Lifestyle Enhancement for ADHD Program
Phase: NA
Conditions: ADHD
Sponsor: Seattle Children's Hospital

 
Principal Researcher: Pooja Tandon MD MPH 
Protocol Version Number: 6 
Protocol Version Date: 09/11/2019 
 
 
 
 
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PROTOCOL TITLE: 
Lifestyle Enhancement for ADHD Program (LEAP) Study 
PRINCIPAL INVESTIGATOR: 
Erin Schoenfelder Gonzalez, Ph.D. 
Center for Child, Health, Behavior, Development  
206-987-2161 
Erin.Schoenfelder@seattlechildrens.org  
Pooja S Tandon, MD, MPH 
Child Health, Behavior, and Development 
206-884-1130 
Pooja.tandon@seattlechildrens.org 
 

 
Principal Researcher: Pooja Tandon MD MPH 
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Table of Contents 
1.0 
Objectives .............................................................................................................. 3 
2.0 
Background ........................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria ............................................................................ 7 
4.0 
Study-Wide Number of Subjects ........................................................................... 9 
5.0 
Study-Wide Recruitment Methods ......................................................................... 9 
6.0 
Multi-Site Research ............................................................................................... 9 
7.0 
Study Timelines ..................................................................................................... 9 
8.0 
Study Endpoints .................................................................................................... 9 
9.0 
Procedures Involved .............................................................................................. 9 
10.0 Data and Specimen Banking ............................................................................... 14 
11.0 Data Analysis/Management ................................................................................. 14 
12.0 Confidentiality ...................................................................................................... 15 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ........................ 15 
14.0 Withdrawal of Subjects ........................................................................................ 15 
15.0 Risks to Subjects ................................................................................................. 17 
16.0 Potential Benefits to Subjects .............................................................................. 18 
17.0 Vulnerable Populations........................................................................................ 18 
18.0 Community-Based Participatory Research .......................................................... 18 
19.0 Sharing of Results with Subjects ......................................................................... 18 
20.0 Setting ................................................................................................................. 18 
21.0 Resources Available ............................................................................................ 18 
22.0 Prior Approvals .................................................................................................... 20 
23.0 Recruitment Methods .......................................................................................... 20 
24.0 Use of Social Media ............................................................................................ 22 
25.0 Local Number of Subjects ................................................................................... 23 
26.0 Provisions to Protect the Privacy Interests of Subjects ....................................... 23 
27.0 Compensation for Research-Related Injury......................................................... 23 
28.0 Economic Burden to Subjects ............................................................................. 23 
29.0 Consent Process ................................................................................................. 24 
30.0 Process to Document Consent in Writing ............................................................ 27 
31.0 Drugs or Devices ................................................................................................. 27 
32.0 Good Clinical Practice ......................................................................................... 27 
 

 
Principal Researcher: Pooja Tandon MD MPH 
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1.0 
Objectives 
1.1 Describe the purpose, specific aims, or objectives. 
Purpose: Increase physical activity (PA) in children with ADHD using a 
novel, family-based intervention that promotes PA within the context of 
evidence-based behavioral management training (BMT) for parents, 
enhanced with mobile health (mHealth) behavior change strategies. 
Specific Aims: 
1) Test the feasibility and acceptability, of an 8-week, family-based, 
multi-level intervention (BMT-Health) to promote PA in young children 
with ADHD 
2)  to derive an estimate of the effect size of the intervention on PA 
 
1.2 State the hypotheses to be tested. 
The BMT-Health intervention will be feasible and acceptable to families for 
children with ADHD and will show promise for increasing PA in children with 
ADHD 
2.0 
Background 
2.1 Describe the relevant prior experience and gaps in current knowledge. 
Dr. Schoenfelder Gonzalez (Co-PI) is a clinical psychologist with expertise in 
psychosocial treatments and health risk behaviors associated with ADHD. She 
has published on the relationship of ADHD to health risk behaviors,61 and on 
health promotion strategies for this population.61-63 She has worked on RCTs of 
behavioral interventions for ADHD and published outcomes research on 
prevention programs for high-risk youth.64-66 She collaborated with Dr. Mendoza 
(co-I) to complete a study using the proposed technological and social media 
components of the BMT-Health intervention (wearable activity tracker, Facebook 
engagement intervention) that was found to increase PA in adolescents with 
ADHD across a 4-week period.14 
Dr. Tandon (Co-PI) is a general pediatrician and PA researcher with a K23 
Career Development Award focused on promoting PA and outdoor time in early 
childhood, with an emphasis on the neurocognitive benefits of PA.  She and her 
team have considerable experience collecting data via accelerometry and in 
community based interventions to promote PA in children. This work formed the 
basis of an R21/R33 application that was funded and will support a PA 
intervention in preschool children using mHealth technology.  
2.2 This study will combine the use of mHealth wearable technology 
(Garmin vivofit) for children and caregivers, with a social media 
program (Facebook group) for caregivers, delivered through and 
integrated in a BMT program for a technologically and theoretically 
integrated, multi-level intervention approach. This proposal 

 
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represents the first study examining such an intervention to increase 
PA levels and improve health and functioning in children with 
ADHD.See section 2.2 for details of team’s prior research.Describe 
any relevant preliminary data.  
National Survey of Children’s Health: Using nationally representative 
data from two time points over the past decade, we found that  children with 
ADHD are at high risk for engaging in inadequate PA.11 Only about a third 
of children with ADHD were reported to have had 20 minutes/day of MVPA 
in the previous week. Also, less than half of children with ADHD 
participated in sports in the past year. Children with more severe ADHD, 
lower SES, and obesity had lower odds of sports participation, which is not 
surprising but concerning, as these children are also at higher risk for co-
morbidities and health disparities. Of note, medication use in ADHD was 
not associated with sports participation or achieving daily PA. Our findings 
highlight the need to focus on children with ADHD as a high-risk group for 
poor health behaviors. The abstract for this study has been accepted for 
presentation at the American Academy for Child & Adolescent Psychiatry 
Annual Meeting in 2017, and this paper is currently under review. 
Clinic survey results: We developed and piloted a self-report survey data from 
44 caregivers of children being seen for ADHD concerns in the Program to 
Enhance Attention Regulation and Learning (PEARL Clinic) at Seattle Children’s 
Hospital. The measure was administered to all families seen for new evaluations 
in the PEARL Clinic during a 2-month time frame in the spring of 2017. Less than 
12% of parents reported that their children engaged in >60 minutes of PA/day on 
7 days/week. Seventy-six percent of parents reported that their child had 2 or 
fewer day of physical education at school/week. The most commonly identified 
barriers for their children to engage in PA activity were 1) does not do well in 
groups/needs 1:1 supervision, 2) not enough time, and 3) no interest (by child). 
Only 33% of responding parents reported that they themselves achieved the 150 
minutes/week of PA recommended for adults. Eighty-one percent of parents said 
they would be potentially interested in participating in a program to increase their 
child’s PA, and 88% said they would be interested in an activity tracker for their 
child. These survey results highlight both need for, acceptability, and local 
interest in a PA intervention for our families with children who have ADHD. 
Teen ADHD Fitbit study: Drs. Schoenfelder Gonzalez (PI) and Mendoza 
(co-I) recently published a pilot study of an intervention to increase PA in 
adolescents (ages 14-18) with ADHD. Participants wore an activity tracker 
paired with a smartphone app, participated in a Facebook group, and 
received brief health coaching focused on PA goal setting. Across 4-weeks, 
adolescents significantly increased their daily PA, and trends were 
observed of improvement in self- and parent-reported ADHD symptoms.14 
Dr. Mendoza has also completed pilot trials of the proposed technological 
methodology (activity tracker, Facebook group, accelerometry 

