Comparing Psychosocial Supports for Adolescents With ADHD: What Works Best for Whom and Why?
Phase: NA
Conditions: ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Sponsor: Seattle Children's Hospital

Principal Researcher: Margaret Sibley   
Protocol Version Number: 1   
Protocol Version Date: 9/25/2025 
 
 
 
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PROJECT TITLE: 
Comparing psychosocial groups for reducing attention problems in adolescents with ADHD 
 
PRINCIPAL INVESTIGATOR: 
Margaret Sibley 
Center for Child Health Behavior and Development 
305 801 2472 
Margaret.sibley@seattlechildrens.org 
 
 
PARTICIPATING SITES1: University of Washington 
 
 
 
 
 

Principal Researcher: Margaret Sibley   
Protocol Version Number: 1   
Protocol Version Date: 9/25/2025 
 
 
 
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Contents 
1. 
Objectives ........................................................................................................................................ 3 
2. 
Background ..................................................................................................................................... 3 
3. 
Study Endpoints ............................................................................................................................. 4 
4. 
Drugs, Devices and Biologics ....................................................................................................... 4 
5. 
Procedures Involved ...................................................................................................................... 5 
6. 
Data and Biospecimen Banking .................................................................................................... 7 
7. 
Sharing of Results .......................................................................................................................... 7 
8. 
Study Timelines .............................................................................................................................. 8 
9. 
Study Population ............................................................................................................................ 8 
10. 
Number of Subjects ........................................................................................................................ 9 
11. 
Withdrawal of Subjects ................................................................................................................ 10 
12. 
Risks to Subjects .......................................................................................................................... 10 
13. 
Potential Benefits to Subjects ..................................................................................................... 11 
14. 
Data Analysis/Management ......................................................................................................... 11 
15. 
Confidentiality and Privacy .......................................................................................................... 12 
16. 
Provisions to Monitor Data to Ensure the Safety of Subjects .................................................. 13 
17. 
Use of Social Media ...................................................................................................................... 13 
18. 
Research Related Injury ............................................................................................................... 13 
19. 
Recruitment Methods ................................................................................................................... 14 
20. 
Consent/Assent/Permission  ....................................................................................................... 14 
21. 
HIPAA Authorization and RCW Criteria ...................................................................................... 19 
22. 
Payments/Costs to Subjects ....................................................................................................... 20 
23. 
Community-Based Settings ......................................................................................................... 20 
24. 
Resources Available .................................................................................................................... 21 
25. 
Coordinating Center Procedures ................................................................................................ 21 
26. 
International Center for Harmonization of Good Clinical Practice (ICH-GCP) ........................ 21 
 
 
 
 
 

Principal Researcher: Margaret Sibley   
Protocol Version Number: 1   
Protocol Version Date: 9/25/2025 
 
 
 
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1. Objectives 
1.1. Purpose, specific aims, or objectives: 
 
The Seattle Children’s Behavior, Attention, Management (BAM) Clinic in the Department of 
Psychiary is adding a new group for adolescents with ADHD focused on mindfulness in the fall 
of 2025 (Mindfulness Awareness Practices for Adolescents (MAPA)). We wish to conduct a 
randomized controlled evaluation to compare it to the existing programming in the clinic for this 
population (Time Management, Organization, and Planning Skills; TOPS) to understand the 
different benefits these two groups may offer as a way to route future patients to the group that 
is likely to best meet their needs. 
   
1.2. Hypotheses to be tested: 
   
The two groups will lead to equal reductions in ADHD symptom severity as measured on 
the Conners 3 Rating Scale. However, the MAPA group will lead to greater 
improvements in self-regulation and trait mindfulness/mind wandering while the TOPS 
group will lead to greater improvements in executive functioning. Therefore, adolescents 
with ADHD who appear to have their greatest impairments in executive functioning 
might best be routed to the TOPS group while those who are struggling with emotion 
and attention regulation would best be routed to the MAPA group  
   
2. Background 
2.1. Relevant prior experience and gaps in current knowledge: 
   
Mindfulness treatment (e.g., Mindfulness Based Interventions) for youth with ADHD has 
emerged as a novel empirically supported treatment for youth with ADHD, as evidence in a 
recent review published in the Lancet Child and Adolescent Health by PI Sibley (Sibley et al., 
2023). TOPS is a well-established treatment for adolescents with ADHD (Evans et al., 2016; 
Sibley et al., 2024 for review). However, among diverse psychosocial approaches for treating 
ADHD in youth, little is known about what works for whom and why—important clinical 
information that can guide precision medicine (i.e., routing of patients to the group that might 
best meet their clinical needs). 
 
2.2. Relevant preliminary data:2 
   
Though several meta-analyses confirm the efficacy of TOPS for adolescents with ADHD, 
research on Mindfulness-Based Interventions (MBI) for adolescentt with ADHD has been 
more recent. Haydicky et al. used a pre-post design (N=20) and an adolescent sample 
(13-18 years), offering preliminary evidence that adolescents with ADHD will engage in 
an MBI and that there do not appear to be iatrogenic treatment effects. Session 
attendance was good (M =6.78 out of 8, SD = 1.11). Parents reported improved conduct 
symptoms and peer relations with medium to large effect sizes, as well as self-reported 
depression, anxiety, and internalizing symptoms at 6 week follow-up with medium to 
large effect sizes. Parent-reported inattention improved from pre- to post (p = .07) with a 
medium effect size. van de Weijer Bergsma et al. was a within group design (ages 11-15 
years). Statistically significant pre-post improvements were reported for attention 
problems at 2-month follow-up (self and paternal report), externalizing problems at post-
treatment and 2-month follow-up (paternal report), EF at 2-month follow-up (paternal 
report), visual sustained attention reaction speed, auditory sustain attention false alarm 
responses at post-treatment, and auditory sustained attention number of misses at 2-
month follow-up. Outside the adolescent-specific age group, mixed-aged RCTs for 
individuals with ADHD have been conducted to further indicate the efficacy of MBIs: 
Valero et al. (9-14 year-olds with ADHD) reported significant improvements for MYmind 
vs. waitlist for inattention symptoms, EF, learning problems, aggression, and peer 

Principal Researcher: Margaret Sibley   
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relations at 6 month follow-up. Siebelink et al. included children and adolescents (ages 
8-16 years) with larger pre-post treatment effects on self-control predicted by older age. 
These studies support the efficacy of adolescent ADHD MBIs.  
   
2.3. Scientific or scholarly background: 
   
Mindfulness-Based Interventions (MBIs) have garnered increasing support for ADHD (Sibley et 
al., 2023). MBIs yield medium to large effects for inattention (d=.91) and hyperactivity-impulsivity 
symptoms (d=.68) in adult ADHD samples with similar effect sizes in mixed child/adolescent 
samples (inattention d=.66, hyperactivity-impulsivity d=.47). In another meta-analysis, MBIs for 
ADHD had a large effect for inattention (Hedges’ g = .83) and hyperactivity-impulsivity (Hedges’ 
g = .68) compared to control conditions, though this was moderated by age with a lesser effect 
for younger age.  
 
TOPS is a well-established treatment for adolescent ADHD that enacts improvement by 
remediating executive function skills specifically related to organization, time management, task 
management, and planning. For example, a 2017 meta-analysis (Bikic et al) found that twelve 
studies involving 1054 children (576 treatment, 478 control) produced a weighted mean effect 
sizes for teacher- and parent-rated outcome measures of organizational skills of g = 0.54 (95% 
CI 0.17 to 0.91) and g = 0.83 (95% CI 0.32 to 1.34), respectively. Weighted mean effect sizes of 
teacher- and parent-rated symptoms of inattention were g = 0.26 (95% CI 0.01 to 0.52) and g = 
0.56 (95% CI 0.38 to 0.74), respectively.  
   
