Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Sponsor: University of Washington

Study Title: Sleep Self-Management Intervention for Children 
With Juvenile Idiopathic Arthritis (SLEEPSMART) 
NCT Number: NCT04066205 
Date: March 23, 2020 
 

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ZIPLINE APPLICATION: IRB Protocol 
 
 
 
INSTRUCTIONS 
• 
If you are requesting a determination about whether your activity is human subjects research or qualifies for exempt status, 
you may skip all questions except those marked with a          . For example 1.1  must be answered. 
• 
Answer all questions. If a question is not applicable to your 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.  
• 
To check a box, place an “X” in the box. To fill in a text box, make sure your cursor is within the gray text box bar before 
typing or pasting text. 
• 
The word “you” refers to the researcher and all members of the research team, unless otherwise specified.  
• 
For collaborative research, describe only the information that is relevant to you unless you are requesting that the UW IRB 
provide the review and oversight for your collaborators 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.  
 
INDEX 
1 Overview 
6 Children (Minors) and Parental Permission 
10 Risk / Benefit Assessment 
2 Participants 
7 Assent of Children (Minors) 
11 Economic Burden to Participants 
3 Research Setting 
8 Consent of Adults 
12 Resources 
4 Recruiting and Screening Participants 
9 Privacy and Confidentiality 
13 Other Approvals, Permissions, and 
Regulatory Issues 
5 Procedures 
 
 
 
1 OVERVIEW 
Study Title: 
Sleep Shared-Management Intervention (SLEEPSMART) for 8-13 year old Children 
with Juvenile Idiopathic Arthritis (JIA) 

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1.1 Home institution. Identify the home institution of the lead researcher as listed on the IRB application. Provide any 
helpful explanatory information.   
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers him/her 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 POLICY: Use of 
the UW IRB. 
 
UW School of Nursing, Department of Psychosocial and Community Health 
1.2 Consultation history. Have you consulted with anyone at HSD about this study? 
It is not necessary to obtain advance consultation. If you have: answering this question will help ensure that the IRB is aware 
of and considers the advice and guidance you were provided.   
 
 
No 
 
 
x 
Yes 
 If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
Elizabeth Falsberg email 06/08/18 
1.3 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. 
 
x 
No 
 
 
 
Yes 
 If 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. 
 
 
 
      

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1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
your proposed activity? 
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 
 
 
x 
Yes 
 If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
We have received a JIT from NIH/NINR who approved our DSMP, and now they are awaiting IRB 
approval before distributing the funds. 
1.5 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 your 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). 
 
This study is not more than minimal risk. 
We aim to develop and test a technology-based sleep self-management intervention delivered for 8-to-13 year-old 
children with JIA and their parents. Initial feasibility, acceptability, and efficacy of the newly developed sleep self-
management intervention will be tested in a pilot randomized controlled trial comparing the active intervention 
against standard care with a sample of 60 children with JIA and their parents. 
The specific aims are to:  
1. 1. Develop a technology-based sleep self-management intervention (SLEEPSMART]) based  on input and 
engagement from JIA children and their parents.  We will use direct stakeholder input from 10 children 
and parents about their needs for sleep self- management as well as intervention material from our prior 
Web-based interventions for child with chronic pain to develop content for the SLEEPSMART. A beta 
version of the program will be evaluated by children, parents, and content experts.   
2. 2. Refine and enhance the intervention product during pilot deployment following user and family 
centered design principles.  Test and refine the prototype of the intervention in two design iterations with 5 
JIA parents and their parents. JIA children and parents will trial the prototype for 2 weeks. Focus groups 
and “think aloud” sessions will be conducted at each phase to identify refinement needs.  
 
3. Assess the feasibility, usability, perceived usefulness, and initial efficacy of the resulting sleep self-
management intervention (SLEEPSMART ) in a pilot RCT. The pilot RCT, comparing usual care to 
SLEEPSMART intervention, will mimic all of the major essentials of the future definitive trial to estimate 
effect size and to further refine. Primary outcomes: actigraphy sleep duration, sleep quality, and 
feasibility/acceptability. Secondary outcomes: child and parent self-management (activation, motivation, 
self-efficacy), technology use, recommendations and feasibility of innovative sleep monitoring. 
  - Aim 3 will involve 60 participants; 30 JIA children will be randomly (online generated program) 
selected to receive the online sleep intervention [active treatment group], and 30 JIA children will be in the 
control group. 
  

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Development of an effective technology-based sleep self-management intervention has the potential to improve 
health outcomes of children living with JIA. Findings regarding intervention feasibility and acceptability will 
guide future intervention optimization, and estimation of intervention efficacy will provide essential information 
for power calculations for the design of a future definitive trial of the intervention. The study will provide findings 
regarding the benefits of a potentially cost-effective intervention that could be implemented on a large scale to 
improve sleep health in children with chronic conditions and their parents. The Internet offers a unique opportunity 
to reach adolescents with JIA and provide the training in self-management strategies that otherwise may not occur 
due to treatment access and resource obstacles.   
1.6 Study design. Provide a one-sentence description of the general study design and/or type of methodology.   
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. 
 
Develop a technology-based sleep self-management intervention (SLEEPSMART) based on input and engagement 
from 15 JIA children and their parents, then describe the initial feasibility, acceptability, and efficacy of the newly 
developed sleep self-management intervention which will be tested in a pilot randomized controlled trial 
comparing the active intervention against standard care with a sample of 60 children with JIA and their parents. 
1.7 Intent. Check all the descriptors that apply to your activity. You must place an “X” in at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each option carefully. 
 
Descriptor 
 
 
1. 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). 
 
 
 
 
 
 
2. Part of an institution, organization, or program’s own internal operational monitoring. 
 
 
 
 
 
 
3. Improve the quality of service provided by a specific institution, organization, or program. 
 
 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, and 
produce results that: 
• 
Are expected to be applicable 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. 
 
x 
 
 
 
 
5. 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. 
 
 
 
 
 
 
6. 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. 
 
 
 
 
 
 
7. 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. 
 
 
 
 
 
 

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x 
8. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire) 
 
 
 
 
9. Expanded access use of a drug or device not yet approved for this purpose 
 
 
 
 
 
 
10. Use of a Humanitarian Use Device 
 
 
 
 
 
 
11. Other. Explain: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if your 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. 
 
a. Background. Provide the rationale and the scientific or scholarly background for your proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that your project is 
intended to address. 
 
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. 
 
There is a critical gap in the treatment of Juvenile Idiopathic Arthritis (JIA) wherein a majority of school-age 
children experience sleep deficiency, pain, and reduced health-related quality of life even with advances in 
medical management of the disease. Sleep deficiency, including inadequate quantity and poor quality, is a 
serious public health problem, is common and highly comorbid in JIA, with an estimated 20 to 25% diagnosed 
with insomnia during adolescence. Despite the pervasiveness of sleep deficiency in JIA, children receive no 
training in self-management strategies (activation, motivation, self-efficacy) that can help empower them to 
improve sleep quantity and quality before transitioning into adolescence. Lack of sleep self-management 
interventions in JIA represents an important problem because these children are more vulnerable to the long-
term consequences of poor sleep, poorer health-related quality of life, and increased healthcare utilization. 
Further, studies in other chronic health conditions show that sleep deficiency is associated with lack of self-
monitoring and goal setting - important components of self-management. Clinical resources to address sleep 
deficiency in JIA are not available, creating a significant unmet clinical need.   
 
     In considering the multiple needs of these children and parents, successful interventions will need to target 
self-management skills and be delivered to families in an accessible format. Based on the experiences of our 
team in developing and testing technology-based pain self-management interventions for children with chronic 
conditions and their families, and conducting usability studies for such tools, we hypothesize that this 
approach will also be effective for delivering a sleep self-management intervention for children with JIA and 
their parents. We aim to develop and test a technology-based sleep self-management intervention delivered for 
8-to-13 year-old children with JIA and their parents. Initial feasibility, acceptability, and efficacy of the newly 
developed sleep self-management intervention will be tested in a pilot randomized controlled trial comparing 
the active intervention against standard care with a sample of 60 children with JIA and their parents. Sleep will 

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be measured using actigraphy, sleep diaries, & self-report measures. Problem-solving skills, motivation, 
beliefs about sleep, and sleep self-efficacy also will be measured before and after the intervention is applied.  
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you or 
your team have that supports the feasibility and/or safety of this study.   
 
It is not necessary to summarize all 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: You have already conducted a Phase 1 study of an experimental drug which 
supports the Phase 2 study you are now proposing to do; you have already done a small pilot study showing that the 
reading skills intervention you plan to use is feasible in an after-school program with classroom aides; you have 
experience with the type of surgery that is required to implant the study device; you have a study coordinator who is 
experienced in working with subjects who have significant cognitive impairment. 
 
 
This proposal builds on my prior studies of sleep deficiency and symptoms in children with arthritis, and my 
existing collaborations with Drs. Palermo and Ringold, at Seattle Children’s Hospital (SCH), as well as, Ching 
Hung, the clinical research associate in the Pediatric Rheumatology clinic who will assist with participant 
recruitment.   
 
Strengths of this study: 1) prior successful recruitment of children with JIA using actigraphy and electronic 
sleep diaries; 2) expertise in sleep, JIA, actigraphy, symptoms, REDCap; 3) leveraging of successful methods 
in a prior studies; and 4) building on Dr. Ward’s prior collaborations with pediatric rheumatology and pediatric 
psychology in child with chronic pain. 
1.9 Supplements. Check all boxes that apply, to identify Supplements you should complete and upload to the 
Supporting Documents SmartForm in 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 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
ZIPLINE 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 your research 
ZIPLINE SUPPLEMENT: 
Drugs 
 
 
 
 
 
 
 
 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research involving 
more than minimal risk 
ZIPLINE SUPPLEMENT: 
Exception from Informed 
Consent for Emergency 
Research (EFIC) 
 
 
 
 
 
 
 
 
 
 
 
 
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 
ZIPLINE SUPPLEMENT: 
Genomic Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 

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Procedures involve the use of any medical device, even if the device is 
not the focus of your research, except when the device is FDA-approved 
and is being used through a clinical facility in the manner for which it is 
approved 
ZIPLINE SUPPLEMENT: 
Devices 
 
 
 
 
 
 
 
 
Multi-site study 
(You are asking the UW IRB to review one or more sites in a multi-site 
study.) 
ZIPLINE SUPPLEMENT: 
Participating Site in Multi-
Site Research 
 
 
 
 
 
 
 
 
 
 
 
 
Participant results sharing 
Individual research results will be shared with subjects. 
ZIPLINE SUPPLEMENT: 
Participant Results 
Sharing 
 
 
x 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
 
 
 
 
 
 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
Aim 1 & 2: Fifteen children, 9-11 years with JIA, and their parent will be recruited from the Rheumatology clinic 
at Seattle Children’s Hospital (SCH). In Washington State, over 6,100 children have been diagnosed with JIA.  
Approximately 500 patients with JIA are seen each year in the Department of Rheumatology, and 250 are between 
9 to 11 years. 
Aim 3: Sixty children, 8-13 years, diagnosed with JIA and one parent will be recruited from the Pediatric 
Rheumatology Clinic at SCH and at The Children’s Hospital of Philadelphia (CHOP),  and remotely via flyers on 
social media.  
 
Girls and boys are eligible, although we expect to enroll more Caucasian girls because of the heightened disease 
prevalence among Caucasian girls, and its relatively low prevalence in underrepresented minorities and boys.  
2.2 Inclusion and exclusion criteria. Describe the specific criteria you will use to decide who will be included in your 
study from among interested or potential subjects. Define any technical terms in lay language. 
 
Inclusion criterion for JIA children: 1) diagnosed with JIA; 2) 8-13 years; 3) able to read/speak English; and 4) 
parent report that child has difficulties with sleep quality(difficulty falling asleep, no bedtime routine, waking up 
in the middle of the night and struggling to fall back asleep) and/or poor sleep impacts their child’s day to day 
function (school, interacting with peers, hobbies).   
Exclusion criteria for JIA children include: (a) diagnosed sleep disorder (obstructive sleep apnea [OSA]); 2) 
positive screen on the Pediatric Sleep Questionnaire (> 0.33) for OSA (we will suggest follow up with the child’s 
primary care provider because treatment of this condition is beyond the scope this intervention); 3) lack of daily 
access to the Internet or mobile device as the study will be conducted online; 4) developmental delay; d 5) children 
who do not speak English; and 6) child is not currently participating in psychological therapy. 
 
Inclusion criteria for parents: 1) > 18 years; 2) able to read/speak English; 3) access to a computer or web-based 
device to complete surveys.  
Exclusion criteria for parents: 1) diagnosed with a chronic illness that would interfere with ability to complete 
study procedures; 2) lack of daily access to the Internet or mobile device.  
 
For families in which the child routinely spends the night in more than one home, a primary study parent will be 
identified and asked to complete all assessments. Parent is defined as the adolescent’s primary caregiver and who 
co-resides with the child more than 50% of the time.  

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2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not an 
intended target population. 
a. Will you recruit or obtain data from individuals that you know to be prisoners? 
For records reviews: if the records do not indicate prisoner status and prisoners are not a target population, select “No”. See 
the WORKSHEET: Prisoners for the definition of “prisoner”.   
 
x 
No 
 
 
 
Yes 
 If yes, answer the following questions (i – iv). 
 
i. Describe the type of prisoners, and which prisons/jails: 
 
      
 
ii. One concern about prisoner research is whether the effect of participation on prisoners’ 
general living conditions, medical care, quality of food, amenities, and opportunity for 
earnings in prison will be so great that it will make it difficult for prisoners to adequately 
consider the research risks. What will you do to reduce the chances of this? 
 
      
 
iii. Describe what you will do to make sure that (a) your 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. 
 
      
 
iv. If your research will involve prisoners in federal facilities or in state/local facilities outside of 
Washington State: check the box below to provide your assurance that you will (a) not 
encourage or facilitate the use of a prisoner’s participation in the research to influence parole 
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. 
 
 
Confirmed 
 
 
b. Is your research likely to have subjects who become prisoners while participating in your 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. 
 
x 
No 
 
 
 
Yes 
 If yes, if a subject becomes a prisoner while participating in your study, will you continue the 
study procedures and/or data collection while the subject is a prisoner? 
 
 
 
 
No 
 
 
 
Yes 
 If yes, describe the procedures and/or data collection you will continue with 
prisoner subjects 
 
 
 
      

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2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check the boxes 
for any of these populations that you will purposefully include in your research. (In other words, being a part of 
the population is an inclusion criterion for your study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed or submitted.   
 
