A Peer-Delivered High School Preparatory Intervention for Students With ADHD
Phase: NA
Conditions: ADHD
Sponsor: Seattle Children's Hospital

Principal Researcher: Sibley  
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Protocol Version Date: 12/5/2019
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PROJECT TITLE:
A Peer-Delivered High School Preparatory Intervention for Students with ADHD.
PRINCIPAL INVESTIGATOR:
Margaret H. Sibley
Center for Child Health Behavior and Development
(206) 884-1424
Margaret.sibley@seattlechildrens.org

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Contents
1.
Objectives........................................................................................................................................3
2.
Background.....................................................................................................................................3
3.
Study Endpoints .............................................................................................................................8
4.
Drugs, Devices and Biologics .......................................................................................................9
5.
Procedures Involved ......................................................................................................................9
6.
Data and Biospecimen Banking ..................................................................................................12
7.
Sharing of Results ........................................................................................................................13
8.
Study Timelines ............................................................................................................................14
9.
Study Population ..........................................................................................................................14
10.
Number of Subjects......................................................................................................................15
11.
Withdrawal of Subjects ................................................................................................................16
12.
Risks to Subjects..........................................................................................................................16
13.
Potential Benefits to Subjects .....................................................................................................18
14.
Data Analysis/Management .........................................................................................................18
15.
Confidentiality...............................................................................................................................19
16.
Provisions to Monitor Data to Ensure the Safety of Subjects..................................................20
17.
Use of Social Media ......................................................................................................................21
18.
Research Related Injury...............................................................................................................21
19.
Recruitment Methods ...................................................................................................................21
20.
Consent/Assent Process .............................................................................................................22
21.
Process to Document Consent in Writing..................................................................................27
22.
HIPAA Authorization and RCW Criteria......................................................................................27
23.
Payments/Costs to Subjects .......................................................................................................28
24.
Setting............................................................................................................................................28
25.
Resources Available.....................................................................................................................28
26.
Coordinating Center Procedures ................................................................................................29
27.
International Center for Harmonization of Good Clinical Practice (ICH-GCP)........................29

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1.
Objectives
1.1. Purpose, specific aims, or objectives:
To test the effect of summer STRIPES (compared to school services plus) on key 
outcomes and mechanisms. We will also test mediational paths between mechanisms 
and outcomes.
To assess indices of engagement and school fit (i.e., parent, student, and peer 
interventionist engagement in the intervention; fidelity, perceived intervention utility and 
burden).
  
1.2. Hypotheses to be tested:
  
Students who receive summer STRIPES will demonstrate greater improvements 
in ninth grade functional outcomes and proposed mechanisms than participants 
in SSU plus. Change in mechanisms will mediate the relationship between 
treatment group and outcome
Students, parents, and peers will demonstrate strong attendance (i.e., at least 
80% of sessions attended). Peer interventionists and school staff sponsors will 
display scores of at least 80% on fidelity checklists and will display positive 
attitudes toward the treatment delivery experience. Satisfaction, perceived 
intervention utility, and bond with interventionists will be strong.
  
2.
Background
2.1. Relevant prior experience and gaps in current knowledge:
  
High school aged adolescents with ADHD experience substantial impairments, 
particularly in the school setting (Kent et al., 2011). However, very few high school students with 
ADHD receive evidence-based interventions (medication or psychosocial treatment) for their 
difficulties. Primary barriers include distaste for stimulant medication (Brinkman et al., 2017), 
parent-teen conflict that curbs family-based service utilization (Barkley et al., 2001), and 
resource barriers that hamper high school intervention delivery (Sibley et al., 2016). In this 
proposal, we seek to improve access to care by adapting evidence-based psychosocial 
intervention components to a low-resource and novel school-based intervention model (a brief 
peer-delivered summer orientation to high school with continued peer-delivered sessions during 
ninth grade). The project will be conducted in real-world high school contexts.
Our previous work in real-world settings (Sibley et a., 2018; Sibley et al., under review) 
identifies two promising school-based intervention models to promote healthy transitions to ninth 
grade: (1) an intensive skill-based summer preparatory program (Summer Treatment Program-
Adolescent; STP-A) and (2) a weekly peer-delivered organization skill and motivational 
intervention (Students Taking Responsibility and Initiative through Peer Enhances Support; 
STRIPES). Yet despite their promise, each of these models possesses significant limitations: (1) 
the costly STP-A (over $4000 per student) is not affordable to school districts and (2) though 
highly effective when attended, ninth grader engagement in STRIPES has been suboptimal 
(only 50% attendance at best). In this project, we propose that the limitations of each model 
may be solved by the strengths of the other—the low-cost STRIPES interventionists can reduce 

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the STP-A’s tremendous expense; the highly engaging STP-A model might boost STRIPES’ 
attendance problems. Meanwhile, the STP-A’s intensive practice and contingency management 
components might go beyond simply preventing decline (Sibley et al., under review) to fully 
increasing performance (Sibley et al., 2018).
2.2. Relevant preliminary data:1
  
This research is the next phase of the “STRIPES” IRB protocol that recently finished. A 
brief summary of the findings of that study are below. 
. 
In 2015, we started developing a peer-delivered intervention for high school students 
with ADHD (STRIPES: Students Taking Responsibility and Initiative through Peer Enhanced 
Support; Sibley et al., under review). STRIPES targets core EF skills and academic motivation. 
Results of our pilot work indicated that intervention credibility, fidelity, satisfaction, and student-
peer bond were positive (see Table 2). Despite these positive results, 9th grade students often 
failed to attend STRIPES. Thus, the current study seeks to solve the engagement problems of 
STRIPES by offering a one week enjoyable orientation based on the Summer Treatment 
Program Adolescent prior to ninth grade, paired with a parenting strategies group. Despite these 
difficulties, eight sessions of STRIPES delivered as a pullout model led to large statistically 
significant between group differences (versus enhanced school services) in bookbag 
organization (d=1.11), extrinsic school motivational indices (d=.85 to 2.05), and class 
attendance (d=1.47) over time. Most notably, STRIPES delivered as pull-out prevented steep 
declines in functioning across ninth grade (see Figure 5a-5c). 
Despite its promise, STRIPES did not produce effects on planner use, intrinsic 
motivation, or GPA. We concluded that STRIPES requires additional components to enhance 
engagement and promote regular practice of EF skills. We believe that the additional STP-A 
skills training modules may increase effectiveness of STRIPES on underperforming outcomes._
  