2.4. Prior approvals: 
   
NA 
 
   
3. Study Endpoints3 
3.1. Primary and secondary endpoints: 
   
At baseline and study endpoint (after the final session of treatment), we will administer the 
Conners 3 (parent and self report), impairment rating scale (parent/self). BRIEF-2 (parent 
report), DERS emotion regulation measure (parent and self), and Trait Mindfulness 
Questionnaire (parent and self report). We also will administer the PROMIS (part a and b) to the 
youth (8 items). We also will administer the client credibility questionnaire and a satisfaction 
measure to the parent and the youth. We will also measure attendance at the intervention and 
treatment homework completion in both groups. A demographic form will also be administered to 
the parent about the teen to characterize the sample. Finally, at post-treatment we will 
administer youth and parent engagement questionnaires.  
   
3.2. Primary or secondary safety endpoints: 
   
NA 
   
4. Drugs, Devices and Biologics4 
4.1. Manufacturer and name of all drugs, devices and biologics: 
   
NA 
   
4.2. Description and purpose of all drugs, devices and biologics: 
   
NA 
   
4.3. Regulatory status of all drugs, devices and biologics:5 
   
NA 

Principal Researcher: Margaret Sibley   
Protocol Version Number: 1   
Protocol Version Date: 9/25/2025 
 
 
 
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4.3.1. 
Drugs or Biologics: 
☐ IND Exempt.  Explain:6 ?Click here to enter text. 
☐ IND. 
 
  
4.3.2. 
Devices: 
☐ IDE Exempt.  Explain:7 ?Click here to enter text. 
☐ Abbreviated IDE / Non-Significant Risk.  Explain:8 ?Click here to enter text. 
☐ IDE / Significant Risk.   
 
 
     
4.4. Plans to store, handle, and administer any study drugs, devices and biologics so they will be 
used only on subjects and be used only by authorized investigators: 
   
NA 
   
5. Procedures Involved 
5.1. Study design:9 
   
This will be a randomized controlled trial in which incoming patients (N=36) who have been 
referred for ADHD psychosocial treatment at the Seattle Children’s Behavior, Attention, 
Management clinic between ages 13-17 will be offered the opportunity to participate in this 
study. Currently, potential participants are referred to a single waitlist for the STAND intervention 
if they have ADHD and are in need of psychosocial treatment. STAND is a combined parent-
teen group for adolescents with ADHD that focuses on building collaborative home plans to 
support the behavioral needs of youth. It runs for 10 weeks as a 90 minute group. During this 
group parents and teens learn a variety of strategies that they can collaboratively apply at home 
such as creating a structured homework plan, making a feasible daily routine, using active 
listening and I statement communication skills, and setting collaborative goals for task 
completion.  
 
The STAND program runs three times a year and the waitlist is much longer than the number of 
patients that this program can accommodate. Accordingly, we have sometimes offered TOPS (a 
lower resource and simpler program to deliver) to adolescents while they wait on the waitlist for 
STAND (so that they can get some form of care while they wait for STAND). Note, TOPS has not 
been offered in a few years. In this case we will specifically recruit from individuals who are on 
the STAND waitlist, waiting for care. We will not remove them from the STAND waitlist if they 
choose to participate in the study. They will still be eligible to receive STAND when it is their turn 
to be moved off the waitlist and into services. There will be no delay in receiving STAND created 
by participation in the study because only those who are not in the current round because they 
were not high enough on the waitilist will be offered the study.  
 
If they wish to participate, they will be randomly assigned to receive the MAPA MBI or to receive 
TOPS at the clinic. Both groups will be 8-week, 90  groups that will run simultaneously via 
telehealth delivered by routine clinicians in the BAM clinic. Both groups will have one “pre-
session” that parents join that explains the purpose of the group and what parents and teens can 
do to work together and support home practice of skills learned during the group. We will collect 
baseline and post-treatment ratings of outcome measures. There will be two cohorts (fall and 
winter and each cohort will enroll 18 youth for random assignment at a 1:1 ratio). Incoming 
patients who do not wish to participate in the study will still be eligible to enroll in standard 

Principal Researcher: Margaret Sibley   
Protocol Version Number: 1   
Protocol Version Date: 9/25/2025 
 
 
 
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psychosocial treatment groups at the BAM clinic that they would otherwise be eligible for (i.e., 
declining to participate will not delay the treatment they otherwise would receive in the clinic).  
 
Like TOPS, which has been an ad-hoc treatment offered at BAM for a number of years, but does 
not run on regular cycles, it is hoped that MAPA will become a fixture in BAM for years to 
come—of course this is contingent on a successful pilot of the program (i.e., that it is well-
received by youth and caregivers and appears to be a program that has value to our clinic’s 
specific patient population).   
   
5.2. Research procedures:10 
   
Parents of patients referred to SCH BAM program who are between the ages of 13-17 will be 
contacted by IRB-approved study team member and the study information will be shared. If 
interested in the study, the family will be contacted by a research assistant who will conduct a 
virtual information session over Zoom with the family to have a consent discussion and complete 
baseline measures over Redcap with an emailed link as described above. Measures will be 
completed during the zoom meeting so as to ensure that they can be reviewed by research 
assistants for completeness. Adolescents will be randomly assigned to receive TOPS or MAPA. 
They will receive the treatments as delivered naturalistically by the SCH clinicians. A trained 
observer will collect fidelity measures through live observation to assess the extent to which 
SCH clinicians implemented the treatments according to their standard elements. The fidelity 
forms will be submitted using a modification at a later date. They will not include any information 
about the clinicians individually but rather serves as documentation that the protocol was 
implemented in its entirety by the research team. Items will be worded such as “the adolescents 
participated in activity X.” Attendance will also be taken by the trained observer and they will 
collect information on homework completion. These will not be participant facing records. 
Finalized materials for the intervention will be submitted to the IRB as a modification prior to 
beginning the group. At the end of the 8-weeks, adolescents and their parents will complete 
post-treatment rating scales as noted above. They will again receive a zoom link. The final 15 
minutes of the last session of the treatment will be reserved for the completion of rating scales 
and parents will be invited to attend this portion of the final session. If the subject was not at the 
group meeting, we will schedule a separate zoom meeting with them to complete the rating 
scales. 
 
Once the study is complete, individuals will have the opportunity to participate in the treatment 
group for which they were not randomized. This would occur for routine care and would not be 
part of the research.  
   
5.3. Data sources that will be used to collect data about subjects:11 
   
Parent and Self-report rating scales, direct observation of groups by a research assistant. The 
fidelity forms will be binary yes/no checklists (to be submitted in a modification) about whether 
adolescents who attended the group received each component of the treatment. The attendance 
records will be yes/no did the adolescent attend the session. The homework records will be 
yes/no did the adolescent complete the assigned homework. These will be collected in Redcap 
by the trained observer during the group. We will not collect any information on the participants 
from the EMR. With respect to contact information, IRB-approved study staff members will 
access contact information from the EMR to initially inform the families of the opportunity. 
However, the research team will collect contact information through redcap once the family has 
been referred to us and has indicated interest in learning more about the study/potentially 
participating. 
   

Principal Researcher: Margaret Sibley   
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5.4. Data to be collected, including long–term follow–up data:12 
   
Please see attached redcap form for the variables that will be collected from parent and self-report.  
 
Baseline: the parent and adolescent will each fill out the Conners-3, Impairment Rating Scale, 
BRIEF-2, DERS, and the FFMQ Trait Mindfulness Questionnaire. 
 
Post-treatment: In addition to repeating the baseline measures, parents and adolescents will 
also complete the client credibility questionnaire and a satisfaction with treatment questionnaire.  
 
   
6. Data and Biospecimen Banking13 
6.1. Complete list of the data and/or biospecimens to be included in the bank:14 
   
We will bank all measures collected in this study but it will be de-identified data. 
   
6.2. Location of data and/or biospecimen storage:15 
   
Redcap 
   
6.3. List of those with direct access to data and/or biospecimens in the bank: 
   
The PI and the research team members. 
   
6.4. Length of time data and/or biospecimens will be stored in the bank: 
   
Indefinitely 
   
6.5. Procedures for protecting the confidentiality and privacy of the subjects from whom the data 
and/or biospecimens were collected:16 
   
This will be completely de-identified, numerical data that will not be able to be linked back to any 
individual participants.  
   
6.6. How the data and/or biospecimens will be made available for future use: 
   
upon request by other research teams 
   
6.6.1. 
Who can request data and/or biospecimens from the bank: 
   
Qualified researchers who are covered by their institution’s IRB, if required. 
   