Population 
Worksheet 
 
 
Children 
WORKSHEET: Children 
 
x 
 
 
 
 
Children who are wards 
WORKSHEET: Children 
 
 
 
 
 
 
Fetuses in utero 
WORKSHEET: Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET: Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET: Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET: Pregnant Women 
 
 
 
 
“Children” are defined as individuals who have not attained the legal age for consent to treatments or procedures involved in 
the research and its specific setting. This will vary according to the location of the research (that is, for different states and 
countries). 
a. If you check any of the boxes above, use this space to provide any information you think may be relevant for 
the IRB to consider.  
 
Study participants are child between 8 and 13 years of age, and their parent. 
2.5 Native Americans or non U.S. indigenous populations. Will you actively recruit from Native American or non-U.S. 
indigenous populations 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 
 
x 
No 
 
 
 
Yes  If yes, name the tribe, tribal-focused organization, or similar community based organization. The 
UW IRB expects that you will obtain tribal/indigenous approval before beginning your research. 
 
 
 
 
      

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2.6 Third party subjects. Will you collect private identifiable information about other individuals from your 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 your 
research team to readily identify the person. For example, suppose that you are studying immigration history. If you ask your 
subjects several questions about their grandparents but you do not obtain names or other information that would allow you to 
readily identify the grandparents, then you are not collecting private identifiable information about the grandparents.  
 
x 
No 
 
 
 
Yes 
 If yes, these individuals are considered human subjects in your study. Describe them and what 
data you will collect about them. 
 
 
 
 
      
2.7 Number of subjects. Can you predict or describe the maximum number of subjects (or subject units) you need to 
complete your 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 your research. 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 you plan to study in the context of risks and benefits. You may submit a Modification 
to increase this number at any time after you receive IRB approval. If the IRB determines that your research involves no more 
than minimal risk: you may exceed the approved number and it will not be considered non-compliance. If your research 
involves more than minimal risk: exceeding the approved number will be considered non-compliance.  
 
 
No 
 If no, provide your rationale in the box below. Also, provide any information you can about the 
scope/size of the research. You do not need to complete the table. 
 
 
 
 
Example: you may not be able to predict the number of subjects who will complete an online survey 
advertised through Craigslist, but you can state that you will post your survey for two weeks and the number 
who respond is the number who will be in your study. 
 
 
      
 
x 
Yes 
 If yes, for each subject group, use the table below to provide your 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 of individuals (or other 
subject unit, such as families) who will complete 
the research 
*For clinical trials: provide numbers for your site and for 
the study-wide total number 
 
Children with JIA 
75 ([Aim 1[10] & Aim 2: 5 JIA children]; Aim 3: 
60) 

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Parents of a child with JIA 
75 ([Aim 1 [10] & Aim 2: 5 JIA parents]; Aim 3: 
60) 
 
 
 
 
      
      
 
      
      
 
      
       
 
 
3 RESEARCH SETTING 
3.1 Reason for sites. Describe the reason(s) why you selected the sites where you will conduct the research. 
 
We selected Seattle Children’s and CHOP Pediatric Rheumatology clinics as our recruitment sites because the 
clinicians manage and care for children with JIA. We will also recruit JIA children outside of WA state via social 
media. 
3.2 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 your 
research or how it is conducted. 
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. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  
 
In our prior research studies in which we recruited from Seattle Children’s, we did not encounter cultural 
challenges with our measures or use culturally inappropriate procedures. We do not anticipate site- specific 
cultural issues, customs, or beliefs that would affect our research and how it is conducted. 
3.3 Site-specific laws. Describe any local laws that may affect your 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 across 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 (including Washington State) have laws that are similar to the 
federal HIPAA law but that have additional requirements. 
 
 

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3.4 Site-specific administrative or ethical requirements. Describe local administrative or ethical requirements that 
affect your research.  
Example: A school district may require you to obtain permission from the head district office as well as school principals before 
approaching teachers or students; a factory in China may allow you to interview factory workers but not allow you to pay 
them.  
 
None 
 
 
4 RECRUITING and SCREENING PARTICIPANTS 
4.1 Recruiting and Screening. Describe how you will identify, recruit, and screen subjects. 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.   
 
Recruitment 
Recruitment will use several methods: SCH Rheumatology clinic; letters to JIA parents seen at SCH; posted 
recruitment flyers, social media posts. 
 
The below is broken down by Aims: 
Aims 1 & 2: will involve recruitment of 15 JIA children and their parent to do semi-structured interviews and test 
out the online modules.   
Recruitment 
• Letters to JIA parents whose children are cared for at SCH, will be sent describing the study, and will 
include the clinical research associate’s (CRA) contact information for questions. 
 
SCH: JIA participants and their parents. The CRA will review the Rheumatology patient list for eligible child. A 
list of names and addresses for children who meet the above criteria will be obtained from the database and 
maintained by the CRA in a secure area. Potential subjects with JIA will be mailed a letter informing them about 
the study, and provide the CRAs contact information.  During the clinic visit, the CRA will give eligible child and 
their parents the study flyer that includes information about the study at a clinic visit. (See Aims 1_2 Recruitment). 
 
Aim 3: will involve 60 JIA children (8 to 13 years) and their parent, and the focus is on feasibility and 
acceptability of the online sleep (SLEEPSMART) intervention. 30 children will be randomized using an online 
program to the active treatment group (online sleep intervention- SLEEPSMART), and 30 will be in the control 
group. 
• The CRA will review the Rheumatology patient list for eligible child. A list of names and addresses for 
children who meet the above criteria will be obtained from the database and maintained by the CRA in a 
secure area. The CRA will contact potential subjects with JIA via the telephone to inform them about the 
study.  Participants who are interested and/or unsure about the study, the CRA will email eligible child and 
their parents the study flyer that includes information about the study, and guide potential participants to 
https://www.sleepsmartstudy.org/ webpage, and will include the CRA contact information with 
questions.. 
•  
• Recruitment flyers will be posted in community-based pediatric primary care clinics, rheumatology 
clinics,recreational centers, and boys and girls clubs within and outside WA state.   
• Social Media posts will describe the study, and provide a link to the online screening webpage as well as 
the Clinical Research Associate (CRA) contact information. Posts may be made to UW School of Nursing 

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webpage/social media accounts, and Facebook.  Posts will guide potential participants to 
https://www.sleepsmartstudy.org/ webpage. 
 
SCH: JIA participants and their parents. The CRA will review the Rheumatology patient list for eligible child. A 
list of names and addresses for children who meet the above criteria will be obtained from the database and 
maintained by the research coordinator in a secure area. Potential subjects with JIA will be called  informing them 
about the study that will guide potential participants to https://www.sleepsmartstudy.org/ webpage, and provide 
the CRAs contact information.   
 
CHOP: Rheumatology staff at CHOP will review the Rheumatology database for eligible children.  Staff at CHOP 
will mail eligible participants a letter informing them about the study that will guide potential participants to 
https://www.sleepsmartstudy.org/webpage.  Interested participants will contact the CRA, who works at SCH, 
with questions. 
 
Screening: The CRA at SCH will review the Rheumatology patient list for eligible youth. A list of names 
and addresses for children who meet the above criteria will be obtained from the database and maintained 
by the CRA in a secure area. Potential subjects with JIA will be called by the CRA who will inform them 
about the study. . Interested participants will contact the CRA with questions. 
 
Aims 1& 2: Interested potential participants will contact the CRA by phone.  For those who contact the CRA by 
phone, the CRA will screen potential participants initially over the phone (see Aims 1_2 Recruitment Script).   
 
Aims 3:  Interested potential participants may choose to visit https://www.sleepsmartstudy.org/webpagewebpage 
or contact the CRA by phone.  For those who contact the CRA by phone, the CRA will screen potential 
participants initially over the phone (see Recruitment Script).  For those who are eligible and interested, they will 
be directed to the https://www.sleepsmartstudy.org/webpage webpage (hosted by REDCap).  From there, 
parents may complete the screening surveys including“does your child has difficulty with sleep quality and/or  
does poor sleep impact your child’s day-to-day function (school, interacting with peers, hobbies)?”   Sleep-Related 
Breathing Disorder Scale from the Pediatric Sleep Questionnaire (SRBD) and is your child currently receiving 
psychological therapy. Instruments are automatically scored within REDCap and indicates whether participants 
appear to meet eligibility criteria or not.  Those who are not eligible are thanked for their time.  Those that are 
eligible are advised that the study team will contact them (see recruitment follow-up script).   
 
REDCap uses unique identifiers for potential participants and only the CRA and PI has the master list connecting 
potential participant email, names, and identifiers. 
4.2 Recruitment materials.  
 
a. What materials (if any) will you use 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. 
 
Aim 1 & 2: Study flyer, letters to participants, Child Sleep Habits Questionnaire (CSHQ), Sleep-Related 
Breathing Disorder Scale from the Pediatric Sleep Questionnaire (SRBD) will be used to recruit and screen 
subjects. 
 
Aim 3: Study flyer, letters to participants, social media posts, https://www.sleepsmartstudy.org/webpage , 
phone scripts, “does your child has difficulty with sleep quality and/or  does poor sleep impact your child’s day 
to day function?”   Sleep-Related Breathing Disorder Scale from the Pediatric Sleep Questionnaire (SRBD), and 
parent report if the child is currently receiving psychological therapy will be used to recruit and screen subjects. 

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b. Upload descriptions of each type of material (or the materials themselves) to the Consent Forms and 
Recruitment Materials SmartForm of Zipline. If you will send letters to the subjects, the letter should include a 
statement about how you obtained the subject’s name, contact information, and any other subject-specific 
information (such as a health condition) that is mentioned in the letter.  
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: 
• 
You could 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, you might 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). In doing so, you would not 
need to submit a Modification if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, you 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, you might 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 Relationship with participant population. Do any members of the study team have an existing relationship with 
the study population(s)?  
Examples: a study team member may have a dual role with the study population (for example, being their clinical care 
provider, teacher, laboratory directory or tribal leader in addition to recruiting them for his/her research). 
 
 
No 
 
 
X 
Yes 
 If yes, describe the nature of the relationship. 
 
 
 
Pediatric Rheumatologists are the clinical care providers for child with JIA 
4.4 Payment to participants. Describe any payment you will provide, including: 
• 
The total amount/value 
• 
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 information about the number 
and amount of payments, and especially the time 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.  
 
Do not include a description of any expenses that will be reimbursed.  
Aim 1 & 2: Participants will receive a $25 gift card for each interview (2-3 interviews are anticipated), and $40 
gift care to test the online module. Total estimated to be $90 - $115 depending if 2 or 3 interviews are needed. 
Aim 3: Participants who agree to participate in this study will receive a monetary incentive of up to $310 per 
dyad (in VISA gift cards).  The compensation will be divided into four portions such that: 
• $75 gift card will be given at the completion of T1 (baseline assessment), after completion of the 10 days of 
actigraphy and sleep diary). Gift card will be mailed to participant home.  
• $110 gift card will be given after T2 (immediately post SLEEPSMART intervention). Gift card will be 
mailed to participant home.  

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• $125 gift card will be given after T3 (1 month after intervention) and 10 days of actigraphy and sleep 
diary). Gift card will be mailed to participant home. 
4.5 Non-monetary compensation. Describe any non-monetary compensation you will provide. Example: extra credit 
for students; a toy for a child. If you will be offering class credit to students, you must provide (and describe) an 
alternate way for the students to earn the extra credit without participating in your research.  
N/A  
4.6 Consent for recruiting and screening. Will you obtain consent 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 
 If no, you must still answer question 4.7 below. 
 
X 
Yes 
 If yes, describe the consent process. 
 
 
 
We will not obtain consent for pre-screening medical records for eligibility and PHI (diagnosis, name, 
contact information etc.) 
 
Aim 1 & 2: Potential study subjects will respond to a letter by calling (or in person during the clinic 
visit) with the CRA.  The CRA will complete a screening process to determine if subjects meet 
eligibility requirements 
 
Aim 3: Potential study subjects will respond to the CRA by a telephone call or email. .  The CRA 
will complete a screening process to determine if subjects meet eligibility requirements and/or 
participants will opt-in for screening procedures via https://www.sleepsmartstudy.org/webpage .  
If they have questions, they are advised to contact the CRA, who will follow-up by phone using the 
Recruitment Script and answer any questions. 
 
 
a. Documentation of consent. Will you obtain a written or verifiable electronic signature from the 
subject on a consent form to document consent for all of the recruiting and screening 
procedures? 
 
x 
No 
 If no, describe the information you will provide during the consent process and 
for which procedures. 
 
 
 
 
Aim 3: Participants will opt-in for screening procedures via 
https://www.sleepsmartstudy.org/webpage .  If they have questions, they are 
advised to contact the CRA, who will follow-up by phone using the Recruitment 
Script and answer any questions. 
 
 
Yes 
 If yes, upload the consent form to the Consent Forms and Recruitment Materials 
page of Zipline. 
 
 
 

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4.7 Data and specimens for recruiting and screening. For studies where you will obtain consent, describe any data 
and/or specimens (including any PHI) you will obtain for recruiting and screening (prior to obtaining consent) and 
whether you will retain it as part of the study data.  
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. 
 
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. 
 
Screening information includes: 
Parent first name, email address, phone number, and preferred mode of contact (text, phone, email) for follow-up.  
Also includes child first name, age, gender, and duration of JIA will be obtained to ensure study eligibility, and 
be retained as part of the study data. Additional information includes screening surveys: “does your child has 
difficulty with sleep quality and/or  does poor sleep impact your child’s day to day function?”   and Sleep-
Related Breathing Disorders, and parent report of child currently participating in psychological therapy.. These 
data will be stored via the secure REDCap database, accessible only by the study team. 
 
 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), time required, and setting/location. If it is available and you think 
it would be helpful to the IRB: Upload a study flow sheet or table to the Supporting Documents SmartForm in 
Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. See UW IRB POLICY: 
Risks of Harm from Standard Care 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. 
 