 
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measurement), finding good feasibility and acceptability in non-clinical 
groups of adolescents72 and adolescent cancer survivors.15  
2.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how will it 
add to existing knowledge. 
Attention Deficit Hyperactivity Disorder (ADHD) is a common pediatric 
disorder associated with persistent and wide-ranging impairments 
and negative health outcomes, including obesity and Substance Use 
Disorders (SUDs). An estimated 5-10% of children worldwide have ADHD, 
which is marked by inattention, impulsivity and/or hyperactivity, and confers 
risk for difficulties in social, academic, vocational, and home functioning 
throughout development.1,2,18,19 ADHD is associated with health risks such 
as obesity, which in turn increases chronic health problems and mortality 
rates.20,10 Though stimulant medications improve ADHD symptoms and 
functioning acutely in the majority of those treated, medication is not 
recommended as the first-line treatment for young children with ADHD.22 
Moreover, many youth do not tolerate or adhere to medication, there are 
concerns regarding diversion,23 and longer-term outcomes of medication 
remain unclear.3 Thus, there is a need for innovative, generalizable 
intervention approaches that could serve as alternatives or adjuncts to 
existing treatments and that show promise for altering longer-term 
developmental and health trajectories. 
Physical activity (PA) enhances neurocognitive and self-regulatory 
development and has been found to decrease ADHD symptoms. There 
is an emerging but limited literature that both brief and sustained periods of 
PA are associated with improved executive functions,24,25 which are frontal 
lobe processes such as response inhibition and working memory that are 
often compromised in ADHD7 and feature prominently in theories of 
ADHD.26 Children with ADHD who participate in moderate-to-vigorous PA 
(MVPA) in clinic and school settings demonstrate improvement on cognitive 
tasks measuring sustained attention, response inhibition, stimulus 
processing, response accuracy, and self-regulation,27-32 and also exhibit 
fewer behavioral symptoms of ADHD and improved reading and math 
achievement.5,33-35  One meta-analysis reported an overall medium effect 
size (Hedge’s g=0.63) of PA on ADHD functional outcomes; effects did not 
vary by PA intensity but increased with PA duration.36 In the only large-
scale randomized trial of a PA-intervention for children with ADHD, a 31-
minute before-school exercise program improved both parent and teacher 
ratings of ADHD symptoms across 12 weeks, indicating lasting effects of 
the intervention throughout the day.35 It should be noted, however, that this 
trial did not objectively measure PA but instead relied on physical fitness as 
a proxy measure. Additionally, observational studies have documented a 
link between PA and “real word” functional outcomes such as scores on 
standardized achievement tests.37,33 Thus,  interventions to increase PA for 

 
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children with ADHD have demonstrated the potential to improve broader 
domains of functioning, offering an alternative or supplementary treatment 
to existing treatment approaches. An acceptable and feasible multi-level, 
family-based intervention to increase PA of children with ADHD has the 
potential to improve executive functioning, reduce ADHD symptoms, and 
promote health, with implications for longer term well-being. 
A3. Children with ADHD are at particular risk for not meeting 
recommendations for daily PA. Although hyperactivity would seem to 
increase daily energy expenditure, children with ADHD have been found to 
have high prevalence of physical inactivity and obesity.10 These children 
may encounter unique barriers to adequate PA and sports participation that 
are related to their diagnosis. For instance, children with ADHD exhibit 
increased rates of disruptive, noncompliant, and aggressive behavior and 
poor motivation.1 Their parents are more stressed38 and tend to use less 
effective and more negative, punitive, and inconsistent parenting 
approaches than parents of non-ADHD youth.39 Moreover, parents of 
children with ADHD have high rates of ADHD, depression, and substance 
use disorders themselves,40 complicating their efforts to implement effective 
parenting strategies to promote PA. As such, parents of children with ADHD 
may have considerable difficulty encouraging participation in PA and/or 
limiting their sedentary behaviors, such as media use.41 In fact, parents 
may offer screen time to their child in order to get a break from parenting. 
Additionally, children with ADHD demonstrate greater rates of oppositional 
behavior and poor sportsmanship in recreational sports settings, interfering 
with their engagement and success in sports and reducing overall PA.42 
A4. Parenting interventions have been shown to be effective in 
modifying child behavior and improving ADHD functional outcomes. 
Decades of research on behavioral treatments for children with ADHD 
indicate strongest support for interventions that target parents, caregivers, 
and teachers rather than children directly.43,44 Behavioral Management 
Training (BMT) for ADHD teaches parents to implement contingency 
management procedures to target the behavioral and functional problems 
associated with ADHD, most often by using behavior change strategies 
such as special playtime, differential attention, praise, incentives, and 
effective consequences to foster child skill development and behavior 
change.45 Such interventions yield reductions in children’s oppositional and 
aggressive behavior, increase parent use of positive parenting strategies, 
and reduce parent criticism and conflict.46,47 However, such programs focus 
primarily on reducing noncompliance and parenting stress, whereas no 
evidence currently exists on how these strategies impact health behaviors 
such as PA. Furthermore, such programs were developed over 30 years 
ago, prior to the internet, WIFI, and cultural changes affecting  the current 
context of parent-child interactions. We hypothesize that enhancing and 
augmenting evidence-based BMT strategies (e.g., special playtime, praise, 

 
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incentive systems) to additionally target PA in ADHD youth will increase 
measured PA and subsequently yield even greater improvements in ADHD 
symptoms and overall functioning than current treatments alone. 
Summary of Scientific Premise: Increasing PA is associated with 
improvements in executive functions, ADHD symptoms, and broader 
academic and social functioning.5,34 Therefore, family-based 
interventions to increase PA in ADHD youth could substantially 
improve ADHD-related functioning if integrated with existing 
evidence-based parenting interventions for ADHD, and may also 
reduce risk for negative health outcomes.. 
3.0 
Inclusion and Exclusion Criteria 
3.1 Describe how individuals will be screened for eligibility. 
Prior to the screening visit, participants will complete a pre-screening 
interview over the phone with one of the study staff. The study staff will 
conduct the interview using a phone screen script. If the subject is eligible 
then potential participants and their caregiver will attend an initial screening 
visit to confirm ADHD diagnosis and global severity. Eligible children will 
then complete a two-step screening procedure for low PA participation 
(caregiver-report survey of daily PA and a 3-day accelerometer wear) to 
determine level of daily PA. 
Describe the criteria that define who will be included or excluded in your 
final study sample.  
Inclusion criteria for children: 
- age 5-10 years 
- ADHD diagnosis 
- engage in <5 days of vigorous physical activity for more than 60 minutes 
at a time based on parent report 
-CGI-S rating >4 and <7 
-One adult caregiver willing to participate in the study and complete 
baseline/follow-up measures 
Inclusion criteria (for participating caregiver): 
- willing to participate in the study and complete baseline/follow-up 
measures 
- able to complete forms in English 
- owns a smart phone or similar Garmin compatible mobile device (e.g. 
iPod Touch) or willing to borrow iPod from study coordinators during the 
study period 
-Agree to install and share data from the Garmin smart phone app with 
investigators 
Inclusion criteria (for supplemental caregiver) 
- caregiver to child already participating in study 
 