6.6.2. 
Format in which data and/or biospecimens will be provided:  
   
Data file such as Excel or SPSS. 
   
6.6.3. 
Process for investigators to request data and/or biospecimens:17 
   
Email to the PI and provision of IRB approval, if required. 
   
6.6.4. 
Restrictions on future use:18 
   
NA 
   
6.6.5. 
Plan for providing data results from banked data/biospecimens: 
   
NA 
   
7. Sharing of Results  
7.1. Plan to share results with subjects/others:19 
   

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We will publish the results of this study in a peer review journal. No results from data will be 
provided directly to participants. 
   
8. Study Timelines 
8.1. Duration of an individual subject’s participation in the study: 
   
Individuals will participate in the study for approximately 12 weeks including baseline data 
collection, 8 weeks of treatment, and post-treatment data collection. 
   
8.2. Duration anticipated to enroll all study subjects: 
   
Two months. 
   
8.3. Estimated date for the investigators to complete this study: 
   
September 1, 2026 
   
9. Study Population20 
9.1. Inclusion criteria for each subject population (e.g., patients, parents, providers): 
   
Incoming patient at Seattle Children’s Psychiatry for ADHD adolescent services age 13-17. 
 
Parents of an incoming patient at Seattle Children’s Psychiatry for ADHD adolescent services 
   
9.2. Exclusion criteria for each subject population: 
   
For adolescent patients: Outside the study age range. Pursuing services for a presenting 
problem unrelated to ADHD. Unable to attend the scheduled group sessions.   
 
For parents: they must be willing to fill out questionnaires about the adolescent.  
 
9.2.1. 
If individuals will be excluded from the research based on language, socioeconomic 
status, physical characteristics (e.g., gender identity, age, ethnicity), sexual 
orientation, religion, or access to technology provide a justification for each 
exclusion criterion:21 
N/A  
   
9.3. Plan to ensure that subject selection is equitable:22 
The BAM clinic offers openings to clinical care on a first come first serve basis. As such, we will 
offer the opportunity to participate in the study to all incoming adolescents during the trial period 
on a first come first serve basis. This includes patients that are already on the waitlist as well as 
those that are joining the waitlist for the first time. We will call patients on the waitlist in the order 
that they joined it before we start offering the study opportunity to new patients.  
 
9.4. Populations with special considerations, involved in the study:23 
☒ Children/Teenagers24 
Risk assessment specific to this vulnerable population and additional safeguards:25 
This is a minimal risk study as it focuses on studying routine care programming for ADHD. 
Students with acute psychiatric needs are not triaged to these programs by BAM. There is 
a risk of breach of confidentiality due to the group nature of treatment, however, as is 
standard clinic procedure we will reiterate the importance of confidentiality at the beginning 
of every group. All research team members will also be trained in the conduct of research, 
confidentiality procedures. Data will be stored securely in REDCap with access limited to 
IRB-approved study team members.  
   

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☐ Children who are Wards of the State26 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
?Click here to enter text. 
   
☐ Adults Unable to Consent 27 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
?Click here to enter text. 
 
☒ Individuals who use a language other than English28 
Anticipated language(s) for subjects and their parent(s)/LAR:  
   
We do not anticipate adolescents who speak a language other than English in this study 
because they rarely present at the clinic. However, if there are potential adolescent 
participants or parents/LARs who use a language other than English, they will be permitted 
to participate and we will submit an amendment at that time for a translated consent 
form/assent form and will use a translator from the hospital for the consent documents, 
assessments, and treatment (as is BAM policy anyway). Spanish and Creole versions of 
the forms are validated and have been used previously by the research team. 
 
    Process to ensure study information is available throughout the research to individuals who 
use a language other than English:29 
We will use hospital interpreters if we find that a parent/child who is eligible for the study 
does not speak English. We will translate the consent forms and all participant-facing 
materials into the language of the individual and interpreters would be present at all 
interactions with the study team, starting with recruitment, and the treatment groups. 
   
☐ Neonates of Uncertain Viability or Non–Viable Neonates30 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
?Click here to enter text. 
   
☐ Pregnant Women31 
Additional safeguards: 
   
?Click here to enter text. 
   
☐ Prisoners32 
Additional safeguards: 
   
?Click here to enter text. 
 
☐ Economically or educationally disadvantaged persons33 
Additional safeguards: 
?Click here to enter text. 
   
10. Number of Subjects 
10.1. Total number of subjects to be enrolled locally:34 
   
36 
   
10.2. Total number of subjects to be enrolled across all participating sites:35 
   
36 
   

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10.3. Number of screened subjects versus the actual number enrolled in the research:36 
   
The waitlist for ADHD adolescent psychosocial groups is currently upwards of 70 adolescents 
in our age range; anyone who is on the waitlist will be eligible. We anticipate we will be able to 
identify 18 families who are interested for our first cohort.  
   
10.4. Power analysis: 
   
A power analysis was conducted to determine the appropriate number of participants needed 
to detect large effects (d=.8; power=.80; α=.05), as this is the average between-group effect 
size across studies of behavioral treatment for ADHD (d=.83; Fabiano et al., 2009). Results 
suggested that at least 32 individuals are needed to obtain sufficient power to detect the 
expected effects in a basic t-test.  
   
11. Withdrawal of Subjects 
11.1. Anticipated circumstances under which subjects will be withdrawn from the research without 
their consent: 
   
If they attend zero sessions of the treatment we will withdraw them from the research study. If 
they attend at least one session of the treatment we will retain them in the research study.   
   
11.2. Procedures for orderly termination: 
   
We will inform the family that they have been removed from the research study if they attend 
zero of the eight sessions of the treatment. 
   
11.3. Procedures that will be followed when subjects withdraw from the research, including partial 
withdrawal from procedures with continued data collection and withdrawal from 
data/biospecimen banking: 
   
We will destroy all baseline data from participants who withdraw.  
   
12. Risks to Subjects 
12.1. Reasonably foreseeable risks to subjects (include each study population, each arm, and 
optional procedures):  
   
The main risk associated with this study is the time it takes to complete extra pre-post rating 
scales, which is not a part of standard clinical care. In addition, there is a risk of emotional 
discomfort filling out personal questions about one’s behavior or problems the youth is having 
at home or school. There is always a chance of loss of confidentiality, although we will make 
all efforts to prevent this. The specific MAPA curriculum that we will use in this study is being 
adapted from existing MBI programs. Though effect sizes for MBIs and youth-only TOPS 
interventions are similar in the research, we do not know whether TOPS or MBI is more 
effective and so patients could be randomized to a group that is less effective than the other. 
However, both groups are expected to be more effective than the alternative (sitting on the 
waitlist for care). The group will start on the standard fall and winter schedules for all BAM 
groups which will be in October and January. There will be enough time to recruit all 
participants in the windows between when the group opens and when it begins. This follows 
standard clinic operating procedures. If we do not have 18 participants by the group’s start 
date, we will start with fewer participants and submit a modification to run the groups a 3rd time 
to ascertain the recruitment goal. For questions about serious misbehavior (i.e., threatening or 
hurting others) we will conduct a risk assessment if these items are endorsed. If an imminent 
risk to others is detected, we will break confidentiality to keep the recipient of the harm safe.  
 
 

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For parents: Parent participation includes filling out some survey questions about what their 
impressions are of the program their child received. For questions about serious misbehavior 
(i.e., threatening or hurting others) we will conduct a risk assessment if these items are 
endorsed. If an imminent risk to others is detected, we will break confidentiality to keep the 
recipient of the harm safe.  
 
For TOPS group: There is no known risk that is associated specifically with the TOPS group 
versus the MAPA group. 
 
For MAPA group: There is no known risk that is associated specifically with the MAPA group 
versus the TOPS group. 
   
12.2. Procedures with unforeseeable risks: 
   
NA  
   
12.3. Procedures with risks to an embryo or fetus should the subject be or become 
pregnant: 
   
NA 
   
12.4. Risks to others who are not subjects: 
   
NA 
   
12.5. Procedures performed to lessen the probability or magnitude of risks: 
   
All data will be stored in seattle children’s redcap. We will keep all data coded with a study id 
number and all identifying data (required for follow-up of participants) will be stored separately 
in a sharepoint list on a secure Seattle children’s server. Consent forms with identities will be 
stored separate from participant data in redcap.  
 