During the pre-screening, the CRA will collect information from the medical records (age, JIA diagnosis, 
comorbid conditions, JIA disease duration, type of JIA, active or inactive disease). 
Aims 1 & 2: 5 JIA children and their parent.  
Phase 1-The initial 6-9 months will be for program development and beta testing of the sleep self-management 
intervention. First, we will conduct semi-structured interviews with open-ended questions with 10 JIA children and 
their parents to explore perceptions of poor sleep, facilitators and barriers to sleep, preferences and attitudes about 
technology to promote better sleep, the type of technology features users would or would not like, and what 
features would make sleep health tools acceptable to JIA children and parents and facilitate their use. Interviews 
will be conducted at a convenient time and place (in person or via phone), audio-recorded, and transcribed. The PI 
and Co-Is have prior experience in conducting and analyzing semi-structured interviews. Program content will be 
developed based on child and parent interviews, existing Web-based interventions for child with chronic pain and 
the current standard of care for sleep deficiency in children.  
The interviews are expected to take 45 to 60 minutes, and we anticipate 2 to 3 interviews per family. 
Phase 2: Beta testing. During months 8-9, we will beta test a prototype of the intervention with five JIA children 
and their parent. Participants will be videorecorded while interacting with the online modules (rate aspects of 
usability and satisfaction with features of the program) using their own smartphone, tablet, or computer, and 
describing what it is like having JIA and sleep problems.  
The testing of the online modules are expected to take 45-60 minutes.  
Aims 1 & 2 (total 6 to 9 months) 

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Participate in 2 to 3 interviews at a convenient time and place (10 JIA 
parents and children) 
o interview questions would explore perceptions of poor sleep, 
facilitators and barriers to sleep, preferences and attitudes 
about technology to promote better sleep, the type of 
technology features you and your child would or would not 
like, and what features would make sleep health tools 
acceptable to JIA children and parents.  
o Each interview will take 45-60 minutes, and would be audio-
recorded 
Sept 2018- May 2019 
 
 
Test the online sleep-based program your own smartphone, tablet, 
or computer (5 JIA parents and children). 
o We would video record participants while interacting with 
the online modules and rating the usability and satisfaction 
of the online modules.  We would also ask participants to 
describe what it is like having JIA and sleep problems.  
o We would like to share this video recording in an online 
intervention we want to develop to help children with JIA 
self-manage their sleep. See aim 3.  Participants will have the 
option of opting out of the video recording. Participants will 
have an option to opt out of the videotaping. 
o We anticipate that the testing of the online modules would 
take 45-60 minutes. 
April  2019- August 2019 
 
Aim 3: A pilot feasibility RCT (Active treatment group [SLEEPSMART online module] vs. control group) is 
proposed to test the feasibility, acceptability, and initial efficacy of the new 6-week sleep self-management 
intervention with 60 children with JIA (8 to 13 years)) and their parents. Outcome assessments will occur at 
baseline (T1), immediately post intervention (8 weeks; T2), and 1 month post-intervention (T3).  Aims 3 will 
occur after Aims 1 and 2 are complete and will require a total of 3 months. 
Following completion of baseline assessments, participants will be randomized to one of two treatment groups 
(Active treatment [ SLEEPSMART] or control group). Active treatment group will include 30 JIA children 
who will be randomized to the online sleep intervention ( SLEEPSMART). Control group will include 30 JIA 
children who will not receive the online  SLEEPSMART intervention.  
A blocked randomization scheme will be generated using an online program will be used to derive randomization 
assignment, programmed in the internet sleep intervention, and not accessible to study investigators. Enrolled 
participants will be continuously randomized 
T1 BASELINE ASSESSMENT 
A member of the research team will connect with eligible and interested participant children and their parent at 
convenient time, will talk about the purpose of the study, and obtain consent from parent/caregiver participants 
(see SLEEPSMART Consent in Appendix A).  Child assent will then be obtained and copies of both 
documents given to the parent (see SLEEPSMART Assent in Appendix A). 
After consent and assent, JIA children and their parent will be given a link with the electronic instruments 
preloaded and instructed to complete the instruments to the best of their ability.  If questions arise, a member 
of the research team will answer as needed.  This technique was successfully used in Dr. Ward and Palermo’s 
prior intervention studies. The surveys for T1, T2, and T3 will take 30 to 35 minutes to complete.  

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Table 1. Summary of T Assessments – All T1, T2, and T3 unless otherwise indicated 
(T1 [Baseline], T2 [immediately post intervention], T3 [1 month post intervention]) 
Parent Items 
Estimated 
Time 
(minutes)/ 
Assessment 
Child Items 
Estimated 
Time 
(minutes) 
Demographics 
• 
(age, gender, race, ethnicity, 
income; child age, race, 
ethnicity; medications) 
• 
Childhood assessment 
questionnaire  
 
5 
T1 
 
 
T1 
 
 
Self-management measures 
• 
Self-efficacy to Manage Chronic 
Disease Scale  
• 
Decision Balance sheet 
• 
Goal setting (# and types of goals 
created of goals tracked and rate of 
goalsCredibility/Expectancy 
Questionnaire 
<5 
 
Self-management measures 
• 
Child Self-efficacy Scale  
• 
Patient activation measure 
• 
Index of self-regulation  
• 
Goal setting (# and types of goals 
created of goals tracked and rate 
of goals 
• 
Sleep problems questionnaire 
<5 
 
SYMPTOMS 
• 
PROMIS 29 profile 
• 
PROMIS Sleep disturbance -adult 
• PROMIS sleep-related 
impairment 
• 
 
<5 
 
 
 
 
SYMPTOMS  
• 
PROMIS Peds Profile (physical 
function, anxiety, depression, 
fatigue, peer relationships, pain 
interference). 
• 
PROMIS Sleep disturbance 
• 
PROMIS sleep-related impairment 
• 
PedsQL Multidimensional Fatigue 
10 
 
 
Children’s Sleep Hygiene Scale  
Children’s Sleep Wake scale  
Children’s Sleep Habits Questionnaire 
Dysfunctional Beliefs about sleep 
scale  
Pittsburgh sleep quality index  
15 
 
 
 
 
 
T1 
 
Adolescent Sleep Hygiene Scale  
Adolescents Sleep Wake scale  
Dysfunctional Beliefs about sleep 
scale  
Pre-Sleep Arousal Scale  
Morning Eveningness questionnaire  
15 
 
 
 
 
 
 
T1 
T1 
Health Outcomes 
• 
PROMIS Global Health  
• 
PedsQL Family Impact Module 
• 
Health Care Utilization  
5 
 
          
 
Health Outcomes 
• 
Health-related Quality of Life 
Questionnaire  
• 
PROMIS Global health  
• 
 
5 
 
 
Treatment Evaluation Inventory 
(Acceptability)  
Sleepsmart end of  Survey 
<5 
T3 
 
T3 
 
Treatment Evaluation Inventory 
(Acceptability 
Sleepsmart end of Survey  
<5 
T3 
 
T3 
Actigraphy After completing the above instruments at baseline, a member of the research team will give the 
parent and child the actigraph.  The actigraph will be worn by children and parents (on non-dominant wrist) 
continuously for 10 days.  Both will be instructed in the application of the monitors including removal during 
bathing, swimming, and how to assess for appropriate fit using the monitor band.  Both will be instructed to 
document times when the actigraphy monitor is removed and replaced using the diary.  Actigraphs will be 

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collected at the end of the 10 days of recording using a prepaid padded envelope.  Sleep variables obtained via 
actigraphy include sleep onset, sleep offset, sleep period time, mean activity during sleep, mean number of 
minutes of sleep and wake, percentage of sleep and wake within the sleep period, and number of waking 
episodes during the sleep period.  These variables are used to derive total sleep time, percent sleep efficiency 
(SE, sleep time/time in bed x 100), percent wake after sleep onset (WASO, wake min/sleep time x 100), and a 
fragmentation index (of waking episodes/hr).  These variables will enable us to reliably characterize sleep 
quality as it is occurring in the home environment. 
Electronic Sleep Diary (wake time and bedtime) 
Parents and children will record their daily sleep.  A standard log of sleep activities (time to bed, sleep onset, 
awakenings, quality) will be completed daily in the morning upon awakening and prior to bedtime using a 
previously established and tested sleep diary.   
SLEEPSMART INTERVENTION (ONLY Treatment group receives this) 
2-3 weeks after parent/caregiver and child actigraphs are returned and analyzed by a member of the team, a 
phone meeting will be schedule at a convenient time for the participants.  A member of the team will provide 
written and verbal feedback to the child and their parent about their sleep.  Based on this assessment, one of 
three web-based modules will be assigned. 
Table 2. SLEEPSMART Modules 
Module 
Goals 
Strategies 
Bedtime routine 
Structured, consistent bedtime routine ≤ 
30 minutes in length and implemented 
consistently 
Family develops tailored routine, uses 
bedtime chart to maintain routine, 
problem-solving around barriers to 
routine 
Sleep Quality 
Sleep scheduling to allow for 9-11 
hours of nighttime sleep (child) or 7-9 
hours (parent); sleep onset-falls asleep 
within 30 minutes, minimal nighttime 
awakenings. 
Family sets sleep/wake schedule that 
allows for enough sleep; strategies for 
decreasing sleep 
disruptions/awakenings; problem-
solving around barriers to routine. 
Sleep Environment 
Creating sleep environment conducive 
to sleep – minimize noise, light, media 
exposure. 
Family develops quiet, dark sleep 
environment, decreases nighttime 
media; problem-solving around barriers 
to routine. 
A member of the team will instruct the family on how to access the SLEEPSMART website and their assigned 
module. Children will be instructed to log on once per week to the website to complete a module and 
assignment, designed to take about 30 minutes to complete.  The SLEEPSMART assigned modules will begin 
with an educational module, then direct participants through goal setting, anticipated barriers, and problem 
solving.  Web pages will include fillable responses to queries, instructions, and assignments.  Tasks for 
children will use multimedia elements to enhance delivery of information, such as links to videos and pictures 
targeting self-efficacy, motivation, and patient activation.  The materials used will be modified from an 
existing intervention, Sleep Habits in Preschoolers (SHIP), which has been pilot tested and has enrolled 450 
typical developing preschool children and their parents (PI: Ward).   
Submissions and progress will be monitored by a member of the research team, who will send email, call or 
text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help 
problem solve any technology issues or barriers to implementing skills.  This online structure and feedback 
process is modeled after the work by Dr. Palermo, Co-I on this grant, who has successfully implemented web-
based interventions with parents and children. 
T2 – IMMEDIATELY FOLLOWING  INTERVENTION ASSESSMENT 
At the end of the 6-week SLEEPSMART intervention, for both the treatment and control groups will be 
mailed actiwatches, and  parents and children will wear for 10 days.  They will also complete the daily sleep 

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diary as described before.  Actigraphs and sleep diaries will be returned via prepaid envelopes.  Plus the above 
questionnaires in Table 2. 
T3 – 1 MONTH following baseline 
For both the treatment and control groups, actiwatches will be mailed to parent/child participants to wear for 
10 days.  They will also complete the daily sleep diary as described before.  Actigraphs and sleep diaries will 
be returned via prepaid envelopes.  Parents and children will individually complete the instruments/research 
items below, nearly identical to T0 baseline visit with the exception of removing the demographic 
questionnaire, and use of health care utilization survey (exit) for parents and the SLEEPSMART Acceptability 
Questionnaire.  The parent/caregiver will be given a link with the electronic instruments preloaded and 
instructed to complete the instruments to the best of their ability.  If questions arise, a member of the research 
team will answer as needed.  After completing the below listed activities, parent and child participants will 
interviewed together using semi-structured interview questions to assess participant acceptability of the 
SLEEPSMART Study.   
 
 
  
 
5. 2 Data variables. Describe the specific data you will obtain (including a description of the most sensitive items). If 
you would prefer, you may upload a list of the data variables to the Supporting Documents SmartForm instead of 
describing the variables below. 
 
Screening  
Parent report of yes to either of the following questions: “does your child has difficulty with sleep quality and/or  
does poor sleep impact your child’s day-to-day function (school, interacting with peers, hobbies)?”   Pediatric 
Sleep Questionnaire (PSQ) Sleep Related Breathing Disordered Scale  
22-item using 3 point scale (yes = 1, no= 0, don’t know = missing).  Number “yes” items divided by total 
number of items responded, with scores ranging from 0-1.  Scores >0.33 considered positive and suggestive of 
high risk for a pediatric sleep-related breathing disorder. 
Does your child currently receive psychological therapy? 
Enrolled subject data to be collected 
Concept 
Measure 
Demographics 
Parent-report survey includes information about parental characteristics (age, gender, 
education, race, ethnicity, household income) and child characteristics (age, gender, 
grade level, race, ethnicity, JIA type, and medications).   
Child Health Assessment Questionnaire-parent report measure that assesses daily 
activities and functional impairment due to chronic pain in child. 
Self-Management 
Measures  
(treatment group only) 
Self-Efficacy- 9-item parent & 5-item children report of their confidence in carrying 
out sleep-related behaviors using 10-point Likert scale (1=not confident at all, 
10=totally confident).  Higher scores indicate higher self-efficacy. 
Index of self-regulation- 12-item parents & child report of motivation (recondition, 
stimulus control, behavioral monitoring) 
Patient activation measure- 13-item parent & child report of knowledge, skill, & 
confidence for self-management. 
Goal Setting: engagement in goal setting will be tracked on the SLEEPSMART web-
based application using # and type of goals created; # of goals tracked; and rate of goal 
completion.  
Sleep Problem questionnaire- 4 item child report of their readiness to change their sleep 
habits.  
Credibility /expectations Questionnaire: 6-item parent report questionnaire to rate 
treatment expectancy  

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Sleep  
 
 
Child Sleep Habits Questionnaire (CSHQ) 45-item retrospective report of child sleep 
habits over typical week using 3 point Likert scale.  Higher scores indicate greater 
likelihood of sleep disturbance, with >41 as the cut-point for clinically significant sleep 
disturbance.  Eight sleep subscales include bedtime resistance, sleep onset delay, sleep 
duration, sleep anxiety, night awakenings, parasomnias, sleep-disordered breathing, and 
daytime sleepiness. 
  
Children’s /Adolescent Sleep Wake Scale – 25-item child report measure of sleep 
quality over the last month; includes 5 domains: going to bed, falling asleep, 
maintaining sleep, reinitiating sleep, and returning to wakefulness. A total score 
indicates overall perception of sleep quality 
 
Children’s Sleep Hygiene  Scale – 17- item parent report measure of sleep hygiene 
(habits) over the past month; includes 8 subscale scores (physiological factor, 
behavioral arousal factor, cognitive/emotional factor, sleep environment factor, sleep 
stability factor, daytime sleep factor, substances factor, bedtime routine factor; yields a 
total score (higher scores indicative of better sleep hygiene) 
Adolescent Sleep Hygiene Scale- 28 items adolescent report of sleep habits over the 
past 1 month; includes 9 domain scores;  
 
Pre-Sleep Arousal Scale- 16 item child report of somatic arousal (e.g., “cold feeling in 
your hands, feet or your body in general”), cognitive arousal (e.g., “worry about falling 
asleep”).  
 
Dysfunctional beliefs and attitudes about sleep- 10-item child and parent report 
measure of beliefs about sleep (a) beliefs that are uncontrollable and unpredictable; (b) 
unrealistic sleep expectations; (c) misconceptions about the causes; (d) erroneous 
beliefs about sleep-promoting habits; (e) dysfunctional beliefs about the consequences. 
Compute the average of all completed16 items.  A higher score reflects greater 
dysfunctional beliefs about sleep.  Target beliefs expressed in items with scores > 5. 
 
