentially eligible adult patients or parent/caregiver of child patients in the case the clinician does 
not mention the research during the intake visit.  
 
Cold Contact 
Research staff will send an email to the parent/caregiver of child patients or directly to adult patients. The email 
will not mention depression treatment. The project will be explained as a study at Seattle Children’s related to 
mental health, and it will be described that they (or their child) were identified by a review of medical records. If 
no response is received within 3 business days, research staff will follow up with a phone call. If reached by phone, 
research staff will confirm the identity of the person before giving information about the study.  
 
Adult patients 

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Research staff will give information over the phone about participation in the study. The patient will be informed of 
basic eligibility criteria, study procedures, and brief details about the ActivaTeen intervention. Research staff will 
elicit and answer any questions, and if the patient is interested, staff will obtain verbal consent to complete screening 
questions over the phone. The screening questions will include the PHQ-8 (Inclusion criterion 4) and questions about 
developmental disabilities and other psychiatric comorbidities (Exclusion criteria 1 & 2). All other inclusion and 
exclusion criteria will be verified by SCH clinical staff.  
 
Child patients  
Children will not be contacted directly about the research program. Instead, their parent or caregiver will be 
engaged by research staff for research purposes. Research staff will obtain permission from a parent or caregiver to 
complete some screening questions with the patient. Research staff will administer the PHQ-8 to the child patient 
directly, and will ask the parents about developmental disabilities and psychiatric comorbidities.  
 
Word of Mouth  
Patients or caregivers in the study are free to tell others who may be eligible about the study and to share the study 
flyer. Interested patients or parents may contact the study team to discuss and potentially enroll in the study. 
Patients who are not already receiving outpatient mental health treatment at SCH will have an SCH medical record 
created upon referral to SCH clinics. Once a teen is referred to treatment at SCH, the rest of the recruitment process 
will operate the same as for other candidate patients.  
 
Recruitment of patient caregivers 
The caregiver will be invited to join the research study to answer survey questions about the enrolled patient at 
regular intervals. The surveys will also collect some information about the caregivers (e.g. demographics, some 
health measures, environmental stressors). Because caregivers are included solely based on the participation of 
their child, a separate screening process is not needed.   
 
Recruitment of clinicians 
Potentially eligible clinicians will be approached by Dr. Jenness, Dr. McCauley, or other research staff (e.g. 
coordinator) either in-person at SCH or via email. They will be asked if they are interested in joining a research 
study that aims to improve the effectiveness of depression treatment for adolescents. The study rationale and 
procedures will be shared and clinician questions will be elicited and answered.  
 
If a clinician is interested, they will complete a brief REDCap confirming their eligibility. If eligible, they will be 
emailed a copy of the consent form and asked to schedule an enrollment and onboarding session with either Dr 
Jenness or other research staff.   
4.2. Recruitment materials. 
4.2.a. What materials (if any) will be used to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; social media 
messages; written materials such as letters, flyers for posting, brochures, or printed advertisements; questionnaires filled 
out by potential subjects. 
Study Flyer – Seek general approval  
Recruitment Talking Points – Upload Copy 
Screening Script – Upload Copy  
Screening Questionnaire – Upload Copy 
Cold Call Recruitment Email – Upload Copy 
Cold Call Recruitment Flyer – Upload Copy 

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4.2.b. Upload descriptions of each type of material (or the materials themselves) to Zipline. If letters or emails will 
be sent to any subjects, these should include a statement about how the subject’s name and contact 
information were obtained. No sensitive information about the person (such as a diagnosis of a medical 
condition) should be included in the letter. The text of these letters and emails must be uploaded to Zipline 
(i.e., a description will not suffice). 
HSD encourages researchers to consider uploading descriptions of most recruitment and screening materials instead of 
the materials themselves. The goal is to provide the researchers with the flexibility to change some information on the 
materials without submitting a Modification for IRB approval of the changes. Examples: 
• 
Provide a list of talking points that will be used for phone or in-person conversations instead of a script. 
• 
For the description of a flyer, include the information that it will provide the study phone number and the name 
of a study contact person (without providing the actual phone number or name). This means that a Modification 
would not be necessary if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, the description below might state that the flyer will list one or a few of the major 
inclusion/exclusion criteria. 
• 
For the description of a video or a website, include a description of the possible visual elements and a list of the 
content (e.g., study phone number; study contact person; top three inclusion/exclusion criteria; payment of $50; 
study name; UW researcher). 
4.3. [DETERMINATION]  Relationship with participant population. Do any members of the study team have an existing 
relationship with the study population(s)? 
Example: a study team member may have a dual role with the study population such as being their clinical care provider, 
teacher, laboratory directory or tribal leader in addition to recruiting them for their research. 
☐ No 
☒ Yes → Describe the nature of the relationship. 
Some members of the investigative team (Drs. Jenness and McCauley) will be colleagues of the clinician 
participants at SCH. Clinicians will be assured they are not required to participate in the study, and that 
their professional and training opportunities will not be affected by choosing to participate or declining 
participation.  
 
The clinician participants will be involved in the clinical treatment of the patient participants. If a 
patient participant decides to withdraw, or a candidate patient decides not to enroll, they will continue 
care with SCH, but not in the context of the research project. Generally, clinician participants will not be 
involved in recruitment other than helping to connect patients with research staff, and ensuring that 
patients and patient families understand that they are not obligated to participate and that their care 
will not be affected by declining to participate. 
 
A member of the study team who is based at Seattle Children's Hospital and may conduct screening 
and/or consent procedures may also be a clinician participant in the study.  
4.4. Payment to participants. The IRB must evaluate subject payment for the possibility that it will unduly influence 
subjects to participate. Refer to the guidance on Subject Payment when designing subject payment plans. Provide 
the following information about your plans for paying research subjects in the text box below or note that the 
information can be found in the consent form.  
• 
The total amount/value of the payment 
• 
Schedule/timing of the payment [i.e., when will subjects receive the payment(s)] 

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• 
Purpose of the payment [e.g., reimbursement, compensation, incentive] 
• 
Whether payment will be “pro-rated” so that participants who are unable to complete the research may still 
receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include all of the above-listed information 
about payment, including the number and amount of payments, and especially when subjects can expect to receive payment. 
One of the most frequent complaints received by HSD is from subjects who expected to receive cash or a check on the day that 
they completed a study and who were angry or disappointed when payment took 6-8 weeks to reach them.  
Researchers should review current UW Financial Management requirements about when Social Security Numbers must be 
collected, and when research payment must be reported to the UW Tax Office and the IRS: https://finance.uw.edu/ps/how-
pay/research-subjects. 
If your study involves the use of Amazon’s Mechanical Turk (MTurk), you must comply with the UW Procurement Services policy 
that no UW employee, family member, or student directly involved in the research will participate as a subject. The policy 
requires adding a qualifying question that asks whether the subject is a UW employee or family member, or UW student who is 
directly involved in the research. If they answer yes, they must be disqualified from MTurk activities. 
Patient participants will be reimbursed with $40 electronic gift cards for each online assessment visit (Baseline, 
Week 12, Week 24) and $15 for completing the mid-treatment online surveys (Weeks 4 and 8). Patients will also 
receive up to $60 for completion of the EMA surveys (up to $5/week for 12 weeks). This sums to a total possible 
reimbursement of $210 ($120 total for 3 longer visits, $30 total for two survey visits, $60 for mood-activity 
reports).  
 
Caregivers will be reimbursed $20 for the Baseline study visit and Month 3 study visit (up to $40 total).  
 
Clinician participants will not be reimbursed for their time spent on the study.  
4.5. [DETERMINATION]  Non-monetary compensation. Describe any non-monetary compensation that will be provided. 
Example; extra credit for students; a toy for a child. 
N/A 
4.5.a. If class credit will be offered to students, there must be an alternate way for the students to earn the extra 
credit without participating in the research. If you will offer class credit, describe the alternative non-research 
method by which students can earn that same course credit, including who will provide the alternative (e.g., a 
student subject pool; the course instructor). 
Click or tap here to enter text. 
4.6. [DETERMINATION]  Will data or specimens be accessed or obtained for recruiting and screening procedures prior to 
enrollment? 
Examples: names and contact information; the information gathered from records that were screened; results of screening 
questionnaires or screening blood tests; Protected Health Information (PHI) from screening medical records to identify possible 
subjects. 
☐ No → Skip the rest of this section; go to question 5.1. 
☒ Yes → Describe the data and/or specimens (including PHI) and whether it will be retained as part of the study 
data. 

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Research staff will access patient PHI and family contact information for patients referred for MDD 
treatment in the SCH system who are awaiting a diagnostic intake clinic visit. The PHI will be accessed 
through the SCH electronic health record (EHR) system to determine if a patient is potentially eligible. 
Health information including previous diagnoses and both outpatient/inpatient encounters will be 
accessed and viewed directly in the SCH EHR system by research staff to aid this determination.  
 
Via the SCH electronic health record system, research staff will transmit the names of potentially 
eligible patients to the clinician assigned to conduct each patient’s diagnostic intake visit in the clinic 
prior to the intake appointment, to ask the clinician to mention the research study to the patient, share 
the flyer, and ask if the patient/caregiver wants to hear more about it. Research staff will obtain the first 
name and medical record number of screened patients, in order to confirm they do not send a message 
for the same patient twice and to track whether the clinician mentioned the study to the patient. This 
database will serve as a method to count the number of potentially eligible patients who did not enroll, 
which is crucial information for understanding the feasibility of a study. The identifiable data will be 
stored in a HIPAA-compliant REDCap database separate from all other study data, and this database 
will be deleted at the end of the study after relevant statistics from the database have been tabulated 
(e.g. counting the number of patients screened). The PHI of enrolled participants will be obtained and 
stored in a separate manner.  
 
If a clinician does not mention the study to a patient that had been identified by research staff (thus 
giving no opportunity for verbal consent to be contacted for research), research staff will reach out to 
the patient’s family or to the patient directly if they are an adult teen. For this, research staff will access 
contact information via the SCH electronic health record system.   
 
Clinicians will indicate to research staff via electronic health record message that a patient or patient 
parent has agreed to be contacted about the research. Research staff will obtain name and contact 
information for candidate patients or patient parents who have verbally consented to their information 
being shared. Research staff will describe study details and seek permission from the family (or verbal 
consent for adult patients) to complete screening with the candidate patient. During screening, 
additional data will be obtained as part of screening responses. These data will be retained as part of 
study data to evaluate the effectiveness of recruitment and screening procedures and to characterize 
people who are ineligible for the study. All candidate patients will be assigned a screening ID and their 
screening data will be stored separately from identifiable information.   
4.7. Consent for recruiting and screening. Will consent be obtained for any of the recruiting and screening procedures? 
(Section 8: Consent of Adults asks about consent for the main study procedures). 
“Consent” includes: consent from individuals for their own participation; parental permission; assent from children; consent from 
a legally authorized representative for adult individuals who are unable to provide consent. 
 
Examples: 
• 
For a study in which names and contact information will be obtained from a registry: the registry should have consent 
from the registry participants to release their names and contact information to researchers. 
• 
For a study in which possible subjects are identified by screening records: there will be no consent process.  
• 
For a study in which individuals respond to an announcement and call into a study phone line: the study team person 
talking to the individual may obtain non-written consent to ask eligibility questions over the phone. 
☐ No → Skip the rest of this section; go to question 5.1. 
☒ Yes → Describe the consent process. 

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Patient/Caregiver Recruitment 
There will be no consent process for research staff viewing EHR for adolescent patients referred to 
outpatient mood disorder treatment at SCH and obtaining first name and MRN to avoid repeat contact of 
a patient.  
 
Verbal consent will generally be obtained for research staff to contact potentially eligible patients, or 
their parent if a child patient, after the patient completes their diagnostic interview. However, if the 
clinician who conducts the interview does not mention the study to the potentially eligible patient (due to 
time constraints, forgetting, etc), research staff will contact the patient or their parent without a consent 
process (i.e. cold contact).  
 
Research staff will obtain parent/guardian permission to complete screening procedures with a 
potentially eligible child patient. Research staff will obtain verbal assent from candidate child patients to 
complete screening. Verbal consent will be obtained directly from adult patients.   
 
Clinician Recruitment 
When a clinician follows the link to the brief REDCap screening survey, the initial page(s) will have 
information about the study and what will be done with their screening data. They will be asked with a 
multiple choice (Yes/No) if they agree to complete screening and they can only proceed with the 
screening survey if they select “Yes” they agree. 
4.7.a. Documentation of consent. Will a written or verifiable electronic signature from the subject on a 
consent form be used to document consent for the recruiting and screening procedures? 
☒ No → Describe the information that will be provided during the consent process and for which 
procedures. 
Patient Screening 
The clinician completing the diagnostic interview will inform a parent/guardian of a child 
patient (or an adult patient directly) that their child (or the adult patient) may be eligible 
for a research study aimed at improving engagement in depression treatment. They will 
be told that participating in the research study is entirely voluntary and they can decline 
the research study at any point without affecting treatment in the clinic.  
 
Prior to completing screening questions, research staff will reiterate 1) research is 
voluntary; 2) they or the child may choose to stop at any point with no penalty to them or 
impact on their treatment; 3) their screening data will be retained as part of the study data 
whether or not they are eligible.  
 
Staff will then ask for permission from the parent to complete screening questions and 
assent from the child, or for adult patients, research staff will ask the adult patient for 
consent.   
 
Clinician Screening 
Prior to completing the brief screening survey, potentially eligible clinicians will be 
presented with information about the study and how their screening data will be stored. 
The information presented will emphasize that participating in the research is voluntary 
and will not affect their professional role at SCH. They will have been sent the study 
consent form to review details of the study prior to screening.    

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☐ Yes, written → If yes and a written signature will be used to document consent:  
• 
Upload the consent form to Zipline. 
☐ Yes, electronic → If yes and an electronic signature will be used to document consent: 
• 
Upload the consent form to Zipline. 
• 
If the eSignature process or method for recruiting and screening is different 
than for the main study procedures, use the questions about electronic 
consent in Sections 8.3. and 8.4. to differentiate between 
recruiting/screening and main study electronic consent. If electronic consent 
will be used for recruiting/screening but not main study consent, use 8.3. 
and 8.4. to describe e-consent and note that it is only for 
recruiting/screening. 
5. PROCEDURES 
5.1. [DETERMINATION]  Study procedures. Using lay language, provide a complete description of the study procedures, 
including the sequence, intervention, or manipulation (if any), drug dosing information (if any), blood volumes and 
frequency of draws (if any), use of records, time required, and setting/location. If it is available: Upload a study flow 
sheet or table to Zipline. 
For studies comparing standards of care: It is important to accurately identify the research procedures. Review the section titled, 
“When to describe risks for studies evaluating medically recognized standards of care” in the Identifying and Describing 
Reasonably Foreseeable Risks in Research guidance and the draft guidance from the federal Office of Human Research 
Protections, “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”; October 20, 2014. 
Information about pediatric blood volume and frequency of draws that would qualify for expedited review can be found in this 
reference table on the Seattle Children’s IRB website. 
Study Procedures & Assessments – Patient & Caregiver Participants  
 
All enrolled patient participants will complete a total of 5 study visits, each of which will involve filling out a 
series of self-report surveys (see Schedule of Evaluations below and the table in Section 5.4). Study visits will 
occur remotely, with the patient (and their caregiver for teen patients) joining Zoom videoconference with research 
staff while completing surveys. Self-report surveys will include assessment of mood symptoms, functional 
impairment, loneliness, therapeutic alliance, and other psychological constructs. Surveys will also assess 
intervention engagement mechanisms and the acceptability of both intervention arms. For all patient participants, 
some visits will also include a semi-structured interview with research staff interview assessing the presence of 
depression. Lastly, patient participants will complete a weekly assessment of depression and anxiety symptoms at 
each BA treatment session.  
 