2.3. Scientific or scholarly background:
  
For adolescents with ADHD, academics are regarded as the most critically impaired 
domain (Barkley, 2006; Robin, 1998). Compared to non-ADHD peers, high school students with 
ADHD perform more poorly on standardized tests (Barkley et al., 1991; Fischer et al., 1990), 
complete fewer assignments (Barkley et al., 1991; Kent et al., 2011; Weiss et al., 1993), and 
receive poorer course grades (Barkley et al., 2006; Kent et al., 2011). By some estimates, up to 
a third of students with ADHD fail to complete high school (Barkley et al., 2002). These 
academic problems are particularly concerning because they predict severe dysfunction in 
adulthood (Masten et al., 2005; Rindfuss et al., 1999). For example, Molina et al., (2012) 
reported that the relationship between ADHD and substance 
abuse by age 18 was mediated by academic, social, and 
disciplinary problems during high school. Adolescents who do 
not finish high school risk further escalating problems, such as 
criminal behavior (Thornberry et al., 1985), drug and alcohol 
addiction (Townsend et al., 2007), unemployment (Stanard, 
2003), and dependence on government assistance programs 
(Martin et al., 2002). Therefore, it is not surprising that young 
Figure 1.  Stimulant medication and psychosocial treatments 
use for ADHD by grade.
0
10
20
30
40
50
60
70
PreK
1
3
5
7
9
11
P1
P3
Grade
% of ADHD Ss who received intervention
Stimulants
Psychosocial

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adults with ADHD are at elevated risk for each of these difficulties (Barkley et al., 2010; 
Hechtman et al., 2017). 
Treatment Access. Despite these impairments, a majority of high school students with 
ADHD do not receive any treatment. Bussing et al., (2011) reported that a majority of 
adolescents with ADHD (58%) had not received mental health services in the past year. 
Although medication is considered the first line treatment for ADHD in adolescence (American 
Academy of Pediatrics, 2011), the Multimodal Treatment of ADHD Study reveals that a majority 
of teens with ADHD find medication unpalatable, desisting use (Brinkman et al., 2017). The 
Pittsburgh ADHD Longitudinal Study also reveals a steep decline (see Figure 1) in utilization of 
medication and psychosocial interventions in high school.  
Because a majority of ADHD-related impairment occurs at school, high schools are a 
logical deployment setting for interventions. However, school-based interventions for ADHD 
(which are widespread in elementary schools; Pelham & Fabiano, 2008) are rarely available to 
high school students. A number of systemic barriers limit access. For one, most high school 
students with ADHD (55%) do not receive special education services and are placed in regular 
education (Barkley et al., 2006). In elementary school, regular education classroom teachers 
often oversee behavior modification programs for students with ADHD (Hart et al., 2017); 
however, their high school counterparts typically teach over 100 students and may have little 
time to devote to individual students (Benner & Graham, 2009). High school counselors are 
historically mental health service providers but have seen a shift to administrative duties that 
include graduation planning, parent liaising, and managing student schedules (American School 
Counselor Association, 2013). Thus, ancillary intervention staff, rather than academic teachers 
or counselors, are often tasked with providing services to struggling high school students with 
ADHD (National Center for Response to Intervention, 2010). Unfortunately, funding for these 
educational support services—particularly for students without special education entitlement—
has slowly declined over the last decade (American Association of School Administrators, 
2012). Thus, most high school students with ADHD have no access to interventions in their 
schools. Regular education students with ADHD are particularly unlikely to access services 
because they are not a priority for earmarked intervention funds. 
Implementation of Extant Interventions. In high resource settings, designated 
interventionists might provide a range of services using models that are successful in 
elementary or middle schools (Evans et al., 2018; Pelham & Fabiano, 2008). The most 
promising approach may be skills training interventions that were developed for middle school 
students (Evans et al., 2016) and have been adapted for high school students in clinical (Sibley 
et al., 2019), school (Evans et al., 2014), and summer treatment settings (Sibley et al., 2018). 
These interventions target two core ADHD-related cognitive deficits: executive functioning (EF) 
and motivation (Sonuga-Barke, 2002: Toplak etal., 2005). They do so by teaching 
compensatory strategies in organization, time management, and planning (OTP) and including 
motivational components such as goal-setting, contingency management, and strength-based 
feedback (Sibley, 2017). 
Despite the promise of these approaches, transfer of intervention delivery to high school 
staff has been largely unsuccessful—particularly in regular education settings (Kern et al., under 
review; Sibley, Olson, et al.,, 2016). Our team illustrated this challenge in a recent publication 
(Sibley, Olson, et al., 2016). Using a secondary school consultation model (Evans et al., 2007), 
outside behavioral consultants identified an in-school interventionist for 218 adolescents with 
ADHD at 114 different schools. Interventionists were 27.4% teachers, 57.2% counselors, 3.4% 