Child Exclusion Criteria: 

 
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- younger than 5 years old or older than 10 years old 
- do not meet criteria for ADHD diagnosis 
- per caregiver report, engage in >60 min/day of MVPA consistently for at 
least 5 days per week 
- Meet diagnostic criteria for psychiatric co-morbidities including Autism 
Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic 
Disorder, or Intellectual Disability that could interfere with intervention 
uptake 
- currently taking psychotropic medications that may decrease ability to 
engage in PA (e.g. Alpha 2 agonists during the day). Children receiving 
stimulant medications who are on a stable dose for the past 30 days will be 
eligible for participation 
- any physical or medical restrictions on PA  
- Child currently/previously used a wearable physical activity sensing device 
the majority of days for a 2 month period in the past year 
Caregiver Exclusion Criteria:  
- Caregiver participated in an evidence-based parent behavior management 
training program (i.e., Incredible Years, Triple P, PCIT, Barkley’s Defiant Child) 
in the past 24 months. 
3.2 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the above 
populations as subjects in your research unless you indicate this in your 
inclusion criteria.) 
• 
Adults unable to consent - excluded  
• 
Individuals who are not yet adults (infants, children, teenagers) - 
included 
• 
Wards of the state - excluded 
• 
Pregnant women - Excluded 
• 
Prisoners – excluded 
3.4 Screening Visit 
 
Screening visits will be completed within 60 days of group treatment start.  Eligible 
participants will be enrolled on the same day as the screening visit.  
Diagnostic evaluation will consist of structured interviewing with the child and caregiver 
on the Schedule for Affective Disorders for School-Aged Children (K- SADS) Present 
and Lifetime Version (K-SADS-PL),[35] which assesses current and past presence of 
DSM-5 disorders in ages 6-18. Interviewing will be completed by a licensed psychologist 
or supervised pre- or post-doctoral trainee. The K-SADS-PL has strong test-retest and 
inter-examiner reliability, with kappas for ADHD above .70.[36] Inter-examiner reliability 
will be established and monitored over the trial by taping interviews and randomly 
selecting 20% for reliability checks. Should kappas fall < .70, additional training will be 
provided. 

 
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The Clinical Global Impressions (CGI-S) ADHD Severity Scale,[37] a clinician-rated, 7-
point scale that describes the severity of ADHD symptoms (using the K-SADS), will be 
used to screen for ADHD severity. Children must have a current CGI-S rating >4 to 
participate. The CGI-S also serves as an exploratory outcome in the R21 phase and a 
secondary outcome in the R33 phase. 
 
4.0 
Study-Wide Number of Subjects 
4.1 N/A  
5.0 
Study-Wide Recruitment Methods 
N/A  
6.0 
Multi-Site Research 
N/A 
 
7.0 
Study Timelines 
7.1 Describe: 
• 
The duration of an individual subject’s participation in the study. 
For participants in the BMT-Health group intervention – approx. 9 - 16 
weeks from the date of screening/baseline enrollment 
• 
The duration anticipated to enroll all study subjects. 
Using a rolling recruitment approach, enrollment for the entire study is 
anticipated to take 2 years.  
• 
The estimated date for the investigators to complete this study 
(complete primary analyses) 
The estimated date for completion of this study is January 2020. 
8.0 
Study Endpoints 
8.1 Describe the primary and secondary study endpoints. 
The study endpoint is the completion of all subjects’ participation in the 
study intervention and completion of all data collection and analysis. 
8.2 Describe any primary or secondary safety endpoints. 
N/A 
9.0 
Procedures Involved 
9.1 Describe and explain the study design.  
LEAP Group Intervention  
At the beginning of the screening visit, informed consent/assent forms will 
be reviewed aloud with participants. Screening consists of completion of the 
K-SADS and physical activity screening questionnaire. Children eligible 
based on these measures will then complete PA tracking using 
accelerometer as described in section 3.1  Following screening into the 

 
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study and completing informed consent/assent and baseline study 
measures, caregivers will be assigned to an 8-week LEAP intervention 
group, with 6-8 caregivers per group. Children and caregivers will complete 
baseline and follow-up assessment batteries at 5 weeks and 9 weeks. 
Caregivers will participate in a 1-hour focus group regarding their 
experience in the intervention during week 9. PA will be measured using 
accelerometry x7 days at baseline and at 9 weeks. The LEAP intervention 
consists of 3 components: 1) an enhanced 8-week, group-based BMT 
curriculum, 2) caregiver and child use of the Garmin daily activity tracker 
accompanied by personalized goal setting, and 3) caregiver participation in 
a private Facebook group to encourage PA goal achievement and promote 
social support and positive parenting. All enrolled families will receive 8 
weekly group BMT-Health sessions led by either Dr. Schoenfelder-
Gonzalez or Dr. Sasser, who have considerable experience leading BMT 
groups for children with ADHD. Groups will include initial enrollment of 6-8 
families, a group facilitator, and a co-facilitator. The curriculum and 
homework is based on existing evidence-based models, namely Barkley’s 
Defiant Children12 curriculum, with integrated content specifically focused 
on promoting PA and addressing barriers to PA. Table 1 presents a 
sampling of session content, highlighting the unique aspects of the BMT-
Health curriculum compared to standard BMT. Later sessions (with related 
homework) will include topics such as: community resources for PA, 
challenges encountered and over-coming barriers, using incentives to 
promote healthy behaviors, role of bedtime routines/sleep, and goal-setting 
for the future/strategies for sustainability. Information and resources 
relevant to that week’s topic will also be provided via Facebook and text 
messages. Fidelity to the curriculum will be assessed by trained coders 
using content checklists in a randomly-selected sampling of session 
audiotapes. We included the standard Barkley curriculum with this IRB 
application. We now include an overview of LEAP curriculum sessions 1-8 
and how the sessions are similar to and differ from the Barkley curriculum 
(see separate attachment). 
 
Table 1. BMT Standard and BMT-Health Curricula Overview – Sessions 1-3. 
Barkley’s Defiant Children12 
 
BMT-Health 
Strategy Instruction 
Homework 
Session 
Unique Strategy Instruction 
Unique Homework 
Unique Targets 
• Psychoeducation: 
ADHD and causes of 
child misbehavior 
• Teach differential 
attending and “special 
time” strategies 
• Daily 
“special 
time” play 
1 
• Psychoeducation: 
ADHD/misbehavior and 
connections with PA and health 
behaviors 
• Teach incorporation of active 
play into daily “special time” 
• Distribute and teach caregivers 
to use Garmins  
• Daily “special time” with 
active play 
• Caregiver & child wear 
Garmin 
• Child and 
caregiver engage 
in active (Non-
sedentary) play 
together 
• Child and 
caregiver monitor 
activity levels 
• Continue “special time” 
practice and planning 
• Teach praise/ 
reinforcement of 
• Continue 
“special 
time” 
• Praise child 
2 
• Discuss PA successes. Identify 
and problem-solve barriers. 
• Teach caregiver self-care 
strategies (e.g., own PA, sleep, 
• Set individual child and 
caregiver PA goals 
based on prior week’s 
Garmin results  
• Establish 
individualized 
goals for PA 
• Increase 