Morning/evening scale for children- 10-item child report that measures when you 
consider “feeling best” and indicate preferred clock time blocks for sleep and 
engagement in various  situations (e.g., physical exercise, tests, school, work), in 
addition to assessing morning alertness, morning appetite, evening tiredness, and alarm 
clock dependency. MEQ scores can range from 16 to 86, with lower scores indicating 
evening types and higher scores indicating morning types.  
Pittsburgh Sleep Quality Index (PSQI)- 19-item parent report measure to assess sleep 
quality and usual sleep habits over the previous month.  PSQI yields subscale scores for 
sleep quality, latency, duration, sleep efficiency, sleep disturbances, use of sleeping 
medications, and daytime dysfunction.  Survey items are rated on a 0-3 Likert scale, 
with higher scores indicating poor sleep quality and poor sleep habits. 
PROMIS 
 
PROMIS Physical 
Functioning, fatigue, 
anxiety, depression, peer 
relationships, pain 
interference 
PROMIS Pediatric profile-  child report of physical function, fatigue, anxiety (6 items 
that tap into fear [fearfulness, worry], depressive symptoms [negative mood [sadness, 
guilt], peer relationships [quality of relationships with friends and other acquaintances] , 
pain interference (pain interfering with routine activities over the past 7 days and one 
single pain intensity item (average pain intensity over the past 7 days) 
PROMIS 29 profile- 29-item parent report of physical function, fatigue, anxiety, and 
depression. 
Peds QL Multidimensional Fatigue Scale 18-item child report of fatigue in last 
month; yields 3 subscale (general fatigue, sleep/rest fatigue, cognitive fatigue) & total 
fatigue score.  
PROMIS Sleep disturbance- - 8-item child and parent report of self-reported 
perceptions of sleep quality, depth, and restoration (e.g., perceived difficulties falling 
asleep and staying asleep, sleep satisfaction) within  r the past 7 days; higher scores 
indicate greater sleep/wake disturbance 
PROMIS Sleep-related impairment- 8-item child and parent report of self-reported 
alertness, sleepiness, tiredness, and functional impairments associated with sleep 

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problems during waking hours within the past 7 days; higher scores indicate more 
impaired alrterness 
 
Health Outcomes 
 Global Health 
 
 
 
 
 
 
 
 
 
 
Family  Function 
 
Health Care Utilization  
 
 
 
Pediatric Quality of Life Inventory -13 item child report of physical functioning, 
emotional functioning, social functioning, and school functioning over the past 7 days. 
Total HRQOL, and two summary scores (Physical Health and Psychosocial Health), 
with higher scores indicating better QoL. 
PROMIS Global Health – child and parent report of overall health and well-being.  
Scores in each dimension are summed per outlined manual protocols. 
.   
Pediatric Quality of Life Family Impact Module (parent) 36-item parent-report 
measure of family function over the last month. Domains include: 1) Physical Function, 
2) Emotional Function, 3) Social Function, 4) Cognitive Function, 5) Communication, 
6) Worry, 7) Daily Activities, and 8) Family Relationships; Items are summed and 
scaled to calculate a total and family functioning score (higher scores indicate better 
functioning).  
 
5-item parent report tool comprised of yes/no questions related to seeking health care on 
behalf of self and/or child. 
 Actigraphy 
Actiwatch 64 Small wrist watch that measures body movement and estimates of total 
sleep time, amount of wake, sleep quality, bedtime and waketime variability. 
 Sleep diary 
 
Electronic daily sleep and pain diary-children and parents will complete an electronic 
sleep diary twice a day for 10 days. Children and parents will complete the diary at 
bedtime and upon waking (what time you went to bed, wake up, # and duration of night 
awakenings), events that may disrupt your sleep (anxious about a test; hobbies [music 
recital, basketball game, school event], parent out of town, fight with a friend, 
homework, sickness). 
Below questionnaires to be completed by treatment group only: 
Treatment Evaluation Inventory and End of Study Survey  Acceptability Survey  only the treatment group will 
complete this survey.  11-item survey to be used in post-intervention interview with parent and child.  Survey includes 6 open-
ended questions and 5 Likert scale questions (1=strongly disagree, 5=strongly agree).  Items assess participant acceptability of 
various components of the SLEEPSMART Study.  
5.3 Data sources. For all types of data that you will access or collect for this research: Identify whether you are 
obtaining the data from the subjects (or subjects’ specimens) or whether you are obtaining the data from some 
other source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
 
Data will be obtained from the child and parents in the form of:  
Aims 1 & 2:  semi-structured interviews, & videotaping, and testing of the REDCap SLEEPSMART Website use 
– site tracks unique ID logon date, time, duration; 
 Aim 3: surveys (REDCap), sleep diaries (REDCap), and wrist watch.  REDCap SLEEPSMART Website use – 
site tracks unique ID logon date, time, duration. 
 
The CRA at SCH will collect information from the child’s medical record (name, age, sex, phone number, 
address), JIA form (disease duration, onset of symptoms, JIA type, active or inactive disease ).  The research 
staff at CHOP will not collect this information, rather parents will complete demographic survey that 
includes child age, gender, disease duration, JIA type, and active or inactive disease. 

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5.4 Retrospective/prospective. For all types of data and specimens that you will access or collect for this research: 
Describe which data are: 
• Retrospective (i.e., exist at the time when you submit this application) 
• Prospective (i.e., do not yet exist at the time when you submit this application) 
• Both retrospective and prospective (for example, past and future school records) 
 
Aims 1 &2: We will collect all prospective data, though semi-structured interviews, video recording, self-report 
data may include retrospective recall via medical charts (e.g. , age, JIA diagnosis). 
5.5 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 to assist you in identifying 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. See, 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 your 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.  
a. Will you or any members of your team have access to any direct or indirect identifiers? 
 
x 
Yes 
 If yes, describe which identifiers and for which data/specimens.  
 
 
 
The CRA, staff at CHOP, RA, and PI will have access to direct identifiers: medical charts 
to determine participant eligibility (name, age, address, phone number, sex, JIA 
diagnosis); and the PI and the team will have access to indirect identifiers: participant 
code.  
 
 
No 
 If 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 you have access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any 
circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. 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. 
 
 
 
 

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There are other legal requirements prohibiting the release of the identifiers or key to 
you. Describe them below.   
 
 
 
 
 
 
      
b. Will you obtain any direct or indirect identifiers? 
 
x 
Yes 
 If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
The CRA at SCH  and staff at CHOP will obtain direct identifiers from medical charts to 
determine participant eligibility (name, age, sex, address, phone number, JIA 
diagnosis).  
Parent: Legal first, middle (if applicable), last name; date of birth; city/country of birth; 
gender at birth; parent email address; telephone number; home address; for study 
communication, study mailings  
• SLEEPSMART website will track IP address for website login dates, usage 
 
Child: Legal first, middle (if applicable), last name; date of birth; city/country of birth; 
gender at birth;  
• SLEEPSMART website will track IP address for website login dates, usage 
 
 
 
No 
 If 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 you have access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any 
circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. 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 to 
you. Describe them below.   
 
 
 
 
 
 
      
c. If you obtain any identifiers, indicate how the identifiers will be stored (and for which data). 
 
 
You will store the identifiers with the data. Describe the data to which this applies: 
 
 
 
 
 
 
You will store identifiers and study data separately but you will maintain a link 
between the identifiers and the study data (for example, through the use of a code). 
Describe the data to which this applies: 
 
x 
 
 
 
 
Study participants will be assigned a number in the order they enroll in the study.  The 
link between the participant identify and study code number (a written list) will kept in 

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the CRA’s locked office in a locked file, separate from the data collected during the course 
of the study and participant identity.  
 
 
You will store identifiers separately from the study data, with no link between the 
identifiers and the study data. Describe the data to which this applies: 
 
 
 
 
 
 
      
d. Research collaboration. Will individuals who provide you with coded information or specimens for your 
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. 
The CRA who works in the Pediatric Rheumatology clinic at SCH and research staff at CHOP Pediatric 
Rheumatology clinic, will review medical record for participant eligibility and assist with participant 
recruitment will have access to direct identifiers.  The PI will also have access to direct identifiers.  Drs. 
Tonya Palermo & Sarah Ringold, who work at SCH will be involved in 1) study, interpretation, or analysis 
of the data that results from the coded information; and (2) authorship on presentations or manuscripts 
related to this work. 
5.6 Newborn dried blood spots. Will you use newborn dried bloodspots collected in the United States on or after 
March 18, 2015? 
 
x 
No 
 
 
 
Yes  If yes, is this research supported by any federal funding (including any fellowship or career 
development award that provides salary support)? 
 
 
 
 
 
No 
 
 
 
Yes 
 If yes, describe how you will ensure that the bloodspots were collected with 
parental permission (in compliance with a 2015 law that applies to federal-funded 
research). 
 
 
 
      
5.7 Protected Health Information (PHI). Will you access, obtain, use, or disclose a participant’s identifiable PHI 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. 
 
 
No 
 If no, skip the rest of this question; go to question 5.8 
 
 
Yes 
 If yes, answer all of the questions below. 
 
 
a. Describe the PHI you will access or obtain, and the reason for obtaining it. Be specific. 
 
The CRA and the staff at CHOP will not obtain consent to obtain information from the child’s 
medical chart - name, age, sex, phone number, address, JIA diagnosis, to identify potential eligible 
subjects. 
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
x 
Yes 
 

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c. Describe how you will access or obtain the PHI. Be specific. 
 
The CRA at SCH and the staff at CHOP will be the only member of the team who will have 
access to the medical records to determine participant eligibility. The CRA at SCH and staff at 
CHOP- who works in the Pediatric Rheumatology clinic, will recruit potential subjects and review 
the medical charts because she will need the above PHI for study eligibility.   
d. For which PHI will you obtain HIPAA authorization from the subjects by having them sign a HIPAA 
Authorization form, before obtaining and using the PHI?  
 
  
 
Confirm by checking the box that you will use the UW Medicine HIPAA Authorization form 
maintained on the HSD website if you will access, obtain, use, or disclose UW Medicine PHI. 
 
 
Confirmed 
 
 
e. For which PHI will you NOT obtain HIPAA authorization from the subjects? 
Name, age, sex, address, JIA diagnosis 
 
Provide the following assurances by checking the boxes. 
 
 
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. 
 
x 
 
 
 
 
You will fulfill the HIPAA “accounting for disclosures” requirement. See UW Medicine Privacy 
Policy #25. THIS IS ONLY FOR UW RECORDS. 
 
x 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
x 
 
 
 
 
5.8 Genomic data sharing. Will you obtain or generate genomic data (as defined at 
https://gds.nih.gov/13faqs_gds.html)? 
 
x 
No 
 
 
 
Yes 
 If yes, answer the question below. 
 
a. Is this research funded by NIH through a grant or contract application submitted to NIH on or 
after January 25, 2015? 
 
 
No 
 
 
 
Yes 
 If yes, you must comply with the NIH Genomic Data Sharing policy. Complete 
the ZIPLINE SUPPLEMENT Genomic Data Sharing and upload it to the 
Supporting Documents SmartForm of Zipline. 
 
 

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5.9 Data and specimen sharing/banking. Do you plan to share some or all of the data, specimens, or subject contact 
information with other researchers or a repository/database, or to bank them for your own future unspecified 
research uses? You are strongly encouraged to consider the broadest possible future plans you might have, and 
whether you will obtain consent now from the subjects for future sharing or unspecified uses. Answer NO if 
your only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
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: informal arrangements to share your banked 
data/specimens with other investigators; establishing a repository from which you formally share with others through written 
agreements; or sending your data/specimens to a third party repository/archive/entity such as the NIH dbGaP database, the 
Social Science Open Access Repository (SSOAR), or the UCLA Ethnomusicology Archive.   
 
 
No 
 
 
X 
Yes  If yes, answer all of the questions below. 
 
a. Describe what will be stored, including whether any direct or indirect (e.g., subject codes) 
identifiers will be stored.  
 
Aim 3 only  
Funding requires use of NIH common data elements Biomedical Research Informatics 
Computing System (BRICS).  This system uses a computer program that researchers 
download onto their university computer.  Researchers then enter subject personally 
identifiable information to derive a series of one-way hashes which securely encrypt the 
subject information.  One way hashes are sent to the GUID server for reference and 
storage.  No personally identifiable information is sent to the system.  The GUID server 
returns a GUID identifier.  If the one way hashes match a known subject, an existing 
GUID will be returned; if it is a new subject, a new GUID will be returned.  PI will 
store GUIDs for subjects.  
 
b. Describe what will be shared, including whether direct identifiers will be shared and (for 
specimens) what data will be released with the specimens.  
 
Aim 3 only 
Once the researcher has a GUID, s/he may submit data associated with this subject.  Researchers 
are then able to access data in the BRICS database across studies without revealing personally 
identifiable information.  Use of GUID is required by the NIH/NINR funding mechanism for 
this study.   
Common Data Elements shared will not contain PHI, but rather the GUID, and relate to parent-
reported PROMIS measures (sleep disturbance, global health, fatigue, anxiety, depression 
scores).  At this time, no plan to share child common data elements. 
 
c. Who will oversee and/or manage the sharing?  
 
Common data elements will be accessible by researchers to potentially pool and analyze 
data across studies. 
 
d. Describe the possible future uses, including limitations or restrictions (if any) on future uses or 
users. As stated above, consider the broadest possible uses. 
 
Examples: data will be used only for cardiovascular research; data will not be used for research on 
population origins. 
 
      

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e. Consent. Will you obtain consent now from subjects for the banking and/or future sharing?  
 
 
No 
 
 
X 
Yes 
 If yes, be sure to include the information about this consent process in the 
consent form (if there is one) and in your answers to the consent questions in 
Section 6. 
 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from banking or sharing?  
 
X 
No 
 
 
 
Yes 
 If 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. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that you will comply with UW 
(and, if applicable, UW Medicine) policies that require a formal agreement between you and 
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 your template agreement forms; the IRB neither 
reviews nor approves them 
 
X 
Confirmed 
 
5.10 Communication with subjects during the study. Describe the types of communication (if any) you 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.  
 
Email, letter to eligible participants about the study; phone calls about reminders for the interview, to 
wear the watch, completing surveys on REDCap, and returning the watch in a prepaid envelope.  
5.11 Future contact with subjects. Do you plan to retain any contact information you obtain for your subjects so that 
they can be contacted in the future? 
 
 
No 
 
 
x 
Yes 
 If yes, describe the purpose of the future contact, and whether use of the contact information will 
be limited to your team; if not, describe who else could be provided with the contact information. 
Describe your criteria for approving requests for the 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. 
 