Along with the patient, the parent/caregiver of teen participants will also be asked to fill out surveys at Visits 1, 4, 
and 5 assessing the mood and behavior of the patient participant as well as surveys about their family environment 
(e.g., family make-up), demographics, family history of mental health diagnoses, and self-reported symptoms of 
depression at the baseline Visit 1 only (see Section 5.4 “Source” column within table).  
 
After completing informed consent, participants will be scheduled for a time to conduct the first study visit. These 
procedures can occur immediately after informed consent or at a different time depending on the participant’s 
schedule. Once they are logged into Zoom videoconferencing, research staff will conduct a brief interview to assess 
the presence of depression. Then patient participants will access the surveys via REDCap link sent to their parent’s 
email or to their personal email if they are an adult and prefer the link to be sent to them directly. Research staff 

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will be available on the Zoom call to answer any questions about the survey. The teenage patient will complete the 
self-report surveys that apply to them, and the caregiver will then complete surveys assessing the patient (e.g. the 
frequency of depression symptoms the child is displaying), the patient’s family and themselves.  
 
After completing all surveys for the baseline (Day 1), participants will be randomized to BA only or 
BA+ActivaTeen app. Regardless of group, participants will be able to ask questions about the upcoming BA 
treatment. Participants in the treatment group (BA+ActivaTeen) will be given an onboarding for using the 
ActivaTeen app, and credentials will be shared with the participant (and/or parent if the participant is a child) to log 
into the app. 
 
All participants will be asked to attend weekly BA sessions, which is part of routine care at SCH outpatient mental 
health clinics. BA sessions will be recorded for the purposes of clinical supervision and assessing treatment 
fidelity.  
 
During the post-treatment study visit (Week 12) in addition to surveys, teen patiecontacnts will be asked to 
complete a semi-structured qualitative interview to give detailed feedback on the acceptability, usability, and 
cultural fit of the treatment they received as part of the study (either BA only or BA+ActivaTeen). These 
interviews will occur over Zoom and will be recorded to the HIPAA-compliant Zoom cloud. Recordings will be 
transcribed for analysis and all identifying information will be removed. The original, unedited transcript and 
recording will be retained as part of study data.   
 
Pre-
consent 
Visit 1  
Day 1 
(Week 1) 
Visit 2 
Day 28 
(Week 4) 
Visit 3 
Day 56 
(Week 8) 
Visit 4 
Day 84 
(Week 12) 
Visit 5 
Day 168 
(Week 24) 
Daily 
Weekly 
(Weeks 1 -12) 
Unscheduled 
Visit 
Procedures 
  
  
  
  
  
 
 
 
 
Screening & Recruitment  
X 
 
 
 
 
 
 
 
 
Informed Consent  
 
X 
 
 
 
 
 
 
 
Randomization  
 
X 
 
 
 
 
 
 
 
Intervention Initiation  
 
X 
 
 
 
 
 
 
 
Adverse Events Reporting  
 
 
X 
X 
X 
X 
 
 
X 
Baseline Only Data  
  
  
  
  
  
 
 
 
 
Demographics 
  
XX* 
  
  
  
 
 
 
 
Family & Medical History 
 
XX 
 
 
 
 
 
 
 
Technology Comfort 
 
X 
 
 
 
 
 
 
 
Neighborhood  
 
XX* 
 
 
 
 
 
 
 
Outcome Evaluation  
  
  
  
  
  
 
 
 
 
Depression Symptoms 
 
XX^ 
X 
X 
X 
X 
 
X 
 
Anxiety Symptoms 
 
X 
X 
X 
X 
X 
 
X 
 
Functional Impairment 
 
X 
 
 
X 
X 
 
 
 
Loneliness 
 
X 
X 
X 
X 
X 
 
 
 
Therapeutic Alliance 
 
 
X 
X 
X 
 
 
 
 
Depressive Disorder 
 
X 
 
 
X 
X 
 
 
 
Conduct  
 
X 
 
 
X 
X 
 
 
 
Treatment Satisfaction 
 
 
 
 
X 
 
 
 
 
Treatment Engagement 
 
 
 
 
 
 
 
X 
 

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Study Treatment and Comparison Groups  
Patient participants randomized to the intervention will receive behavioral activation (BA) therapy plus access to 
the ActivaTeen app, while those randomized to the control group will receive BA alone. The control group will 
complete daily mood logging (see "Mood and Activity Tracking" section below) to serve as a comparison to the 
ActivaTeen group.  
 
Behavioral Activation Treatment 
Behavioral activation therapy involves weekly sessions with a trained therapist for 12 weeks. The sessions are 
completed either in-person or via telehealth. The treatment focuses on behavioral manifestations of depression such 
as isolating, and how these behaviors are interconnected with low mood and depressive emotions. BA helps 
patients find ways to engage in behaviors that are meaningful to them based on their values, priorities, and goals, 
with the aim of creating positive loops between doing meaningful activities and improved mood. The therapist 
provides structure and problem-solving for activating these behaviors and keeping track of changes over time. The 
treatment sessions will be audio recorded for use in treatment supervision sessions.  
 
The standard of care at SCH adolescent outpatient mood clinics is group BA therapy with the option to follow up 
with individualized therapy after finishing group. Participants in this study will be routed to individualized care 
upon enrollment. 
 
ActivaTeen App 
The ActivaTeen app is built on Seattle Children’s Hospital’s HIPAA-compliant instance of Microsoft Teams. 
Participants in the treatment group can access the app at any time via desktop or mobile, where they can find 
features designed to enhance their receipt of BA therapy. These features include: weekly BA skills and homework 
completion support, in-app messaging with their BA therapist, mood and activity tracking and data visualizations, 
chatbot check-ins on progress and guided problem-solving around barriers, and moderated peer support using the 
ActivaTeen app. The app will have a moderator, who is part of the study team, to manage peer-to-peer interactions 
within ActivaTeen. The components of ActivaTeen are described in more detail below:  
 
BA Skills and Homework Support 
Participants in the ActivaTeen+BA group will have access to homework assignments and reminders as part of the 
app. There are several built in, guided homework tools such as tracking situations, moods, and behaviors related to 
positive and negative moods in the week (i.e, Upward/Downward Mood Spirals), choosing, setting, and following 
through on therapy goals (i.e., SMART Goal Planning), and problem-solving barriers to goal completion (i.e., 
Overcoming Internal/External Barriers). There is also a “custom homework” option where clinicians can attach 
editable homework documents for the patient to complete. The patient will only have access to assigned homework 
by the clinician with the exception of SMART Goal Planning and Overcoming Internal/External Barriers, which 
can be initiated by the patient as needed. 
 
Qualitative Interview  
 
 
 
 
 
X 
 
 
 
Acceptability/Usability 
 
 
X 
X 
X 
 
 
 
 
Mood & Activity Log 
 
 
 
 
 
 
X 
 
 
ActivaTeen Only 
 
 
 
 
 
 
 
 
 
Group Cohesiveness 
 
 
X 
X 
X 
 
 
 
 
ActivaTeen Engagement 
 
 
X 
X 
X 
 
X 
 
 
* Measures marked with a double X ("XX") are completed by both the teen and teen's caregiver. The caregiver questions will ask about the 
caregiver (e.g. the caregiver's demographics). 
^ Measures marked with Bold X are also completed by patient’s caregiver in reference to the patient (e.g. rating the patient’s level of 
depression).  

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Communication with Clinicians 
Patients can send direct messages to their therapist via the app to ask questions about the weekly exercises or about 
other aspects of therapy.  
 
Mood and Activity Tracking  
Participants will receive 5 random text message notifications each day asking them to log their current mood and 
what activity they are engaging in. There will also be an open text field for patients to provide more context about 
their mood/activities. These notifications will also be sent to control participants in order to compare mood ratings 
over time.  
 
Chatbot Coaching 
Participants can access an automated chatbot that offers BA coaching related to Overcoming Internal/External 
Barriers. This is only initiated after a patient has set a SMART Goal and is meant to provide a check-in on progress 
and assist in problem-solving barriers to goal completion.  
 
Peer Support 
Participants can interact with other study participants who are currently in the intervention via a moderated group 
Team “channel” (i.e., a private group set up by the moderator that includes 3-10 teens) in the ActivaTeen Teams 
tenant. The moderator will send weekly posts that ask teen participants to reflect on BA skill successes and 
challenges as well as provide support to one another. They will be able to request via the platform moderator (see 
below) to create a direct chat with another participant if desired. The second participant must consent to the request 
for the moderator to create the chat. The moderator will be able to review and monitor all direct chats and chats 
occurring on the peer channel.   
 
ActivaTeen Moderator  
A study staff member will have access to the ActivaTeen platform being used by patient and clinician participants 
in order to serve in a moderator role. The moderator will monitor the main ActivaTeen peer channel once per 
business day to monitor activity. Teen participants will be given a “Group Guidelines” document (see attachment) 
that is based on previous teen ARCs conducted by the present research team. If a moderator observes unallowed 
activity or behavior from a teen, they will follow the protocol outlined in the Group Guidelines document. Teen 
participants can contact the moderator if needed with concerns about the behavior or language of other teens.  The 
moderator will also review all peer-to-peer direct chats on a daily basis. See risk/benefit assessment for mitigation 
procedures if unwanted interaction between peers occurs.  
 
Study Procedures & Assessments – Clinician Participants  
 
Newly-enrolled clinicians will complete a battery of surveys assessing demographics and comfort with technology. 
Clinicians will also complete certification in BA training and will be trained in how to use the ActivaTeen 
platform. All clinicians will be onboarded to ActivaTeen, as they will treat participants in both intervention groups.  
 
Group BA is the standard of care at the SCH Outpatient Psychiatry Clinic and individual BA is commonly offered, 
so therapy sessions and session preparations not related to study participation will be billed to insurance/workplace 
and not to the study. Clinicians seeing BA+ActivaTeen patients will be asked to review EMA survey completion 
during sessions and respond to patient questions on the app during their normal business hours. Beyond this, they 
will be encouraged to use the platform as desired and clinically indicated. They will not be asked to monitor for 
crisis or safety concerns as a moderator will be assigned per ActivaTeen group. Twice per month clinical 
supervision meetings will be required as part of study participation to ensure treatment fidelity.  
 
Clinician participants will keep a time diary of time spent working on the ActivaTeen platform (sent 2x/week). 
They will also be asked to self-report on session fidelity and patient engagement per treatment session. They will 
be asked to remain in the study for the duration of the treatment phase of the clinical trial. They will be asked to 

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complete a semi-structured interview to share opinions and feedback on the acceptability and feasibility of the 
ActivaTeen app at two time points- once after approximately 3-months of study participation and once when a 
clinician terminates their study participation. These interviews will occur over Zoom and will be recorded to the 
HIPAA-compliant Zoom cloud. Recordings will be transcribed for analysis and all identifying information will be 
removed. The original, unedited transcript and recording will be retained as part of study data.   
 
 
Pre-
consent 
Visit 1 
Day 1 
Weekly 
(Patient’s 
Weeks 1 -12) 
Visit 2 
Day 90 
Visit 3 
Day 545 
Unscheduled 
Visit 
Procedures 
 
 
 
 
 
 
Screening & Recruitment  
X 
 
 
 
 
 
Informed Consent  
 
X 
 
 
 
 
Adverse Events 
Reporting  
 
 
 
 
 
X 
Baseline Only Data  
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
Technology Comfort 
 
X 
 
 
 
 
Outcome Evaluation  
 
 
 
 
 
 
Therapeutic Alliance 
 
 
X 
 
 
 
Treatment Engagement 
 
 
X 
 
 
 
Treatment Fidelity 
 
 
X 
 
 
 
Qualitative Interview 
 
 
 
X 
X 
 
Acceptability/Usability 
 
 
 
X 
X 
 
Therapist Time Diary 
 
 
X 
 
 
 
Intervention Engagement 
 
 
X 
 
 
 
 
 
5.2. [DETERMINATION]  Recordings. Does the research involve creating audio or video recordings? 
☐ No → Go to question 5.3. 
☒ Yes → Verify that you have described what will be recorded in the answer to question 5.1., and answer question 
the question below. 
5.2.a. Before recording, will consent for being recorded be obtained from subjects and any other 
individuals who may be recorded? 
☐ No → Email hsdinfo@uw.edu before submitting this application in Zipline. In the email, include a 
brief description of the research and a note that individuals will be recorded without their 
advance consent. 
☒ Yes 
5.3. [DETERMINATION]  MRI scans. Will any subjects have a Magnetic Resonance Imaging (MRI) scan as part of the study 
procedures? 
This means scans that are performed solely for research purposes or clinical scans that are modified for research purposes (for 
example, using a gadolinium-based contrast agent when it is not required for clinical reasons). 
☒ No → Go to question 5.4. 
☐ Yes → Answer questions 5.3.a through 5.3.c. 

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5.3.a. Describe the MRI scan(s). Specifically: 
• 
What is the purpose of the scan(s)? Examples: obtain research data; safety assessment 
associated with a research procedure. 
• 
Which subjects will receive an MRI scan? 
• 
Describe the minimum and maximum number of scans per subject, and over what time period 
the scans will occur. For example: all subjects will undergo two MRI scans, six months apart. 
Click or tap here to enter text. 
5.3.b. MRI facility. At which facility(ies) will the MRI scans occur? Check all that apply. 
☐ UWMC Radiology/Imaging Services (the UWMC clinical facility) 
☐ DISC Diagnostic Imaging Sciences Center (UWMC research facility) 
☐ CHN Center for Human Neuroscience MRI Center (Arts & Sciences research facility) 
☐ BMIC Biomolecular Imaging Center (South Lake Union research facility) 
☐ Harborview Radiology/Imaging Services (the Harborview clinical facility) 
☐ Northwest Diagnostic Imaging 
☐ Other: identify in the text box below: 
Click or tap here to enter text. 
5.3.c. Personnel. For MRI scans that will be conducted at the DISC, CHN or BMIC research facilities: 
Indicate who will be responsible for operating the MRI scanner by checking all that apply. 
☐ MRI technician who is formally qualified 
☐ Researcher who has completed scanner operator training provided by a qualified MRI operator 
5.4. [DETERMINATION]  Data variables. Describe the specific data that will be obtained (including a description of the 
most sensitive items). Alternatively, a list of the data variables may be uploaded to Zipline. 
 