 
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compliance 
compliance 
self-talk, social support) 
• Introduce caregiver Facebook 
group 
 
• Join and participate in 
Facebook group 
caregiver PA and 
social support via 
Facebook group 
• Teach effective 
commands and limit 
setting (i.e., rules, 
when/then commands, 
timers) 
• Use 
effective 
commands, 
limit setting 
strategies 
3 
• Teach limit setting strategies 
applied to PA and rules for 
media use 
• Psychoeducation: media use 
and ADHD 
 
• Develop and implement 
family media use plan 
• Use effective limit 
setting  to support family 
media use plan 
 
• Reduce child and 
caregiver media 
use 
• Replace 
sedentary activity 
with active play 
 
 
9.2 Provide a description of all research procedures being performed and when 
they are performed, including procedures being performed to monitor 
subjects for safety or minimize risks.  Please be clear about how the 
procedures performed differ from standard of care.  If procedures preclude 
or delay standard of care, please be sure to include this information.   
Garmin Wrist-worn Activity Tracker – Vivofit Jr; The Garmin vívofit jr is a 
wrist worn activity tracker intended for children ages 4 to 9 years old. It has 
a 1+ year battery life, is waterproof, and tracks steps and PA with a built in 
tri-axial accelerometer. The child-friendly displays shows step count and 
whether the "activity goal" of >60 minutes was met. Caregivers can use a 
compatible application on their Apple or Android smartphone to monitor the 
activity of up to 8 family members. The device can store data for 4 weeks. 
For the caregivers, we will use an adult oriented wrist-worn product, the 
Garmin vívofit4, which has a1+ year battery life and a digital display with 
steps, PA duration and intensity, and a “move bar” which alerts them to 
move. Participants will be encouraged and supported in setting 
personalized goals based on their actual PA data collected by the Garmin 
in week 1 and incrementally increase activity to meet and maintain 
population recommendations for their age. Using a texting platform, we will 
set up automated weekly texts to go out to participating caregivers with 
reminders and goals.  The content of the texts will be submitted to the IRB 
prior for review prior to using them in the study. The weekly texts will 
continue until the last data collection period at each phase of the study. 
Intervention participants will be encouraged to share their Garmin data on 
their own personal social media profile with their online friends and other 
study participants. Participants will also receive brief health coaching 
regarding PA goal setting each week with study staff, which has been found 
to be effective in other PA interventions.9 
BMT group based curriculum - BMT programs – such as Barkley’s Defiant 
Children12 – are front-line treatments for childhood ADHD,13 and focus on 
issues such as reducing noncompliance and parenting stress. We propose 
to enhance Barkley’s program to target PA via BMT strategies such as 
special time, praise, and incentive systems, which we hypothesize will 
increase PA and yield greater improvements in ADHD symptoms and 

 
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functioning than existing BMT programs or stand-alone interventions 
providing structured PA sessions. 
Facebook Group.  
We will create a private (invitation only) Facebook group for each LEAP 
intervention group to provide encouraging advice and messages to promote PA, 
announce weekly individual and group badges/awards (e.g., most improved, most 
steps, most active minutes, most Facebook posts, etc.), and to provide a forum for 
participants to discuss PA and use of the Garmin devices. A group facilitator profile 
will be created with which research assistants can post to the group page, interact 
with participants, and screen content posted by members daily to remove it if 
inappropriate. The facilitator will make about 5 posts per week providing 
encouragement, reminders and study procedures, and opportunities to 
troubleshoot and answer questions. We have included a manual with information 
on planned posts. Participants will earn digital badges for meeting their weekly 
activity goals, as well as for social interactions (e.g.“liking” other’s posts) or making 
improvement toward goals to ensure that all participants receive positive feedback. 
We will begin the first 4 weeks with badges awarded to individuals only (e.g. most 
improved individual, most steps (from baseline) for an individual, etc.). Starting in 
week 5, we will award additional badges contingent on the entire intervention group 
meeting pre-specified criteria (e.g. 250,000 steps attained). This “all for one and 
one for all” approach is designed to foster encouragement and cooperation among 
the participants to promote PA and to keep participants engaged. Participants will 
be encouraged but not required to post in the group and to encourage their fellow 
participants. Participants will also receive standardized weekly text messages 
(using a free service) reminding them to wear/sync their Garmin and increase PA 
in their family routines. The facilitator and investigators will build upon the 
operations manual used in our teen ADHD pilot study to add practical information 
and troubleshooting tips for the purposes of training and guiding others to fulfill the 
role as independently as possible. Facilitator will track time spent each week as an 
indicator of implementation burden. 
 
Questionnaires/Measures – listed in Table 2; completed by teachers, 
caregivers, child participants, or therapists.  Of the measures listed below, 
we will submit the HBD for IRB approval prior to administration. 
• 
Hip –worn Accelerometer – Actigraph model GT3X+; A small rectangular device 
housing a tri-axial accelerometer and worn on an elastic belt, the GT3X+ has been 
used in a number of studies conducted by Dr. Tandon’s (Co-PI) research group and 
a number of other research groups at Seattle Children’s. Children will be asked to 
wear the device with an elastic belt for 7 days on their hip. In order to maximize valid 
accelerometer data, participants will be asked to wear accelerometers for 24 
hours/day, except for water-based activities,[38] and to re-wear accelerometers for 
another 7-day period if they have < 4 valid days at each measurement time point. 
The 24-hr wear has been validated for use to collect sleep data in school age 

 
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children, which is an exploratory outcome in this study.[39] While sleep has 
traditionally been measured with wrist actigraphy, algorthims have been produced, 
validated, and refined to fully automate the capture of sleep duration for children 
using 24-hour waist-worn acclerometry.[40] As we plan to use a 24-hour waist-worn 
accelerometer protocol to maximize compliance for the PA data, we will also be able 
to capture quantitative sleep data on our participants for a broader perspective on 
these related health behaviors. 
 
Digit Span task asks children to repeat strings of numbers of increasing 
length forward, then backwards.  
• 
Stop Signal Reaction Time (SSRT): In this computerized task, the participant must 
respond to an arrow stimulus, by selecting one of two options, depending on the 
direction in which the arrow points. If an audio tone is present, the subject must 
withhold making that response (inhibition). The test consists of two parts: 
In the first part, the participant is introduced to the test and told to select the left-
hand button when they see a left-pointing arrow and the right-hand button when 
they see a right-pointing arrow. There is one block of 16 trials for the participant to 
practice this. 
In the second part, the participant is told to continue selecting the buttons when 
they see the arrows but, if they hear an auditory signal (a beep), they should 
withhold their response and not select the button. The total task requires 15-20 
minutes to complete. 
 