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administrators, and 12.0% special education staff. Success rate for the intervention was low. 
Monthly contact between consultants and interventionists was challenging 
(38.5% success rate) and only 40.0% of interventionists completed 
in-person meetings with consultants. Analyses suggested that lower 
success rates were associated with high school (vs. middle school) 
and regular education (vs. special education) settings. When 
surveyed about engagement barriers, staff highlighted resource 
problems (see Table 1).Thus, an ongoing challenge for high schools 
is identifying qualified and available interventionists who are willing to 
deliver evidence-based interventions to regular education students with ADHD.
Ninth Grade as a Critical Intervention Period. When resources are low, it becomes 
important to intervene wisely—conserving services for windows 
that promote maximal impact (Cohen et al., 2017). Failure to 
access ADHD treatment may be particularly detrimental to 9th 
grade students. Typical adolescents display a decline in GPA 
(Isakson et al., 1999), self-esteem (Barber et al., 2004), and 
psychological adjustment at the transition to high school (Barone et 
al., 1991). This deterioration is especially marked in students with 
ADHD, whose 9th grade year marks the low point of their academic 
performance (Figure 2; Kent et al., 2011). Performance during ninth 
grade is implicated as one of the strongest predictors of eventual 
high school dropout (Neild et al., 2008). Thus, 9th grade is a strategic intervention period to 
prevent escalating school disengagement among students with ADHD.
Peers as Interventionists. One group of interventionists who are available, qualified, 
and willing may be academically excellent 11/12th grade peers. Peers are numerous and free 
interventionists who may possess more time than school staff for intervention delivery. High 
schoolers have ample opportunities to interact with peers throughout the school day and unlike 
school staff, peer interventionists may be highly motivated to deliver interventions. Such an 
experience can enhance college applications, provide community service hours that are 
required for graduation, and serve as an enriching service learning leadership experience. This 
low-resource model may be particularly fitting for regular education students with ADHD, who 
may have mild to moderate impairments that do not require intensive intervention. There is 
abundant evidence that high school students can deliver a range of interventions to peers with 
fidelity (Stenhoff et al., 2007; Fuchs et al., 2000; Mastropieri et al., 2003; Stephenson et al., 
2004). In fact, a meta-analysis (Wilson, Lipsey, et al., 2003) suggests that peer-delivered 
interventions for disruptive behavior produce effect sizes that are equal to adult-delivered 
interventions. Peers play a central role in the lives of high school students, as adolescents 
spend decreasing amounts of time with adults (Steinberg & Morris, 2001). Thus, adolescents 
with ADHD may be highly interested in engaging with peer interventionists. There is also 
evidence that peers can serve as salient reinforcers in behavior therapy (Kalfus, 1984), which 
may be particularly true in high school. Peers also are ecologically valid members of the 
adolescent context who may serve as promising facilitators of generalization. Since high school 
students with ADHD are at risk for peer rejection and often possess few or deviant friends 
(Bagwell et al., 2001), a peer-delivered intervention may provide additional social and mental 
health benefits to students with ADHD.
Table 1. % of School Staff 
Endorsing Barrier
Insufficient time 
75.0
Forgot 
21.4
Too tired
10.7
Unable to coordinate 
with other teachers
7.1
Figure 2. High school GPA of 
ADHD and comparison 
students

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Summer before 9th Grade as a Window. A pre-9th grade orientation model (delivered 
immediately prior to start of 9th grade) may be a strategic option for boosting the EF skills and 
motivation necessary for high school success. Summer provides available time to participate in 
focused skill-building before academic demands begin. Orientations prior to high school are 
common and parents are accustomed to participating in these programs—which often provide 
important information about the upcoming high school experience. As a result, a high school 
orientation model may also promote parent engagement and allow for age-appropriate parent 
training. Finally, including social activities may also engage adolescents in an enjoyable 
intervention that promotes attendance and introduces students with ADHD to a culture of 
prosocial peers. One solution to school intervention engagement problems is to consider natural 
contexts in which students and parents may be naturally present and engaged (Owens et al., 
2014). Creating an engaging summer orientation for students with appealing peers may also 
generate interest in continuing school-year intervention.
Treatment Mechanisms. Compared to elementary and middle school, high school is 
less structured and offers limited prompts, assistance, and immediate reinforcements from 
teachers. High school academic work is assigned in large parcels with expectations for 
independent work completion (Barber & Olsen, 2004). Thus, the transition to high school 
presents increased expectations for self-regulated learning—independent management of 
academic work that requires one to regulate both their motivational state and behavior 
(Zimmerman, 2002). Compared to peers, adolescents with ADHD show marked high school 
academic problems culminating in an increased risk for dropout (Barkley et al., 1991; Kent et al., 
2011). Hallmarks of this impairment are poor work completion and inadequate test preparation 
(Kent et al., 2011)—tasks that draw heavily on self-regulated learning (Zimmerman, 2002). 
Self-regulated learning is bolstered by: (1) intrinsic motivation (i.e., interest in and 
enjoyment of academic activities), (2) extrinsic motivation (i.e., valuing the outcomes associated 
with academic success), and (3) EFs (i.e., organization and time management, planning, task-
initiation, maintaining on-task behavior, and task shifting; Kim, 2013; Zimmerman, 2002). Due to 
cognitive control and rewards processing deficits, students with ADHD show impairments in all 
of these processes (Modesto-Lowe et al., 2013; Sonuga-Barke, 2003). Higher ADHD-related 
impairments in self-regulated learning are documented as academic demands increase in 
secondary school (Lee et al., 2017). Therefore, we propose three mechanisms for the proposed 
intervention: (1) intrinsic motivation, (2) extrinsic motivation, and (3) EFs. Effective ADHD 
interventions that address these mechanisms have been developed in controlled settings (see 
Chan et al., 2016; Sibley, Kuriyan et al., 2014 for review); however, their implementation has 
been stifled in high school contexts.
Intrinsic Motivation. With respect to intrinsic motivation, students with ADHD report 
lower levels of academic task interest and perceive lengthy assignments to be highly aversive 
(Carlson et al., 2002; Morsink et al., 2017). Intrinsic motivation deficits appear tied to abnormal 
anticipatory dopamine response (Oudeyer, et al., 2007)—which is implicated as a core 
neurocognitive deficit in ADHD (Volkow et al., 2011). Thus, typical academic tasks may feel less 
intrinsically rewarding to individuals with ADHD (i.e., lower experiences of novelty, curiosity, 
enjoyment). In the high school context, these deficits may be prominent due to the repetitive and 
complex nature of many academic tasks (Barber & Olsen, 2004). Intrinsic motivation deficits 
also may be compounded by ADHD-related delay aversion (Sonuga-Barke et al., 2008)—
mental discomfort when tasks contain particularly delayed rewards (i.e., long-term projects, final 
exams). To escape this aversive mental state, high school students with ADHD may gravitate to 