Consent includes section where parent may opt in/out of retaining contact information for 
future research studies.  If they opt in, subject provides preferred method of contact (phone, 
email, mailing address).  If opt in, information will be stored on PI’s secure network and 
accessible only to the PI and her research team. This procedure was successful in our prior 
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5.12 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.  
 
x 
No 
 
 
 
Yes 
 If yes, describe the alternatives. 
 
 
 
      
5.13 Upload to the Supporting Documents SmartForm of Zipline all data collection forms (if any) that will be directly 
used by or with the subjects, and any scripts/talking points you will use 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 you will cover 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 your research, provide a description of the process by which you will establish the data 
collection/questions as you interact with subjects, how you will document your data collection/questions, the topics you 
plan to address, the most sensitive type of information you will plan to gather, and the limitations (if any) on topics you 
will raise or pursue. 
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 you will use for data that will be gathered in an evolving way. 
• The general content of questionnaires, surveys and similar instruments for which you are seeking general 
approval. (See the NOTE bullet point in the instructions above.) 
 
Primary data collection method will be via semi-structure interviews (Aims 1 & 2), and  
REDCap surveys – PDF versions of these surveys will be attached (Aim 3). 
5.14 Send HSD a Confidentiality Agreement if you will obtain or use any private identifiable UW records without 
subject’s written consent (for example, screening medical records or class grades to identify possible subjects). 
The Confidentiality Agreement form must be completed, printed, signed, and mailed to the Human Subjects Division at Box 
359470. Your IRB application cannot be approved until we receive the Confidentiality Agreement. 
 
 

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6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does your 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. See the 
WORKSHEET: Children for details.   
• The generic age of consent may be different in other states, and in other countries.  
 
 
No 
 If no, go to Section 8. 
 
x 
Yes 
 If yes, provide the age range of the minor subjects for this study and the legal age for consent in 
your population(s). If there is more than one answer, explain.   
 
 
 
 
8-13 YEARS 
 
 
Don’t know 
This means is it not possible to know the age of your subjects. For example, this may be 
true for some research involving social media, the Internet, or a dataset that you obtain 
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. 
a. Will you obtain parental permission for: 
 
 
All of your research procedures 
 Go to question 6.2b. 
 
x 
 
 
 
 
None of your research procedures 
 Use the table below to provide your justification, and skip 
question 6.2b. 
 
 
 
 
 
 
Some of your research procedures 
 Use the table below to identify the procedures for which you will 
not obtain written parental permission. 
 
 
 
 
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 
permission 
Reason why you will not 
obtain parental 
permission 
Will you inform 
them about the 
research?2 
 
 
 
YES 
NO 
N/A 
N/A 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
2. Will you inform them about the research beforehand even though you are not obtaining active permission? 
b. Indicate by checking the appropriate box(es) your plan for obtaining parental permission 
 
 
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.  
 
x 
 
 
 
 
This is all that is required for minimal risk research. 
 
If you checked both boxes, explain: 
 
      Research is minimal risk, one parent will provide consent.      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
 
x 
No 
 
 
 
Yes  If 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). Your answer 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 
 
 
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
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 giving their verbal choice about whether they want to 
participate. They may also provide a written assent if they are older. See WORKSHEET: Children for circumstances 
in which a child’s assent may be unnecessary or inappropriate.   
a. Will you obtain assent for: 
 
 
All of your research procedures and child groups 
 Go to question 7.2. 
 
x 
 
 
 
 

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None of your research procedures and child groups 
 Use the table below to provide your 
justification, then skip to question 7.5. 
 
 
 
 
Some of your research procedures and child groups 
 Use the table below to identify the 
procedures for which you will not obtain 
assent.  
 
 
 
 
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 you will not obtain assent 
N/A 
Consent and Assent will be obtained verbally 
& electronically. 
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
7.2 Assent process. Describe how you will obtain assent, for each child group. If your research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how you will ensure that they comprehend the information you provide. 
 
Following parental consent, a research team member will read the assent form to the child with the parent nearby- 
either on the phone or in person at the clinic visit.  The CRA will answer any questions, and will 
emphasize that participation is voluntary, and they can stop anytime. All participants will provide assent 
verbally and electronically thru REDcap. The parent will be provided a copy of the assent form. 
Participants will be given the opportunity to ask questions of the CRA over the telephone, and/or in the 
presence of their parent/legal representative.  
7.3 Dissent or resistance. Describe how you will identify a child’s objection or resistance to participation (including 
non-verbal indications) during the research, and what you will do in response.  
 
We will remind participants that no one will be mad at them if they chose not to participate or complete the study, 
and we will ask whether the participant is comfortable with participation prior to beginning the study procedures, 
and during the study procedures. We will invite questions from the participants, and efforts to clarify and simplify 
the research and participants’ roles will be prioritized, as well as providing reminders that research participants 
always retain the right to withdraw from the study at any time. 
7.4 Documentation of assent.  Which of the following statements describes whether you will obtain documentation of 
assent? 
 
 
None of your research procedures and child groups 
 Use the table below to provide your 
justification, then go to question 7.4.a. 
 
x 
 
 
 
 
All of your research procedures and child groups 
 Go to question 7.4.a, do not complete the 
table 
 
 
 
 
 
 
Some of your research procedures and/or child groups 
 
 

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 Complete the table below and then to go 
question 7.4.a 
Children 
Group1 
Describe the procedures or data/specimen 
collection (if any) for which assent will 
NOT be documented 
Reason why you will not document assent 
Children and 
parents 
 We are not obtaining an ink signature for 
subjects assent 
 Verbal and electronic (RECap) assent will be 
documented 
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
 
a. Describe how you will document assent. If the children are functionally illiterate or are not fluent in English, 
include a description of what you will do. 
 
 
Assent for child and parents will be obtained verbally and electronically thru a secured link (REDCap). Study 
eligibility for participants includes understanding and speaking English because the surveys have not been 
translated into other languages, and given we are asking child to respond to the surveys—literacy is needed. 
Thus participants who are not fluent in English and/or functionally illiterate are  not eligible for the study. 
 
b. Upload all assent materials (talking points, videos, forms, etc.) to the Consent Form and Recruitment 
Materials SmartForm of 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. 
7.5 Children who reach the legal age of consent during participation in longitudinal research.  
Children who were 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 you did not at the beginning of their participation).  
Children who reach the legal age of consent: You must obtain informed consent 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.  
 
a. Describe your plans (if any) to re-obtain assent from children.  
 
We will not re-obtain assent from participants. 
 
b. Describe your plans (if any) to obtain consent for children who reach the legal age of consent.  
• If you plan to obtain consent, describe what you will do about now-adult subjects whom you are unable 
to contact.   
• If you do not plan to obtain consent or think that you will be unable to do so, explain why.  
 
N/A 

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7.6 Other regulatory requirements. (This is for your 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 
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 usually (but not always) includes an 
opportunity for subjects to ask questions. It does not necessarily include the 
signing of a consent form. This question is about the consent process. 
CONSENT DOCUMENTATION 
refers to how a subject’s decision to participate in the research is documented. 
This is typically obtained by having the subject sign a consent form. 
CONSENT FORM 
is a document signed by subjects, by which they agree to participate in the 
research as described in the consent form and in the consent process. 
ELEMENTS OF CONSENT 
are specific information that is required to be provided to subjects. 
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. 
SHORT FORM CONSENT 
is an alternative way of obtaining written documentation of consent that is most 
commonly used with individuals who are illiterate 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. 
WAIVER OF DOCUMENTATION 
OF CONSENT 
means that there is IRB approval for not obtaining written documentation of 
consent. 
8.1 Groups Identify the groups to which your answers in this section apply. 
 
X Adult subjects 
 
x 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. 

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8.2 The consent process. This series of questions is about whether you will obtain consent for all procedures except 
recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.6. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which you will not obtain consent? 
 
x 
No 
 
 
 
Yes 
 If yes, use the table below to identify the procedures for which you will not obtain consent. 
“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 or 
data/specimen collection (if 
any) for which there will be NO 
consent process 
Reason why you will not obtain 
consent 
Will you 
provide 
subjects with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
N/A 
N/A 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all groups you can collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if you will obtain consent 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).  
• 
Whether/how you will provide an opportunity for questions 
• 
How you will provide an adequate opportunity for the subjects to consider all options 
 
 
The CRA at SCH will meet with potential parent participants over the phone at a convenient time.  There, she 
will describe the study, answering any questions, and emphasize that their participation is voluntary.  
Participants may ask questions any time. Should the CRA be unable to answer these questions, they will be 
referred to the PI who will then communicate the answers back to the potential participant and allow ample 

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time for any questions. Parental permission and consent will be obtained verbally and electronically through 
REDCap. All participants will receive a copy of the signed consent. 
    Participants recruited from CHOP will contact the CRA directly via email or phone to learn more about the 
study. 
c. Comprehension. Describe how you will ensure or test the subjects’ understanding of the information during the 
consent process. 
 
Ask if the subject has any questions.  Ask the subject to review the basic study procedure, providing prompts if 
needed (baseline visits, study duration, follow-up visits).  Intervention involves weekly online activities. 
 
We will ask the participants to describe the study in their own words.  Assessment of the potential child’s 
understanding of the research and what is expected of them will be done by asking child to describe in their 
own words what they would do if they agreed to participate. For example, please tell me why we are having 
your wear a wristwatch?  In addition, CRA and/or PI can assess how well participants understand the study 
through the types of questions, and appropriateness of questions, raised by participants during discussions 
related to the study. 
d. Influence. Does your research involve any subject groups that might find it difficult to say “no” to your research 
because of the setting or their relationship with you, even if you don’t pressure them 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 
 
 
x 
Yes 
 If yes, describe what you will do, for each of these subject groups, to reduce any effect of the 
setting or relationship on their decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects’ physician; the researcher will 
not know which subjects agreed to participate; subjects will have two days to decide after hearing about 
the study. 
 
Participants will  use electronic consent and assent via REDCap. The CRA at SCH will obtain 
consent instead of the participant’s physician.   
e. Ongoing process. For research that involves multiple or continued interaction with subjects over time, describe 
the opportunities (if any) you will give subjects to ask questions or to change their minds about participating. 
 
Prior to any subject interaction, parents and children will be asked if they have any questions or concerns about 
participating.  They will be reminded that they may stop at any time.  During online participation, written 
prompts remind that they may stop at any time. 
8.3 Written documentation of consent. Which of the statements below describe whether you will obtain 
documentation of consent? NOTE: This question does not apply to screening and recruiting procedures which 
have already been addressed in question 4.6. 
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 
a. Are you obtaining written documentation of consent for: 
 
 
None of your research procedures  
 Use the table below to provide your justification then go to 
question 8.4. 
 
x 
 
 
 
 

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All of your research procedures  
 Do not complete the table; go to question 8.4. 
 
 
 
 
Some of your research procedures 
 Use the table below to identify the procedures for which you will 
not obtain written documentation of consent from your adult 
subjects.  
 
 
 
 
Adult subject 
group1 
Describe the procedures or data/specimen collection (if any) for 
which there will be NO documentation of consent 
Will you 
provide them 
with a written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
N/A 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
JIA children and 
parents 
parental permission and parental consent verbally and electronically 
through REDCap. 
 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all adult groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
8.4 Non-English-speaking or -reading adult subjects. Will you enroll adult subjects who do not speak English or who 
lack fluency or literacy in English? 
 
x 
No 
 
 
 
Yes 
 If yes, describe the process you will use 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. 
 
 
 
      
 
a. Interpretation. Describe how you will provide interpretation 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.  
 
      

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b. Translations. Describe how you will obtain translations of all study materials (not just consent 
forms) and how you will ensure 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 locale in which they will be used.  
 
      
8.5 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. 
a. Describe your 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). Skip this 
question if you are not obtaining written documentation of consent for any part of your research.  
Examples of solutions: Translated consent forms; use of the Short Form consent process; reading the form to the person; 
excluding individuals who cannot read and understand the consent form.   
 
We will exclude participants who cannot read and understand the consent form because we are interested in 
child’s responses about sleep and symptoms.  Thus understanding of English is required. 
8.6 Deception. Will you deliberately withhold information or provide false information to any of the subjects? Note: 
“Blinding” subjects to their study group/condition/arm is not considered to be deception. 
 
x 
No 
 
 
 
Yes 
 If yes, describe what information and why. 
 
 
Example: you may wish to deceive subjects about the purpose of the study. 
 
      
 
a. Will you debrief the subjects later? (Note: this is not required.) 
 
 
No 
 
 
 
Yes 
 If yes, describe how you will debrief the subjects. Upload any debriefing 
materials, including talking points or a script, to the Consent Form and 
Recruitment Materials SmartForm of Zipline. 
 
 
 
      
8.7 Cognitively impaired adults, and other adults unable to consent. 
 
a. Cognitively impaired adults and other adults unable to consent. Do you plan to include such individuals in 
your research? 
 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, or who are 
significantly intoxicated. 
 
x 
No 
 If no, go to question 8.8. 
 
 
Yes 
 If yes, answer the following questions. 

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a.1. Rationale. Provide your rationale for including this population in your research.  
 
      
 
a.2. Capacity for consent / decision making capacity. Describe the process you will use to 
determine whether a cognitively impaired individual is capable of consent decision 
making with respect to your research protocol and setting.  If you will have repeated 
interactions with the impaired subjects over a time period when cognitive capacity could 
increase or diminish, also describe how (if at all) you will re-assess decision-making 
capacity and consent during that time. 
 
 
      
 
a.3. Permission (surrogate consent). If you will include adults who cannot consent for 
themselves, describe your process for obtaining permission (“surrogate consent”) from a 
legally authorized representative (LAR).   
 
For research conducted in Washington State, see the SOP: Legally Authorized Representative to 
learn which individuals meet the state definition of “legally authorized representative”. 
 
 
      
 
a.4. 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 you will use to obtain and document assent from the subjects.  
 
 
      
 
a.5. Dissent or resistance. Describe how you will identify the subject’s objection or resistance 
to participation (including non-verbal) during the research, and what you will do in 
response. 
 
 
      
8.8 Consent-related materials. Upload to the Consent Forms and Recruitment Materials SmartForm of 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 you will use. 
• 
Translations must be included. However, you are strongly encouraged to wait to provide them until you know that the IRB 
will approve 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 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. 
 
 

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9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Describe the steps you will take, 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 call” recruitment letters will inform the subject 
about how their information was obtained. 
• 
Recruiting subjects immediately prior to a sensitive or invasive procedures (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. 
 