 
Table 2 – Study Measures and Assessments 
Construct   
Measure 
Rater 
Source 
Screening 
Baseline 
5 weeks 
9 weeks 
ADHD diagnosis 
K-SADS-PL 
P/C 
CR 
X 
 
 
 
ADHD severity 
CGI-S 
Clinician 
CR 
X 
 
 
X 
PA, Sleep 
MVPA, light & sedentary time, Step 
count, sleep duration x 7 days 
G/C/A 
E 
 
X 
 
X 
Feasibility 
Garmin (wear time), Facebook likes 
and comments 
G/P/C 
E, SE 
 
 
X 
X 
Acceptability 
Attendance, TAI  
P 
CR, DP 
 
 
X 
X 
Acceptability 
CSQ, Focus group 
 
DP 
 
 
 
X 
Executive function 
SSRT, DS, BRIEF-2 
C/P 
SE 
 
X 
 
X 
ADHD symptoms 
Conners-3 (P), Vanderbilt (T) 
P/T 
DP 
 
X 
 
X 
Functional impairment 
IRS 
P/T 
DP 
 
X 
 
X 
Parenting 
APQ 
P 
DP 
 
X 
 
X 
PA, Sleep, Media use 
HBS 
P 
DP 
 
X 
X 
X 
Sleep problems 
CSHQ 
P 
DP 
 
X 
 
X 
BMI 
Height, weight 
C 
SE 
 
X 
 
X 
Complementary/Alt
ernative medicine 
use 
HBS 
P 
DP 
 
X 
 
X 
Media Use 
Problematic Media Use 
P 
DP 
 
X 
 
X 
Medication use 
HBS 
P 
DP 
 
X 
X 
X 
Mindfulness 
Mindful Attention Awareness 
 
DP 
 
X 
X 
X 

 
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Scale 
Socio-demographics 
Survey 
P 
DP 
 
X 
 
 
APQ = Alabama Parenting Questionnaire. BMI = Body Mass Index. BRIEF = Behavior Rating Inventory of Executive Function. CGI-
S = Clinician Global Impressions Scale – Severity. Conners-3 = Conners–Third Edition. CSHQ = Children’s Sleep Habit 
Questionnaire. CSQ = Client Satisfaction Questionnaire. DS = Digit Span task. ERC = Emotion Regulation Checklist. FW = Finger 
Windows task. HBS = Health Behaviors Survey. IRS = Impairment Rating Scale. K-SADS-PL = Kiddie-SADS-Present and Lifetime 
Version. MVPA = Moderate-to-Vigorous Physical Activity; PA = Physical Activity. SSRT = Stop-Signal Reaction Time task. TAI = 
Treatment Adherence Inventory. A = Actigraph GT3x+; C = Child; G = Garmin Device; P = Parent; T = Teacher. DP=digitally 
entered by parent/caregiver; CR=Clinician rated; E=electronic device data; SE =study staff entered 
 
For the K-SADS instrument:  
• 
the Pregnancy and Birth Questions will not be included 
• 
the Family History for Biological Relatives will not be included 
 
10.0 Data and Specimen Banking 
N/A  
 
11.0 Data Analysis/Management 
Describe the data analysis plan, including any statistical procedures. 
Given the pilot nature of the R21 study, data analysis will be largely descriptive and 
exploratory. We will focus on parameter estimates instead of formal hypothesis testing. 
The feasibility and acceptability of the research protocol as outlined above is the main 
outcome of interest, as is now recommended for pilot studies, rather than effect size 
estimates.109 
Study aim 1: To test the feasibility and acceptability of the intervention 
Feasibility will be assessed by (a) demand through inquiry and enrollment rates and (b) 
practicality and participation through attrition rates and adherence with intervention 
(attendance, percentage of days wearing and syncing Garmin, participation in Facebook 
group) and study procedures (screening, follow-up batteries, accelerometry). 
Acceptability will be assessed through participant ratings and qualitative interviews. 
Fidelity of the social media/text component will be evaluated following a procedure for 
prior mHealth intervention pilots conducted by the study team including tracking 
facilitator posts, participant views, likes, and posts. We will summarize the measures 
listed above using means, medians, and standard deviations for continuous variables 
and proportions for categorical variables and then conduct bivariate analyses. Non-
parametric tests will be used on non-normally distributed continuous variables, and 
Fisher’s exact test on sparse categorical variables. The proportions that reflect 
acceptability and feasibility will be assessed using 95% exact (Clopper-Pearson) 
confidence intervals 
Exploratory Aim: To explore the effects of the intervention on PA 
We will compare within-subject pre to post activity using accelerometer data (step count; 
sedentary, light and MVPA; sleep duration), MVPA as an exploratory outcome. We will 
examine gender as an effect modifier given that differences in PA are seen between 
boys and girls from an early age and differential effects of previous PA interventions by 
gender have been noted.(111) We will also look at associations of the measures from 
Aim 1 with PA outcomes. Pre- and post-intervention outcomes will be compared using t-

 
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tests, paired t-tests, chi-square and when appropriate, Fisher’s exact test. We will 
account for within-subject correlation due to repeated measures. Due to the pilot nature 
of the intervention, we emphasize the analyses will be primarily descriptive; confirmatory 
analysis will await future studies.  
 
11.1 Provide a power analysis. 
We anticipate needing to screen up to 45 children for low PA to ensure 
enrollment of 30 eligible families, but will screen more if needed. Treatment 
groups will begin on a rolling basis as soon as 6-8 eligible families have 
enrolled. 
 
11.2 Describe any procedures that will be used for quality control of collected 
data. 
N/A 
12.0 Confidentiality  
12.1 Describe the steps that will be taken to secure the data or specimens (e.g., 
training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and 
data) during storage, use, and transmission.  
We will take the following steps to ensure data will be secure during 
storage, use, and transmission: proper and consistent training of staff 
members, limit authorization of access to study team members, password 
protect the electronic data files, physically lock forms with identifiable 
information in a locked cabinet in staff offices, and ensure separation of 
identifiers and PHI data.  
12.2 Describe how data and specimens will be managed study-wide  
Staff will be informed of the need for confidentiality as information to be obtained 
will contain PHI (e.g. name, DOB, contact information, basic demographic info). 
Forms with identifiable names will be kept in a locked cabinet room in staff offices 
at SCRI. The electronic data files will not have any personally identifying names in 
the file, and will kept on a secure HIPAA compliant server hosted by Children’s for 
a minimum of 6 years. Digitally audio recorded interviews will be deleted following 
transcription and will not be kept on file. No names or addresses will be reported in 
publications. Only the PI, research coordinator, and research administrator have 
keys to the offices and locked cabinets at SCRI.  
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
13.1 Describe: 
Prior to implementing the study, the protocols, information sheet, recruitment materials 
and evaluation procedures will be reviewed by Seattle Children’s Institutional Review 

 
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Board.  Any adverse events will be recorded and reviewed by the PIs (Dr. Tandon, Dr. 
Gonzalez) and their study team. Any adverse event and the actions taken will be 
reported to the IRB at Seattle Children’s Research Institute.  
 
A two-person DSMB will be established for the proposed study who will advise the study 
investigators.  The DSMB is comprised of (1) a pediatrician and NIH-funded investigator 
studying early childhood development (Dimitri Christakis, MD), and (2) a psychiatrist and 
specialist in child and adolescent and mental health including ADHD , William French, 
MD, Professor of Psychiatry & Behavioral Sciences at the University of Washington. 
Neither of the DSMB members are investigators or key personnel of the proposed 
research study, but all have expertise for essential components of the intervention.  
 