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Measure  
Type of measure  
Instrument  
Source  
Sample Characteristics  
  
  
  
Demographics  
Descriptive  
Questionnaire  
Patient, Clinician 
Medical History and 
Comorbidities 
Descriptive 
Electronic Health Record, DSM-5 
Cross-Cutting Symptoms Measure 
Survey 
Case Report Form, 
Patient, Caregiver 
Neighborhood 
Descriptive 
MESA Neighborhood Questionnaire Patient, Caregiver 
Intervention Acceptability 
Primary outcome  
System Usability Scale 
Patient, Clinician  
User Burden Scale 
Patient, Clinician  
AIAFIM 
Patient, Clinician  
CSQ-18 
Patient, Clinician  
Trial Design Feasibility  
Secondary outcome  
Recruitment/Enrollment rate, Loss 
to Follow Up rate 
Case Report Form  
Treatment Engagement  
Secondary outcome  
BA Session Attendance,  
Homework Completion, Skill Use  
Case Report Form 
Intervention Engagement  
Secondary outcome  
Time on platform, messaging rates, 
latency to respond to prompts 
Case Report Form  
Intervention Safety 
Secondary outcome 
Adverse Events Interview 
Patient, Caregiver, 
Clinician 
Suicidality  
Secondary outcome  
SMFQ-4  
Case Report Form   
Depression 
Secondary outcome  
PHQ-9, BDI (caregiver only) 
Patient, Caregiver 
Anxiety  
Secondary outcome  
GAD-7  
Patient, Caregiver 
Functional Impairment 
Secondary outcome  
WFIRS 
Patient, Caregiver 
Loneliness 
Secondary outcome  
NIH Loneliness Survey  
Patient 
Therapeutic Alliance 
Secondary outcome  
WAI-SR 
Patient 
Depressive Disorder 
Secondary outcome 
CDRS-R 
Patient 
Conduct  
Secondary outcome  
Strengths and Difficulties 
Questionnaire   
Patient, Caregiver 
Technology Comfort 
Secondary outcome  
FACETS 
Patient 
Online intervention attitudes 
Exploratory 
ETAP 16 
Patient 
Client-centeredness of 
treatment 
Exploratory 
 
GYV-20 
Patient 
Baseline Anxiety 
Descriptive 
RCADS-25 
 
Caregiver 
5.5. [DETERMINATION]  Data sources. For all types of data that will be accessed or collected for this research: Identify 
whether the data are being obtained from the subjects (or subjects’ specimens) or whether they are being obtained 
from some other source (and identify the source). 

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If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
See Section 5.4 
5.6. [DETERMINATION]  Identifiability of data and specimens. Answer these questions carefully and completely. This will 
allow HSD to accurately determine the type of review that is required and the relevant compliance requirements. 
Review the following definitions before answering the questions: 
Access means to view or perceive data, but not to possess or record it. Consider, in contrast, the definition of “obtain”. 
Identifiable means that the identity of an individual is or may be readily (1) ascertained by the researcher or any other member 
of the study team from specific data variables or from a combination of data variables, or (2) associated with the information.  
Direct identifiers are direct links between a subject and data/specimens. Examples include (but are not limited to): name, date of 
birth, medical record number, email or IP address, pathology or surgery accession number, student number, or a collection of 
data that is (when taken together) identifiable.  
Indirect identifiers are information that links between direct identifiers and data/specimens. Examples: a subject code or 
pseudonym. 
Key refers to a single place where direct identifiers and indirect identifiers are linked together so that, for example, coded data 
can be identified as relating to a specific person. Example: a master list that contains the data code and the identifiers linked to 
the codes. 
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice recording, etc.) for research 
purposes and to retain for any length of time. This is different from accessing, which means to view or perceive data. 
5.6.a. Will you or any members of you team have access to any direct or indirect identifiers? 
☒ Yes → Describe which identifiers and for which data/specimens. 
Direct identifiers of participants (both clinicians and patients) will be stored in a REDCap database 
that can be accessed by study team members. These include: name, date of birth, phone number, 
MRN, email, and mailing address. All direct identifiers will be stored together and with a study ID 
linking each individual to their study data that is stored in a separate REDCap database. Direct 
identifiers of third-party subjects (name and contact information of parent/guardian of child 
participants) will also be stored in the database of identifiable data and will be stored with the 
associated child’s identifiable information.  
☐ No → Select the reason(s) why you (and all members of your team) will not have access to direct or indirect 
identifiers. 
☐ There will be no identifiers 
☐ Identifiers or the key have been (or will have been) destroyed before access. 
☐ There is an agreement with the holder of the identifiers (or key) that prohibits the release of the 
identifiers (or key) to study team members under any circumstances. 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, Repository 
Gatekeeping form, or documented email. 
☐ There are written policies and procedures for the repository/database/data management center 
that prohibit the release of the identifiers (or identifying link). This includes situations involving an 
Honest Broker. 
☐ There are other legal requirements prohibiting the release of the identifiers or key. Describe them 
below. 

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Click or tap here to enter text. 
5.6.b. Will you or any study team members obtain any direct or indirect identifiers? 
☒ Yes → Describe which identifiers and for which data/specimens. 
Yes, the accessible identifiers described in part 5.6.a will be obtained and stored as part of the 
study records.  
☐ No → Select the reason(s) why you (and all members of your team) will not obtain direct or indirect 
identifiers. 
☐ There will be no identifiers. 
☐ Identifiers or the key have been (or will have been) destroyed before access. 
☐ There will be an agreement with the holder of the identifiers (or key) that prohibits the release of 
the identifiers (or key under any circumstances. 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, Repository 
Gatekeeping form, or documented email. 
☐ There are written policies and procedures for the repository/database/data management center 
that prohibit the release of the identifiers (or identifying link). This includes situations involving an 
Honest Broker. 
☐ There are other legal requirements prohibiting the release of the identifiers or key. Describe them 
below. 
Click or tap here to enter text. 
5.6.c. If any identifiers will be obtained, indicate how the identifiers will be stored (and for which data). NOT: Do 
not describe the data security plan here, that information is requested in question 9.6. 
☐ Identifiers will be stored with the data. Describe the data to which this applies: 
Click or tap here to enter text. 
☒ Identifiers and study data will be stored separately but a link will be maintained between the identifiers 
and the study data (for example, through the use of a code). Describe the data to which this applies: 
All identifiable data will be stored in a separate REDCap database from study data (e.g. treatment 
history, self-report survey responses). The identifiable database will include a study ID that can be used 
to link the study data to the identifiable data. 
☐ Identifiers and study data will be stored separately, with no link between the identifiers and the study 
data. Describe the data to which this applies: 

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Click or tap here to enter text. 
5.6.d. Research collaboration. Will individuals who provide coded information or specimens for the research also 
collaborate on other activities for this research? If yes, identify the activities and provide the name of the 
collaborator’s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that results from the coded 
information or specimens; and (2) authorship on presentations or manuscripts related to this work. 
N/A 
5.7. [DETERMINATION]  Protected Health Information (PHI). Will participants’ identifiable PHI be accessed, obtained, 
used, or disclosed for any reason (for example, to identify or screen potential subjects, to obtain study data or 
specimens, for study follow-up) that does not involve the creation or obtaining of a Limited Data Set? 
PHI is individually identifiable healthcare record information or clinical specimens from an organization considered a “covered 
entity” by federal HIPAA regulations, in any form or media, whether electronic, paper, or oral. You must answer yes to this 
question if the research involves identifiable health care records (e.g., medical, dental, pharmacy, nursing, billing, etc.), 
identifiable healthcare information from a clinical department repository, or observations or recordings of clinical 
interactions. 
For information about what constitutes the UW Covered Entity, review UW Medicine Compliance Patient Information Privacy 
Policy 101 and diagram of the healthcare components. 
☐ No → Skip the rest of this question; go to question 5.8. 
☒ Yes → Answer all of the questions below (5.7.a. through 5.7.f.) 
5.7.a. Describe the PHI and the reason for using it. Be specific. For example, will any “free text” fields (such 
as physician notes) be accessed, obtained, or used? 
Screening  
Patient medical records will be accessed during screening in order to identify potentially eligible 
patients from SCH outpatient mental health clinics. The following will be reviewed for each patient 
to assess potential eligibility:  
- 
Patient Information 
o Confirm age and primary language of English 
- 
Active problem list 
o Screen for exclusions such as intellectual disability, developmental disorder, 
psychosis, substance use 
- 
Intake visit conducted during initial visit with SCH outpatient mental health  
o Confirm primary psychiatric diagnosis of major depressive disorder  
o Screen for exclusions such as intellectual disability, developmental disorder, 
psychosis, substance use 
 
Research staff will obtain contact information for potentially eligible patients to be used in 
recruitment and screening.  
 
Study Data Collection  

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Once a patient is enrolled and a HIPAA authorization has been obtained, research staff will access 
and obtain patient PHI. 
 
The eligibility data described in the list above will be obtained as part of study data.   
 
Research staff will obtain the following from the patient medical record:  
- 
Behavioral treatment records at the SCH outpatient clinic including the pre-consent intake 
visit 
- 
Current and past history of mental health diagnoses 
- 
Current physical health diagnosis  
- 
Mental health symptom surveys or interviews completed during treatment 
- 
Current medications  
 
Treatment records generated before or during the patient’s participation in the study will be 
eligible to be obtained.  
 
5.7.b. Is any of the PHI located in Washington State? 
☐ No 
☒ Yes 
5.7.c. Describe the pathway of how the PHI will be accessed or obtained, starting with the source/location 
and then describing the system/path/mechanism by which it will be identified, accessed, and copied 
for the research. Be specific. For example: directly view records; search through a department’s 
clinical database; submit a request to Leaf. 
Screening  
Records will be directly viewed by research staff. First name and MRN will be obtained for all 
those screened via medical record to avoid repeat contacts. When study recruitment is complete, 
identifiable data will be deleted for anyone who is not screened or enrolled in the study. Aggregate 
statistics (e.g. number of records screened, outcomes) will be calculated and retained with study 
data. During recruitment, contact information will be accessed in order to initiate cold contact.   
 
Study Data Collection 
Research staff will access the SCH medical record system remotely, in line with SCH policy, or via 
an SCH desktop computer. Information from the EHR will be recorded to an electronic case report 
form (CRF) that is stored in REDCap.  
 
5.7.d. For which PHI will subjects provide HIPAA authorization before the PHI is accessed, obtained and/or 
used? 
Enrolled participants will provide HIPAA Authorization for all access and obtaining of PHI 
completed by the research team during their study involvement.  
Confirm by checking the box that UW Medicine HIPAA Authorization form maintained on the HSD 
website will be used to access obtain, use, or disclose any UW Medicine PHI. 

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☐ Confirmed 
5.7.e. Will you obtain any HIPAA authorizations electronically (i.e., e-signature)? 
☐ No 
☒ Yes → Confirm by checking the box that you have read and understand the Electronic 
Documentation of Consent section of the worksheet on Consent Requirements and Waivers 
the guidance on Documentation of Consent for information regarding the use of electronic 
signatures and HIPAA authorizations. 
☒ Confirmed 
5.7.f. For which PHI will HIPAA authorization NOT be obtained from the subjects? 
HIPAA Authorization will not be obtained for screening patient records research staff or obtaining 
name and MRN for those whose medical records have been screened. The contact information 
obtained by the research team will be deleted for those who do not eventually screen or consent for 
the study. The PHI will be the minimum amount needed for the research team to make contact with 
potential participants.  
Provide the following assurances by checking the boxes. 
☒ The minimum necessary amount of PHI to accomplish the purposes described in this application 
will be accessed, obtained and/or used. 
☒ The PHI will not be reused or disclosed to any other person or entity, except as required by law, 
for authorized oversight of the research study, or for other research for which the use or 
disclosure of PHI would be permitted. 
☒ The HIPAA “accounting for disclosures” requirement will be fulfilled, if applicable. Review UW 
Medicine Compliance Policy #104. 
☒ There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
5.8. [DETERMINATION]  Genomic data sharing. Will the research obtain or generate genomic data? 
☒ No 
☐ Yes → Answer the question below. 
5.8.a. Will genomic data from this research be sent to a national database (for example, NIH’s dbGaP 
database)? 
☐ No 
☐ Yes → Complete the supplement for Genomic Data Sharing and upload it to Zipline. 
5.9. Whole genome sequencing. For research involving biospecimens: Will the research include whole genome 
sequencing? 
Whole genome sequencing is sequencing of a human germline or somatic specimen with the intent to generate the genome or 
exome sequence of that specimen. 

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☒ No 
☐ Yes 
5.10. [DETERMINATION]  Cannabis (marijuana), hemp, and related compounds. These questions are about: cannabis 
(any part of the plant in any form), hemp, cannabidiol (CBD), delta-8-THC, any product derived from cannabis or 
hemp, and related synthesized compounds. All UW research must comply with federal laws about cannabis 
because of conditions associated with the federal money that UW receives. Answer the questions below so that 
HSD can determine whether the federal laws apply to your specific situation. Review the UW Guidance on Research 
Involving Marijuana for additional information. 
5.10.a. Does your research involve any of the following? Check all that apply. 
☐ Study staff will obtain or handle any of the above items 
☐ Study will provide money to the participants to obtain any of the above items 
☐ Study participants will use or consume any of the above items on campus or in any UW-owned or leased 
facility 
☒ None of the above 
5.10.b. If you checked any box except “None of the above”, provide the following information about each cannabis 
and related item your research will involve: Name of the item, how you will obtain it, the source, and 
whether it contains ≥0.3% THC (tetrahydrocannabinol). 
Click or tap here to enter text. 
5.11. [DETERMINATION]  Possible secondary use or sharing of information, specimens, or subject contact information. 
Please consider the broadest possible future plans and whether consent will be obtained now from the subjects for 
future sharing or research uses (which it may not be possible to describe in detail at this time).  
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include (for example): analyzing data using machine learning models; 
informal arrangements to share banked data/specimens with other investigators; establishing a repository that will formally 
share with other researchers through written agreements; or sending data/specimens to a third-party repository/archive/entity 
such as the Social Science Open Access Repository (SSOAR), or the UCLA Ethnomusicology Archive. 
5.11.a Is this research funded by an NIH funding application submitted on or after January 25, 2023. 
☒ No → 
Continue to next question. 
☐ Yes →  NIH Data Management and Sharing Policy applies to this research. Complete the rest of this 
section accordingly. If the policy applies and data will not be shared, provide the justification in 
response to 5.11.d and write NA in response to the other questions. 
 
5.11.b. Does this research involve analyzing UW patient health information using machine learning outside of UW 
IT systems (e.g., ChatGPT or other external language models)? 
☒ No → 
Continue to next question. 
☐ Yes →     A security review of the research is required by UW Medicine. Please check the box to confirm 
that this review has been completed and upload a copy of the approval letter to Zipline. 
 

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Note: Your IRB application cannot be approved without documentation that the security review has been 
completed. For more information about the security review, contact Sally Beahan, Senior Director, UW 
Medicine Enterprise Records & Health Information at sbeahan@uw.edu . 
☐ Confirmed 
Answer all of the questions below.  If sharing is unlikely or if the only sharing will be through the NIH Genomic 
Data Sharing per question 5.8., write NA in remaining response boxes.  
5.11.c. Describe what will be stored for future use, including whether any direct or indirect (e.g., subject codes) 
identifiers will be stored. 
We will store all study data with indirect identifiers for future use. Direct identifiers will be retained in 
accordance with federal regulations but will not be eligible for sharing. 
5.11.d. Describe what will be shared with other researchers or with a repository/database/registry/machine 
learning platform, including whether direct identifiers will be shared and (for specimens) what data will 
be released with the specimens. If shared through a repository, specify if it is unrestricted access (i.e., 
publicly accessible). 
A de-identified dataset will be available for sharing in some circumstances (see 5.11.d). No direct 
identifiers will be shared with outside researchers. 
5.11.e. Who will oversee and/or manage the sharing? 
The principal investigator, Dr. Jessica Jenness 
5.11.f. Describe the possible future uses, and any limitations or restrictions on future uses or users.  
Examples of limitations:  
• 
Consent prohibits or limits the scope of sharing and use (e.g., consent states that data will be used only for 
cardiovascular research) 
• 
Privacy or safety or research participants would be compromised (e.g., there is risk of reidentification and/or 
harm) 
• 
Explicit federal, state, or local, or Tribal law, regulation, or policy prohibits disclosure 
• 
Restrictions imposed by existing or anticipated agreements (e.g., with third party funders, partners, with 
repositories, medical centers providing health information under a data use agreement) 
 
De-identified data will be eligible to be shared: 
- 
For any purpose related to fulfilling grant requirements and obligations 
- 
To meet requirements for scientific publication  
- 
With all co-investigators for secondary analysis  
- 
With other academic research teams or researchers, given written permission by this study’s 
principal investigator (Dr. Jenness) 
- 
With other projects for which Dr. Jenness is a PI or co-I 
- 
With University of Washington students under the guidance of Dr. Jenness for the purpose of 
teaching or publication  
 
Identified data will not be shared beyond the study research team. 