When using Zoom, the follow actions will be taken to protect confidentiality and privacy: 
• 
Use the latest version of Zoom available. 
• 
Make the meeting private. 
• 
Require a password for meeting entry. 
• 
Disable private chat. 
  
13. Potential Benefits to Subjects 
13.1. Potential benefits that individual subjects may experience from taking part in the research:37 
   
The benefit to participating in this study is that youth may receive extra care for their ADHD 
while they are waiting for standard services at the BAM clinic.  
   
14. Data Analysis/Management 
14.1. Data analysis plan, including statistical procedures: 
   
Using the General Linear Model (GLM), we will conduct a series of mixed design analyses in SPSS 
with each outcome variable as the dependent variable and group (MAPA vs. TOPS) as the between-
subjects predictor. Time (baseline, post-treatment) will be the within-subjects predictor. Cohen’s d 
effect size will be calculated as a measure of change over time for each group. Using standard 

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interpretation guidelines, .2 = small effect, .5 = medium effect, and .8 = large effect (Cohen, 1988). In 
considering relative change between the groups, we will calculated an effect size based on the mean 
baseline to post-treatment change in the MAPA group minus the mean baseline to post-treatment 
change in the OST group, divided by the pooled baseline standard deviation (Morris, 2008). Prior to 
analyses, all assumptions of the GLM will be tested. 
   
14.2. Quality control procedures for collected data:38 
   
We will have a research assistant review all data collected in redcap immediately after 
participants complete the forms to identify questions that were not answered and to request 
that the participant answers the questions if they were missed accidentally.  
  
15. Confidentiality and Privacy39 
15.1. Procedures to secure research records40, data, and/or biospecimens during storage, use, and 
transmission: 
   
We will store all data from the study in secure REDCap Research Servers at Seattle 
Childrens. No data or research records will be stored at UW. 
   
15.2. Steps that will be taken to protect the privacy interests throughout the study:41 
   
We will hold all study assessments over secure Zoom room and we will request that 
participants take Zoom meetings in a private location. Links to redcap will be sent directly to 
participants (by text message/direct message/email depending on the preference of the 
participant). When conducting asessments we will use the latest version of zoom available, 
make the meeting private, require a password for meeting entry, disable private chat. We will 
not audio or video record. We will only share the screen if requested by the participant during 
a discussion of the consent form. However, no screen sharing will occur for the assessment 
portion of the meeting.  
 
When Seattle Children’s clinicians are delivering the treatment over zoom, screen sharing will 
be used during the Zoom meetings to show powerpoint slides related to the treatment (which 
will be uploaded through a modification prior to the start of the group). The clinicians delivering 
the treatment will follow the standard procedures at Seattle Children’s for running telehealth 
groups—which includes using the latest version of zoom, the meeting link is only accessible 
through direct link in the patient’s secure mychart portal, private chat is always disabled, there 
is a waiting room that the clinician decides who can enter. There will be no audio or video 
recording.  
   
15.3. Location where the data and/or biospecimens will be stored: 
   
Seattle Children’s Redcap 
   
15.4. Length of time data and/or biospecimens will be stored: 
   
Indefinitely.  
   
15.5. Individuals with access to data and/or biospecimens: 
   

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IRB-approved study team members and those who later request data as described in banking 
section.  
   
15.6. Process for the transmission of data and/or biospecimens outside Seattle Children’s: 
15.6.1. List of data and/or biospecimens that will be transmitted: 
   
If we share data with an external collaborator, we will do so by giving them access 
to a seattle children’s redcap/one drive server. A modification will be submitted to 
provide more information about external collaborators if they become involved in the 
research. 
   
15.6.2. Individual(s) who will transmit data: 
   
N/A 
   
16. Provisions to Monitor Data to Ensure the Safety of Subjects42 
16.1. Plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe:43 
   
NA no more than minimal risk 
   
16.2. Data reviewed to ensure safety of subjects: 
   
NA 
   
16.3. Safety information collection procedures: 
   
NA 
   
16.4. Frequency of cumulative data review: 
   
NA 
   
16.5. Conditions that trigger an immediate suspension of the research: 
   
NA 
   
17. Use of Social Media 
17.1. Types of social media to be used and how: 
   
NA 
   
17.2. Measures in place to protect the privacy or confidentiality of subjects:44 
   
NA 
   
17.3. Types of communications that will be submitted to the IRB for review:45 
   
NA 
   
17.4. If user-generated content will be active, how it will be monitored and what actions will be taken 
to ensure subject safety and study integrity: 
   
NA 
   
18. Research Related Injury46   
18.1. Available compensation in the event of research related injury: 
   
NA 
   

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19. Recruitment Methods47 
19.1. When, where, and how potential subjects will be recruited48: 
   
A clinic staff member in the Psychiatry Clinic, who is also a member of the research team, will 
call families who are on the STAND waitlist to share the opportunity to participate in this study. 
We will call patients on the waitlist in the order that they joined it before we start offering the 
study opportunity to new patients. If interested in the study, the family will give verbal consent 
to share their first name and contact information with a research team member so that they 
can be contacted by the research assistant to conduct a virtual information session over Zoom 
with the family to have a consent discussion and complete baseline measures over Redcap 
with an emailed link.  
 
19.2. Steps that will be taken to protect privacy during the recruitment process:49 
Private zoom/phone calls will be made when engaging with families. The study team will ask if 
families are in a private space when they speak to them.  
 
19.3. Sources of subjects:50 
   
BAM clinic incoming patients. 
   
19.4. Methods that will be used to identify potential subjects: 
   
We will call patients on the STAND waitlist for adolescent ADHD psychosocial services in BAM 
and offer it to them on a first come first serve basis.   
   
19.5. Materials that will be used to recruit subjects:51  
 
Phone script in Click  
   
19.6. Recruitment methods not controlled by Seattle Children’s: 
   
N/A   
   
20. Consent/Assent/Permission52  
20.1. Consent/assent/permission process:53 
Prior to the group starting, each adolescent and their parent will schedule a zoom call together 
with a study staff member who will go through the consent form (which will be signed digitally). 
The parent will be the point of contact for scheduling the zoom call. Parent consent and youth 
assent will be obtained and after they have gone through the consent form in its entirety, the 
study staff member will summarize the main points on the consent form and offer an 
opportunity to discuss questions and concerns. The family members will sign digitally a 
consent form using an e-signature (in redcap). Given the age range of this study, all 
participants are expected to be in 8th grade or higher, thus conducting a consent conversation 
at an 8th grade language level should be appropriate for both the parent and the youth 
together. The electronic process of an e-signature is used because we will not be in person 
with the family, but we will still be meeting face to face over zoom for an otherwise 
comprehensive consent discussion that emphasizes the autonomy of the parent and youth in 
deciding whether to participate in the study. We will not record the meeting. The consent 
materials will be on one page in redcap and they will review them while on the zoom call with 
the research team. They will be able to scroll up and down. If preferred by the family, the 
research team can share the screen to go over the consent form section by section together. 
Otherwise the family members can indepdnetntly review the redcap consent forms and sign 
them  .If a participant has trouble navigating the consent form, which is available by a 
web=link, we will explore alternatives to reduce technology barriers such as sending the link to 
their smartphone or putting it in the zoom chat (as well as screen sharing demonstration as 

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mentioned above).They will be able to move backwards and forwards through the redcap 
forms (consent and surveys). We will be in the zoom with them to provide technology support 
as needed. They will be able to stop and continue at a later time through a link that allows 
them to restart the survey where they left off. They can stop participating at any time in the 
process. The forms are expected to take approximately 15 minutes to complete. We will 
estimate 30 minutes for the visit including both the consent process and the survey 
completion.  
20.1.1. Alternative way of obtaining consent/assent/permission information for individuals who are 
not able to receive/access/use the electronic consent system being used or explanation as 
to why an alternative process is unnecessary:54 
If a patient cannot access a redcap link, we will mail them a physical copy of the consent. 
If a patient does not have access to zoom technology at the moment of the meeting, we 
will perform the consent conversation over the phone.  
 