The primary responsibilities of the DSMB will be to (1) periodically review and evaluate 
the accumulated study data for participant safety, study conduct and progress, and (2) 
make recommendations to the PI and co-investigators concerning the continuation, 
modification, or termination of this study.  The PI and co-investigators will report any 
serious unexpected adverse event (whether associated with the intervention or not) to 
the DSMB, IRBs, and NIH within 48 hours by telephone and within 5-working days in 
writing. The DSMB and IRBs will also determine whether the adverse event is causally 
related, probably related, possibly related, or unrelated to the intervention.  A serious 
unexpected adverse event is provisionally defined as any of the following: 
a) death 
b) any acute life-threatening event, including any serious physical activity-related injuries 
c) any event requiring hospitalization or emergency department care 
d) any other event that warrants a designation of a “serious” event in the PI’s, Co-Is’, or 
DSMB’s judgment, including threats to safety or “near-miss” injury events that could 
have led to items a-c above 
All other adverse events will be filed annually with the DSMB, the IRBs, and the NIH.  
Routine monitoring for adverse events will be performed by the study staff and 
coordinators, the PIs, and co-investigators.  Since there are no investigational drugs or 
devices, there will be no routine post-study follow-up of participants.   
 
Should a Caregiver or child enrolled in the study report concerning information related to 
suicidal ideation or safety in the course of their participation, Dr. Gonzalez will meet with 
the family individually to further assess concerns, engage in safety planning as needed, 
and connect the participant with mental healthcare or emergency services. Regarding 
medical symptoms related to exercise, we will contact the participant’s family and refer 
the child or parent for the appropriate medical attention with the family’s primary care 
provider.   
 
14.0 Withdrawal of Subjects 
14.1 Describe anticipated circumstances under which subjects will be withdrawn 
from the research without their consent. 
We do not anticipate conditions where subjects will be withdrawn from the 
research without their consent.  

 
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14.2 Describe any procedures for orderly termination. N/A 
14.3 Describe procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with continued data 
collection. 
Should subjects withdraw from the research, we will keep their data (unless 
requested otherwise from subject) for later analyses. Like all other data to 
be analyzed, subjects who withdraw will have their data de-identified and 
kept on HIPAA compliant servers. As much as possible, we will remove 
content posted by the participant from the Facebook group and direct the 
participant to delete the Garmin app.  
15.0 Risks to Subjects 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include as may be useful for the IRB’s consideration, describe the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, and economic risks. 
There are no drugs or devices used in this study. This is a minimal risk 
study that has no potential serious harms or risks related to participating in 
this study. Study procedures may include possible participant discomfort as 
discussing personal experiences and opinions may become emotional for 
participants. To avoid or mitigate any psychological risks, research staff will 
be trained to provide appropriate support and help participants calm in the 
even that s/he becomes emotional. Participants may also be offered a 
break and reminded that they can take as much time as needed. Subjects 
may feel some discomfort wearing the Garmin wrist activity tracker or the 
Actigraph hip-worn activity meter but these devices are designed for daily 
use and have been used by our research group (and others here at Seattle 
Children’s) without major incident. The Facebook page will be monitored 
each weekday by study staff in order to ensure that inappropriate language 
or behavior between study participants is identified. 
15.2 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
N/A 
15.3 If applicable, indicate which procedures may have risks to an embryo or 
fetus should the subject be or become pregnant. 
N/A 
15.4 If applicable, describe risks to others who are not subjects. 
For others who are not subjects (e.g. other family members not participating 
in the study), there may be risk of emotional or social discomfort should 
participant discuss challenges related to group participation (e.g., 
discussion of ADHD-related difficulties) or use of program skills at home 

 
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(implementation of consequences, rewards), or inconvenience of 
accommodating lifestyle changes to increase PA caused by the program. 
16.0 Potential Benefits to Subjects 
16.1 Describe the potential benefits that individual subjects may experience from 
taking part in the research. Include as may be useful for the IRB’s 
consideration, the probability, magnitude, and duration of the potential 
benefits. 
Potential benefits to subjects may include increase in PA, as well as a 
decrease in ADHD symptoms and associated behavioral difficulties through 
participation in the BMT program.  
17.0 Vulnerable Populations 
The research is minimal risk as child participants will not be engaging in any 
activity that carries significantly greater risk than what they would likely already 
be doing as a child.  Wearing the activity tracker does introduce monitoring of 
activity so it is possible that they may feel encouraged to be more active. 
Children’s caregivers may provide additional opportunities for physical activity but 
these would unlikely significantly increase their level of risk.. Adult participants 
will not be prescribed any intense physical activity as part of the study. The 
activity meter is worn on a soft elastic belt and has been used in several other 
studies within our research group and department without incident. We have 
used similar versions of the Garmin Vivofit activity tracker in previous research 
studies with no issues or complaints. 
18.0 Community-Based Participatory Research 
N/A  
19.0 Sharing of Results with Subjects 
 
Data analysis, manuscript writing, publications, and presentations will all be derived from 
de-identified data; all research products (e.g. publications, presentations) will be double 
checked for possible identifying information prior to submission. Results and research 
products will be shared with participants once finalized post analyses and publication.  
 
20.0 Setting 
20.1 Describe the sites or locations where your research team will conduct the 
research. 
Potential subjects will be identified and recruited through primary care and 
specialty clinics affiliated with Seattle Children’s Hospital. Screening visits 
and BMT program meetings will take place at the Seattle Children’s main 
campus in Seattle, WA.  
21.0 Resources Available 

 
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21.1 Describe the qualifications (e.g., training, education, experience, oversight) 
of you and your staff as required to perform their role. When applicable 
describe their knowledge of the local study sites, culture, and society. 
Provide enough information to convince the IRB that you have qualified 
staff for the proposed research.   
 
The PIs of the study include a clinical psychologist with expertise in 
psychosocial treatments and health risk behaviors associated with ADHD 
(Schoenfelder) and a general pediatrician and PA researcher with a k23 
Career Development Award focused on promoting PA and outdoor time in 
early childhood (Tandon). 
 
The CRA for the study has extended experience working with 
accelerometry data and Garmin wearable technology. 
 
21.2 Describe other resources available to conduct the research: For example, 
as appropriate: 
• 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
 
We will recruit participants through primary care and specialty clinics 
affiliated with Seattle Children’s Hospital. This strategy was effective 
in several prior studies conducted by the study team. Within the 
PEARL Clinic, an ADHD specialty clinic within outpatient psychiatry, 
484 unique patients were seen in 2016, of which 210 were ages 6-8 
years. Medical and mental health providers will be asked to 
disseminate study information to ADHD-diagnosed youth under their 
care in the PEARL Clinic and outpatient psychiatry. Since the majority 
of youth with ADHD are treated in primary care, we will also distribute 
study information to local primary care clinics. Co-PI Tandon is a 
provider in the Roosevelt Clinic through UW, where she can 
coordinate recruitment efforts.  Advertisements via Facebook, one of 
the platforms to be used in the intervention, and through the Seattle 
Children's Hospital and Seattle Children’s Research Institute website 
will be used if needed. These methods have worked well in prior 
studies by the co-PIs and Co-Is. If such advertisements are needed, 
we will submit the proposed ad to the IRB for approval. 
 
Describe the time that you will devote to conducting and completing 
the research. 
 

 
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The grant provides for protected time for the PIs and Co-Is to conduct 
the proposed research. 
 
• 
Describe your facilities. 
Assessments and study groups will be conducted at Seattle Children’s 
Hospital. The co-PI (Schoenfelder) and several of the Co-Is (Stein, 
Sasser) have offices there.  There are private treatment and group 
rooms available for  the study.  
 
• 
Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated consequences of the 
human research. 
 