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immediately rewarding activities, such as video games or social media (Mazurek et al.,  2013; 
Yen et al., 2007). It is also likely that intrinsic motivation is hampered by ADHD-related learning 
problems that increase the aversive properties of schoolwork (Loe & Feldman, 2007).
Extrinsic Motivation. With respect to extrinsic, value-driven motivation, students with 
ADHD report valuing academic achievement and mastery less than peers (Barron et al., 2006; 
Colomer et al., 2017; Gut, et al., 2012; Olivier & Steenkamp, 2004; Zentall et al., 2012). 
Extrinsic motivation reflects the perceived utility of a task (i.e., both its reward value and the 
expected probability of achieving it; Wigfield & Eccles, 2000). For students with ADHD, a built-in 
preference for immediate rewards (i.e., deficits in delay discounting; Scheres et al., 2006) may 
prevent high valuation of grades, which are a long-term and symbolic reinforcer. Students with 
ADHD also show insensitivity to future negative consequences (Toplak et al., 2005), which may 
reduce extrinsic motivation to avoid negative outcomes (e.g., course failure, expulsion). Thus, 
high school students with ADHD may be less extrinsically motivated than peers to pursue high 
grades and avoid problematic consequences. Furthermore, high school students with ADHD 
may exert lower academic effort because they perceive a reduced probability of achieving high 
grades, due to years of school failure and negative feedback from adults (i.e., reduced self-
efficacy; Newark et al., 2016).
EFs. Even with adequate motivation, deficits in EF—particularly organization skills and 
goal-directed behavior (Gollwitzer et al.,1997; Zimmerman, 2002) may prevent academic 
success. This aspect of self-regulated learning involves using top-down executive functions to 
implement actions in support of one’s goals and suppress counterproductive motivational states 
(Kim, 2013). These functions include working memory (i.e., ability to sustain mental 
representation of a desired outcome), response inhibition (i.e., ability to suppress urges to 
engage in problematic behaviors), and cognitive flexibility (i.e., ability to shift from one strategy 
to another according to the demands of a new situation). Together, these functions promote 
organization skills and goal-directed behaviors such as planning, task-initiation, inhibiting 
unproductive behaviors, and task disengagement. The executive functions that are associated 
with organization skills and goal-directed behavior are notably impaired in individuals with 
ADHD (Castellanos et al., 2006; Sonuga-Barke, 2003). Thus, it is not surprising that individuals 
with ADHD show difficulties with organization skills (Kofler et al., 2018) and goal pursuit (Hoza 
et al., 2001; Nyman et al., 2010). Both of these impairments are linked to academic 
performance in individuals with ADHD (Gropper & Tannock, 2009; Langberg et al., 2013).
  
2.4. Prior approvals:
  
Garfield High School and Roosevelt High School (Seattle Public Schools) have agreed to serve 
as site; school and district level approval of the research project were obtained. 
  
3.
Study Endpoints2
3.1. Primary and secondary endpoints:
  
We will assess three ecological school outcomes: GPA, class attendance, and ADHD 
symptom severity over time. Report cards and attendance records will be obtained 
directly from schools. GPA for each quarter will be calculated by converting academic 
grades (e.g., English, Math, Science, Social Studies) to a 5-point scale (i.e., 4.0=A to 
0.0=F). Grades will not be weighted for the difficulty of the class. Number of class 
absences will be calculated for each quarter. ADHD symptoms will be measured at 
each assessment (BL, FU1, FU2, FU3) via parent and teacher reports on a DSM-5 

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ADHD checklist (Sibley & Kuriyan, 2016) that has strong psychometric properties and in 
sensitive to intervention response for adolescents with ADHD (Sibley et al., 2019). 
These rating scales will be administered electronically through redcap.
  
3.2. Primary or secondary safety endpoints:
  
Not applicable—testing an academic intervention.
  
4.
Drugs, Devices and Biologics3
4.1. Manufacturer and name of all drugs, devices and biologics:
  
Not applicable
  
4.2. Description and purpose of all drugs, devices and biologics:
  
Not applicable.
  
4.3. Regulatory status of all drugs, devices and biologics:4
  
Not applicable
  
4.3.1.
Drugs or Biologics:
☐ IND Exempt.  Explain:5 Click here to enter text.
☐ IND.
 
4.3.2.
Devices:
☐ IDE Exempt.  Explain:6 Click here to enter text.
☐ Abbreviated IDE / Non-Significant Risk.  Explain:7 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:
  
Not applicable
  
5.
Procedures Involved
5.1. Study design:8
  
A randomized trial (N=72) that will assign rising ninth grade students with ADHD at two high 
schools to (1) summer STRIPES or (2) enhanced school services as usual (SSU plus). Students 
will be randomized within school and cohort using a permuted block randomization strategy. In 
each of the two annual cohorts, 18 rising ninth grade students will be recruited for each school 
(nine randomly assigned to each condition), resulting in a total N of 72. . Four assessments will 
occur at baseline (BL; end of eighth grade), start of ninth grade (FU1), mid-ninth grade (FU2), and 
end-of-ninth grade (FU3). All assessments and treatments will be delivered in the school setting. 
Fidelity and intervention attendance measurements will be ongoing during treatment delivery.
  
5.2. Research procedures:9
  
Intervention
Full intervention procedures will be finalized in Y01 of the trial and will be based on the STP-A 
and STRIPES manuals.  The finalized intervention will be submitted via Modification prior to use. 
The intervention will be a one week (i.e., five days, four hours per day) intervention immediately 