20.1.2. Where the consent/assent/permission process will take place: 
   
Over Zoom will be standard practice but a phone call will be used if the individual cannot 
access zoom. 
   
20.1.3. Steps that will be taken to protect privacy during the consent/assent/permission process:55 
   
We will ask families to take the Zoom call in a private location. The research staff 
member will also be in a private location.  
 
20.2. Plan for documenting consent/assent/permission:56 
Digitally in Redcap using an e-signature.  
 
20.2.1. Plan to confirm that the individual who provides the electronic signature57 is the subject (or 
their parent/LAR), when the signature is not personally witnessed by a member of the 
study team or explanation as to why such a plan is unnecessary:58 
N/A the research team member will be on zoom with the families and will be able to 
confirm that they digitally signed the consent forms.  
 
20.2.2. If using electronic consent, plan to manage consent documentation over the life of the 
study in a way that maintains integrity and accessibility:59 
The Redcap functionality allows you export the consents as pdfs-so we can export them as pdfs and keep 
them in a specific folder on a secure Seattle children’s server to have back-up documentation. 
20.2.3. If consent/permission will be documented in writing (check one): 
☒ “SOP: Written Documentation of Consent (HRP-091)” will be followed. 
☐ “SOP: Written Documentation of Consent (HRP-091)” will not be followed. 
 
Process of documenting consent:60 
  
   
20.2.4. If consent/permission will not be documented in writing (check all that apply, complete 
Section 21.11 to request a Waiver of Documentation of Consent)61 
☐ A written statement/information sheet describing the research will be provided to 
subjects.62 
☐ A written statement/information sheet describing the research will not be provided to 
subjects.  Explain: ?Click here to enter text. 
☐ A consent script will be used.63 
   
20.3. Waiting period available between approach and obtaining consent/assent/permission: 
   

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Up until the start date of the group.  
   
20.4. Process to ensure ongoing consent/assent/permission: 
   
We will inform families that they can inform the study staff at any time if they no longer want to 
participate in the research. Families will be informed that they can inform the study staff at any 
time if they no longer wish to participate in the study and this will not impact the treatment in 
which they are entitled to. 
   
20.5. If this box is checked, “SOP: Informed Consent Process for Research (HRP-090)” will be 
followed:  ☒ 
   
20.6. If “SOP: Informed Consent Process for Research (HRP-090)” will not be followed, address the 
following:64 
20.6.1. Role of the individuals listed in the application as being involved in the consent 
process: 
     
?Click here to enter text. 
   
20.6.2. Time that will be devoted to the consent discussion: 
   
?Click here to enter text. 
   
20.6.3. Steps that will be taken to minimize the possibility of coercion or undue influence: 
   
?Click here to enter text. 
   
20.6.4. Steps that will be taken to ensure the subject’s understanding: 
 
?Click here to enter text. 
   
20.7. Individuals who use a language other than English 
   
20.7.1. Presentation of Research Information and Documentation: 
☒  Appendix A-10 of the Investigator Manual will be followed65  
☐  Short form procedures may be used per HRP-091. If so, choose applicable 
box(es): 
☐ Per section 5.5.1 
☐  Per section 5.5.2 
☐  Appendix A-10 of the Investigator Manual will not be followed.  Explanation of 
procedures not following Appendix A-10: 
?Click here to enter text. 
 
    
20.8. Subjects Who Are Not Yet Adults (Infants, Children, Teenagers)  
20.8.1. Process used to determine whether an individual has not attained the legal age of 
consent under the applicable law of the jurisdiction in which the research will be 
conducted (e.g., individuals under the age of 18 years):66 
 
 
 
 
 
Clinic staff have access to adolescent dates of birth in Epic and will verify patient 
age in Epic. They will be asked to only refer to the research team families that are 
within the 13-17 year old age range. 
 
   
20.8.2. Permission will be obtained from:67 

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☐  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, or LAR. 
☒  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, or 
LAR. 
☐  Permission will not be obtained.68 
 
20.8.3. Waiver of permission designed for conditions or for a subject population for which 
parent/LAR permission is not a reasonable requirement to protect the subjects (for 
example, neglected or abused children).69 
20.8.3.1. 
The research involves no more than minimal risk to the subjects 
because: 
N/A 
 
20.8.3.2. Parent/LAR permission is not a reasonable requirement to protect 
subjects because: 
 N/A 
 
20.8.3.3. Description of the mechanism in place that substitutes the 
parent/LAR for protecting the children who will participate:  
 N/A 
   
20.8.4. Process used to ensure permission is obtained from an individual or individuals 
(when two parent permission is required) with legal authority to provide such 
permission::70 
   
We will verify in the EMR who the adolescent’s legal guardian is and confirm  the 
individual’s identity over Zoom prior to obtaining consent. 
 
   
20.8.5. Assent will be obtained from:71 
☒ All children.   
☐ Some children.  Specify:   
?Click here to enter text. 
☐ None of the children.  Explain: ?Click here to enter text. 
 
20.8.6. Procedures for obtaining and documenting assent: 
   
 
Adolescents will also be in the consent discussion with their parents and will be 
given a separate redcap link to confirm their assent.  
 
   
 
20.8.7. Plan for re-approaching children who have reached the age of majority to obtain 
consent:72 
   
We will call the adolescent on the phone and set up a separate zoom meeting to 
obtain consent if they reach the age of majority while actively participating in the 
study. They would not be re-approached if the only procedures left are data 
analysis.  
   
20.9. Cognitively Impaired Adults/Adults Unable to Consent73 

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20.9.1. Process used to determine whether an individual is capable of consent: 
   
N/A 
   
20.9.2. Individuals from whom permission will be obtained in order of priority:74 
   
N/A 
   
20.9.3. Assent will be obtained from: 
☐ All of these subjects. 
☐ Some of these subjects.  Specify:  ?Click here to enter text. 
☐ None of these subjects.  Explain:  ?Click here to enter text. 
 
20.9.4. Process for obtaining and documenting assent:75 
   
N/A 
   
20.10. Waiver or Alteration of Consent/Assent/Permission76 
20.10.1. Reasons for requesting a waiver or alteration of informed 
consent/assent/permission:77 
   
NA 
   
20.10.2. Consent/Assent Waiver/Alteration Criteria justifications:78 
20.10.2.1. The research involves no more than minimal risk to the subjects 
because: 
   
NA 
 
20.10.2.2. The waiver or alteration will not adversely affect the rights or welfare 
of the subjects because:79 
   
NA 
   
20.10.2.3. The research could not practicably be carried out without the waiver 
or alteration because:80 
   
NA 
 
20.10.2.4. If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be 
carried out without using such information or biospecimens in an 
identifiable format because:81 
NA 
   
20.10.2.5. Whenever appropriate, the subjects or legally authorized 
representatives will be provided with additional pertinent information 
after participation: 
   
NA 
   
20.10.3. If the research involves a waiver of the consent process for emergency research, 
provide sufficient information for the IRB to make it determinations:82 
   
NA 
 
20.11. 
Waiver of Written Documentation of Consent/Permission (address one option): 
20.11.1. 
Option 1: 

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• 
The research involves no more than minimal risk to the subjects because: 
 
• 
The research involves no procedures for which written consent is normally 
required outside of the research context because: 
 
 
20.11.2. 
Option 2: 
• 
The principle risk of a signed consent document would be the potential harm 
resulting from a breach of confidentiality because: 
?Click here to enter text. 
• 
Both are true: 
☐ The only record linking the subject and the research would be the consent 
document 
☐ The subject or LAR will be asked whether the subject wants documentation 
linking the subject with the research, and the subject’s wishes will govern. 
20.11.3. 
Option 3: 
• 
The research involves no more than minimal risk to the subjects because: 
?Click here to enter text. 
• 
The subjects or LARs are members of a distinct cultural group or community in 
which signing forms is not the norm.  Explain: 
?Click here to enter text. 
• 
 There is an appropriate alternative mechanism for documenting that informed 
consent was obtained.  Explain: 
?Click here to enter text. 
 