Physical activity it taking place in the participants’ own homes and 
neighborhoods. We will refer patients to consult regarding fitness-
related concerns or injuries with their primary care doctor. The need 
for additional psychological resources will be assessed by the Co-PIs 
or Co-Is. Emergency services are available at Seattle Children’s.  We 
will facilitate referrals for individual mental health treatment within 
Outpatient Psychiatry or in the community if needed. 
 
• 
Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions. 
 
Upon hiring, the co-PIs will provide training in the study protocol to all 
hired research assistants or other personnel working on the study. Job 
descriptions will be provided prior to hiring. The co-PIs will supervise all 
personnel on the study. 
22.0 Prior Approvals 
N/A 
23.0 Recruitment Methods 
23.1 Describe when, where, and how potential subjects will be recruited. 
Subjects will be recruited through a Seattle Children’s Hospital-based 
specialty ADHD Clinic and primary care clinics associated with Seattle 
Children’s (Roosevelt clinic; Harborview Primary Care). One of the Co-PIs 
(Schoenfelder) is a provider in the Program to Enhance Attention 
Regulation and Learning (PEARL) Clinic in Outpatient Psychiatry at SCH, 
the other Co-PI (Tandon) is a provider at the Roosevelt Clinic, and one of 
the Co-Is (Mendoza) is a provider at Harborview Primary Care . Within the 
PEARL Clinic, 484 unique patients were seen in 2016, of which 210 were 
ages 6-8.  Medical and mental health providers will be asked to disseminate 

 
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study information via a study flyer to ADHD-diagnosed youth under their 
care in PEARL and outpatient psychiatry. We will send letters to families on 
the PEARL Clinic wait list and former PEARL Clinic patients. We will also 
have a study description in the PCP referral system to the PEARL Clinic, so 
PCPs will see a description of the LEAP study in the list of studies that get 
faxed back to PCPs when the PEARL Clinic not accepting new referrals.  
Because the majority of youth with ADHD are treated in primary care85, we 
will also distribute study information to the Roosevelt associated with 
Seattle Children’s to be posted in waiting areas and given to providers to 
distribute to patients with ADHD. Recruitment will take place during the first 
phase of the project and will be rolling until all treatment groups have been 
filled. 
23.2 Describe the source of subjects. 
  
Please see above for information regarding the PEARL clinic and primary 
care clinics, as well as Facebook/Instagram advertisements. 
23.2 Describe the methods that will be used to identify potential subjects. 
Providers will be asked to distribute study flyers to patient with ADHD 
diagnosis or probable ADHD. Flyers will direct interested families to a 
website customized for the present study, which will connect them with 
study staff for further information. The website will contain only study title, 
purpose of study, protocol summary, basic eligibility criteria, study site 
locations, how to contact the study site for more info.   The 
Facebook/Instragram ad (to be submitted via Modification) will be run three 
times weekly during the recruitment period, directed at users who are 
caregivers of school-aged children. The link will direct interested individuals 
to a study website with contact information for the study coordinator. 
23.3 Describe materials that will be used to recruit subjects. (Attach copies of 
these documents with the application. For printed advertisements, attach 
the final copy. For online advertisements, attach the final screen shots 
(including any images).  When advertisements are taped for broadcast, 
attach the final audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of inappropriate 
wording, provided the IRB reviews the final audio/video tape.) 
Facebook/Instragram advertisement will be submitted via modification. If the 
participant consents to participate in the study then information collected during the 
pre-screening phone call will be kept in a locked cabinet. If the participant does not 
wish to participate or does not sign a consent form then the information collected 
during the pre-screening interview will be destroyed. 
23.4 Describe the amount, method (e.g. gifts, check, gift cards) and timing of any 
payments to subjects.  Provide details on who will be the recipient of the 
payment (caregiver or child). 
 

 
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For each assessment visit (screening visit, Baseline, 5 week and 9 week 
assessments), subjects will will receive parking validation. Participants will receive 
compensation for completing study assessments in the following amounts: (1) $15 for 
screening visit and completion of accelerometry screening; (2) $25 for baseline battery 
completion (3) $25 for Week 5 (4) $50 for week 9 (5) $15 for participating in focus group. 
Supplementary caregivers will not receive any payment for participating. The amount will 
total $130 per family. Up to $20 will be provided for each group session for families that 
need to purchase childcare, totaling up to $160 per family for childcare reimbursement. 
Teachers will be reimbursed $10 for each of the two questionnaire batteries they are 
asked to complete (baseline and 9 weeks). 
24.0 Use of Social Media 
Facebook Advertisements: As described above, we will recruit for the study using 
Facebook advertisements targeted at caregivers of school-aged children. This 
advertisement will be submitted via modification. 
 
BMT-Health Facebook Group: We will create a private (invitation only) Facebook group 
for each BMT-Health intervention group to provide encouraging advice and messages to 
promote PA, announce weekly individual and group badges/awards (e.g., most 
improved, most steps, most active minutes, most Facebook posts, etc.), and to provide a 
forum for participants to discuss PA and use of the Garmin devices. A group facilitator 
profile will be created with which research assistants can post to the group page, interact 
with participants, and screen content posted by members daily to remove it if 
inappropriate. The facilitator will make about 5 posts per week providing encouragement, 
reminders and study procedures, and opportunities to troubleshoot and answer 
questions. Participants will earn digital badges for meeting their weekly activity goals, as 
well as for social interactions (e.g.“liking” other’s posts) or making improvement toward 
goals to ensure that all participants receive positive feedback. We will begin the first 4 
weeks with badges awarded to individuals only (e.g. most improved individual, most 
steps (from baseline) for an individual, etc.). Starting in week 5, we will award additional 
badges contingent on the entire intervention group meeting pre-specified criteria (e.g. 
250,000 steps attained). This “all for one and one for all” approach is designed to foster 
encouragement and cooperation among the participants to promote PA and to keep 
participants engaged. Participants will be encouraged but not required to post in the 
group and to encourage their fellow participants. Participants will also receive 
standardized weekly text messages (using a free service) reminding them to wear/sync 
their Garmin and increase PA in their family routines. The facilitator and investigators will 
build upon the operations manual used in our teen ADHD pilot study to add practical 
information and troubleshooting tips for the purposes of training and guiding others to 
fulfill the role as independently as possible. Facilitator will track time spent each week as 
an indicator of implementation burden. 
 
All Facebook group content and text messages will be submitted for approval via 
modification prior to contact with participants. 
 

 
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25.0 Local Number of Subjects 
 
We aim to recruit 45 families (child, accompanying parent, and any supplemental 
caregivers) to ensure a total of 30 families will be enrolled after the screening process.  
 
26.0 Provisions to Protect the Privacy Interests of Subjects 
26.1 Describe the steps that will be taken to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on whom they 
interact or whom they provide personal information. 
This is a minimal risk study that has no potential serious harms or risks 
related to participating in this study. Study procedures may include possible 
participant discomfort as discussing personal behavioral health information 
may become emotional for participants.  
All screening materials and interview files/transcripts will be de-identified 
prior to analysis. Participants will have their own study ID. The key of 
participant study IDs matched to names and other identifiers collected 
during recruitment will be kept in a separate password protected database. 
Only select study staff (e.g. data manager, study coordinator, PI) will have 
access to the key. Data analysis, manuscript writing, publications, and 
presentations will all be derived from de-identified data. All research 
products (e.g. publications, presentations) will be double checked for 
possible identifying information prior to submission.  
26.2 Describe what steps you will take to make the subjects feel at ease with the 
research situation in terms of the questions being asked and the 
procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in 
response to questions, examinations, and procedures. 
To lessen the burden on subjects, they will be interviewed in a private room 
at Seattle Children’s; minors are welcome to have caregivers present upon 
request. 
27.0 Compensation for Research-Related Injury 
 
This research does not involve more than Minimal Risk to subjects and research 
is unlikely to result in injury.  
28.0 Economic Burden to Subjects 
 
Subjects will be responsible for their own transportation to Seattle Children’s 
(Main Campus) for screening/study visits (e.g. fuel, childcare for other children). 
Upon arrival, parking will be free/validated for subjects. A $20 transportation 
reimbursement will be provided for each study visit. 