Some participants may feel a violation of privacy if they receive a letter asking them to participate in a study 
because their child has JIA, when their name, contact information, and medical condition were drawn from 
medical records without their consent.  Eligible participants will receive a phone call  and/or a letter asking them 
to participate in this study because they have a child with JIA. 
This research will gather several types of sensitive information, around which special care must be taken.  We will 
take measures to ensure that this information is handled appropriately, safely, and only for the scope of this 
research.  There are additional privacy and confidentiality concerns with reporting health-related information in 
the study. 
Loss of Privacy: Participants will be informed that their information will be kept confidential.  Participant 
confidentiality will be protected by using a study identification number on all records.  The audio-recorded 
interviews and videorecording with the participant’s study specific identification number and stored on a separate 
password-protected, secure server at the SON. Participants’ contact information will also be stored separate from 
study data and identifying numbers in a file on a password-protected server. All electronic data will be stored on 
password-protected servers and all identifying information will be deleted from the qualitative interviews during 
the transcription process. The wrist watch device will not contain any private or confidential information and will 
be linked to the participant only through the unique study identification number. Information will be compiled 
from all the participants in the study and, when published, data will be reported in aggregate form. As a result of 
aggregation, no individual participants will be identifiable from the written materials.  
 
Data collection forms used during the study will be surveys and identified only by assigned code number. 
Participants will complete sleep diaries through the web-based electronic data capture interface, which is 
password-protected and encrypted (no direct identifiers will be present among the electronic data).  Research paper 
forms will be kept in a locked file cabinet in CRA’s office separate from the consent forms and code list, available 
only to authorized research colleagues assisting with data analysis.  No participants will be identified in any report 
or publication about this study.  Data collected via surveys using the iPad will use REDCap, which is password 
protected and encrypted, with no direct identifies present among electronic data. 
 
The protection of human subjects in the proposed study is ensured through control of access to the data, 
maintenance of locked files for data and consent forms, and careful training and supervision of all research 
personnel.  Subject identifying information will be accessible only to study personnel with appropriate access 
privileges and will be kept in a locked office in a locked file, separate from other study materials.  Electronic data 
will be stored on a secure server that requires password access form a computer with a registered domain to gain 
entry. 
 
Risk of unauthorized disclosure of an individual’s data to others outside of the study personnel is possible.  To 
protect information, we will keep subject names or any number that could identify them separate from study data.  
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9.2 Identification of individuals in publications and presentations. Do you plan to use potentially identifiable 
information about subjects in publications and presentations, or is it possible that individual identities could be 
inferred from what you plan to publish or present?  
 
 
No 
 
 
x 
Yes  If yes, will you obtain subject consent for this use? 
 
x 
Yes 
 
 
 
No 
 If no, describe the steps you will take to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
With child and parent permission, we will share the video recording in an online 
intervention that we would like to develop (see Aim 3) to help JIA children self-
manage their sleep. Participants will have the option of opting out of the video 
recording. 
9.3 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 your research team likely to learn of any of the above events or circumstances while 
conducting your research AND feel obligated to report it to state authorities? 
 
 
No 
 
 
x 
Yes 
 If yes, the UW IRB expects you to inform subjects of this possibility in the consent form or during the 
consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers and data. Check the box below to indicate your assurance that you will not destroy any 
identifiers (or links between identifiers and data/specimens) and data that are part of your research records until 
after the end of the applicable records retention requirements (e.g. Washington State; funding agency or sponsor; 
Food and Drug Administration) for your research. If you think it is important for your specific study to say 
something about destruction of identifiers (or links to identifiers) in your consent form, state something like “the 
link between your identifier and the research data will be destroyed after the records retention period required by 
state and/or federal law.” 
This question can be left blank for conversion applications (existing paper applications that are being “converted” into a Zipline 
application.) 
 
See the “Research Data” sections of the following website for UW Records management for the Washington State research 
rectords retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/gs/research?title=R 
 
See the “Research Data and Records” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: http://www.uwmedicine.org/about/Documents/UWMRRS-1.5.pdf 
 
x 
Confirm 

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9.5 Certificates of Confidentiality. Do you have or, are you planning to obtain, a federal Certificate of Confidentiality 
for your research data? 
 
x 
No 
 
 
 
Yes 
 
9.6 Data and specimen security protections. Identify your data classifications and the security protections you will 
provide, referring to the ZIPLINE GUIDANCE: Data and Security Protections for the minimum requirements for 
each data classification level. You cannot answer this question without reading this document. Data security 
protections should not conflict with records retention requirements. 
 
a. Which level of protections will you apply to your data and specimens? If you will use more than one level, 
describe which level will apply to which data and which specimens. 
 
 
LEVEL 3 DATA.  These data could result in harm that can have genuine impact, but the magnitude and/or 
duration are generally not serious, long-lasting, and/or irreversible. 
 
b. Use this space to provide additional information, details, or to describe protections that do not fit into one of 
the levels. 
 
 
 
 
 
10 RISK / BENEFIT ASSESSMENT 
10.1 Anticipated risks. Describe the reasonably foreseeable 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 you will manage or reduce the risks. Do not describe data security protections here, these are 
already described in Question 9.6. 
• 
Consider physical, psychological, social, legal, and economic risks, including risks to financial standing, employability, 
insurability, educational advancement or reputation. 
• 
Examples of “others”: embryo, fetus, or nursing child; family members; a specific group.  
• 
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; applying appropriate data security measures to prevent 
unauthorized access to individually identifiable data; coding data; taking blood samples to monitor something that 
indicates drug toxicity. 
• 
As with all questions on this application, you may refer to uploaded documents. 
 
Potential Risks: There are potential risks around anxiety related to the interviews, video recording, time 
commitment, possible mild skin irritation from the actigraphy, and confidentiality. Although asking 
questions about what helps you sleep and what keep you up at night, and questions about anxiety, 
depression, pain, fatigue, and global health does not typically result in increased distress in the 
participant, emotional distress is a potential risk. We have used all of the proposed measures in our 
previous studies without any untoward effects. In the course of the study, we may become aware of 
symptoms of depression. There is some indication that child with JIA have increased depressive 
symptoms although data does not suggest that they have increased rates of suicidal ideation. Our 
measure of depressive symptoms (PROMIS measure) does not assess suicidality. However, a child may 
disclose such information in their communication with research team. The Research team is trained to 
carefully monitor such issues (see Suicidal Ideation Assessment Plan below).  There should be minimal 

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discomfort related to the length of the assessments. Total time burden is estimated at 30 minutes for 
parents and child. 
Protection against Risk 
Informed Consent: Participants who meet eligibility criteria and want to participate will complete 
informed consent and pre-treatment measures via the phone and Research Electronic Data Capture 
(REDCap), a secure web-based tracking and on-line data acquisition system. All of the study procedures 
will be explained at that time over the phone as well as the potential risks and benefits of participation. 
Child and parents will be able to ask questions about participation and have them answered. Consent, 
assent and HIPAA forms will be available online for participants to view and save for their records. 
Similar to procedures in our prior studies, these forms will be reviewed over the phone and verbal assent 
and consent will be obtained and documented per the UW IRB. Names and phone numbers of the PI and 
the UW Institutional Review Board are provided in these consent forms. Screening for study eligibility 
involves questions about age, SLE diagnosis, and whether the parent and child speak and understand 
English. 
Time Commitment. Participant burden, specifically time commitment, is the most likely risk related to 
this study. For aims 1 & 2 we anticipate screening and consent to take 30 minutes, and the interviews to 
take 45 to 60 minutes each, and 45 to 60 minutes to videorecord and interact with the online modules. 
For Aim 3, we anticipate screening to take screening and consent to take 10 minutes, and 30 to 35 
minutes for parents and children to complete the surveys per assessment. To minimize subject burden 
during data collection, we chose only the most relevant instruments for sleep, self-management, daytime 
function, health outcomes, and demographic and clinical data. In order to reduce subject burden from the 
length of the data collection, we will allow participants to complete questionnaires at their convenience 
on REDCap. REDCap is designed so that participants can save their information, log off and return to it 
at any time. These data are safeguarded as soon as they are entered providing protection against privacy 
risk even if all measures are not completed at one time. Subjects will receive modest financial 
compensation (gift cards) for the time commitment necessary for their study participation. There will be 
no cost to the subject, parent, or their insurance company for participation in the study.  
Anxiety. To help reduce any discomfort about semi-structured interview questions about sleep or 
answering questions about self-report measures, the research protocol includes standardized measures 
that have been widely used in other research without adverse effects. Prior to initiating the semi-
structured interview questions participants will be reminded that the interview will take between 45 and 
60 minutes to complete. If participants experience stress or discomfort in response to interview 
questions, the interview will be discontinued to tend to the participant’s emotional needs. Prior to video 
recording, the participants will be reminded that the video recording may take between 45 -60 minutes.  
If participants experience stress or discomfort in response to the video recording, participants will have 
an option of not being video recorded  Data collection will resume if and when the participant is ready to 
proceed or delayed until a later date. We will be very clear with participants that their comfort takes 
precedence. In cases where the interview needs to be delayed due to discomfort, that will be noted. Self-
report questionnaires are routinely used in research, and pose no risks.  
Although asking about sleep, pain, fatigue, anxiety, depression, and global health does not typically 
result in increased distress in the participant, emotional distress or anxiety is a potential risk. We have 
used all of the proposed measures in our previous studies without any untoward effects. It is likely that 
some child and/or parents may experience some mild anxiety or discomfort related to completing the 
questionnaires; in rare cases a child or parent may experience substantial stress or discomfort. The 
likelihood of substantial stress or discomfort upon completing questionnaires is extremely low however 
in the event of this rare occurrence the PI would refer the child and/or parent to their legal medical 
provider, provide crisis line information, and provide a list of community counseling resources. In 

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addition, participants will be informed of their right to refuse to participate in any part of the data 
collection and will be given the phone numbers of the PI as well as the UW Institutional Review Board 
in the event that they desire further information or would like to issue a formal complaint. In our prior 
trials we have had no incidents and have successfully followed this monitoring protocol. 
In addition, participants will be informed of their right to refuse to participate in any part of the data 
collection and will be given the phone numbers of the Principal Investigator as well as the UW 
Institutional Review Board in the event that they desire further information or would like to issue a 
formal complaint. 
Suicidal Ideation Assessment Plan. In the event that one of the procedures reveals indicators of suicidal 
ideation, a standard suicide-risk plan will be implemented. Specifically, if any child comments about 
suicide in response to screening, assessments, or volunteers information about suicide or another crisis 
spontaneously in their online communications, staff will follow a flow chart that requires phone contact 
(not email) with the participant to complete several screening measures (Suicide Ideation Scale, Suicide 
Intent Scale) to assess risk. Staff will notify the PI and or Co-I in real-time. The PI who is a nurse (or a 
designated covering investigator such as Dr. Palermo, Co-I and licensed psychologist familiar with this 
protocol & has used this protocol successfully in her prior studies.) will be available 24 hours a day to be 
called via cell phone to address crisis questions. Psychiatric or other life crises that are high risk and 
imminent will be acted upon immediately with staff linking participants to appropriate crisis services. 
These are reviewed immediately with the clinically responsible PI and/or co-Investigator. Lower risk and 
less imminent crises are reviewed within 24 hours by the clinically responsible PI and/or co-Investigator. 
All actions taken will be documented on a case report form.  
Skin irritation. The participant may experience mild skin irritation from wearing a watch device on 
their wrist. Child will have the option of wearing the Actiwatch over a long sleeve shirt to prevent skin 
irritation. If the participant cannot tolerate the watch, the participant may remove the watch. In our prior 
studies, none of the participants experienced skin irritation or intolerance of the Actiwatch. 
Confidentiality. We have several safeguards planned to protect against the loss of confidentiality. All 
data will be coded with a study specific identifying number and all data (quantitative and qualitative) 
will be de-identified. The identifying number will be kept on a password-protected, secure server 
through the Information Technology (IT) department at the SON. The majority of data will be collected 
electronically via the REDCap system and minimal data (screening) will be obtained on paper. 
Participants’ contact information will also be stored separate from study data and identifying numbers in 
a file on a password-protected server. All electronic data will be stored on password-protected servers. 
The wrist watch device will not contain any private or confidential information and will be linked to the 
participant only through the unique study identification number. Information will be compiled from all 
the participants in the study and, when published, data will be reported in aggregate form. As a result of 
aggregation, no individual participants will be identifiable from the written materials.  
 
The subject’s identity as a participant in this study will remain confidential; the research records kept 
confidential; and protected health information safeguarded as required by the UW IRB and HIPAA 
regulations. The research staff and the UW IRB will be allowed to inspect the information collected from 
this study. Only study identification numbers will be used to identify participants on the web site. 
Participants will be given unique user logins and passwords to access the Internet program and will be 
asked not to share these with anyone else. The software will be hosted on a secure server which has 
extensive safeguards in place with two firewalls, the latest virus protection, and daily back up of data. 
All contact information and identifying data will be stored in a secure location within the PI’s sleep lab. 
The subject codebook will be kept on a password protected server to which only study staff has access. 

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Only the research staff and the UW IRB will be allowed to inspect the information collected from this 
study. 
Web-based Security. Use of Secure Hyper Text Transmission Protocol (HTTPS) will provide an 
encrypted communication channel for all communications between the subject and the study staff, 
thereby minimizing the likelihood of interception or modification of data. Specifically, the encrypted 
connections will be used between the subject and the UW server where the data are housed, and between 
the study staff and the UW server. The system will identify individuals responsible for input by 
maintaining an audit trail associated with any creation, modification, or deletion of data. The audit trail 
will also require an explanation of why the data were changed, deleted, or added. The security of the UW 
web database servers, which only allow secure and restricted access to authorized individuals and is 
maintained by the UW Information Technology Group, makes the theft, alteration, or access of data 
extremely unlikely. As data accumulate in the relational database on the database server, it becomes 
increasingly important that the data be protected from theft, alteration, or unauthorized access of any 
kind. The database will reside on a server that is not used as a web server; therefore that server will be 
secured from HTTP, FTP and other forms of remote access. Placement of the database on a distinct, 
secure server will minimize the likelihood of theft or other malicious attacks. These security procedures 
will ensure that access to the server and the database is minimized and tightly controlled. An audit trail, 
with required explanation for any validating, editing, modification, or deletion of data will also be 
required at the database level. 
10.2 Reproductive risks. Are there any risks of the study procedures to men and women (who are 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. 
 
x 
No 
 If no go to question 10.3 
 
 
Yes 
 If yes, answer the following questions: 
 
a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
 
 
 
      
 
b. Steps to minimize risk. Describe the specific steps you will take 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 you will require the use of contraception: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what you will do if a subject (or a subject’s partner) becomes pregnant 
For example; will you require the subject to immediately notify you, so that you can discontinue or modify 
the study procedures, discuss the risks, and/or provide referrals or counseling? 
 
 
 
      

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10.3 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. 
 
x 
No 
 
 
 
Yes 
 If yes, identify the procedures. 
 