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prior to the start of ninth grade, delivered by peer interventionists (2:1 ratio + extra interventionist 
in case of absences) and a school staff sponsor (e.g., teacher, school psychologist). The 
intervention will be group-based, however within the group, ninth grade students are assigned to 
a specific peer mentor who will be their primary counselor in the group and will hold “break” out 
conversations with the teen within the group context during the intervention session. The 
activities that will be included in the orientation are listed in Table 3 below:
The 
orientation will be held at the student’s school and will contain the classroom-style modules listed 
in Table 3. In the note-taking intervention, students will receive a 15 minute lecture delivered by 
the school staff member and will be asked to take notes. For the second 15 minutes, the peer 
mentor will give feedback on the student’s note-taking performance. During the materials 
management module, the students will be given school supplies and taught a bookbag and binder 
organization system. They will go through a bookbag organization checklist each day to practice 
monitoring and maintaining organization of school materials. The peer will conduct this 
organization check. Homework tracking module will include teaching the student how to use a 
daily planner to record assignments and how to log on to the school’s electronic gradebook to 
monitor missing assignments. In the time management module students will learn prioritization, 
time budgeting, and procrastination reduction strategies and will be taught to plan out daily work 
plans to complete homework and other assignments. Peers will provide feedback on the student’s 
use of these strategies. Study skills will teach age appropriate test preparation strategies such as 
using flashcards, taking notes while reading, and mnemonic memorization strategies. A one hour 
recreation period is included in the program to allow for social bonding and to increase program 
engagement. These recreational activities will be selected by the stakeholders and will include 
outdoor group-based activities such as soccer, ultimate Frisbee, softball, or indoor activities such 
as board games, collaborative art projects, and drama games. Finally, a goal setting meeting will 
close each day and is a 15 minute discussion between the student and the peer to discuss daily 
performance on goals and set new goals for the upcoming day (and school year).  
A classroom behavior management system will be employed to promote prosocial behavior during 
the summer orientation. This includes setting clear written expectations for behavior (e.g., no 
electronics use during program, be respectful to others, stay on task) that the intervention 
stakeholders will determine. Peers will help each student set personalized goals (e.g., less than 
three rule violations per day, get at least a 90% on all note-taking tasks, remember to write down 
all homework assignments) at the start of the intervention.
Table 3. Core summer STRIPES components (all group-based)
Summer Teen (1 wk/ 5 days 
a week)
School Year (16 wks/ 1 day a week)
Note-taking (30 mins)
Goal setting (10 mins)
Materials manag. (15 mins)
Organization check (5 mins)
Tracking homework (15 mins)
Homework tracking (5 mins)
Time management (15 mins)
Study skills (30 mins)
Rec period (1 hour)
Goal Setting (15 mins)
Reviewing progress through online gradebook (10 
mins)
Summer Parent
School Year Parent (16 wks)
Motivational Strategies I (90 
mins)
Motivational Strategies II (90 
mins
Monthly Prob. Solving Session (60 mins—4 months)
Daily Coaching (5 mins)
Weekly Coaching (5 mins- 16 weeks)

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Parents will receive a 90 minute class on motivational strategies for teenagers before the first day 
of the summer orientation. During this class they will learn a variety of motivational strategies that 
parents can use to increase academic engagement in high school students. Among these will be 
learning how to use contingency management, or linking daily performance to privilege access at 
home. During this first class, parents will be instructed that adolescents will work with school staff 
and peers to set personally meaningful daily goals each day in the program. Parents will be 
coached how to build a contract with their student that builds in rewards at home (e.g., video game 
time, electronics use) for meeting daily goals. The school staff sponsor will run this meeting and 
also will provide brief daily coaching (up to five minute phone call) on contingency management 
implementation to the parent after each orientation day. On this phone call, the school staff 
member will share the student’s performance on their goals and ask the parent about their 
intentions for using the contract to offer or restrict privileges based on student performance. The 
school staff member will offer individualized feedback on the parent’s response (i.e., clarifying 
what the student has earned at home based on their performance, problem-solving roadblocks to 
providing or restricting the privilege). At the end of the orientation, a second 90 minute parenting 
class will be delivered on how to use the new motivational strategies during the school year. 
Parents will be encouraged to discuss their experiences with the contract during the orientation 
and to envision how this plan may be adapted to monitor and reinforce school performance.
During the school year, ninth grade students will continue to meet weekly with their peer 
interventionists in a group setting under the supervision of the school staff sponsor. This school 
year follow-up component of summer STRIPES will occur for 16 weeks and occur according to the 
original STRIPES manual (see Table 3). During STRIPES the student will be pulled out of elective 
for 30 minutes each week by the peer who will conduct a standardized checklist with the student 
(see attachment). This meeting includes checking performance on the previous week’s academic 
goal, setting a new academic goal for the week, monitoring organization of the book bag, 
discussing daily planner use (i.e., recording homework), checking the online gradebook and 
discussing missing assignments and how to complete them. The intervention is delivered in a 
group setting with a school staff member in the room, but the peer holding an individualized 
meeting with the student. At the end of the 30 minute meeting, peers receive 30 minutes of 
supervision from the school staff member. A standardized agenda for supervision includes 
discussing whether each student met their weekly goal, discussing overall progress for the 
student, problem-solving difficulties with intervention engagement, and checking to make sure the 
peer completed paperwork. All paperwork for the intervention (i.e., student workbooks) are kept by 
the school staff member in their classroom until the next meeting.
Parent components during the school year will include optional monthly group problem solving 
sessions with the school staff sponsor and a weekly phone call (up to five minutes) from the school 
staff sponsor to discuss student progress and providing additional coaching on the privilege 
contract. 
Training
Peer interventionists/mentors: will receive a treatment manual and two full days of training (16 
hours) prior to delivering the intervention. They will receive 30 minutes of supervision per day 
during the summer orientation and 30 minutes per week for 16 weeks during the school year. 
Supervision will be received from the school staff sponsor.
School Staff Sponsor: Supervision of the peer interventionists will be co-led by the school staff 
sponsor and the SCH school mental health liaison. The school staff sponsor will receive two days 