21. HIPAA Authorization and RCW Criteria 
21.1. HIPAA Authorization (check all boxes that apply): 
☐  The study does not involve the receipt, creation, use and/or disclosure of protected health 
information (PHI).83 
☒  HIPAA authorization will be obtained as part of a signed consent form.  
☒  The study will access PHI without prior authorization from subjects (including for 
recruitment purposes – e.g., reviewing the medical record to determine eligibility).  
Complete Section 21.2 to request Waiver of HIPAA Authorization. 
☐  Subjects will review a written statement/information sheet with the appropriate HIPAA 
language but will not provide a written signature.  Complete Section 21.2 below to 
request an Alteration of HIPAA Authorization.84 
☐  Other.  Explain:85 
?Click here to enter text. 
   
21.2. HIPAA Waiver/Alteration Criteria: 86   
21.2.1. Reasons for requesting a waiver or alteration of HIPAA Authorization:  
we will request a HIPAA waiver because in order to call families to let them know 
they are eligible for the study, we will need to access their PHI. 
 
21.2.2. The use or disclosure of PHI involves no more than a minimal risk to privacy of 
individuals, based on, at least the presence of the following elements: 
 
21.2.2.1. An adequate plan to protect the identifiers from improper use and 
disclosure: We will not extract any identifiers from the EPIC record that 

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they came from during this process. The study team members, who are 
also clinic staff, will view the names and contact information of the 
waitlisted potential participants in EPIC and will contact them using this 
information. We will not need to access any additional information 
besides their contact information. Since we will not extract any 
information, there will not be information to destroy. We will not share 
information viewed in EPIC with anyone outside the research or clinical 
team. 
   
   
21.2.2.2. An adequate plan to destroy identifiers at earliest opportunity consistent 
with conduct of research: 
 
 
 
 
 
Refer to Section 15. 
 
 
 
   
21.2.2.3. Assurances that PHI will not be reused or disclosed to any other party or 
entity, except as required by law or for authorized oversight of the 
research: 
 
 
 
 
 
PHI will be used as described in the protocol. 
   
21.2.3. The research could not practicably be conducted without the waiver or alteration of 
authorization: 
   
We could not know the contact information or identity of eligible participants without 
looking this information up in EPIC. Therefore we cannot ask them for authorization 
since we wouldn’t know who they are until we access it.  
   
21.2.4. The research could not practicably be conducted without access to and use of the 
PHI:87 
   
There is no way to know who is on the waitlist and how to contact them without 
accessing their PHI. 
   
22. Payments/Costs to Subjects88 
22.1. Amount, method, and timing of payments to subjects:89 
   
None 
   
22.2. Reimbursement provided to subjects:90 
   
None 
   
22.3. Additional costs that subjects may be responsible for because of participation in the 
research:91 
   
None. Patients will pay for clinical services as they normally would in the SCH Psychiatry 
clinic..All of the interventions described in this study will be billed to insurance as group 
psychotherapy- 90 minutes. The same billing code will be used for both groups.  
   
23. Community-Based Settings92 
23.1. Site(s) or location(s) in the community where the research team will conduct the research: 
   
N/A 
   
23.2. Composition and involvement of any community advisory board: 
   
Deleted:   
Deleted:   

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N/A 
   
23.3. For research conducted outside of the organization and its affiliates:93 
23.3.1. Site-specific regulations or customs affecting the research: 
   
N/A 
   
23.3.2. Local scientific and ethical review structure: 
   
N/A 
   
24. Resources Available 
24.1. Qualifications (e.g., training, education, experience, oversight) of investigator(s) to conduct 
and supervise the research:94 
   
The PI has a long history of conducting clinical research, including treatment evaluation 
studies like this one, with adolescents with ADHD across a wide range of settings. This 
includes seven federally or foundation funded clinical trials of organization skills training for 
adolescents with ADHD. The PI has over 130 publications on ADHD across the lifespan and 
has conducted treatment research in a variety of settings including schools, university clinics, 
community mental health centers, and recreational programs. 
   
24.2. Other resources available to conduct the research:95 
   
N/A 
   
25. Coordinating Center Procedures 
25.1. Coordinating center institution: 
   
Seattle Children’s Research Institute  
   
25.2. If Seattle Children’s is the coordinating center: 
25.2.1. Process to ensure communication among sites:96 
   
N/A there is only one site. 
   
25.2.2. Process to ensure all site investigators conduct the study according to the IRB 
approved protocol and report all non-compliance: 
     
N/A      
   
25.2.3. Process to ensure all required approvals are obtained at each site: 
     
N/A 
   
25.2.4. Process to ensure all sites are informed of any problems and/or interim results: 
   
N/A 
   
26. International Center for Harmonization of Good Clinical Practice (ICH-GCP) 
26.1. If you have committed to conducting the described study per ICH-GCP, check this box: ☐97 
• 
This is generally applicable for contracts with industry-sponsored studies or sponsor 
protocols. See your contract/agreement or Sponsor Documentation if you are unsure. 
• 
Note that completing GCP training is a separate activity and does not automatically mean 
that you have committed to conducting the study per ICH-GCP. 
If you check the box, upload a current curriculum vitae (CV) for the PI to the “Other 
Attachments” section of the “Local Site Documents” SmartForm.   
 

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1 Provide a list of the participating sites (pSITEs). pSITEs are those sites outside Seattle Children’s that will rely on 
the Seattle Children’s IRB as their IRB of record. All pSITEs should be listed even if no study procedures will occur at 
the site. Remove the heading if this is not a study where Seattle Children’s IRB will serve as the IRB of record for 
other institutions. 
2 Include information if this protocol is associated with other IRB-approved studies (e.g. is this application the next 
part/phase of a previously approved application. 
3 In clinical trials, an endpoint is an event or outcome that can be measured objectively to determine whether the 
intervention being studied is beneficial. Some examples of endpoints are survival, improvements in quality of life, 
relief of symptoms, and disappearance of the tumor.   
4 Include information on a drug or biologic in this section if: (1) the study specifies the use of an approved drug or 
biologic; (2) the study uses an unapproved drug or biologic; (3) the study uses a food or dietary supplement to 
diagnose, cure, treat, or mitigate a disease or condition; or (4) data regarding subjects will be submitted to or held for 
inspection by the Food and Drug Administration (FDA).  Only include information on a device in this section if: (1) the 
study evaluates the safety or effectiveness of a device; (2) the study uses a humanitarian use device (HUD) for 
research purposes; or (3) data regarding subjects will be submitted to or held for inspection by the FDA.  Please note 
that certain software functions, mobile medical applications, and general wellness products may meet the definition of 
a device. As of October 2024, the IRB no longer applies enforcement discretion to device studies because the FDA 
has clarified that enforcement discretion only applies to manufacturer requirements. 
5 See the Investigator Manual HRP-103 for sponsor requirements for FDA-regulated research. 
6 Explain what IND exemption category applies to the drug and why.  Note that a drug is not exempt from an IND 
unless all criteria for one category are met.  See “HRP-306: Drugs” for more information. 
7 Explain what IDE exemption category applies to the device and why.  Note that a device is not exempt from an IDE 
unless all criteria for one category are met.  See “HRP-307: Devices” for more information. 
8 Explain why the device is NOT a significant risk device.  A significant risk device means an investigational device 
that: (a) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a 