 
 
      
10.4 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
subjects-patients are under general or regional anesthesia, or during the 3 hours preceding general or regional 
anesthesia (supplied for non-research reasons)? 
 
x 
No 
 
 
 
Yes 
 If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
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 you checked any of the boxes: 
You must provide the name and institutional affiliation of a physician anesthesiologist who is a 
member of your research team or who will serve as a safety consultant about the interactions 
between your research procedures and the general or regional anesthesia of the subject-
patients. If your procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member.  
 
 
      
 
 
** If you checked the box about radio-isotopes: you are 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. 
10.5 Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as defined 
by NIH). If required for your research, upload your DSMP to the Supporting Documents SmartForm in Zipline. If 
it is embedded in another document you are uploading (for example, a Study Protocol, use the text box below to 
name the document that has the DSMP. 
 
See DSMP—approved by NINR (see supplement materials). 

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10.6 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or you 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 
10.7 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 may withdraw from the study at any time.  Participants will also be asked to provide rationale behind 
their decision to withdraw, though they may choose not to provide rationale.  A member of the team will ask 
if the participants are willing to continue with follow-up assessments, participants may choose to participate 
in data collection or not.   
In the event that one of the procedures reveals indicators of suicidal ideation (e.g., talking about suicide, 
forming a plan for suicide attempt) a standard suicide-risk plan will be implemented.  
10.8 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.  
 
Benefits to participants include learning about their sleep patterns and strategies that may improve sleep self-
management.   
10.9 Individual subjects findings.   
 
a. Is it likely that your research will unintentionally discover a previously unknown condition such as a disease, 
suicidal intentions, or genetic predisposition? 
 
 
No 
 
 
X Yes 
 If yes, explain whether and how you would share the information with the subject. 
 
 
 
In the event participants screen positive for a sleep disorder and/or clinical depression and 
anxiety, we will inform participants and recommend an appointment with their primary care 
provider and we will also provide referral information.  
 
b. Do you plan to routinely share the individual results of your study procedures with the subjects – such as 
genetic test results, laboratory tests, etc.? 
 
 
No 
 
 
x 
Yes 
 If yes, complete and upload the SUPPLEMENT: Participant Results Sharing to the Supporting 
Documents SmartForm of Zipline 
 
 
10.10 Commercial products or patents. If a commercial product or patent could result from this study, describe 
whether subjects might receive any remuneration/compensation and, if yes, how the amount will be 
determined: 
 
N/A 
 
 

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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.  
 
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.   
 
N/A  
11.2 Costs to subjects. Describe any research-related costs for which subjects may be responsible (e.g., CT scan 
required for research eligibility screening; co-pays; cost of a device; travel and parking expenses that will not be 
reimbursed). 
 
Participants will not have research-related costs. 
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses).   
 
Participants will not be reimbursed for travel because we do not require travel in this study.  
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about your faculty advisor.  
• Advisor’s name 
• Your relationship with your advisor (for example: graduate advisor; course instructor) 
• Your plans for communication/consultation with your advisor about progress, problems, and changes.  
 
N/A 
12.2 Study team communication. Describe how you will ensure 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. 
 
 
 
 
The study team has collaborated together on prior studies and are familiar with UW and SCH IRB policies, 
trained and certified in IRB, coercion, HIPAA, risk and benefits.  The PI will provide the CRA and research 
team members at SCH with the approved consent forms and surveys prior to the start of the study. Procedure 
manuals will be used and checklists for data collection sessions.  Any research assistants will be trained by 
the PI and monitored for adherence to procedures.  If modifications are needed, the PI will use the same 
procedure.  Further the study team will meet on a bi-weekly basis to discuss study procedures, recruitment, 
and challenges.  
 
 
 

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13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Other regulatory approvals. Identify any other regulatory approvals that are required for this research, by 
checking applicable boxes 
Do not attach the approvals unless requested by the IRB.   
 
Approval 
Research for which this is required 
 
 
Radiation Safety 
Procedures involving the use of radioactive materials or an ionizing 
radiation producing machine radiation, if they are conducted for research 
rather than clinical purposes. Approvals need to be attached to the 
Supporting Documents page in Zipline. 
 
 
 
 
 
 
Institutional Biosafety 
Procedures involving the transfer/administration of recombinant DNA, 
DNA/RNA derived from recombinant DNA, or synthetic DNA. 
 
 
 
 
 
 
RDRC 
Procedures involving a radioactive drug or biological product that is not 
approved by the FDA for the research purpose and that is being used 
without an IND, for basic science research (not to determine safety and 
effectiveness, or for immediate therapeutic or diagnostic purposes). 
 
 
 
 
 
 
ESCRO 
Procedures involving the use of some types of human embryonic stem 
cells. 
 
 
 
 
13.2 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.   
Do not attach the approvals and permissions unless requested by the IRB. 
 
SCH Rheumatology clinic 
13.3 Financial Conflict of Interest. Does any member of the team have a Financial Conflict of Interest (FCOI) in this 
research, as defined by UW policy GIM 10?    
 
X No 
 
 
 
Yes 
 If yes, upload the Conflict Management Plan for every team member who has a FCOI with respect 
to this research, to the Supporting Documents page of 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. 
 
 
 
 
      
 
 