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of training from SCH staff (16 hours) prior to the peer training and 30-minutes of weekly 
consultation from the SCH school mental health liaison during the intervention period.  
Comparison Condition
An enhanced school services as usual (SSU plus) comparison condition was selected to test 
whether summer STRIPES improves upon optimal school services as usual. Students who are 
assigned to the SSU plus group will be referred to their identified school counselor for referral to 
services available in the school setting. The counselor will be provided with a report from the 
student’s intake assessment that summarizes the student’s symptoms and presenting problems. 
The student will also receive new school supplies at the beginning of ninth grade. There are no 
other activities associated with enhanced school services. In our past trials, SSU plus students 
typically received subject-specific tutoring or after-school homework help (Sibley et al., 2013). 
These activities are not a part of the research, but are naturalistic services the students in the 
control group receive from their school. We will systematically track services received by students 
in the SSU plus condition. The research study will have no impact on eligibility for other services 
already being received by the youth or for future services. They will continue all other interventions 
as usual.
Assessment Procedures 
At each assessment, peer interventionist, student, parent, and teacher measures will be obtained 
as detailed below. Students will be monitored at BL, a FU1 assessment completed during the first 
quarter of the school year (i.e., October), FU2 at the school year’s midpoint (i.e., January), and an 
end of year FU3 assessment (i.e., May). Student assessments take 90 minutes and will occur at 
the school with a trained research team member. We will work with the schools to choose an 
appropriate time during the school day to complete the assessments. Rating scales will be 
completed electronically on a tablet via RedCap, a scalable, secure, enterprise-level application for 
data collection. Direct observation of skills and cognitive and analogue academic tasks will be 
complete in a private room at the school with a trained research staff member. 
All students will be required to refrain from taking stimulant medication on the day of their 
assessment (i.e., 24-hour washout period). Medication use during the study will be monitored via a 
parent and student medication use survey that our team has used for over a decade to track 
naturalistic medication use for adolescents with ADHD in psychosocial treatment studies. 
Medication use will be examined as a covariate in analyses. 
Parents, peers, and teachers will complete ratings electronically via RedCap using a link that is 
sent to their email address. All assessors are masked to group.
Students: At each assessment, ninth grade students will complete three brief academic motivation 
questionnaires (see attached measures), one youth behavior checklist (youth self-report; YSR), 
and five computer tasks that measure aspects of cognition and rewards processing. These tasks 
take three to twenty minutes each and are administered on computers or tablets. Below is a 
description of each task to be completed:
Hungry Donkey: A computerized Iowa gambling task (Hungry Donkey Task; Crone & van der 
Molen, 2004) will be administered as a measure of risky decision making (i.e., sensitivity to future 
negative consequences). Participants were told to assist the hungry donkey to collect as many 
apples as possible by pressing one of four keys corresponding to four separate doors. The future 

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yield of each door varied, with higher wins at the high paying doors (A and B), and lower wins at 
low paying doors (C and D). Selecting door A or B resulted in a gain of four apples, whereas door 
C or D resulted in a gain of two apples. Number of low-risk doors selected minus number of high-
risk doors selected was computed as an index of risky decision making (Crone et al., 2004). The 
task shows good convergent validity in adolescents (Crone & van der Molen, 2007).
Choice Delay: Delay discounting will be measured using a computerized Choice-Delay Task 
(Scheres et al., 2006) in which participants are instructed to make repeated choices between a 
small variable reward (0, 2, 4, 6, 8, or 10 cents) that would be delivered immediately (i.e., after 0 
seconds) and a large constant (10 cents) reward that would be delivered after a variable delay of 
0, 5, 10, 20, or 30 seconds. After completion of the task, participants receive the total earnings 
from the examiner. The total amount of money earned serves as an index of delay discounting. 
This task shows developmental sensitivity (Scheres et al., 2006) and correlates with symptoms of 
ADHD (Scheres, Lee, & Sumiya, 2008).  The Choice Delay Task is unique in that it is a monetary 
incentive task to measure response to rewards and involves earning real money (i.e., quarters: 
maximum earnings is $4.00) for performance in the game. 
Go-no-Go Task: Response inhibition will be measured using a go/no-go task that uses both 
positively and negatively valenced emotional stimuli (Hare, Tottenham, Davidson, Glover, & 
Casey, 2005). Happy and sad facial expressions are alternated as go and no-go cues across the 
four blocks in an HSSH order, which results in equal numbers of happy and sad faces serving as 
go and no-go cues. The number of commission errors on no-go trials across the whole task will be 
utilized as a measure of response inhibition. The task shows good convergent validity (Schultz et 
al., 2007) and has been validated with adolescents (Hare et al., 2008).
NIH Toolbox Tasks: Working memory will be measured using the National Institute of Health (NIH) 
Toolbox List Sorting Working Memory Test. In this task, a series of stimuli is presented visually 
and orally. Participants are instructed to recall the stimuli in order of size, from smallest to largest. 
The List Sorting task takes approximately 7 minutes to administer and test scores consist of total 
items correct across all trials. This task shows excellent test-retest reliability and convergent and 
discriminant validity. Cognitive flexibility will be measured using the NIH Toolbox Dimensional 
Change Card Sort Test. In this task, a target visual stimulus must be matched to 1 of 2 choice 
stimuli according to shape or color. The relevant sorting criterion word, “color” or “shape,” appears 
on the screen. An algorithm weights accuracy and reaction time. A total of 40 trials require 4 
minutes. The task shows excellent developmental sensitivity and convergent validity. Response 
inhibition will be measured using the NIH Toolbox Flanker Task. On this task, participants indicate 
the left–right orientation of a stimulus presented in the center of the screen while inhibiting their 
attention to incongruent stimuli on either side. Psychometrics for the flanker task are excellent. The 
NIH Toolbox Pattern Comparison task will be used as a measure of processing speed. This timed 
task requires participants to compare two pictures and determine if they are the same or different, 
completing as many items as possible during a 90-second period. This task shows good 
convergent and discriminant validity.
Note-taking analogue task.  Adolescents watch a lecture on video and are asked to take notes 
like they would in class. This lecture is approximately 8 minutes long. 
Matrix reasoning:  A series of puzzles in which the student will have to guess which shape goes 
next in a pattern. 
Vocabulary: A list of increasingly difficult vocabulary words that students must define to the 
examiner. The tests are scored based on age norms and the number of questions the student gets 