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5.11.g. Consent. Will consent be obtained now from subjects for the secondary use, banking, and/or future 
sharing? 
☐ No 
☒ Yes → Be sure to include the information about this consent process in the consent form (if there is 
one) and in the answers to the consent question in Section 8.  
5.11.h. Withdrawal. Will subjects be able to withdraw their data/specimens from secondary use, banking or 
sharing? 
☒ No 
☐ Yes → Describe how, and whether there are any limitations on withdrawal. 
Example: data can be withdrawn from the repository but cannot be retrieved after they are released. 
Click or tap here to enter text. 
5.11.i. Agreements for sharing or release. Confirm by checking the box that the sharing or release will 
comply with UW (and, if applicable, UW Medicine) policies that require a formal agreement with the 
recipient for release of data or specimens to individuals or entities other than federal databases. 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used for 
specimens (or specimens plus data). Do not attach any template agreement forms; the IRB neither reviews 
nor approves them. 
☒ Confirmed 
5.12. Communication with subjects during the study. Describe the types of communication (if any) the research team 
will have with already-enrolled subjects during the study. Provide a description instead of the actual materials 
themselves. 
Examples: email, texts, phone, or letter reminders about appointments or about returning study materials such as a 
questionnaire; requests to confirm contact information. 
Enrolled participants or their parent/legal guardian(s) may receive phone call, email, and/or text reminders of 
study and treatment appointments and completion of online data collection (e.g., mood-activity ecological 
momentary assessment measures). 
5.13. Future contact with subjects. Is there a plan to retain any contact information for subjects so that they can be 
contacted in the future? 
☐ No 
☒ Yes → Describe the purpose of the future contact, and whether use of the contact information will be limited to 
the study team; if not, describe who else could be provided with the contact information. Describe the 
criteria for approving requests for information. 
Examples: inform subjects about other studies; ask subjects for additional information or medical record access that is 
not currently part of the study proposed in this application; obtain another sample. 

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Participants will be asked if they would like to be re-contacted in the future about other research projects 
that they might be eligible for. Contact information will be used by the study team or by future study 
teams led by the PI, Dr. Jenness. Only projects under Dr. Jenness’s purview as Principal Investigator or 
Co-Investigator will be allowed to access contact information for future contact 
5.14. Alternatives to participation. Are there any alternative procedures or treatments that might be advantageous to 
the subjects? 
If there are no alternative procedures or treatments, select “No”. Examples of advantageous alternatives: earning extra class 
credit in some time-equivalent way other than research participation; obtaining supportive care or a standard clinical treatment 
from a health care provider instead of participating in research with an experimental drug. 
☐ No 
☒ Yes → Describe the alternatives. 
Patients who decline to participate or who withdraw participation will be able to continue clinical mental 
health care at SCH. If they have begun BA treatment as part of the study, they will be able to continue 
this treatment if desired.  
5.15. Upload to Zipline all data collection forms (if any) that will be directly used by or with the subjects, and any 
scripts/talking points that will be used to collect the data. Do not include data collection forms that will be used to 
abstract data from other sources (such as medical or academic records), or video recordings. 
• 
Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• 
NOTE: Sometimes the IRB can approve the general content of surveys and other data collection instruments rather than 
the specific form itself. This prevents the need to submit a modification request for future minor changes that do not add 
new topics or increase the sensitivity of the questions. To request this general approval, use the text box below to identify 
the questionnaires/surveys/ etc. for which you are seeking this more general approval. Then briefly describe the scope of 
the topics that will be covered and the most personal and sensitive questions. The HSD staff person who screens this 
application will let you know whether this is sufficient or whether you will need to provide more information. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
• 
For data that will be gathered in an evolving way: This refers to data collection/questions that are not pre-determined 
but rather are shaped during interactions with participants in response to observations and responses made during those 
interactions. If this applies to the proposed research, provide a description of the process by which the data 
collection/questions will be established during the interactions with subjects, how the data collection/questions will be 
documented, the topics likely to be addressed, the most sensitive type of information likely to be gathered, and the 
limitations (if any) on topics that will be raised or pursued. 
Use this text box (if desired) to provide: 
• 
Short written descriptions of materials that cannot be uploaded, such as URLs 
• 
A description of the process that will be used for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which general approval is being 
sought. (Review the NOTE bullet point in the instructions above.) 
Click or tap here to enter text. 

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6. CHILDREN (MINORS) AND PARENTAL PERMISSION 
6.1. [DETERMINATION]  Involvement of minors. Does the research include minors (children)? 
Minor or child means someone who has not yet attained the legal age for consent for the research procedures, as 
described in the applicable laws of the jurisdiction in which the research will be conducted. This may or may not be 
the same as the definition used by funding agencies such as the National Institutes of Health. 
• 
In Washington State the generic age of consent is 18, meaning that anyone under the age of 18 is 
considered a child.  
• 
There are some procedures for which the age of consent is much lower in Washington State. 
• 
The generic age of consent may be different in other states, and in other countries. 
☐ No → Go to Section 8. 
☒ Yes → Provide the age range of the minor subjects for this study and the legal age for consent in the study 
population(s). If there is more than one answer, explain. 
Participants are aged 13-18; legal age of consent is age 18. 
☐ Don’t know → This means is it not possible to know the age of the subjects. For example, this may be true for 
some research involving social media, the Internet, or a dataset that is obtained from another 
researcher or from a government agency. Go to Section 8. 
6.2. Parental permission. Parental permission means actively obtaining the permission of the parents. This is not the 
same as “passive” or “opt out” permission where it is assumed that parents are allowing their children to participate 
because they have been provided with information about the research and have not objected or returned a form 
indicating they don’t want their children to participate. 
6.2.a. Will parental permission be obtained for: 
☒ All of the research procedures → Go to question 6.2.b. 
☐ None of the research procedures → Use the table below to provide justification and skip question 6.2.b. 
☐ Some of the research procedures → Use the table below to identify the procedures for which parental 
permission will not be obtained. 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data 
and specimens for future work. 
Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which there will be 
NO parental permission2 
Reason why parental permission 
will not be obtained 
Will parents be 
informed about 
the research?3 
 
 
 
YES 
NO 
Click or tap here to 
enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
☐ 
☐ 

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Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which there will be 
NO parental permission2 
Reason why parental permission 
will not be obtained 
Will parents be 
informed about 
the research?3 
 
 
 
YES 
NO 
Click or tap here to 
enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Table footnotes 
1. If the answer is the same for all children groups or all procedures: collapse the answer across the groups and/or procedures. 
2. If identifiable information or biospecimens will be obtained without parent permission, any waiver granted by the IRB does 
not override parents’ refusal to provide broad consent (for example, through the Northwest Biotrust). 
3. Will parents be informed about the research beforehand even though active permission is not being obtained? 
6.2.b. Indicate the plan for obtaining parental permission. One or both boxes must be checked. 
☐ Both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when 
only one parent has legal responsibility for the care and custody of the child. 
☒ One parent, even if the other parent is alive, known, competent, reasonably available, and shares legal 
responsibility for the care and custody of the child. 
This is all that is required for minimal risk research. 
If both are checked explain: 
Click or tap here to enter text. 
6.3. Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
☒ No  
☐ Yes → An advocate may need to be appointed for each child who is a ward. The advocate must be in addition to 
any other individual acting on behalf of the child as guardian or in loco parentis. The same individual can 
serve as advocate for all children who are wards. 
Describe who will be the advocate(s). The description must address the following points: 
• 
Background and experience 
• 
Willingness to act in the best interests of the child for the duration of the research 
• 
Independence of the research, research team, and any guardian organization 
Click or tap here to enter text. 
6.4. UW Office of the Youth Protection Coordinator. If the project involves interaction (in-person or remotely) with 
individuals under the age of 18, researchers must comply with UW Administrative Policy Statement 10.13 and the 
requirements listed at this website. This includes activities that are deemed to be Not Research or Exempt. It does 
not apply to third-party led research (i.e., research conducted by a non-UW PI). Information and FAQs for 
researchers are available. 

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This point is advisory only; there is no need to provide a response. 
7. ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
When designing assent processes and forms, researchers should first review the guidance on Protected and Vulnerable 
Populations and tipsheet on Assent and Legally Authorized Representative. 
7.1. Assent of children (minors). Though children do not have the legal capacity to “consent” to participate in research, 
they should be involved in the process if they are able to “assent” by having a study explained to them and/or by 
reading a simple form about the study, and then verbally expressing whether they want to participate. They may 
also provide a written assent if they are older. Review the guidance on Protected and Vulnerable Populations and 
the worksheet on Children for circumstances in which a child’s assent may be unnecessary or inappropriate.  
7.1.a. Will assent be obtained for: 
☒ All research procedures and child groups → Go to question 7.2. 
☐ None of the research procedures and child groups → Use the table below to provide justification, then 
skip to question 7.6. 
☐ Some of your research procedures and child groups → Use the table below to identify the procedures for 
which assent will not be obtained. 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data 
and specimens for future work. 
Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which assent will not 
be obtained 
Reason why assent will not be obtained 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse your answer across the groups and/or 
procedures. 
7.2. Assent process. Describe how assent will be obtained, for each child group. If the research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how their comprehension of the information will be evaluated. 
All children will be English speaking adolescents. Assent will be obtained by either the PI or RA 
(referred to as the interviewer) via a HIPAA compliant video conference platform (e.g., Zoom). Once the 
participant and their parent/guardian have entered the video conference, assent will be reviewed and 
signed via REDCap by sending the family the REDCap link and screen sharing while we review 

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assent/consent. The assent is written in age-appropriate language (see attached forms). The 
interviewer will then go through each point of the informed consent/assent allowing the participant 
and their parent/guardian to ask any questions they have before the interviewer goes on to the next 
section. Once the interviewer has thoroughly gone over the consent/assent/authorization form with 
the subject and their guardian, the interviewer will then follow up by asking “Do you have any 
questions about the study or is anything unclear to you?” The interviewer will ensure that the 
participant is given sufficient time to review the consent and assent forms. Only after the participant 
and their parent/guardian have thoroughly read the forms and the interviewer has answered all 
questions will the interviewer offer to let the participant and their parent to electronically sign the 
forms on REDCap. The interviewer will then provide an electronic signature on the form as the 
“witness.”   
 
At all stages of the study, participants and parents will be informed that refusal to participate will not 
affect their ability to receive care at the University of Washington or Seattle Children’s Hospital clinics 
and that they are free to withdraw at any time. Parents will also be informed about federal and state 
laws mandating reporting (e.g., child, elder abuse; risk of harm to self or others) . In cases where 
mandated reporting is required, the family will be told prior to our contacting any state agency (see 
10.1 Anticipation of Risks). 
 
7.3. Dissent or resistance. Describe how a child’s objection or resistance to participation (including non-verbal 
indications) will be identified during the research, and what the response will be. 
Examples of verbal dissent include the youth participant clearly stating they do not wish to participate, 
asking their parent why they are being asked to participate or if they “need” to participate, or asking 
whether they can have more time to think about participating. Possible examples of non-verbal dissent 
include not reading the assent, shrugging, sighing, or not making eye contact when asked if they have 
questions, when asked if they would like to participate after reviewing the assent, or during any other 
point in the consent/assent process. If the youth participant either verbally or non-verbally indicates 
dissent or resistance to participate in the study, the interviewer will again review that participation is 
completely voluntary and dependent upon both the youth and parent agreeing to participate. The 
interviewer will offer to provide the youth and parent with more information, answer any remaining 
questions, and provide a private space to the youth/parent to discuss participation. If there is still 
concern with whether the youth objects to participation, the  interviewer will offer to cancel the visit to 
give the youth and their parent more time to think about whether they would like to participate. The 
interviewer will offer to either re-contact the family after an agreed upon amount of time has passed or to 
wait for the family to contact the study coordinator, depending on family preference.  
7.4. E-consent. Will any electronic processes (email, websites, electronic signatures, etc.) be used to present assent 
information to subjects/and or to obtain documentation (signatures) of assent? If yes, describe how this will be 
done. 
Consent/assent will be reviewed and signed via REDCap by sending the family the REDCap link and 
screen sharing while we review assent/consent. 
7.5. Documentation of assent. Which of the following statements describes whether documentation of assent will be 
obtained? 
☐ None of the research procedures and child groups  
→ Use the table below to provide justification, then go 
to question 7.5.b. 

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☒ All of the research procedures and child groups   
→ Go to question 7.5.a., do not complete the table. 
☐ Some of the research procedures and/or child groups  
→ Complete the table below and then go to question 
7.5.a. 
Children Group1 
Describe the procedures or data/specimen collection (if any) for which assent will 
NOT be documented 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Click or tap here to enter text. 
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse your answer across the groups and/or 
procedures. 
7.5.a. Describe how assent will be documented. If the children are functionally illiterate or are not fluent in English, 
include a description of the documentation process for them. 
Assent will be documented and stored electronically on REDCap. Non-English speaking or illiterate youth 
will not be eligible to participate in this study.  
7.5.b. Upload all assent materials (talking points, videos, forms, etc.) to Zipline. Assent materials are not required to 
provide all of the standard elements of adult consent; the information should be appropriate to the age, 
population, and research procedures. The documents should be in Word, if possible. 
7.6. Children who reach the legal age of consent during participation in longitudinal research. 
When children are enrolled at a young age and continue for many years, it is best practice to re-obtain assent (or to 
obtain it for the first time, if it was not obtained at the beginning of their participation).  
When children reach the legal age of consent, informed consent must be obtained from the now-adult subject for 
(1) any ongoing interactions or interventions with the subjects, or (2) the continued analysis of specimens or data 
for which the subject’s identify is readily identifiable to the researcher, unless the IRB waives this requirement. 
7.6.a. Describe the plans (if any) to re-obtain assent from children. 
The study length is 24 weeks, so re-assent will not be necessary. 
 
7.6.b. Describe the plans (if any) to obtain consent for children who reach the legal age of consent.  
• 
If adult consent will be obtained from them, describe what will happen regarding now-adult subjects 
who cannot be contacted. 
• 
If consent will not be obtained or will not be possible, explain why. 
If a youth turns 18 during the study, we will obtain consent as an adult from the youth at that time.  In 
order to continue to send mood-activity report promts to their smartphones on a daily basis, we will 

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consent them over the phone for EMA notifications as soon as possible once they turn 18. We will 
then obtain written consent for all study procedures when the youth comes in for the next face to face 
session.  See “Consent Forms and Recruitment Materials” for the Youth Consent Form.  
 