RESEARCH STRATEGY 
SIGNIFICANCE 
JIA and Sleep Deficiency. JIA is the most common pediatric inflammatory disease with no known cure. An 
estimated 350,000 children in the U.S. are diagnosed with JIA; 20% of those experience lifelong pain and long-
term disability.12 JIA occurs throughout childhood with peak onset between 7 to 12 years.13 Sleep deficiency, 
defined as a deficit in the quantity or quality of sleep obtained 14 is comorbid in JIA, affecting 20-30% of 
children.1-4 Our previous findings show that 20% of 9-to-11 year-old JIA children slept 7.5 hours (below the 9 
hour recommendation), and had poor quality sleep that was associated with increased fatigue and poorer 
HRQoL, regardless of active/inactive disease, disease duration, and pain.1 Comorbid sleep deficiency with JIA 
may further exacerbate disease-related symptoms, and increase healthcare costs. 
Sleep Assessments in Pediatric Rheumatology Care. In our prior study1, 20% of the 9-11 year-old JIA 
children had sleep deficiency, yet none of these children had been screened for sleep deficiency, likely 
because the co-morbidity is often overlooked in clinical care. Pediatric providers have limited knowledge and 
skills to manage sleep deficiency in children,15-17despite it being highly comorbid in JIA.  Low provider 
reimbursement rates, and high caseloads are barriers to assessing and treating sleep deficiency in pediatric 
care.15-17 
Conceptual Framework. Our research was 
informed by the “impaired sleep” framework.18 The 
self-management intervention for sleep deficiency 
(SMID) intervention targets self-management 
behaviors (patient activation, motivation, self-
efficacy), expected to lead to better engagement in 
learning specific sleep strategies to increase sleep 
duration and improve health outcomes (Fig. 1). Self-
management is an ongoing process of self-
identifying needs and wants that require continual 
self-monitoring, problem solving, and the taking of 
appropriate actions.19,20 Self-efficacy (belief in one’s 
capabilities to organize and execute a course of 
action required to produce given goal)21,22 is central to understanding changes in individuals’ attainment in 
health status due to participation in self-management intervention programs. Individuals also need to be 
motivated and to become actively engaged in behavioral change. Because of the important role of parents in 
children’s JIA management, self-management also includes parent’s support of their child’s treatment goals. 
Self-management interventions for JIA. Inadequate amounts of sleep and poor quality are modifiable 
behaviors. Technology-based interventions that integrate self-management skills to promote healthy 
sleep in JIA do not exist. Thus, treatment of sleep will remain suboptimal in a population at risk for sleep 
deficiency. Many of the existing sleep apps have been primarily tested in adults but are not developmentally 
appropriate for children,23,24 do not include self-management components, have not been validated against 
actigraphy,25-27 and target parents of young children.28,29 Sleep deficiency in JIA is likely multifactorial, including 
pre-bedtime activities (homework, media), inconsistent sleep habits (bedtime variability), and/or a lack of 
necessary skills and self-efficacy to follow through with recommendations. An intervention that can modify 
negative beliefs (“My child will sleep better if I let him watch TV”), and increase outcome expectations (“Better 
sleep could make a big difference in my child’s health”) serves to motivate children and parents to make 
behavioral changes. Likewise, an intervention that promotes self-efficacy (“I can be patient and consistent in 
responding when my child wants to use media before bed”) and facilitate changes in the social (“I can get my 
child on board with this plan”) and physical (“I can remove the TV from my child’s bedroom”) environments can 
empower parents and children to follow through with behavioral changes. Lastly, an intervention that 
encourages child/parent activation (“My child and I can monitor progress, set new goals, and seek out the 
support we need”) can give children and parents the tools to ensure their continued success. The proposed 
SMID intervention will be specifically designed to improve child sleep by modifying child/parent negative 
beliefs, increasing outcome expectations and self-efficacy, facilitating change in the social and physical 
environments, and encouraging child/parent activation. 
Scientific Premise. Sleep deficiency is highly comorbid in JIA. Lack of sleep self-management interventions is 
an important problem because these children are vulnerable to the long-term consequences of poor sleep. 
Self-management interventions to promote healthy sleep do not exist, leaving a critical gap in care for this 
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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Fig 2: Study participation in the qualitative 
aspects of the study (including design, 
assessing usability and acceptance).  
population. Based on the success of self-management programs in other chronic illness populations, we 
expect that similar approaches to implementing a sleep self-management intervention in JIA will also be 
feasible and effective. 
INNOVATION. Parents and children routinely use technology as a source of health information. Most children 
and parents do not have access to sleep self-management interventions in their communities. Access to Web-
based technologies among youth is high 30,31 making the proposed intervention have extended reach and 
potential impact. The intervention itself is innovative in several ways, including the focus on the parent-child 
dyad, which offers an important opportunity to explore co-participation, and its emphasis on building self-
management skills to effect changes in sleep health. The school-age years are an important age for healthy 
sleep habits and learning self-management skills32-34 under parental supervision that contribute to improved 
health outcomes. This proposal builds on our prior collaborations with the Center for Innovation in Sleep Self-
Management (Drs. Ward [Co-Director], Demiris [Core Director], Palermo [Advisory board]).  
PRELIMINARY DATA. The team has extensive experience in JIA, sleep, use of actigraphy, development and 
testing of Web-based interventions, usability science, and intervention research in children and families. 
Sleep Deficiency in JIA. Our prior work shows that 40% of JIA children have sleep deficiency as measured by 
actigraphy, with an average duration of 7.5 hours and poor sleep quality (< 85%).1,2 Sleep deficiency was 
associated with fatigue and increased anxiety.35 None of the children had been previously screened or 
assessed for sleep deficiency.  
Evaluation of Web-Based Management of Adolescent Pain (WebMAP). Dr. Palermo (Co-I) has 
successfully conducted a series of RCTs with an internet delivered cognitive-behavioral self-management 
program (WebMAP) for chronic pain.7,9,36-39 WebMAP components were based on evidence-based practices 
that incorporated strategies such as pain coping skills training, parent operant strategies, and relaxation 
training. The RCT involved 273 adolescents with chronic pain and their parents recruited from 14 pain centers 
in the U.S. and Canada.7 Adolescents were randomized to one of two Internet treatment conditions, WebMAP 
(CBT pain intervention) vs WebED (education control). Adolescents receiving WebMAP achieved greater 
improvements on disability, pain-related anxiety, and parent behavior, and distress at 6-month follow up 
compared to adolescents receiving Internet Education. This experience in designing and delivering effective 
web-based self-management skills will help guide the approach of the proposed SMID. 
APPROACH 
Methodology. There is a growing body of literature on the importance of usability testing for smartphone and 
web-based health programs.40-44 Usability methodologies incorporate an iterative process of testing and 
refining the prototype to address user needs.41 A qualitative approach using semi-structured, audio-taped 
interviews and user observation will be undertaken with 
iterative cycles of children with JIA and their parents to 
determine usability of the SMID user interface and to 
further refine the prototype.40-44 This iterative rapid design 
development approach will concentrate on user 
performance (ease of use and learning, errors, and 
efficiency) and satisfaction with program content and 
functionality (reports, goal-setting). Based on 
recommendations45 and previous team experience, each 
usability cycle will include 10 end-users. It typically takes 2-
3 cycles to identify and resolve usability issues.45 While 
human computer interaction literature recommends 5 users 
for a usability cycle, we aim for 10 end-users in each cycle 
to capture the potential breadth of user experiences and 
levels of familiarity with technology use (Fig 2).46,47 
Participants. A sample of 15 children, 9-11 years with JIA, 
and parent (Aim 1, Fig 2) will be recruited from the Rheumatology clinic at Seattle Children’s Hospital (SCH, 
LOS Ringold). In Washington State, over 6,100 children have been diagnosed with JIA.48 Approximately 500 
patients with JIA are seen each year in the Department of Rheumatology, and 250 are between 9 to 11 years.  
Inclusion criterion for children: 1) diagnosed with JIA; 2) 9-11 years; 3) able to read/speak English; and 4) a 
score > 41 on the Child Sleep Habits Questionnaire (CSHQ), suggestive of poor sleep.1-3,49 This age group was 
chosen because of the developmental and physiological sleep needs are similar among children. Nine years of 
age was selected as the lower cut-off due to difficulty in reliably obtaining self-management measures with 
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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children < 8 years.32-34 Exclusion criteria for children: 1) diagnosed sleep disorder (obstructive sleep apnea); 2) 
positive screen on the Pediatric Sleep Questionnaire for OSA50(we will suggest follow up with the child’s 
primary care provider because treatment of this condition is beyond the scope this intervention); 3) co-morbid 
conditions (e.g., ADHD, depression); 4) lack of daily access to the Internet or mobile device as the study will be 
conducted online. Parent is defined as the child’s primary caregiver who co-resides with the child > 50% of the 
time. Inclusion criteria for parents: 1) > 18 years; 2) able to read/speak English. Exclusion criteria for parents: 
1) working nightshift; 2) diagnosed with a chronic illness that would interfere with ability to complete study 
procedures;3) lack of daily access to the Internet or mobile device. If families have more than one eligible child, 
the child with the higher CSHQ score will be included. For families in which the child routinely spends the night 
in more than one home, a primary study parent will be identified and asked to complete all assessments.  
Aim 1. Apply a user-centered design approach to develop and refine a technology-based sleep self-
management intervention (SMID). We will use direct stakeholder input from children and parents about their 
needs for sleep self-management as well as intervention material from our prior Web-based interventions for 
youth with chronic pain that includes sleep hygiene education and a self-management focus to develop content 
for the SMID. We will use qualitative methods (iterative cycles of semi-structured audiotaped sessions with 10 
children and parents and think-aloud observation sessions by a trained observer) to evaluate the usability of 
the SMID prototype. Results of these analyses will guide program finalization.  
Content development team will involve PI (Ward), Co-I’s (Palermo, Demiris),11 and 3 pediatric behavioral sleep 
experts who are familiar in treating sleep deficiency. Palermo’s existing WebMAP program for youth with 
chronic pain will guide the overall structure of the program and use of multimedia elements.7 Content will be 
developed to address core components for treating sleep deficiency in children including sleep education, 
sleep skills training (consistent sleep schedule, bedtime routine), lifestyle changes (activities prior to bed), 
relaxation techniques, positive coping skills, communication) and parents (reinforce and modeling of positive 
coping skills, reward systems for activity participation, communication with children).7 The content team will 
meet on a weekly basis to review content. After the team agrees on the content, multimedia elements, and 
structure of the program, the content will be integrated into an online format. The team will review and provide 
feedback, and modifications to the webpage prototypes will be incorporated. 
Given the diverse platforms utilized currently (ranging from desktop to mobile devices) we will ensure that the 
system will be accessible not just for devices with keyboards and mouse, but also for smartphones and tablets. 
We will follow principles of “responsive web design” namely, a design solution that is adjustable to a variety of 
browser specifications and screen resolutions. This approach takes into account several factors such as user 
behavior, screen size, and operating platform. Responsive design responds automatically and optimally to the 
preferences of the user, regardless of their screen, hardware or browser software of choice. 
In order to reflect user needs into the design, we will use an iterative approach with rounds of interview 
sessions with 10 dyads of children and parents per cycle for up to 3 cycles (Fig 2). Each interview session will 
be a one-hour semi-structured interview. During this interview the trained RA will solicit overall impressions 
about the design of the interface, perceived strengths and weaknesses of the approach as well as any 
suggestions for improving the content or functionality of the system. Following each cycle, changes will be 
made to the user interface based on problems and preferences identified during the previous cycle. The 
revised user interface will then be evaluated in a subsequent cycle (for a total of up to 3 cycles). The same 
participants will be recruited for each cycle.  
Once the design has been finalized and the iterative design process has led to the finalized overall design 
approach, we will organize think-aloud sessions with 5 children-parent dyads (new participants; not previously 
involved in the iterative design process) to identify any potential usability issues (during months 8 and 9) and 
identify opportunities for improvement at a more granular level. We will use a mobile usability laboratory, 
including an electronic tablet loaded with the web application, data for 2 simulated dyads for testing, Morae 
recorder software (version 3.3). Co-I (Demiris) and RA will directly observe (and audio-record) 10 users 
individually (5 children and 5 parents) as they interact with the system. In addition, each user will be asked to 
“think aloud” about how they make specific choices in their interactions, talk through their engagement with the 
tools, verbally describe their actions and strategies when interacting with the tools, any suggestions, what they 
like or dislike, and whether or not navigation is intuitive.51,52 As Nielsen points out,53  running more test subjects 
increases the number of problems found but with progressively diminishing returns; since five test subjects will 
lead to identifying 77-85% of usability problems, it is recommend to engage 5 test users for think aloud 
sessions (in our case as we recruit dyads, we will have 5 children and 5 parents in the think-aloud sessions). A 
think-aloud protocol is based on the concept of participants being asked to think aloud as they interact with the 
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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system and perform a set of specified tasks. Participants are asked to say whatever comes into their mind as 
they complete the task.54 This might include what they are looking at, thinking, doing, and feeling. We will 
identify a series of tasks (such as setting goals, accessing graphs and educational resources) and ask 
participants to verbalize their thoughts as they try to complete these tasks. This provides insight into the 
participant's cognitive processes (rather than only their final impression), making thought processes as explicit 
as possible during task performance.55 All verbalizations during these session will be transcribed and then 
analyzed. 
Data Analysis. Quantitative data from the Usability Error and Efficiency Documentation Form will be analyzed 
using SAS 9.3. using descriptive statistics. Descriptive statistics will be calculated for quantitative usability 
measures (i.e., response time and accuracy) for specific tasks. Incomplete tasks or tasks that take longer than 
planned, will indicate a need for design improvements based on user feedback. Audio-recordings will be 
transcribed and then analyzed by members of the research team. Following procedures explicated by Braun 
and Clarke,56 researchers will employ thematic analysis techniques to identify, analyze, and report patterns in 
the data. First, they will review all transcribed data, creating memos describing their initial impressions and 
noting areas for additional exploration. Then, they will meet to generate an initial list of codes. Over a series of 
face-to-face meetings, they will use NVivo 11 qualitative data management software to code the data with 
existing, refined, or newly created codes. Approximately halfway through qualitative data collection, 
researchers will begin sorting coded data into broader themes. Finally, researchers will define and name each 
theme, highlighting relationships among themes. Disagreements about themes will be handled through analyst 
consensus. Identified glitches, feedback, recommendations will be synthesized for programmers.  
Aim 2. Determine feasibility and initial efficacy of the SMID with children with JIA in a pilot RCT. We will 
determine study accrual and dropout rates as well as levels of patient acceptability and engagement in 
a pilot randomized controlled trial (RCT) comparing usual care to SMID intervention. Preliminary effect 
sizes of the SMID will be determined in youth receiving treatment compared to usual care on primary outcomes 
of actigraphy sleep duration, sleep quality, and feasibility/acceptability, and secondary outcomes of child and 
parent self-management (activation, motivation, self-efficacy), technology use, recommendations for innovative 
sleep monitoring. We hypothesize that children who receive technology-based SMID vs. those who receive 
Usual Care will achieve increased sleep duration and efficiency (quality), immediately post-treatment and at 3 
month follow-up.  
Sample. Sixty children, 9-11 years, diagnosed with JIA and one parent will be recruited from the Pediatric 
Rheumatology Clinic at SCH and remotely via a flyer on the JIA foundation website. 
Recruitment. At SCH, the clinical research assistant (CRA) will give eligible JIA families a study information 
flyer; the flyer will also be posted on the WA JIA website. For both SCH and the JIA website, interested families 
will contact the CRA by calling a phone number on the study flyer. The CRA will describe the study and screen 
for participation. Interested participants will be sent a consent/assent forms by mail, with a prepaid envelope. 
The recruitment methods were fruitful in our prior studies. Inclusion and exclusion criteria for JIA children and 
parents is above. Gender/minority inclusion: Girls and boys are eligible; we expect to enroll more Caucasian 
girls because the heightened disease prevalence among Caucasian girls and its relatively low prevalence in 
other ethnic groups.57,58 JIA patients seen at SCH approximate the national ratio of female:male patients 4:1 
and 95% Caucasian. Biologic variables: We will include sex as covariate in the statistical analysis due to the 
potential confounding effect on sleep.  
Measures. Table 2 shows the measurement plan for the study assessments.2-27,59-72  
Power. We will enroll 60 dyads for a projected sample size of 50 (25/group), assuming 15% attrition. This 
meets recommendations for pilot trials73 and provides 80-90% power to detect moderate effects based on a 
RM ANOVA model with three repeated measures and a correlation of 0.3 between the measurements. This 
power calculation was based on the moderate to large effect sizes for our outcomes of interest (total sleep 
time, d=.48; health related quality of life, d=.51; and fatigue, d = .79) found in our previous research. 
Intervention. All JIA children and parents will receive access to the SMID program, which consists of two 
separate, password-protected web programs, one for child access and one for parent access. The intervention 
is completed in an 8-week period. The program design and treatment content of SMID follow cognitive 
behavioral, social learning, and family systems frameworks. Given the important role of parents in children’s 
self-management of sleep deficiency, parents are engaged throughout the intervention period in their own 
treatment content intended to support their child’s goals and to learn strategies to modify their own behavior in 
response to their child’s sleep deficiency. The child modules will include: sleep education, sleep skills training  
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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(e.g., daily record of 
activities before bed, 
sleep routine and 
schedule), lifestyle 
changes, relaxation 
techniques positive 
coping, relapse 
prevention, reward 
systems for activity 
participation. The 
parent modules 
include: sleep 
education, use of 
attention and praise 
to increase positive 
coping, strategies to 
support self-
management skills 
and goals, modeling 
and communication. 
The program is 
designed to 
enhance self-
management of 
sleep. Children set 
structured and 
personalized goals 
aimed at improving 
their self-
management skills 
and sleep. Given the 
importance of 
homework and practice to change behavior, several components (e.g., positive feedback loops) actively 
encourage user attention and motivation in order to promote skills acquisition and rehearsal. The intervention 
will be interactive and personalized with tailored feedback. Using a diary function on the web site, children track 
their sleep in real-time and can generate customized reports and graphs from their data. Modules will take an 
estimated 20 minutes to complete and will include multimedia elements to enhance learning. Participants will 
be asked to spend additional time practicing skills and completing assignments at the end of each module. A 
message center will allow each child and/or parent to ask questions as they progress in the program. The PI 
will review messages, provide individualized feedback through Web message center. The web site uses a 
multimedia-rich format (e.g., animations, videos, audio clips) to deliver content. The website is built on a 
responsive platform and can be viewed on multiple devices (e.g., smartphones, laptops, tablets) to increase 
ease and flexibility of use. All app and website content is (a) written at a grade 4th grade reading level, (b) 
developmentally appropriate for 9-11 year-olds, and (c) is based on a unifying theme/narrative.  
Measurement Plan. Assessment will occur at (T1 baseline), immediately after intervention (T2) and repeated at 
3 months post-intervention (T3) for both the SMID and usual care groups. All questionnaires will be 
administered using REDCap, a secure web-based tracking and on-line data acquisition system. Children will 
wear an actigraph a reliable and validated measure of sleep25-27 on their non-dominant wrist for 10 consecutive 
days, and complete an electronic symptom diary. After 10 days, parents will mail back the actiwatches in a 
prepaid self-addressed envelope used in PIs prior sleep studies.1,27,35 Actigraphy data will be downloaded, 
scored, and a member of the team will follow up with parents to discuss the baseline sleep patterns within 1 
week. Estimated time burden is 20 minutes for children and 10 minutes for parents. Response burden is 
minimized by online administration, which saves and stores responses. 
Perceived usefulness and acceptance. About one third of all participants (33%; 20 out of 60 dyads) will be 
interviewed at study exit to assess their overall perceptions of the web-based program, the perceived 
usefulness and ease of use. All interviews will be conducted by trained RA in person or via telephone and will 
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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be digitally audio-recorded. Specifically, questions will address the perceived impact of the system on sleep 
self-management, barriers and facilitators to use and whether children and parents would foresee future use 
and recommend the system to others. Audio-recordings will be transcribed and then analyzed by members of 
the research team. Following procedures explicated by Braun and Clarke,56 described above. 
Randomization. Following completion of baseline assessments, participants will be randomized to one of two 
treatment arms. Across groups, children will continue to receive their usual specialty medical care for JIA. A 
blocked randomization scheme will be generated using an online program to derive randomization assignment, 
programmed in the Internet sleep intervention, and not accessible to study investigators. Enrolled participants 
will be continuously randomized.  
Usual Care. This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, 
medications, routine clinical and laboratory tests, physical therapy, follow-up appointments. Sleep intervention 
is not a part of usual care. The CRA will routinely review medical records and document any changes in 
medical care received during the intervention period. 
Data Analysis Plan. Descriptive summaries of recruitment outcomes (number of contacts made related to 
interest in the study, numbers screened, eligible, enrolled, completed), and retention (number of parents and 
children who completed the study, dropouts, reasons given, timing of withdrawals) will be reported. Treatment 
engagement will be measured by completion of at least one module in the SMID program while adherence is 
defined as the completion of 5 or more modules. The administrative interface of the SMID program will have a 
tracking system in place for recording each time a user logs onto the web program. Overall usage statistics will 
include monitoring of program usage (number of logins, duration of time spent completing, time spent on a 
page or feature). Each module will contain multiple-choice quizzes concerning the content presented as well as 
behavioral assignments, fill-in-the-blank fields, and use of the diary tracker. All data fields that are completed 
within modules are stored, generating a comprehensive activity record of module specific use including self-
management tasks. Exit interviews will be assessed as described above. 
Data will be reviewed for completeness and errors including consistency checks for relevant variables. Tabular 
and graphical methods of data exploration including frequency tables and scatterplots will be used to explore 
distributions of study variables. We will adjust for sex, and considered use of either RM ANCOVA or 
generalized estimating equations (GEE) to evaluate intervention effects. We prefer GEE since it allows us to 
account for clustering of repeated assessments within individuals as well as the longitudinal nature of the data 
and provides higher power. Missing data will be examined for patterns and we will employ GEE multiple 
imputation to carry out ITT analysis. Single degree of freedom contrasts by group will be examined if there are 
significant changes in sleep measures from pre- to post-treatment and/or from pre- to 3-month follow-up for 
SMID vs Usual Care. Secondary treatment outcomes will be examined using GEE to explore for mean 
changes across time and between groups using interaction terms and contrasts. The range of outcome 
measures will allow us to obtain experience with alternative measures of sleep, self-management measures 
that will inform our future research. Outcome data will also be used to generate effect size point estimates for 
the future large-scale trial. Design Considerations, Alternative Strategies and Timeline. Project constraints 
on research time and resources will pose study limitations, which we have adjusted for in the study design and 
timeline. As the study requires participant enrollment for 5 months, we anticipate some challenges around 
retention, and have addressed this with a number of strategies described below. Co-I, Dr. Palermo 
successfully recruited and retained youth with chronic pain in Web-based interventions over a period of 12 
months (>90% retention). An attention control group and other parent/child variables were considered but 
feasibility, acceptability, and proof of concept were prioritized for this initial phase. Rigor and Transparency 
will be ensured by: 1) the proposed methods (usability, expert panel, parent/child input); 2) use of successful 
retention strategies from prior studies; 3) documentation of attrition; 4) sample size derived from a priori power 
analysis; 5) statistical methods to account missing data and change overtime. Retention. We will make every 
effort to retain participants with fruitful methods used in our prior studies including: 1) automated reminders built 
into the Web program; 2) phone calls scheduled at convenient times, 3) incentives for completion of each 
assessment ($20 gift card/each Aim 1; Aim 2 [ T1 $40 gift card each; T2 $60 gift card each; T3 $80 gift card 
each]), 3) semi-structured interviews prior to intervention development; and 4) exit interviews post-intervention. 
Strengths include: 1) successful recruitment of JIA children; 2) expertise in sleep, technology-based 
interventions, usability assessments; 3) leveraging of successful methods in a prior Web-based interface; 4) 
development of the first low resource demand, convenient, and personalized sleep self-management 
intervention for JIA. Findings generated will address important methodological issues needed to develop 
innovative sleep self-management intervention for children with chronic illnesses and their parents. 
Contact PD/PI: Ward, Teresa M.
Research Strategy                                                                                             
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