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correct. 
Students will also participate in a five minute observation of strategy use—the trained assessor will 
record the number of times the student wrote in their daily planner during the last five school days. 
They will also conduct a standardized checklist (attached) of how organized the student’s bookbag 
is. Finally, they will ask the student to log on to their online grade book through their phone and 
show the rater their grades on recent assignments. The rater will count the number of Fs and 
missing assignments during the assessment period. Proper permission to collect this information 
will be obtained from the parent and student during the intake process. At the intake assessment 
they will complete a brief IQ screener (WASI) to determine study eligibility (Matrix reasoning and 
vocabulary subtests only). This test will be reviewed by two psychologists following the 
assessment to ensure eligibility. If the student is ineligible based on the IQ score, the participant 
will be withdrawn from the study and their information will be destroyed.
At the end of treatment, the treatment group will complete three brief rating scales about their 
satisfaction with the program. They will also complete focus groups and surveys which will be 
designed at a later date and submitted to the IRB at that time.
Parents: Parents will complete three ratings of student behavior and one rating of parent strategy 
use at each assessment. Post-treatment, they will also complete three satisfaction scales and 
participate in to-be-determined surveys and focus groups at the end of the study. 
Peers: Peers will complete three questionnaires about their satisfaction with the intervention and 
will complete the assessments, as listed in the table in Section 5.3. They will also participate in to 
be determined surveys and focus groups at the end of the study.  
Teachers: Teachers are informants who will complete a brief rating scale on the student’s behavior 
in the classroom. 
Fidelity observations: Sample fidelity checklists are attached. They will be modified based on the 
development of the intervention in year 1 of the grant. The final fidelity checklists will be submitted 
to the IRB prior to their use. Observers who are members of the research team will observe the 
intervention occurring and will check off whether each item on the checklist occurs.
  
5.3. Data sources that will be used to collect data about subjects:10
  
Table 4. Summer STRIPES Battery
Rater
Preliminary Outcome Measures (All time points)
GPA
O
Class Attendance
O
ADHD Symptom Severity 
PAR,T
Mechanisms (All time points)
Expectancy-Value Motivation Measure (Wigfield et al., 2000)
S
Quick Delay Questionnaire (Clare et al., 2010)
S
Change Ruler (LaBrie et al., 2005)
S
Daily strategy use (organization checklist, planner use)
R
Hungry Donkey Task (Crone et al., 2004)
S
Choice Delay Task (Scheres et al. 2008)
S
Goal Setting & Planning (Zimmerman & Pons)
PAR
NIH Toolbox Tasks (Zelazo et al., 2013)
S
Go/No-Go Task (Hare et al., 2005)
S
Behavior Rating Index of EF (BRIEF; Gioia et al 2000)
PAR
Note-taking Analogue Task
S
Youth Self Report (Achenbach 1998)
S

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5.4. Data to be collected, including long–term follow–up data:11
  
See adjacent table and attached documents. We also may contact the participants for long-term 
follow-up.  If we determined that follow-up is necessary, a Modification will be submitted to the 
IRB to update the Protocol. 
  
6.
Data and Biospecimen Banking12
6.1. Complete list of the data and/or biospecimens to be included in the bank:13
  
In order to conduct long-term follow-up, we will keep all of the data collected in this study 
indefinitely.
De-identified data will be banked in the NIMH National Data Archive (NDA).
  
6.2. Location of data and/or biospecimen storage:14
  
We will work with the NIMH to place a fully de-identified version of this dataset in their National 
Data Archive. 
Data kept locally will be stored in Redcap. Physical data (i.e., IQ tests) will be stored in a locked 
file cabinet in CHBD.
  
6.3. List of those with direct access to data and/or biospecimens in the bank:
  
The investigators of this trial will have direct access to the data.  NIMH staff managing the NDA 
will have access to de-identified data. The researchers will also maintain the dataset locally for 
long-term use after the end  of the study.
  
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:15
  
The data that is shared with the NDA will be fully de-identified and will not include codes that will 
allow the data to be linked back to a key.  Only the PI will retain a key with the subject identities, 
which is kept to facilitate follow-up. This key will be stored on a secure SCRI research server.
  
6.6. How the data and/or biospecimens will be made available for future use:
  
Engagement & Fit Measures (During & Post-Treatment)
Fidelity checklists (ongoing-to be adapted as needed)
R
Intervention Attendance (Parent, Peers, Teens)
R
Parent Academic Management Scale (Sibley et al., 2016)
PAR
Client Credibility Questionnaire (Borkovich et al., 1972) 
S, PI, 
PAR
STRIPES Satisfaction Questionnaire (Sibley et al., in prep)
S, PI, 
PAR
Therapy-Bond and Engagement Scales (Shirk et al., 1992)
S, PI
Follow-up Focus Groups and Surveys to Guide Next Steps
S, PI, 
PAR
S=Student; PI=Peer Interventionist; T=Teacher; R=Research Assistant; O=Official School Records; 
PAR=Parent

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The NIMH has specific procedures through the National Data Archive that include signing a data 
use agreement, submitting an application to use the data that specifies the purpose and 
substantiates the credentials of the applicant, and affirmation of compliance with a long set of 
policies around the appropriate use of the data.
  
6.6.1.
Who can request data and/or biospecimens from the bank:
  
The NIMH will determine who has permission to obtain the data.
Data stored locally will be available to study team members for long-term 
follow – up.
  
6.6.2.
Format in which data and/or biospecimens will be provided: 
  
We will provide the NDA with data entered into excel templates that they provide 
based on each measure that we collected. 
Only study team members who have access to the data as part of the study will 
have access to the data retained for long-term follow-up.
  
6.6.3.
Process for investigators to request data and/or biospecimens:16
  
The investigators who wish to use the data must fill out a Data Use Agreement and 
Data Use Certificate from the NIMH’s National Data Archive.
Data stored locally for long-term follow-up will only be available to study team 
members.
  
6.6.4.
Restrictions on future use:17
  
No restrictions.
  
6.6.5.
Plan for providing data results from banked data/biospecimens:
  
The NIMH NDA has a policy that all publications stemming from NDA data must be 
made public access.
  
7.
Sharing of Results 
7.1. Plan to share results with subjects/others:18
  
Results will be posted in group form on a publicly available lab website for participants to 
access. We will only share results that are already published in a peer-review journal. The IRB 
will review this content before it is posted.
  
8.
Study Timelines
8.1. Duration of an individual subject’s participation in the study:
  
The student and parent participants will enroll in the spring of 8th grade and will continue to 
participate until all follow-up points are complete or attempted (through the end of ninth grade). 
We may also conduct annual follow-up through the remainder of high school. Participants will be 
informed of this possibility during the consent/assent. The peers will participate for a single 
school year.
  
8.2. Duration anticipated to enroll all study subjects:
  
18 months.
  