7.7. Other regulatory requirements. (This is for information only; no answer or response is required.) Researchers are 
responsible for determining whether their research conducted in schools, with student records, or over the Internet 
comply with permission, consent, and inspection requirements of the following federal regulations: 
• 
PPRA – Protection of Pupil Rights Amendment 
• 
FERPA – Family Education Rights and Privacy Act 
• 
COPPA – Children’s Online Privacy Protection Act 
8 CONSENT OF ADULTS 
We provide researchers with many resources for designing the consent process and form(s).  
▪ 
The general Consent guidance provides a broad overview of all consent-related topics. Researchers are 
strongly encouraged to review HSD’s Consent Overview and the section on Key Information before designing 
consent process/form.  
▪ 
The guidance on Designing the Consent Process lists the general requirements for consent, required elements 
of consent, and the criteria for waivers of consent and documentation of consent. This guidance can be used 
with, or independent of, our Consent Templates. 
▪ 
Information about parental permission can be found in the guidance on Protected and Vulnerable 
Populations. 
Review the following definitions before answering the questions in this section. 
Consent is the process of informing potential subjects about the research and asking them whether they want to 
participate. It does not necessarily include the signing of a consent form.  
Parental permission is the parent’s active permission for the child to participate in the research. Parental permission 
is subject to the same requirements as consent, including written documentation of permission and required 
elements. 
Consent form is a document that provides details about the research so that subjects can make an informed decision 
about whether they want to participate. 
General requirements for consent are the qualities of the consent process as a whole and can be found in the 
guidance on Designing the Consent Process.  
Elements of consent are specific information that is required to be provided to subjects and can be found in the 
guidance on Designing the Consent Process. 
Consent documentation refers to how a subject’s decision to participate in the research is documented. This is usually 
obtained by having the subject sign a consent form. 

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8.1. Groups. Identify the groups to which the answers in this section apply: 
☒ Adult subjects 
☒ Parents who are providing permission for their children to participate in research 
→ If you selected PARENTS, the word “consent” below should also be interpreted as applying to parental 
permission and “subjects” should also be interpreted as applying to the parents. 
8.2. The consent process and characteristics. This series of questions is about whether consent will be obtained for all 
procedures except recruiting and screening, and, if yes, how. 
The issue of consent for recruiting and screening activities is address in question 4.7. You do not need to repeat your answer to 
question 4.7. 
8.2.a. Are there any procedures for which consent will not be obtained? 
☒ No  
☐ Yes → Use the table below to identify the procedures for which consent will not be obtained. “All” is an 
acceptable answer for some studies. 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and 
specimens for future work. 
Group1 
Describe the 
procedures of 
data/specimen 
collection (if any) for 
which there will be NO 
consent process 
Reason why consent 
will not be obtained 
Will subjects be 
provided with info 
about the research 
after they finish? 
(Check Yes or No) 
 
 
 
YES 
NO 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Short form consent is an alternative way of obtaining written documentation of consent for the unanticipated 
enrollment of individuals with low literacy or whose language is one for which translated consent forms are not 
available. 
Waiver of consent means there is IRB approval for not obtaining consent or for not including some of the elements of 
consent in the consent process. Note if you plan to obtain identifiable information or identifiable biospecimens 
without consent, any waiver granted by the IRB does not override a subject’s refusal to provide broad consent (for 
example, the Northwest Biotrust). 
Waiver of documentation of consent means that there is IRB approval for not obtaining written documentation of 
consent. 

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Group1 
Describe the 
procedures of 
data/specimen 
collection (if any) for 
which there will be NO 
consent process 
Reason why consent 
will not be obtained 
Will subjects be 
provided with info 
about the research 
after they finish? 
(Check Yes or No) 
 
 
 
YES 
NO 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
Click or tap here to 
enter text. 
☐ 
☐ 
Table footnotes 
1. If the answer is the same for all groups, collapse your answer across the groups and/or procedures. 
8.2.b. Describe the consent process, if consent will be obtained for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names) 
• 
How subjects will be provided sufficient opportunity to discuss the study with the research team and consider 
participation. 
Similar to the assent process, informed consent will be obtained by either the PI or RA (referred to as the 
interviewer) via a HIPAA compliant video conference platform (e.g., Zoom). Once the participant and their 
parent/guardian have entered the video conference consent will be reviewed and signed via REDCap by 
sending the family the REDCap link and screen sharing while we review consent. The consent is written in 
age-appropriate language (see attached forms). The interviewer will then go through each point of the 
informed consent allowing the participant and their parent/guardian to ask any questions they have before 
the interviewer goes on to the next section. Once the interviewer has thoroughly gone over the consent form 
with the subject and their guardian, the interviewer will then follow up by asking “Do you have any 
questions about the study or is anything unclear to you?” The interviewer will ensure that the participant is 
given sufficient time to review the consent forms. Only after the participant and their parent/guardian have 
thoroughly read the forms and the interviewer has answered all questions will the interviewer offer to let the 
participant and their parent to electronically sign the forms on REDCap. The interviewer will then provide 
an electronic signature on the form as the “witness.”   
 
At all stages of the study, participants and parents will be informed that refusal to participate will not affect 
their ability to receive care at the University of Washington or Seattle Children’s Hospital clinics and that 
they are free to withdraw at any time. Parents will also be informed about federal and state laws for 
mandated reporting , verbally and in writing. In cases where a report of child abuse is indicated, the family 
will be told prior to our contacting any state agency (see 10.1 Anticipation of Risks). 

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Clinician Participants 
After filling out a brief survey to confirm eligibility, clinician participants will be sent the link to the 
electronic consent. The research coordinator will reach out and ask to schedule a brief call to discuss the 
consent form and study procedures, and to answer any questions. During the call the clinician will complete 
the electronic consent.  
 
8.2.c. Comprehension. Describe the methods that will be used to ensure or test the subjects’ understanding of the 
information during the consent process. 
Parents and youth will be given an opportunity to ask questions and will be prompted with questions 
throughout the reading of the consent/assent process.   
8.2.d. Influence. Does the research involve any subject groups that might find it difficult to say “no” to participation 
because of the setting or their relationship with someone on the study team, even if they aren’t pressured to 
participate? 
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research; study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
☐ No 
☒ Yes → Describe what will be done to reduce any effect of the setting or relationship on the participation 
decision. 
Examples: a study coordinator will obtain consent instead of the subject’s physician; the researcher will not 
know which subjects agreed to participate; subjects will have two days to decide after hearing about the study. 
Patient participants and parents may be concerned that not participating in the study will affect 
their treatment, especially if the clinician providing treatment is already in the study. They will be 
assured that they are free to choose not to participate. Research staff not involved in the care of 
the patient will conduct consent procedures and study visits. 
 
Clinician participants may feel pressure to participate if they are a colleague of Drs. Jenness or 
McCauley and/or if they are professionally supervised by them. Potential clinician participants will 
be assured that their participation will have no bearing on their professional relationship with Drs. 
Jenness or McCauley.   
8.2.e. Information provided is tailored to the needs of the subject population. Describe the basis for concluding that 
the information that will be provided to subjects (via written or oral methods) is what a reasonable member of 
the subject population(s) would want to know. If the research consent materials contain a key information 
section, also describe the basis for concluding that the information present in that section is that which is most 
likely to assist the selected subject population with making a decision. Review the guidance on Key 
Information and examples of Key Information. 
For example: Consultation with publications about research subjects’ preferences, disease-focused nonprofit groups, 
patient interest groups, or other researchers/study staff with experience with the specific population. It may also involve 
directly consulting selected members of the study population. 

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We have developed the consent forms based on the prior experience of our researchers in working with 
populations of parents and their children as well as mental health clinicians.  Dr. Jenness has experiences 
with clinical trials, parents, clinicians and youth.  
8.2.f. Ongoing process, new information, and reconsent.  
For research that involves multiple or continued interaction with subjects over time, describe the 
opportunities (if any) that will be given to subjects to ask questions or to change their minds about 
participating.  
Throughout the course of the study, subjects may need to be notified about new information. This might take 
the form of a verbal or written communication or may require subjects to provide reconsent. When a 
modification is submitted in which subjects need to be informed about new information, describe the method 
and process the research team will use to provide this information. 
Review the tipsheet on Reconsent and Ongoing Subject Communication and guidance on Reconsent and Ongoing Subject 
Communication  for details. 
When scheduling follow-up visits and phone calls we will instruct research assistants to phrase scheduling 
requests in a way that indicates the participant has a chance to change their mind about participation (i.e., 
“Are you still interested in scheduling this follow-up visit/phone call?” 
8.3. Electronic presentation of consent information. Will any part of the consent-related information be provided 
electronically for some, or all of the subjects? 
This refers to the use of electronic systems and processes instead of (or in addition to) a paper consent form. For example, an 
emailed consent form, a passive or an interactive website, graphics, audio, video podcasts. Review the guidance on Electronic 
Consent and Documentation of Consent for information about electronic consent requirements at UW. 
☐ No → Skip to question 8.4. 
☒ Yes → Answer questions 8.3.a. through 8.3.e. 
8.3.a. Describe the electronic consent methodology and the information that will be provided. 
All information materials must be made available to the IRB. Website content should be provided as a Word 
document. It is considered best practice to give subjects information about multi-page/multi-screen information 
that will help them assess how long it will take them to complete the process. For example, telling them that it 
will take about 15 minutes, or that it involves reading six screens or pages. 
Once the participant and their parent/guardian have joined the HIPAA compliant video 
conference platform (e.g., Zoom) they will be presented with a copy of the informed 
consent (parent/guardian) signed via REDCap. If the consent process is conducted over 
Zoom, the family will be sent the REDCap link and the consent will be reviewed with the 
parent/guardian through screen sharing. The consent is written in age-appropriate 
language (see attached forms). The interviewer will then go through each point of the 
informed consent allowing the participant and their parent/guardian to ask any questions 
they have before the interviewer goes on to the next section. Once the interviewer has 
thoroughly gone over the consent/assent/authorization form with the subject and their 
guardian, the interviewer will then follow up by asking “Do you have any questions about 
the study or is anything unclear to you?” The interviewer will ensure that the participant’s 
parent/guardian is given sufficient time to review the consent forms. Only after the 
participant and their parent/guardian have thoroughly read the forms and the interviewer 

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has answered all questions will the interviewer offer to let the participant and their parent 
to electronically sign the forms on REDCap. The interviewer will then provide an electronic 
signature on the form as the “witness.”   
8.3.b. Describe how the information can be navigated (if relevant).  
For example, will the subject be able to proceed forward or backward within the system, or to stop and continue 
at a later time? 
On the RedCap online consent form, participants will be able to navigate forwards and backwards 
during their review. 
8.3.c. In a standard paper-based consent process, the subjects generally have the opportunity to go 
through the consent form with study staff and/or to ask study staff about any question they may 
have after reading the consent form. Describe what will be done, if anything, to facilitate the 
subject’s comprehension and opportunity to ask questions when consent information is presented 
electronically. Include a description of any provisions to help ensure privacy and confidentiality 
during this process. 
Examples: hyperlinks, help text, telephone calls, text messages or other type of electronic messaging, video 
conference, live chat with remotely located study team members. 
Once the interviewer has thoroughly gone over the consent/assent/authorization form with 
the subject and their guardian, the interviewer will then follow up by asking “Do you have 
any questions about the study or is anything unclear to you?” The interviewer will ensure 
that the participant is given sufficient time to review the consent and assent forms. 
Participants and their parent(s)/guardian(s) will be able to ask questions as needed on the 
Zoom conference if meeting virtually. Questions can be asked/answered verbally or 
through the chat feature on Zoom. 
8.3.d. What will happen if there are individuals who wish to participate but who do not have access to the 
consent methodology being used, or who do not wish to use it? Are there alternative ways in which 
they can obtain the information, or will there be some assistance available? If this is a clinical trial, 
these individuals cannot be excluded from the research unless there is a compelling rationale. 
For example, consider individuals who lack familiarity with electronic systems, have poor eyesight or impaired 
motor skills, or who do not have easy email or internet access. 
Paper/PDF consent forms will be available for participant/parent/guardian review if requested. Text 
size of documents can be adjusted via print or electronically.  
8.3.e. How will the research team ensure continued accessibility of consent materials and information 
during the study? 
Participants and parents will be given a copy of the consent form to retain for their review as 
needed. They will be advised they can ask the research staff questions about their consent at any 
time.  
 
During research meetings, we will review the consent process and any questions or concerns that 
are coming up regarding understanding of the materials. We will update and consult with the IRB 
if needed.  

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8.3.f. How will additional information be provided to subjects during the research, including any significant 
new findings (such as new risk information). If this is not an issue, explain why. 
Adult participants or a parent of each child participant will be informed promptly about any 
unanticipated serious adverse event that the independent study monitor determines is definitely 
related to the study intervention.   
 
Otherwise, since this is a user centered design study seeking feedback regarding a digital support 
tool added onto a standard of care treatment, we do not anticipate new findings or new risk 
information from this work. In addition, as a pilot study, we would not be able to determine if any 
findings would be significant enough to share with participants. 
8.4. Written documentation of consent. Which of the statements below describe whether documentation of consent 
will be obtained? NOTE: This question does not apply to screening and recruiting procedures which have already 
been addressed in question 4.7. 
Documentation of consent that is obtained electronically is not considered written consent unless it is obtained by a method 
that allows verification of the individual’s signature. In other words, saying “yes” by email is rarely considered to be written 
documentation of consent. 
8.4.a. Is written documentation being obtained for: 
☐ None of the research procedures  
→ Use the following table to provide justification then go to 
question 8.5. 
☐ All of the research procedures 
→ Do not complete the following table, go to question 8.4.b. 
☒ Some of the research procedures  
→ Use the following table to identify the procedures for which 
written documentation of consent will not be obtained from 
adult subjects. 
Adult subject 
group1 
Describe the procedures or data/specimen collection (if 
any) for which there will be NO documentation of 
consent 
Will they be 
provided with a 
written statement 
describing the 
research (optional)?  
(Check Yes or No) 
 
 
YES 
NO 
Youth who turn 18 
during study 
As noted previously, if a youth turns 18 during the study, 
we will obtain consent as an adult from the youth at that 
time.  In order to continue to send mood-activity report 
promts to their smartphone, we will obtain verbal 
consent over the phone for monitoring their 
smartphones as soon as possible once they turn 18. We 
will then obtain written consent for all study procedures 
when the youth comes in for the next face to face 
session, so will eventually be provided with a written 
statement of the research.  See “Consent Forms and 
Recruitment Materials” for the Youth Consent Form.  
 