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subject; (b) is purported or represented to be for use supporting or sustaining human life and presents a potential for 
serious risk to the health, safety, or welfare of a subject; (c) is for a use of substantial importance in diagnosing, 
curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject; or (d) otherwise presents a potential for serious risk to the 
health, safety, or welfare of a subject.  
9 Be sure to indicate if controls will be included and include information about why control arms are ethically 
acceptable. 
10 Describe all of the research procedures being performed. Be sure to make it clear which procedures apply to each 
subject population. When applicable, describe how research procedures differ from standard of care and/or affect 
standard of care.  Describe any audio/video recording that will be involved. 
11 Attach all surveys, scripts, and data collection forms to the “Supporting Documents” page. 
12 Include information about the frequency of data collection. 
13 See HRP-001 - SOP – Definitions for definition of banking.  Type N/A if not applicable.  If the data is subject to NIH 
Genomic Data Sharing Policies or other data sharing policies (e.g. you will submit data to dbGaP, NDAR, FITBIR), 
indicate here. Note that sharing with federal policies requires information to be included the consent forms.  See 
HRP-502 F Language Resource Text for sample language.   
14 If applicable, include a list of identifiers that will be banked. 
15 Be general (e.g., researchers’ lab, clinic, etc.) 
16 Generally, data and/or biospecimens should be released in a coded, non – identifiable manner. 
17 Include a description of the process used to verify and document that any required approvals have been obtained 
prior to release of data/biospecimens from the bank. 
18 You can allow for use for broad purposes 
19 This includes putting results and/or data in the subject medical records. 
20 If your population will differ from the representative population where the study will take place (e.g., race, ethnic 
group, or gender), provide a rationale for the differences. 
21 Seattle Children’s IRB prohibits the exclusion of populations based on language, socioeconomic status, physical 
characteristics (e.g., gender identity, age, ethnicity), sexual orientation, religion, or access to technology unless there 
is sufficient justification for the exclusion. Specifically for language, the cost of translation and/or interpreter services 
will not be considered sufficient justification for the exclusion of  participants who use a language other than English 
in accordance with NIH guidelines, in most circumstances. (“Cost is not an acceptable reason for exclusion except 
when the study would duplicate data from other sources.” 59 FR 11146, March 28, 1994). See Investigator Manual 
HRP-103 for additional information. 
22 The plan must take into consideration the purpose of the research and the setting in which the research will be 
conducted. The plan must ensure that no group of people is either unfairly over-represented or unfairly excluded from 
participating in research. Your response should include how the recruitment process and other aspects of the study 
(as appropriate) are designed to facilitate equitable selection. 
23 If you check a box below, be sure to include the additional considerations associated with the population. 
24 Refer to HRP-416 CHECKLIST: Children.   
25 If the study is minimal risk, explain why. For studies that present greater that minimal risk include, as applicable: (1) 
why direct benefits are anticipated, (2) why risks are justified by anticipated benefit and/or the relationship between 
risk and prospective benefit compared to available alternatives, (3) why risk represents only minor increase over 
minimal risk, (4) how study procedures are reasonably commensurate with those inherent to the child’s actual or 
expected conditions, (5) whether the interventions/procedures are likely to yield generalizable knowledge about the 
participant’s condition and why it is of “vital importance” to understanding or amelioration of the participant’s 
underlying disorder or condition, and (6) an explanation of what alternative methods/approaches were considered to 
make the above assessments (as applicable). As applicable, provide evidence-based information to support your 
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26 This population may be wards of the state or any other agency, institution, or entity. For studies that present 
greater than minimal risk, refer to HRP-416 CHECKLIST: Children, Section 6, for additional guidance on required 
considerations for this population. 
27 This refers to both cognitive impairments and adults who are incapacitated for any other reason.  As applicable, 
refer to HRP-417 CHECKLIST: Cognitively Impaired Adults. 
28 This includes subjects and their parent(s)/LAR. 
29 Applicable to information conveyed in writing and verbally. For example, your plan could include translating all 
study documents and having a study team member or interpreter available who can speak the language to answer 
questions. 
30 Refer to HRP-413 CHECKLIST: Neonates and HRP-414 CHECKLIST: Neonates of Uncertain Viability. 
31 This box does not need to be checked if pregnant women are not a target population and pregnancy is irrelevant to 
risk considerations. Refer to HRP-412 CHECKLIST: Pregnant Women. 
32 Refer to HRP-415 CHECKLIST: Prisoners 
33 Indicate how you will ensure that there is no coercion or undue influence 
34 A subject is considered “enrolled” when they consent to be in the study. 
35 Only applicable for multisite studies. 
36 i.e., numbers of subjects excluding screen failures. 
37 Payment for participation is not considered a benefit. 
38 For example, data will be double entered, data will be reviewed by another study team member to ensure 
accuracy, etc. 
39 If your study is multisite and there are differences in how confidentiality will be maintained by the coordination 
center and our local site, this should be explained in this section (e.g. local site will have samples that are linked to a 
person’s name, but the coordination center will only receive coded samples without any links).  Confidentiality 
regarding use of Social Media will be explained in a protocol section below. 
40 Including the signed consent/assent/permission forms and any information/documentation collected during the 
consent process. 
41 Privacy refers to persons and their interests in controlling the access of others to themselves. For example, based 
on privacy interests, people want to control the time and place where they give information, the nature of the 
information they give and who receives and can use the information. 
 
When providing a response, consider the subject population and nature of the study.  For example, persons might not 
want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is clearly 
identified as such by signs on the building. 
42 Applicable for studies that present more than minimal risk. 
43 Include information about who (describe in terms of role or group) will review the data. 
44 This should be specific to the social media you are using for the research. 
45 All communications that are directed towards subjects and specific to a particular study will require prior IRB review 
and approval.  All non-IRB reviewable communications can be described in general terms by category – news stories, 
relevant publications – and representative examples of each can be provided.   
46 Applicable if the research involves more than minimal risk to subjects.  If minimal risk, this section is N/A. 
47 If this is a multicenter study and subjects will be recruited by methods not under the control of the local site (e.g., 
call centers, national advertisements) those methods should also be described here. 

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48 If the study will enroll or seek permission from individuals who speak a language other than English and 
recruitment methods will differ for these individuals (e.g., they will be approached by a bi-lingual person outside the 
study team), be sure your description covers these methods as well. 
49 For example, subjects will be initially approached in a private room or a letter rather than a postcard will be sent 
when the study name may disclose health information about the potential subject. 
50 For example, medical records, CIS, clinical databases, other study records. If the study will access PHI for 
recruitment purposes without prior authorization from subjects, please address this in the HIPAA Authorization 
section below. 
51 Attach copies of these documents to the Recruitment Materials section of the study SmartForm. For printed 
advertisements, attach the final copy. For online advertisements, attach the final screen shots (including any images).  
When advertisements are taped for broadcast, send the final audio/video tape to IRB@seattlechildrens.org. You may 
attach the wording of the advertisement to the SmartForm prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final audio/video tape. 
52 “Permission” refers to consent obtained from a parent or LAR. 
53Address the following in the response, as applicable:  
1. 
How you will ensure that subjects and/or their parent/LAR have sufficient opportunity to discuss and 
consider whether or not to participate in the research.  
2. 
Speak to the suitability of the intended consent process for the intended audience, taking into consideration 
the subject’s and/or parent/LAR’s age, language, comprehension level, and familiarity with technology tools 
(if applicable). 
3. 
If using an electronic process to send consent information or obtain documentation of consent (e.g., e-
signature), identify the process to be used to send the consent information (e.g., e-mail). 
4. 
If using an electronic process (e.g., e-mail), describe the procedures that ensure the electronic process 
allows subjects/parents/LARs to ask questions they may have before signing (e.g., by in-person discussions, 
telephone calls, videoconferencing). If conducting a consent conference, describe the method to be used for 
the conference (e.g., telephone call, video conference), specifying any programs (e.g., Zoom) to be used. If 
applicable, indicate that the consent discussion will be audio or video recorded and whether recording will 
occur within any programs being used (e.g., Zoom). 
5. 
 If using an electronic process, describe how the subject and/or parent/LAR will navigate the consent 
materials, including whether the subject/parent/LAR will have the ability to move backwards and forwards 
within the electronic system and to stop and continue at a later time. Also indicate how long it will take.  
6. 
The availability of study personnel to assist subjects and/or their parent/LAR in using the electronic process, 
if applicable. 
54 Some study teams are currently considering creative solutions for such individuals; these potential solutions 
include snail mail, drive through paperwork for consent, and loaner device/hotspots for e-consenting.  If no alternative 
will be made available (meaning these individuals cannot be enrolled), the IRB will look for a sufficient rationale for 
this exclusion. 
55 For example, the consent discussion will take place in a private room. 
56 Address the following in the response, as applicable: 
1. 
Identify the means of documenting consent/assent/permission (e.g., in writing, verbally, etc.). If obtaining an 
electronic signature, identify the specific software/application to be used.  
2. 
Include a description of how the consent/assent form(s) will be delivered, including any programs (e.g. 
REDCap) to be used.  
3. 
Include a list of any information about the individual that will be collected during the 
assent/consent/permission process. 
4. 
If the research is conducted outside of Washington State, provide confirmation that the electronic 
documentation of consent is legally effective in that jurisdiction. Note, the study team’s location while 