 
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29.0 Consent Process 
29.1 Indicate whether you will you be obtaining consent, and if so describe: 
Research staff (PI or research coordinator or research assistant) will obtain 
subject consent prior to conducting any study activities. The exception to this 
is the pre-screening phone call, study staff will ask potential participants 
questions to see if they are a good fit for the study. Consent will occur in 
private rooms at Seattle Children’s Hospital or Seattle Children’s Research 
Institute. 
At the beginning of the screening, informed consent/parental permission 
and/assent forms will be reviewed aloud with participants. If supplemental 
caregivers will be participating, the supplemental caregiver consent form will 
also be reviewed. Adults will sign informed consent documents for their 
participation. If a family wishes to have a second caregiver participate in the 
groups, they will sign a separate consent form (IRB approved) to consent for 
group participation, though study data will not be collected from this 
caregiver. For children, caregivers will review and sign a caregiver permission 
form. Children who are 5-6 yo at time of enrollment will be asked to provide 
verbal assent (please see verbal assent script uploaded to Click). Children 
who are 7-10 yo at time of enrollment will be asked to sign an assent form. 
Participants will be invited to review the forms independently for as much time 
as desired and ask questions directly to the PI before signing. We will ask 
children to reiterate in their own words what they are asked to do and their 
right to decline to answer or withdraw from the study at any time to confirm 
comprehension. 
We will be following the “SOP:HRP-090 informed consent process for 
research” protocol. As such, a copy of the signed consent form will be 
provided to subjects. This signed copy will be provided to families. 
Non-English Speaking Subjects 
Hint: please see HRP-090, HRP-091, and Investigator Manual HRP-103 for 
more information. 
• 
Indicate what language(s) other than English are understood by 
prospective subjects or representatives. 
• 
If subjects who do not speak English (LEP participants) will be 
enrolled, please indicate whether you will be following the steps 
outlined in the Investigator Manual.   
All study participants will be English speaking. For the purposes of this 
pilot study, we are not able to obtain all measures in other languages, 
nor translate all other study materials. Many of our measures have not 
been validated in other languages. 

 
Principal Researcher: Pooja Tandon MD MPH 
Protocol Version Number: 6 
Protocol Version Date: 09/11/2019 
 
 
 
 
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Waiver or Alteration of Consent Process (consent/caregiver 
permission will not be obtained, required information will not be 
disclosed, or the research involves deception); Waiver or Alteration of 
HIPAA 
• 
Review the “CHECKLIST: Waiver or Alteration of Consent Process” 
and “CHECKLIST: HIPAA Waiver of Authorization” (HRP-410 and 
HRP-441) to ensure you have provided sufficient information for the 
IRB to make these waiver determinations.  
o Waivers for recruitment 
o Waivers for participants who turn 18  
o Waivers for information collected about a non-present 
caregiver 
o Other waivers as necessary 
A waiver of HIPAA authorization and alteration of the consent process (caregiver 
permission) is requested to complete the pre-screening phone call. The 
purpose of the phone call is to provide caregivers with more information 
about the research study as well as ask preliminary questions to determine if 
the family is a good fit to bring in for a screening visit. Caregivers of potential 
participants will be asked to provide verbal consent for the questions being 
asked in the phone script. The study staff completing the call will be required 
to destroy the information collected in the phone call if the participant decides 
they are not interested in the study. If the participant signs a consent form 
then the information will be kept in a locket cabinet and kept with study data.  
Justifications for these waivers: 
• 
The recruitment procedures involve no more than minimal risk to the 
research subjects and their privacy because: the information we are 
collecting in this phone call does not surpass the probability and 
magnitude of harm or discomfort anticipated during a routine interview 
with a health care professional. Participants also have the option not 
to answer any questions they do not wish to answer.  
• 
The waiver of HIPAA authorization and caregiver permission will not 
adversely affect the rights, including the right to privacy, nor adversely 
affect the welfare of the subjects whose data are being used because: 
the information will be safely destroyed if the participant does not wish 
to proceed with study procedures after the phone call. If the 
participant does wish to proceed with study procedures then the 
information collected during the phone call will be kept in a locked 
room, per HIPAA requirements.  
• 
The research could not practicably be conducted without the waiver of 
consent and/or HIPAA Authorization because: This interview will take 

 
Principal Researcher: Pooja Tandon MD MPH 
Protocol Version Number: 6 
Protocol Version Date: 09/11/2019 
 
 
 
 
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Click Template Version: February  2016
 
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place over the phone. It is impractical to collect a signature of consent 
since this phone call will only take about 15 minutes to complete. 
• 
The research could not practicably be carried out without access to 
protected health information because the information is needed for 
additional contact of subjects who are interested in participating and 
the health information is needed to complete the screening 
procedures. 
• 
If the research involves a waiver the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of 
Consent for Emergency Research (HRP-419)” to ensure you have 
provided sufficient information for the IRB to make these 
determinations. 
Subjects who are not yet adults (infants, children, teenagers) 
 
 
• 
Subjects will be enrolled between 6 and 8 years of age inclusive. 
Subject age will be confirmed with caregiver or legal guardian during 
the initial phone contact and again at time of consent.  
Caregiver permission will be obtained from one legal guardian. Only parents 
or legal guardians will be allowed to sign the consent (caregiver permission) 
form.  
• 
Caregiver permission will be obtained from: 
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. 
• 
Indicate whether assent will be obtained from all, some, or none of the 
children. If assent will be obtained from some children, indicate which 
children will be required to assent. 
 
Children who are 5-6 yo at time of enrollment will be asked to provide 
verbal assent (please see verbal assent script uploaded to Click). 
Children who are 7-10 yo at time of enrollment will be asked to sign 
an assent form. 
 
• 
When assent of children is obtained describe whether and how it will 
be documented. 
 
We will keep signed assent forms (7-10 year old subjects) in a locked 

 
Principal Researcher: Pooja Tandon MD MPH 
Protocol Version Number: 6 
Protocol Version Date: 09/11/2019 
 
 
 
 
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cabinet at CHBD and their assent will be noted on in our participant 
tracking database. Children who provide verbal assent (5-6 year olds) 
will have their assent noted in the participant tracking database.  
Cognitively Impaired Adults 
N/A 
Adults Unable to Consent 
N/A 
Consent for use of HUD 
         N/A 
30.0 Process to Document Consent in Writing 
 
We will be following “SOP: Written Documentation of Consent (HRP-091).  Please see 
attached caregiver permission and teacher consent forms. 
 
31.0 Drugs or Devices 
N/A 
32.0 Good Clinical Practice 
We have committed to conduct the described study per International Center for 
Harmonization of Good Clinical Practice (ICH-GCP).