☒ 
☐ 

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Adult subject 
group1 
Describe the procedures or data/specimen collection (if 
any) for which there will be NO documentation of 
consent 
Will they be 
provided with a 
written statement 
describing the 
research (optional)?  
(Check Yes or No) 
 
 
YES 
NO 
Click or tap here 
to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here 
to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here 
to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Click or tap here 
to enter text. 
Click or tap here to enter text. 
☐ 
☐ 
Table footnotes 
1. If the answer is the same for all adult groups or all procedures, collapse the answer across the groups and/or 
procedures. 
8.4.b. Electronic consent signature. For studies in which documentation of consent will be obtained, will subjects 
use an electronic method to provide their consent signature? 
• 
Review the guidance on Documentation of Consent and UW E-Signature Tools for information about options 
(including REDCap e-signature and the DocuSign system) and any associated requirements. 
• 
FDA-regulated studies must use a system that complies with the FDA’s “Part 11” requirements about electronic 
systems and records. Note that the UW-IT supported DocuSign e-signature system does not meet this 
requirement. 
• 
Having subjects check a box at the beginning of an emailed or web-based questionnaire is not considered legally 
effective documentation of consent. 
☐ No 
☒ Yes → Indicate which methodology will be used 
☒ UW ITHS REDCap (excludes REDCap Mobile application, which is a separate software application for 
use with a mobile device for consent when internet service is absent or unreliable) 
☐ Other REDCap installation → Please name the institutional version you will be using (e.g., 
Vanderbilt, Univ. of Cincinnati) in the following field and provide a 
completed supplement Other REDCap Installation with your 
submission. 
Click or tap here to enter text. 
☐ UW DocuSign 
☐ Other  
→ Please describe in the following field and provide a signed Other E-
signature Attestation Letter with your submission. 

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Click or tap here to enter text. 
8.4.b.1. Is this method legally valid in the jurisdiction where the 
research will occur? 
NOTE: UW ITHS REDCap (excludes REDCap Mobile application) and 
UW DocuSign have been vetted for compliance with Washington 
State and federal laws regarding electronic signatures. 
☐ No 
☐ Yes → What is the source of information about legal 
validity? 
Click or tap here to enter text. 
8.4.b.2. Will verification of the subject’s identity be obtained if the 
signature is not personally witnessed by a member of the 
study team? Note that this is required for FDA-regulated 
studies. 
Review the guidance Documentation of Consent for information and 
examples 
☐ No → Provide the rationale for why this is not required or 
necessary to protect subjects or the integrity of the 
research. Also, what would be the risks to the actual 
subject if somebody other than the intended 
signatory provides the consent signature? 
Click or tap here to enter text. 
☐ Yes → Describe how subject identity will be verified, 
providing a non-technical description that the 
reviewer will understand. 
Click or tap here to enter text. 
8.4.b.3. How will the requirement be met to provide a copy of the 
consent information (consent form) to individuals who provide 
an e-signature? 
The copy can be paper or electronic and may be provided on an 
electronic storage device or via email. If the electronic consent 
information uses hyperlinks or other websites or podcasts to convey 
information specifically related to the research, the information in 
these hyperlinks should be included in the copy provided to the 
subjects and the website must be maintained for the duration of the 
entire study. 

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Click or tap here to enter text. 
8.4.c. Barriers to written documentation of consent. There are many possible barriers to obtaining written 
documentation of consent. Consider, for example, individuals who are functionally illiterate; do not read 
English well; or have sensory or motor impairments that may impede the ability to read and sign a consent 
form. 
8.4.c.1. Describe the plans (if any) for obtaining written documentation of consent from potential subjects 
who may have difficulty with the standard documentation process (that is, reading and signing a 
consent form). 
Examples of solutions: Translated consent forms; use of the Short Form consent process; reading the form to 
the person before they sign it; excluding individuals who cannot read and understand the consent form. 
Our inclusion criteria include English-speaking youth and parents and exclusions criteria include 
IQ<80 and or the presence of a developmental disability that would preclude understanding of our 
protocol and treatment, as it would not be clinically appropriate to enroll a youth in an 
intervention that they are unable to understand. Therefore, we do not anticipate difficulty with the 
standard documentation process. 
8.5. Non-English-speaking or-reading adult subjects. Will the research enroll adult subjects who do not speak English or 
who lack fluency or literacy in English? 
☒ No 
☐ Yes → Describe the process that will be used to ensure that the oral and written information provided to them 
during the consent process and throughout the study will be in a language readily understandable to them 
and (for written materials such as consent forms or questionnaires) at an appropriate 
reading/comprehension level. 
Click or tap here to enter text. 
8.5.a. Interpretation. Describe how interpretation will be provided, and when. Also, describe the 
qualifications of the interpreter(s) - for example, background, experience, language proficiency in 
English and in the other language, certification, other credentials, familiarity with the research 
related vocabulary in English and the target language. 
Click or tap here to enter text. 
8.5.b. Translations. Describe how translations will be obtained for all study materials (not just consent 
forms). Also, describe the method for ensuring that the translations meet the UW IRB’s requirement 
that translated documents will be linguistically accurate, at an appropriate reading level for the 
participant population, and culturally sensitive for the local in which they will be used. 
☐  Check this box to confirm that before using them with subjects, you will upload in Zipline all 
translated consent materials that will be provided to subjects in written or electronic form (per 
HSD policy). 

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If the IRB determines that your study is greater than minimal risk, or otherwise determines it is 
required, you will need to work with your translator to provide a Translation Attestation. If the 
attestation is required, you will be informed by the IRB during the course of the review. 
Click or tap here to enter text. 
8.6. [DETERMINATION]  Deception. Will information be deliberately withheld, or will false information be provided, to 
any of the subjects? 
NOTE: “Blinding” subjects to their study group/condition/arm is not considered to be deception, but not telling them ahead of 
time that they will be subjects to an intervention or about the purpose of the procedure(s) is deception. 
☒ No 
☐ Yes → Describe what information and why. 
Example: it may be necessary to deceive subjects about the purpose of the study (describe why). 
Click or tap here to enter text. 
8.6.a. Will subjects be informed beforehand that they will be unaware of or misled regarding the nature or 
purposes of the research? (Note: this is not necessarily required.) 
☐ No 
☐ Yes 
8.6.b. Will subjects be debriefed later? (Note: this is not necessarily required.)  
☐ No → Provide your reasoning for not debriefing subjects. 
Click or tap here to enter text. 
☐ Yes → Describe how and when this will occur. Upload any debriefing materials, including talking 
points or a script, to Zipline. 
Click or tap here to enter text. 
8.7. [DETERMINATION] Cognitively impaired adults, and other adults unable to consent. Will such individuals be 
included in the research? 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, or who are significantly 
intoxicated. 
☒ No → Go to question 8.8. 
☐ Yes → Answer the following question. 
8.7.a. Rationale. Provide the rationale for including this population. 
Click or tap here to enter text. 

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8.7.b. Capacity for consent/decision making capacity. Describe the process that will be used to determine 
whether a cognitively impaired individual is capable of consent decision making with respect to the 
research protocol and setting. 
Click or tap here to enter text. 
8.7.b.1. If there will be repeated interactions with the impaired subjects over a time period when 
cognitive capacity could increase of diminish, also describe how (if at all) decision-making 
capacity will be re-assessed and (if appropriate) consent obtained during that time. 
Click or tap here to enter text. 
8.7.c. Permission (surrogate consent). If the research will include adults who cannot consent for 
themselves, describe the process for obtaining permission (“surrogate-consent”) from a legally 
authorized representative (LAR). 
For research conducted in Washington State, review the guidance on Diminished and Fluctuating Consent 
Capacity and Use of a Legally Authorized Representative (LAR) to learn which individuals meet the state 
definition of “legally authorized representative”. 
Click or tap here to enter text. 
8.7.d. Assent. Describe whether assent will be required of all, some, or none of the subjects. If some, 
indicate which subjects will be required to assent and which will not (and why not). Describe any 
process that will be used to obtain and document assent from the subjects. 
Click or tap here to enter text. 
8.7.e. Dissent or resistance. Describe how a subject’s objection or resistance to participation (including 
non-verbal) during the research will be identified, and what will occur in response. 
Click or tap here to enter text. 
8.8. Research use of human fetal tissue obtained from elective abortion. Federal and UW Policy specify some 
requirements for the consent process. If you are conducting this type of research, check the boxes to confirm these 
requirements will be followed. 
☐ Informed consent for the donation of fetal tissue for research use will be obtained by someone other than the 
person who obtained the informed consent for abortion. 
☐ Informed consent for the donation of fetal tissue for research use will be obtained after the informed consent for 
abortion. 
☐ Participation in the research will not affect the method of abortion. 
☐ No enticements, benefits or financial incentives will be used at any level of the process to incentivize abortion or 
the donation of human fetal tissue. 
☐ The informed consent form for the donation of fetal tissue for use in research will be signed by both the woman 
and the person who obtains the informed consent. 

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8.9. Consent-related materials. Upload to Zipline all consent scripts/talking points, consent forms, debriefing 
statements, Information Statements, Short Form consent forms, parental permission forms, and any other 
consent related materials that will be used. Materials that will be used by a specific site should be uploaded to 
that site’s Local Site Documents page. 
• 
Translations must be submitted and approved before they can be used. However, we strongly encourage you to wait to 
provide them until the IRB has approved the English versions. 
• 
Combination forms: it may be appropriate to combine parental permission with consent if parents are subjects as well as 
providing permission for the participation of their children. Similarly, a consent form may be appropriately considered an 
assent form for older children. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participants. URLs (website 
addresses) may also be provided, or written descriptions of websites. Examples of materials that usually cannot be 
uploaded: mobile apps; computer-administered text; licensed and restricted standardized tests. 
9. PRIVACY AND CONFIDENTIALITY 
9.1. [DETERMINATION]  Privacy protections. Describe the steps that will be taken, if any, to address possible privacy 
concerns of subjects and potential subjects. 
Privacy refers to the sense of being in control of access that others have to ourselves. This can be an issue with respect to 
recruiting, consenting, sensitivity of the data being collected, and the method of data collection. 
Examples:  
• 
Many subjects will feel a violation of privacy if they receive a letter asking them to participate in a study because they 
have ____ medical condition, when their name, contact information, and medical condition were drawn from medical 
records without their consent. Example: the IRB expects that “cold contact” recruitment letters will inform the subject 
about how their information was obtained. 
• 
Recruiting subjects immediately prior to a sensitive or invasive procedure (e.g., in an outpatient surgery waiting room) 
will feel like an invasion of privacy to some individuals. 
• 
Asking subjects about sensitive topics (e.g., details about sexual behavior) may feel like an invasion of privacy to some 
individuals. 
All online telecommunication platforms will be HIPAA compliant and administered through UW/Seattle 
Children’s Hospital supported accounts. To ensure privacy and confidentiality, we will do and inform 
subjects of the following: 
 
• 
All consent/assent forms will be signed electronically via REDCap. If the parent/child requests a 
paper copy to sign, they will be placed into a manila envelope and kept with the interviewer. The 
forms will be placed in a locked file cabinet, in a locked room at Dr. Jenness’ Lab after the 
session is complete.   
 
• 
All data will be identified only with a subject number, including interviews and questionnaires .  
 
• 
Any data linking identifiers with a subject number will be kept in REDCap in a separate project 
from study data. 
 
• 
We will ask youth and parents for their permission to record treatment sessions to ensure 
therapist fidelity to the treatment protocol. To ensure privacy, we will utilize digital recording 
devices that will allow us to immediately upload digital recordings to our secure, password 
protected server. All recordings will be labeled by subject ID and recordings will be erased from 

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the recorder immediately after uploading to the server. Recordings will be kept on the server for 
at least 3 years after study end.  
 
• 
Because all patient participants will receive treatment from SCH, we will need to open a medical 
record at SCH where we will keep very general notes regarding the youth’s participation in 
treatment (i.e., we would include the teaching content of the session, but not specific quotes from 
the patient). These notes will be in line with standard clinical notes recorded during BA sessions.   
 
• 
All teens in the study will use the ActivaTeen app. The control group will log their mood, while the 
treatment group will have full access. Teens will be informed that the data shared through the 
platform may be vulnerable to being hacked or leaked. ActivaTeen is hosted on an instance of 
Microsoft Teams operated by Seattle Children's Hospital. It has been developed to be secure and 
HIPAA compliant.   
9.2. [DETERMINATION]  Identification of individuals in publications and presentations. Will potentially identifiable 
information about subjects be used in publications and presentations, or is it possible that individual identities could 
be inferred from what is planned to be published or presented? 
☒ No 
☐ Yes → Will subject consent be obtained for this use? 
☐ Yes 
☐ No → Describe the steps that will be taken to protect subjects (or small groups of subjects) from being 
identifiable. 
Click or tap here to enter text. 
9.3. [DETERMINATION]  State mandatory reporting. Each state has reporting laws that require some types of individuals 
to report some kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
Are you or a member of the research team likely to learn of any of the above events or circumstances while 
conducting the research AND feel obligated to report it to state authorities? 
☐ No 
☒ Yes → The UW IRB expects subjects to be informed of this possibility in the consent form or during the consent 
process, unless you provide a rationale for not doing so: 
Click or tap here to enter text. 
9.4. [DETERMINATION]  Records retention requirements. Check the box below to indicate assurance that any identifiers 
(or links between identifiers and data/specimens) and data that are part of the research records will not be 
destroyed until after the end of the applicable records retention requirements (e.g., Washington State; funding 
agency or sponsor; Food and Drug Administration). If it is important to say something about destruction of 

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identifiers (or links to identifiers) in the consent form, state that identifying information will be destroyed at the end 
of the study or after the records retention period required by state and/or federal law. 
Review the “Research Data” and “Personal Identifiers” sections of the following website for UW Records management for the 
Washington State research records retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/gs/research?title=R; https://finance.uw.edu/recmgt/gs/research?title=P. 
 
Review the “Research Records and Data” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: https://www.uwmedicine.org/recordsmanagementuwm-records-retention-schedule.pdf 
☒ Confirm 
9.5. [DETERMINATION]  Certificates of Confidentiality. Will a federal Certificate of Confidentiality be obtained for the 
research data? NOTE: Answer “No” if the study is funded by NIH or the CDC, because most NIH-funded and CDC-
funded studies automatically have a Certificate. 
☒ No 
☐ Yes 
9.6. [DETERMINATION]  Data and specimen security protections. Identify the data classifications and the security 
protections that will be provided for all sites where data will be collected, transmitted, or stored, referring to the 
guidance on Data and Security Protections for the minimum requirements for each data classification level. It is not 
possible to answer this question without reading this document. Data security protections should not conflict with 
records retention requirements. 
9.6.a. Choose the level(s) of protections that will be applied to the data and specimens. If more than one level will 
be used, use the text box to describe which level will apply to which data and which specimens and at which 
sites. 
☐ Level 1: Very low risk of harm if disclosed 
☐ Level 2: Some risk of minor harm if disclosed 
☒ Level 3: Could cause risk of material harm if disclosed 
☐ Level 4: Would likely cause serious harm to individuals if disclosed 
☐ Level 5: Extremely sensitive; could cause severe harm to individuals if disclosed 
 
Click or tap here to enter text. 
9.6.b. Use this space to provide additional information, details, or to describe protections that do not fit into one of 
the levels. HSD allows researchers to request exceptions to data security requirements, if the exception is 
necessary and does not significantly increase risk to participants. If there are any protections within the level 
listed in 9.6.a which will not be followed, list those here, including identifying the sites where this exception 
will apply. For example, if you intend to store subject identifiers with study data (not permitted under 
requirement U9 for Risk Levels 3-5), then indicate this in the box below (e.g., “We will not adhere to 
requirement U9 for screening data”). 
Click or tap here to enter text. 