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conducting the study dictates the jurisdiction. For single IRB studies, the participating site’s study team 
location while conducting the study dictates the jurisdiction. 
57 Electronic signature in this context refers to a legally effective electronic signature (e.g., a signature obtained via 
DocuSign) and does not apply to procedures where a waiver of documentation of consent is requested. 
58 Indicate “N/A” if not obtaining an electronic signature. Researchers are encouraged to consider the risks and 
benefits of the research when determining whether it is necessary to verify the subject/parent/LAR identity. For 
example, consider how likely it is that someone other than the subject would provide the consent.  Social behavioral 
minimal risk research will not typically warrant identity verification.   
59 For example, consent forms will be downloaded as soon as they are full executed and saved electronically in a 
location accessible to the study team. 
60 This section describes the ways in which the procedures will not follow Seattle Children’s SOP. 
61 See “HRP-411: Waiver or Written Documentation of Informed Consent” for further information. 
62 An information sheet template (HRP-502D) can be found in the Click IRB Library and should be attached to the 
consent form of the study SmartForm.  For internet research, the information sheet can be translated to an on-line 
format, if desired. 
63 The IRB sometimes requires a script if you are having the consent conversation over the phone rather than in 
person.  Templates for a consent script are available on the IRB website on the Participant Recruitment page and 
should be attached to the study SmartForm. 
64 This section describes the way(s) in which the processes for this study will not follow Seattle Children’s SOP. 
65 Note the Short Form Consent may only be used when certain conditions are met.  See HRP-091 for requirements 
for Short Form consent form use. 
66 For research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians 
(HRP-013)” to be aware of which individuals in the state meet the definition of “children.”  The age of majority in 
Washington is 18; however, sometimes younger children have ability to consent for certain types of care (e.g. sexual 
reproduction/health; mental health; drug/alcohol treatment).  For research conducted outside of the state, provide 
information that describes which persons have not attained the legal age for consent to treatments or procedures 
involved the research, under the applicable law of the jurisdiction in which research will be conducted. One method of 
obtaining this information is to have a legal counsel or authority review your protocol along the definition of “children” 
in “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013).”  If the sites in other states in the 
study are conducting their own IRB review, you do not need to worry about this--type N/A.  If you are conducting 
research and are actively recruiting participants outside of Washington who are NOT coming to SCH to give consent 
and who will be covered under SCH IRB approval, this section should be addressed in your protocol. 
67 For minimal risk studies and greater than minimal risk studies that offer a prospect of benefit, the IRB generally 
requires one parent to provide permission for the child to participate. 
68 If permission will not be obtained, please address this in the Waiver or Alteration of Consent Process below. 
69 A waiver under this category is not available for FDA regulated studies. If you are requesting a waiver 
of parent/LAR permission under this category, you do not need to complete Section 20.10 for the same 
population. 
70 See HRP-013 for more information. 
71 The IRB generally follows the following guidelines for written assent: children 7-12 should provide written assent on 
the “simple” assent form (HRP-502G); children 13-17 should provide written assent by co-signing the parental 
permission form (HRP-502A).  The IRB will consider other assent scenarios (e.g. verbal assent for some or all 
children; not requiring assent for some or all children; or waiving assent): please provide details about the plan for 
your study.  See HRP-090 and HRP-416 for more information on waiving assent and when assent is not necessary. 
72 See Appendix A-13 of the Investigator Manual HRP-103 for requirements for re-consent at age 18.  If you think you 
meet the conditions for a waiver at 18, please address this in the Waiver or Alteration of Consent Process below. 
73 See “HRP-417 Cognitively Impaired Adults” for further information.   

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74 For example: durable power of attorney for health care, court appointed guardian for health care decisions, spouse, 
and adult child.  If you are following HRP-013 in order to make this determination, simply state that in this section. For 
research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-
013)” to be aware of which individuals in the state meet the definition of “legally authorized representative.” For 
research conducted outside of the state, provide information that describes which individuals are authorized under 
applicable law to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this 
research. One method of obtaining this information is to have a legal counsel or authority review your protocol along 
the definition of “legally authorized representative” in “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013).”  If the sites in other states in the study are conducting their own IRB review, you do not need 
to worry about this--type N/A.  If you are conducting research and are actively recruiting participants outside of 
Washington who are NOT coming to Washington to give consent and who will be covered under SCH IRB approval, 
this section should be addressed in your protocol. 
75 The IRB may allow the person obtaining assent to document assent on the consent document. 
76 Provide justifications/explanations for each subject population for which a waiver/alteration is being requested.   
77 For example: consent/parental permission will not be obtained, required information will not be disclosed, the 
research involves deception, waiver for participants who turn 18, waiver for information collected about a non-present 
parent, or other waivers as necessary. 
78 The IRB needs to make all the waiver findings and key to this determination is that the IRB understand why it is not 
practicable to do the research without a waiver of consent.  You need to provide a rationale in order for the IRB to 
consider whether the waiver criteria are met. See “HRP-410: Waiver or Alteration of the Consent Process” for further 
information.   
79 Possible reasons might include: a) you are not collecting information that could put subjects or their families at 
harm, e.g., affect eligibility for insurance, employability, stigmatization; b) you are not collecting information that would 
alter or affect the subject’s care; c) any publication or presentation of research results would be done in a manner that 
would never reveal an individual’s identity either directly or indirectly. 
80 Possible reasons could be: a) inability to locate families because of the lengthy time period over which the 
records/samples were created; b) many of the subjects whose records, data, or biospecimens will be used may have 
died and contacting the families about the research could cause harm and anguish to families; c) all eligible patients 
must be included in the study for the results to be meaningful. 
81 For example, identifiers are necessary, so that researchers can perform quality checks or identifiers are necessary 
to link data from multiple sources. 
82 See “HRP 419: Waiver of Consent for Emergency Research” for further information. 
83 PHI is health information that is also identifiable because it includes one or more of the 18 HIPAA identifiers.  See 
Investigator Manual HRP-103 for the list of HIPAA identifiers.   
84 If your study involves using or creating PHI and your only contact with participants is online, you can request an 
alteration of HIPAA authorization to remove the signature requirement.  As an alternative to a waiver of 
documentation of consent and an alteration of HIPAA authorization, you must demonstrate that the electronic consent 
signatures are compliant with applicable state/international law (in Washington, see RCW 19.34.300).   
85 For example: altering HIPAA elements for international research. 
86 Provide justifications/explanations for each subject population for which a waiver/alteration is being requested.   
87 Possible reason could be: the nature of the research is specific to individuals’ health and requires access to 
individuals’ health records. 
88 See “HRP-316: Payments” for further information. 
89 Methods of payment include check, ClinCard, gift cards, etc.  Provide details on who will be the recipient of the 
payment (parent or child). 

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90 Reimbursement is used when the subject is paid back for travel expenses such as transportation, food, childcare, 
or lodging.  Reimbursement is generally distributed to person who incurred cost (usually parent) and requires receipts 
to be submitted.   
91 This could include things like fuel/transportation costs, parking, and/or childcare. 
92 Community-based settings may include community clinics, schools, non-profit organizations, etc. 
93 Type N/A if this section does not apply. 
94 Provide enough information to convince the IRB that  the principal and/or co-investigator(s) are appropriately 
qualified to conduct and supervise the proposed research. When applicable, describe their prior clinical experience 
with the test article or study-related procedures, or describe their knowledge of the local study sites, culture, and 
society.  
95 For example, as appropriate: (1) 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? (2) Describe the time that you will devote to conducting and 
completing the research. (3) Describe the facilities in which the research will be conducted. (4) Describe the 
availability of medical or psychological resources that subjects might need as a result of an anticipated consequences 
of the human research. (5) 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. 
96 Including communication between sites of current study document versions and modifications. 
97 If you check the box, you are required to conduct your study according to the principles outlined at 
https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-
practice.html.