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10. RISK / BENEFIT ASSESSMENT 
10.1. [DETERMINATION]  Anticipated risks. Describe the anticipated risks of harm, discomforts, and hazards to the 
subjects and others of the research procedures.  
For each harm, discomfort, or hazard: 
• 
Describe the magnitude, probability, duration, and/or reversibility of the harm, discomfort, or hazard, AND 
• 
Describe how the risks will be reduced or managed. Do not describe data security protections here, these 
are already described in question 9.6. 
• 
Consider possible physical, psychological, social, legal, and economic harms, including possible negative effects on 
financial standing, employability, insurability, educational advancement, or reputation. For example, a breach of 
confidentiality might have these effects. 
• 
Examples of “others”: embryo, fetus, or nursing child; family members; a specific group.  
• 
Ensure applicable risk information from any Investigator Brochures, Drug Package Inserts, and/or Device Manuals is 
included in your description. 
• 
Do not include the risks of non-research procedures that are already being performed.  
• 
If the study design specifies that subjects will be assigned to a specific condition or intervention, then the condition or 
intervention is a research procedure - even if it is a standard of care.  
• 
Examples of mitigation strategies: inclusion/exclusion criteria; taking blood samples to monitor something that 
indicates drug toxicity. 
• 
Review the guidance on Identifying and Describing Reasonably Foreseeable Risks in Research for information about 
which risks should be described in the consent process/form. 
• 
As with all questions on this application, you may refer to uploaded documents. 
Risks to Patient Participants  
Interviews and Questionnaires. There is a moderate likelihood that patient participants will experience 
psychological distress, fatigue, or a time burden during completion of the study interviews. Patient participants 
will be asked about psychiatric symptoms that may be distressing. Participant psychological distress during 
completion of the study interview is likely to be mild to moderate in severity. All questions included in study 
interviews have been used extensively in prior intervention and depression research, and alternative 
procedures for obtaining information on these constructs, which are of central importance to study 
hypotheses, are unavailable. Participants will be reminded that all information they provide is voluntary and 
they are able to skip questions they may feel uncomfortable answering. 
 
Psychological distress will be addressed during the interview using standard interviewing and debriefing 
strategies. Interviewers will be trained to take a nonjudgmental matter-of-fact stance in their interactions with 
participants designed to reduce any embarrassment associated with questions or answers. Normalization 
phrases will be used throughout the interview to reduce discomfort or embarrassment (e.g., “Lots of people 
feel…How about you? Have you ever felt this way?).  Positive filler questions will be interspersed throughout 
the interview to give participants an opportunity to discuss pleasant topics. Research staff will be trained to 
identify participant distress through behavioral observation (i.e., tearful, sudden lack of responding to 
questions) and monitoring answers to specific questions (i.e., reporting suicidal ideation) and will inform Dr. 
Jenness immediately if this occurs during the in-person visits or follow-up calls. Dr. Jenness will conduct an 
additional assessment prior to the end of the assessment for all participants reported to have displayed 
significant distress in response. Dr. Jenness will ask explicit questions about distress caused by the interview 
and evaluate the extent to which participants continue to experience distress. Any participant continuing to 
display distress by the assessment’s end will be contacted again by a research staff member within 48 hours of 
the visit to re-assess psychological distress and discuss whether study participation is appropriate and/or a 
mental health referral is needed at this time. 

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Patient Clinical Deterioration. Even with evidence-based treatment, continued depression or worsening of 
depressive symptoms is always a possibility, even for those treated with medication and/or psychotherapy. 
Patient participants will receive access to BA intervention within 3 weeks of the Baseline visit, and their 
psychiatric symptoms will be monitored on a weekly basis while enrolled in treatment to monitor for latent 
(e.g., bipolar disorder) or worsening (e.g., increase in depression symptoms) psychiatric conditions. By study 
completion, all participants deemed appropriate for inclusion will have received treatment with high-quality BA, 
one of the evidence-based treatments for adolescent depression. Patient participants will, at a minimum, 
receive weekly monitoring of psychiatric symptoms and suicidality that are reviewed by their clinician who will 
meet weekly with MPI Dr. Jenness for supervision, and the study will follow standard safety procedures to 
ensure that all adolescents are receiving optimal care throughout the study. 
 
The risk of worsening of psychiatric illness will be addressed by 1) by providing psychoeducation about 
depression and developing a safety and crisis prevention/distress management plan with all study participants 
who endorse current suicidal ideation/plan throughout the study and 2) monitoring symptoms of depression 
closely during weekly assessments that occur as part of BA treatment. 
 
If a participant deteriorates clinically defined as an increase in PHQ-9 >4 above their baseline PHQ-9 score (i.e., 
~1 standard deviation increase), and/or becomes suicidal, we will review the case in the research team’s weekly 
clinical supervision meetings to outline strategies needed to address participant treatment issues and conduct 
an additional session that week if indicated. Additionally, if the increase in PHQ-9 persists over three weeks of 
treatment, the research team will consult with the Independent Study Monitor, Cari McCarty, PhD, (approved 
by NIMH) in order to determine whether the participant can still be safely managed in the study and what 
course of action is recommended, which could include continuing in treatment with increased frequency of 
sessions, change in treatment intensity (e.g., inpatient hospitalization), or referral for a different treatment 
modality (e.g., family therapy, antidepressant medication). Dr. McCarty is not affiliated with the study and has 
no conflict of interest with the project or its principal investigators. If Dr. McCarty recommends either increased 
intensity or a different treatment modality and the family and participant agree, we will provide close case 
management to find an appropriate provider (i.e., location that is convenient for the family, appropriate 
specialization, accepts the family’s insurance plan, and who does not have an extensive waiting list) across UW, 
SCH, and other community clinics or private practice practitioners. If feasible, even if treatment is modified, 
participants will be asked to complete remaining research assessments, which are voluntary and can be 
declined. 
 
Some youth will encounter crises. Most crisis management involves a combination of case management and 
creative problem solving, which can be accomplished within the framework of the existing treatment with the 
youth’s treating clinician. If participants miss appointments or self-report by mobile phone, the PI or study staff 
will contact the participant and family, and if that is unsuccessful, we will have obtained parent and participant 
permission to activate the emergency contacts obtained at the initial assessment in order to re-engage with the 
family. 
 
Safety and Reporting.  
Suicidality. Patients with current suicidal ideation or past suicide attempts are eligible for the study (unless 
required level of care is more intense than outpatient treatment), as ongoing suicidal ideation and behaviors 
are frequently seen in depressed youth. Therefore, ongoing suicidal ideation or worsening of suicidal ideation 
and behavior may occur. Dr. Jenness and research therapists are clinically experienced in working with suicidal 
individuals and minimizing the risk of suicidality.  
 

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Adolescent patient participants and families will be educated about suicidal thinking and behaviors prior to 
initiating treatment as well as undergo safety and crisis prevention/distress management planning if suicidality 
is indicated which will be updated throughout treatment as well as throughout study visits. All participants will 
be given county and teen specific 24-hour crisis line information if they experience any worsening or 
emergence of suicidal ideation. Information on local and national crisis resources is also included as part of the 
ActivaTeen dashboard (accessible to ActivaTeen enrolled participants) and embedded within the mood-activity 
EMA logs (accessible to all participants). As part of the safety and crisis prevention plans, families will be 
coached to take their teen to their local emergency room if they are concerned for their child’s safety or can 
contact their treating BA clinician for non-emergent concerns.  
 
Adolescents will complete weekly self-report measures of depression as part of their clinical care that includes a 
question about suicidal ideation. If this question is endorsed by a participant, the therapist will conduct a 
suicide risk assessment as part of their clinical session with the adolescent. Adolescents who are at risk of 
suicide attempts may need to be psychiatrically hospitalized. We follow the procedures of the AACAP Practice 
Parameters on Suicidal Behavior. These parameters indicate that subjects should be referred for hospitalization 
if their condition is unstable—as manifested by, suicidal ideation with inability to contract for safety, psychosis, 
current intoxication, mania, rapid cycling, or mixed state. Social factors that may cause the clinician to consider 
hospitalization include lack of sufficient environmental support and structure to guarantee the child’s safety.  
 
Mandated Reporting. There is the possibility that adolescents will disclose information that we may be required 
to report to the appropriate state or local government agency, such as homicidal intent or current or past 
maltreatment of youth or elders. In the case of maltreatment, this has potential legal risks to the abuse 
perpetrator, which could be the parent or legal guardian. If a participant discloses that they are being abused or 
neglected, we will be legally obligated to report that information to the Department of Children, Youth, & 
Families (DCYF) in the state of Washington. The provision of such a report may result in DCYF initiating an 
investigation into potential maltreatment of the patient participant or other abused individual. Legal charges 
and change of custody may occur in serious instances of abuse or neglect. In such a case, reporting this 
information to DCYF is most likely in the best interest of the child. We will refrain from informing the parent or 
guardian that we have made a report when we believe the child's safety may be jeopardized by sharing that 
information or when we believe the child is in imminent danger. The exact scenarios that may arise are difficult 
to predict. Oftentimes, informing the parent or guardian is an effective step to protecting the child, as the 
parent can limit contact with the suspected party. Generally, we will refrain from informing the parent or 
guardian if any of the following are true: 
- 
We have reasonable suspicion the parent or guardian is directly causing the abuse or neglect or is 
aware of it and is not acting to stop it 
- 
We have reasonable suspicion the parent or guardian may retaliate against the child if they know we 
have made a report or will allow someone else to retaliate against the child  
 
Reasonable suspicion will rely on the report of the teen (for example, if the teen reports abuse and states they 
believe their parent will retaliate if their parent knows abuse has been reported to authorities), and if that is 
absent, the judgment of the PIs based on qualitative interactions (or reports of interactions from staff) with the 
teen and parent/guardian.  
 
While there is some degree of risk in the potential reporting of abuse or neglect to DCYF, if an adolescent 
participant is being maltreated, disclosure to DCYF is required by law, and it is in the best interest of the 
participant that the legal authorities are made aware of the situation. Drs. Jenness and McCauley are both 
licensed clinical psychologists and have extensive experience working with children and adolescents who have 
been maltreated, in research and clinical contexts. Dr. Jenness has previously had to file numerous reports 

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about potential child abuse or neglect to child protection agencies and is familiar with the procedures involved 
in doing so. Drs. Jenness and McCauley will ensure that the state of Washington guidelines regarding the 
reporting of abuse or neglect of a minor are upheld. Any referral to DCYF will be made by a licensed clinical 
psychologist and supervised by Dr. Jenness who has extensive experience assessing and treating children who 
have been maltreated in both research and clinical contexts. 
 
Digital Support Tool. The ActivaTeen platform has undergone user testing to identify software bugs and 
technical challenges experienced by teen patients, and this study will represent the first full evaluation of the 
platform. As such, the risk profile of the ActivaTeen platform is not fully known. Based on both user testing 
results and the design and clinical experience of the investigative team we expect the following risks could be 
possible:  
 
- 
EMA bothersome/burdensome (moderate probability, low severity, short duration, high reversibility)  
o Note: this also applies to the control group who will do EMA but not the other components of 
ActivaTeen 
- 
Peer-to-peer bullying, harassment, unwanted contact via the platform (low probability, moderate 
severity, short duration, moderate reversibility) – similar to in group therapy, moderator role will 
mitigate this concern 
- 
Emotional distress such as frustration or sadness (moderate probability, low severity, short duration, 
high reversibility)  
o Associated with completing homework tasks within app  
o If encountering software bugs/glitches that affect usability of the platform 
o A breach in confidentiality of ActivaTeen platform data is unlikely. Data security is described in 
9.1. 
 
Risks to Clinician Participants 
Interviews and Questionnaires. Clinician participants may experience fatigue or time burden associated with 
completing study assessments. We expect this to be moderate probability with mild severity, short duration, 
and high reversibility. Participants will be reminded they can skip questions if needed. Drs. Jenness and 
McCauley will utilize intervention supervision sessions with clinician participants who are fatigued or time 
burdened from study assessments to problem-solve.  
 
Using ActivaTeen. As stated above, the risk profile of ActivaTeen platform has not been fully established, but 
user testing and previous work by the investigative team suggest minimal and mild risks associated with 
administering the study intervention for clinicians.  
 
- 
Time burden 
- 
Psychological distress  
o Responding to patient messages and concerns 
o Distress related to encountering bugs or glitches 
o Breach in confidentiality   
10.2. [DETERMINATION]  Reproductive risks. Are there any risks of the study procedures to subjects or partner of 
subjects related to pregnancy, fertility, lactation or effects on a fetus or neonate? 
Examples: direct teratogenic effects; possible germline effects; effects on fertility; effects on a woman’s ability to continue a 
pregnancy; effects on future pregnancies. 
☒ No → Go to question 10.3. 

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☐ Yes → Answer the following questions: 
10.2.a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
Click or tap here to enter text. 
10.2.b. Steps to minimize risk. Describe the specific steps that will be taken to minimize the magnitude, 
probability or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before and 
during the study; require subjects to use contraception; advise subjects about banking of sperm and ova. 
 
If the use of contraception will be required, describe the allowable methods and the time period when 
contraception must be used. 
Click or tap here to enter text. 
10.2.c. Pregnancy. Describe what will be done if a subject (or a subject’s partner) becomes pregnant. 
For example; will subjects be required to immediately notify study staff, so that the study procedures can be 
discontinued or modified, or for a discussion of risks, and/or referrals or counseling? 
Click or tap here to enter text. 
10.3. [DETERMINATION]  MRI risk management. A rare but serious adverse reaction called nephrogenic systemic fibrosis 
(NSF) has been observed in individuals with kidney disease who received gadolinium-based contrast agents (GBCAs) 
for the scans. Also, a few healthy individuals have a severe allergic reaction to GBCAs. 
10.3.a. Use of gadolinium. Will any of the MRI scans involve the use of a gadolinium-based contrast agent (GBCA)? 
☒ No 
☐ Yes → Which agents will be used? Check all that apply. 
Check all 
that apply 
Brand Name 
Generic Name 
Chemical Structure 
☐ 
Dotarem 
Gadoterate meglumine 
Macrocylic 
☐ 
Eovist / Primovist 
Gadoxetate disodium 
Linear 
☐ 
Gadavist 
Gadobutro 
Macrocyclic 
☐ 
Magnevist 
Gadpentetate dimeglumine 
Linear 
☐ 
MultiHance 
Gadobenate dimeglumine 
Linear 
☐ 
Omniscan 
Gadodiamide 
Linear 
☐ 
OptiMARK 
Gadoversetamide 
Linear 
☐ 
ProHance 
Gadoteridol 
Macrocyclic 
☐ 
Other, provide name: 
 
 
Click or tap here to enter text. 
10.3.a.1. The FDA has concluded that gadolinium is retained in the body and brain for a significantly 
longer time than previously recognized, especially for linear GBCAs. The health-related 
risks of this longer retention are not yet clearly established. However, the UW IRB expects 

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researchers to provide a compelling justification for using a linear GBCA instead of a 
macrocyclic GBCA, to manage the risks associated with GBCAs. 
Describe why it is important to use a GBCA with the MRI scan(s). Describe the dose that 
will be used and (if it is more than the standard clinical dose recommended by the 
manufacturer) why it is necessary to use a higher dose. If a linear GBCA will be used, 
explain why a macrocyclic GBCA cannot be used. 
Click or tap here to enter text. 
10.3.a.2. Information for subjects. Confirm by checking this box that subjects will be provided with 
the FDA-approved Patient Medication Guide for the GBCA being used in the research or 
that the same information will be inserted into the consent form. 
☐ Confirmed 
10.3.b. Who will (1) calculate the dose of GBCA; (2) prepare it for injection; (3) insert and remove the IV catheter; 
(4) administer the GBCA; and (5) monitor for any adverse effects of the GCBA? Also, what are the 
qualifications and training of these individual(s)? 
Click or tap here to enter text. 
10.3.c. Describe how the renal function of subjects will be assessed prior to MRI scans and how that information 
will be used to exclude subjects at risk for NSF. 
Click or tap here to enter text. 
10.3.d. Describe the protocol for handling a severe allergic reaction to the GBCA or any other medical 
event/emergency during the MRI scan, including who will be responsible for which actions. 
Click or tap here to enter text. 
10.4. [DETERMINATION]  Unforeseeable risks. Are there any research procedures that may have risks that are currently 
unforeseeable? 
Example: using a drug that hasn’t been used before in this subject population. 
☒ No 
☐ Yes → Identify the procedures. 
Click or tap here to enter text. 
10.5. Subjects who will be under regional or general anesthesia. Will any research procedures occur while patients are 
under general or regional anesthesia, or during the 3 hours preceding general or regional anesthesia (supplied for 
non-research reasons)? 
☒ No 
☐ Yes → Check all the boxes that apply. 
☐ Administration of any drug for research purposes 

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☐ Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
☐ Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research purposes 
☐ Obtaining a research sample from tissue or organs that would not otherwise be removed during 
surgery. 
☐ Administration of a radio-isotope for research purposes** 
☐ Implantation of an experimental device 
☐ Other manipulations or procedures performed solely for research purposes (e.g., experimental liver 
dialysis, experimental brain stimulation) 
If any of the boxes are checked: 
Provide the name and institutional affiliation of a physician anesthesiologist who is a member of the 
research team or who will serve as a safety consultant about the interactions between the research 
procedures and the general or regional anesthesia of the subject-patients. If the procedures will be 
performed at a UW Medicine facility or affiliate, the anesthesiologist must be a UW faculty member, and  
the Vice Chair of Clinical Research in the UW Department of Anesthesiology and Pain Medicine must be 
consulted in advance for feasibility, safety and billing. 
Click or tap here to enter text. 
** If the box about radio-isotopes is checked, the study team is responsible for informing in advance all appropriate 
clinical personnel (e.g., nurses, technicians, anesthesiologists, surgeons) about the administration and use of the 
radio-isotope, to ensure that any personal safety issues (e.g., pregnancy) can be appropriately addressed. This is a 
condition of IRB approval. 
10.6. Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as defined by 
NIH). If required for this research, or if there is a DSMP for the research regardless of whether it is required, upload 
the DSMP to Zipline. If it is embedded in another document being uploading (for example, a Study Protocol) use the 
text box below to name the document that has the DSMP. Alternatively, provide a description of the DSMP in the 
text box below. For guidance on developing a DSMP, review the ITHS webpage on Data and Safety Monitoring 
Plans. 
We have uploaded our DSMP (“R34_Jenness_Data and Safety Monitoring Plan_ISMUpdate-11-2023.pdf”). 
10.7. Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or relevant study team 
members do not know the group to which the participant is assigned, describe the circumstances under which un-
blinding would be necessary, and to whom the un-blinded information would be provided. 
N/A 
10.8. Withdrawal of participants. If applicable, describe the anticipated circumstances under which participants will be 
withdrawn from the research without their consent. Also, describe any procedures for orderly withdrawal of a 
participant, regardless of the reason, including whether it will involve partial withdrawal from procedures and any 
intervention but continued data collection or long-term follow-up. 
Participants are free to withdraw from the study at any time. If a participant chooses to withdraw from BA 
treatment or research assessments, they will be asked to return for a final assessment and exit interview. If 
clinically appropriate, participants will be given recommendations for treatment, and will be asked if they may be 
contacted in the future to determine how the adolescent is doing. Patient participants and their families are told 
that access to future services in our program is not affected by their participation status. Similarly, clinician 

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participants are told that their withdrawal will not impact relationships with study team members, UW, or SCH or 
their employment with SCH. Patient participants who miss 3 consecutive treatment sessions, develop exclusionary 
criteria (e.g., psychosis, mania, substance abuse, pregnancy) or require a higher level of care will continue to be 
followed for clinical assessment pursuant to an intent to treat approach.  If the participant withdraws or is removed 
due to needing different or a higher level of care, they will be offered close case management assistance to match 
them with a provider that is convenient for the family, with appropriate specialization, who accepts the family’s 
insurance plan, and who does not have an extensive waiting list. 
10.9. [DETERMINATION]  Anticipated direct benefits to participants. If there are any direct research-related benefits that 
some or all individual participants are likely to experience from taking part in the research, describe them below: 
Do not include benefits to society or others, and do not include subject payment (if any). Examples: medical benefits such as 
laboratory tests (if subjects receive the results); psychological resources made available to participants; training or education 
that is provided. 
Generally we do not expect direct benefits to patient participants. We expect participants in the study will, on 
average, benefit from receiving high-quality, supervised BA care for depression; however this care will be 
available to similar patients who are not in the study. All patient participants will receive an intensive clinical 
evaluation that may provide more detail than what would be ordinarily available in the community.  
 
If participants are still depressed after treatment, they will be offered close case management assistance to 
match them with a provider that is convenient for the family, with appropriate specialization, who accepts the 
family’s insurance plan, and who does not have an extensive waiting list. 
 
We do not expect direct benefit to the clinician participants.  
 
10.10. [DETERMINATION]  Return of individual research results. 
In this section, provide your plans for the return of individual results. An “individual research result” is any information 
collected, generated or discovered in the course of a research study that is linked to the identity of a research participant. 
These may be results from screening procedures, results that are actively sought for purposes of the study, results that are 
discovered unintentionally, or after analysis of the collected data and/or results has been completed. 
 
Review the guidance on Return of Individual Results for information about results that should and should not be returned, 
validity of results, the Clinical Laboratory Improvement Amendment (CLIA), consent requirements and communicating results. 
10.10.a. Is it anticipated that the research will produce any individual research results that are clinically 
actionable? 
“Clinically actionable” means that there are established therapeutic or preventive interventions or other available 
actions that have the potential to change the clinical course of the disease/condition or lead to an improved health 
outcome. 
In general, every effort should be made to offer results that are clinically actionable, valid and pose life-threatening or 
severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if 
this can be accomplished without compromising the research. 
☒ No 
☐ Yes → Answer the following questions (10.10.a.1 through 10.10.a.3.) 

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10.10.a.1. Describe the clinically actionable results that are anticipated and explain which results, 
if any, could be urgent (i.e., because they pose life-threatening or severe health 
consequences if not treated or addressed quickly). 
Examples of urgent results include very high calcium levels, highly elevated liver function test 
results, positive results for reportable STDs. 
 
10.10.a.2. Explain which of these results will be offered to subjects. 
Click or tap here to enter text. 
10.10.a.3. Explain which results will not be offered to subjects and provide the rationale for not 
offering these results. 
Reasons not to offer the results might include: 
• 
There are serious questions regarding validity or reliability  
• 
Returning the results has the potential to cause bias 
• 
There are insufficient resources to communicate the results effectively and 
appropriately 
• 
Knowledge of the result could cause psychosocial harm to subjects 
Click or tap here to enter text. 
10.10.b. Is there a plan for offering subjects any results that are not clinically actionable? 
Examples: non-actionable genetic results, clinical tests in the normal range, experimental and/or uncertain results. 
☒ No 
☐ Yes → Explain which results will be offered to subjects and provide the rationale for offering these 
results. 
 
10.10.c. Describe the validity and reliability of any results that will be offered to subjects. 
The IRB will consider evidence of validity such as studies demonstrating diagnostic, prognostic, or predictive value, 
use of confirmatory testing, and quality management systems. 
N/A 
10.10.d. Describe the process for communicating results to subjects and facilitating understanding of the results. 
In the description, include who will approach the participant with regard to the offer of results, who will 
communicate the result (if different), the circumstances, timing, and communication methods that will 
be used. 
N/A  

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10.10.e. Describe any plans to share results with family members (e.g., in the event a subject becomes 
incapacitated or deceased). 
N/A 
10.10.f. Check the box to indicate that any plans for return of individual research results have been described in 
the consent document. If there are no plans to provide results to participants, this should be stated in the 
consent form. 
Review the guidance on Return of Individual Results for information about consent requirements. 
☐ Confirmed 
10.11. Commercial products or patents. Is it possible that a commercial product or patent could result from this study? 
☐ No 
☒ Yes → Describe whether subjects might receive any remuneration/compensation and, if yes, how the amount 
will be determined. 
Participants will be reimbursed for time spent completing the study. There is no current plan for any 
participant renumeration/compensation in the event of a commercial product or patent resulting from 
the research. 
 11. ECONOMIC BURDEN TO PARTICIPANTS 
11.1. Financial responsibility for research-related injuries. Answer this question only if the lead researcher is not a UW 
student, staff member, or faculty member whose primary paid appointment is at the UW. 
For each institution involved in conducting the research: Describe who will be financially responsible for research-
related injuries experienced by subjects, and any limitations. Describe the process (if any) by which participants 
may obtain treatment/compensation. 
Click or tap here to enter text. 
11.2. Costs to subjects. Will there be any research-related costs for which subjects and/or their health insurance may be 
responsible (examples might include: CT scan required for research eligibility screening; co-pays; surgical costs 
when a subject is randomized to a specific procedure; cost of a device; travel and parking expenses that will not be 
reimbursed)? 
☒ No 
☐ Yes → Provide a description of the costs that may be incurred. 
Click or tap here to enter text. 
 12. RESOURCES 
12.1. [DETERMINATION]  Faculty Advisor. (For researchers who are students or residents.) Provide the following 
information about the faculty advisor. 
• 
Advisor’s name 

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• 
Your relationship with your advisor (for example: graduate advisor; course instructor) 
• 
Your plans for communication/consultation with your advisor about progress, problems, and changes. 
Click or tap here to enter text. 
12.2. UW Principal Investigator Qualifications. Upload a current or recent Curriculum Vitae (CV), Biosketch (as provided 
to federal funding agencies), or similar document to the Local Site Documents page in Zipline. The purpose of this 
is to address the PI’s qualifications to conduct the proposed research (education, experience, training, 
certifications, etc.). 
For help with creating a CV, review http://adai.uw.edu/grants/nsf_biosketch_template.pdf and 
https://intranet.medicine.uw.edu/academic-hr/curriculum-vitae-cv  
☒ The CV will be uploaded. 
12.3. UW Study team qualifications. Describe the qualifications and/or training for each UW study team member to 
fulfill their role on the study and perform study procedures. (You may be asked about non-UW study team 
members during the review; they should not be described here.) You may list these individuals by name, however 
if you list an individual by name, you will need to modify this application if that individual is replaced. 
Alternatively, you can describe study roles and the qualifications and training the PI or study leadership will 
require for any individual who might fill that role. The IRB will use this information to assess whether risks to 
subjects are minimized because study activities are being conducted by properly qualified and trained individuals. 
Describe: The role (or name of person), the study activities they will perform, and the qualifications or training 
that are relevant to performing those study activities. 
Examples:  
Research Study Coordinator: Obtain consent, administer surveys, blood draw. Will have previous experience 
coordinating clinical research and be a certified phlebotomist in WA. 
Undergraduate Research Assistant: Obtain consent, perform all study procedures. Will have had coursework in 
research methods, complete an orientation to human subjects protections given by the department, and will 
receive training from the PI or the graduate student project lead on obtaining consent and debriefing subjects. 
Acupuncturist: Perform acupuncture procedures and administer surveys. Must be licensed with WA State DoH 
and complete training in administering research surveys given by the project director, an experienced survey 
researcher. 
Co-Investigator: Supervise MRI and CT scan procedures and data interpretation, obtain consent. MD, specialty 
in interventional radiology and body imaging. 5-years clinical research experience. 
 
Key Personnel 
Jessica Jenness, PhD, PD/PI: Dr. Jenness serves as the PI and will take the primary lead on all 
aspects of the research including data collection and management, supervising study staff and the 
postdoctoral fellow, and coordinating with Dr. McCauley at our partner site, Seattle Children’s Hospital 
(SCH). She will also oversee research therapist participant recruitment, training and management, and 
adolescent patient participant recruitment and retention. As a licensed clinical psychologist, Dr. Jenness 
will be responsible for supervising assessment and reporting related to the safety of patient participants 
(e.g., reports of suicidality or maltreatment). Dr. Jenness will also assist in data analysis, manuscript 
publication, and preparing future grants that stem from this pilot work. 
 

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Julie Kientz, PhD, PD/PI: will serve as MPI and will serve in a supervisory role to monitor all aspects of 
the research including having ultimate responsibility for data collection and management and 
coordinating with data analysts for analyses. Dr. Kientz will assist in data analysis, manuscript 
publication, and preparing future grants that result from this pilot work.  
 
Elin A. Björling, PhD, Co-Investigator: will be responsible for direct implementation of study goals 
including data collection and management, supervising research staff, coordinating with the SCH IT 
Team regarding implementation of design specifications, and assisting with data analysis and 
manuscript publications. 
 
Sean Munson, PhD, Co-Investigator: will be responsible for providing weekly consultation on the 
design and build of the ARC platform, with greater time spent on usability testing and a reduced role in 
consultation across once the platform has been implemented in the RCT.  
 
Other Personnel 
Data Scientists (MS or PhD) will have expertise in quantitative analyses, especially comparative 
effectiveness trials, psychometric evaluation, structural equation modeling, and multivariate modeling. 
They will conduct quantitative analyses and prepare dissemination materials. 
 
 
Research Coordinator (BA/BS or higher): will be trained by the MPIs and Co-Is and responsible for 
participant recruitment, telephone screening procedures, informed consent process, conducting study 
visits, data management, moderating the ARC platform, and creating and managing our participant 
database. 
 
Research Assistants (BA/BS or higher): will be trained by the MPIs, Co-Is, and/or project coordinator 
and responsible for assisting the research team with participant recruitment, telephone screening 
procedures, informed consent process, conducting study visits, data management, moderating the ARC 
platform, and data entry.  
 
 
12.4. Study team training and communication. Describe how it will be ensured that each study team member is 
adequately trained and informed about the research procedures and requirements (including any changes) as well 
as their research-related duties and functions. 
☐ There is no study team 
All team members that will interact with study participants will complete a Collaborative Institutional Training 
Initiative (CITI) training in Good Clinical Practice. Those who access study databases will be complete courses in 
HIPAA compliance. Our team will develop SOPs (standard operating procedures) based on the approved study 
protocol. New team members will utilize the SOPs to learn study procedures. 
13. OTHER APPROVALS, PERMISSIONS, AND REGULATORY ISSUES 
13.1. [DETERMINATION]  Approvals and permissions. Identify any other approvals or permissions that will be obtained. 
For example: from a school, external site/organization, funding agency, employee union, UW Medicine clinical 
unit. 

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Do not attach the approvals and permissions unless requested by the IRB. 
N/A 
13.2. Financial Conflict of Interest. Does any UW member of the team have ownership or other Significant Financial 
Interest (SFI) with this research as defined by UW policy GIM 10? 
☒ No 
☐ Yes → Has the Office of Research made a determination regarding this SFI as it pertains to the proposed 
research? 
☐ No → Contact the Office of Research (206.616.0804, research@uw.edu) for guidance on how to 
obtain the determination. 
☐ Yes → Upload the Conflict Management Plan for every UW team member who has a FCOI with 
respect to the research, to Zipline. If it is not yet available, use the text box to describe 
whether the Significant Financial Interest has been disclosed already to the UW Office of 
Research and include the FIDS Disclosure ID if available. 
Click or tap here to enter text.