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8.3. Estimated date for the investigators to complete this study:
  
We will complete the entire study (including possible follow-up through high school) by 2026.
  
9.
Study Population19
9.1. Inclusion criteria for each subject population (e.g., patients, parents, providers):
  
Students: Students will be eligible for participation if they display at least six symptoms of either 
inattention (IN) or hyperactivity/impulsivity (HI) as reported on the parent and teacher DSM-5 
ADHD checklists and significant academic impairment, defined as meeting two of the following 
four criteria: (1) at least one D or F in a core academic class, (2) at least 20% of assignments 
missing in one class, (3) at least a “3” on the academic impairment item of the 0-6 teacher 
Impairment Rating Scale (Fabiano et al, 2006) or (4) elevated academic problems on the 
teacher Adolescent Academic Problems Checklist (AAPC; 4 items endorsed as “pretty much” or 
“very much;” Sibley et al., 2014).. 
Eligible participants will complete a BL assessment at their middle school. Participants will be 
required to demonstrate an IQ > 70 on the Wechsler Abbreviated Scale of Intelligence, 2nd 
edition (WASI-II; Wechsler, 2011). Although DSM-5 symptom and impairment criteria must be 
met based on parent, teacher, and self rating scales, formal DSM-5 ADHD diagnoses will not be 
a requirement as it is not ecologically valid for schools to conduct full diagnostic assessments 
when determining intervention eligibility. Instead, this study will take an ecologically-grounded 
impairment-based approach to measuring and treating ADHD symptoms in the school setting. 
Provisional ADHD diagnoses will be assessed by two licensed psychologists (Sibley and 
Sasser) using combined parent, teacher, and self symptom and impairment ratings (using an 
item-level “or” rule that specifies that either rater may endorse a symptom; Sibley et al., 2012). 
Due to the school-based context of this study, we will not assess age of onset (DSM-5 “B-
criterion”) or rule out other disorders (DSM-5 “E-criterion”), which would require a 
comprehensive parent diagnostic interview.
Parents: No inclusion criteria other than being the parent of an enrolled student.
Peer Interventionists: Peer interventionists will be nominated by their teachers. Peers will be 
required to have at least a 3.0 GPA and good behavior at school (defined as no in- or out-of-
school suspensions during the past twelve months). Peer interventionists will participate in an in-
person interview. Each school will follow their own internal peer interventionist selection process, 
so the study team will not facilitate or control the content of the in-person interviews.  At each 
school, the summer STRIPES school staff sponsor will work with the SCH team to select six 
peer interventionists per year among the pool of applicants.
School Staff Sponsor: The School staff sponsor must be an employee in the appropriate school 
district.
  
9.2. Exclusion criteria for each subject population:
  
Participants will be excluded if they are placed in special education classes, as the purpose of 
this study is to test a low-cost intervention for use in regular education settings 
  
9.3. Populations with special considerations, involved in the study:20
☒ Children/Teenagers21
Risk assessment specific to this vulnerable population and additional safeguards:22

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We are evaluating an intervention for ninth grade students to improve the transition to high 
school. Thus, in order to conduct the study, minors must be participants. The risks to 
participation are minimal (described below).
  
☐ Children who are Wards of the State23
Risk assessment specific to this vulnerable population and additional safeguards:
  
Click here to enter text.
  
☐ Adults Unable to Consent 24
Risk assessment specific to this vulnerable population and additional safeguards:
  
Click here to enter text.
  
☐ Neonates of Uncertain Viability or Non–Viable Neonates25
Risk assessment specific to this vulnerable population and additional safeguards:
  
Click here to enter text.
  
☐ Pregnant Women26
Additional safeguards:
  
Click here to enter text.
  
☐ Prisoners27
Additional safeguards:
  
Click here to enter text.
☐ Economically or educationally disadvantaged persons28
Additional safeguards:
Click here to enter text.
  
10. Number of Subjects
10.1. Total number of subjects to be enrolled locally:29
  
72 students, 72 parents, 22 peer interventionists, 2 school staff sponsors
  
10.2. Total number of subjects to be enrolled across all participating sites:30
  
 72 students, 72 parents, 22 peer interventionists, 2 school staff sponsors
  
10.3. Number of screened subjects versus the actual number enrolled in the research:31
  
We anticipate, based on previous research, that we will screen 100 students and their parents, 
and 60 peer interventionists.
  
10.4. Power analysis:
  
The mean effect size for adolescent interventions for ADHD compared to no treatment is 
approximately d=.4, as was the mean acute effect for the STP-A compared to LI (Sibley et al., 
2014; Sibley et al., 2018). To substantiate summer STRIPES as incrementally superior to SSU 
plus, we will define a d=.4 difference between summer STRIPES and SSU plus as a 
successful outcome signaling the need for further study in an R01 clinical trial. Power analysis 
for a mixed effects model with N = 72, power = .80 and alpha = .05 were conducted using 

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GPower 3.1. Because the power for this analysis depends partly on the correlation between 
baseline and follow-up measures of the outcome, we assessed power for several values of 
this correlation. The proposed analysis has power to detect effects of d = 0.42, 0.33, and 0.21 
for BL to FU correlations of .2, .5, and .8, respectively. In addition, there are 36 subjects per 
group; Maas & Hox (2005) recommend at least 30 clusters (here, subjects) per group to 
reduce bias in estimation of growth models, so we expect little bias in models.
  
11. Withdrawal of Subjects
11.1. Anticipated circumstances under which subjects will be withdrawn from the research without 
their consent:
  
None.
  
11.2. Procedures for orderly termination:
  
NA
  
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:
  
If a participant withdraws from research we will seek consent to maintain already-collected 
data. If this consent is not provided, we will destroy all of the participant’s data.  Once data is 
sent to the NDA, it cannot be withdrawn.
  
12. Risks to Subjects
12.1. Reasonably foreseeable risks to subjects (include each study population, each arm, and 
optional procedures): 
  
Risk: The primary risk to participants from the assessment sessions will be the time 
commitments of completing the necessary ratings. Procedure: By hosting visits at the school, 
and offering electronic assessments for parents, the time commitment of the study is 
minimized. There is little extra burden to families beyond what constitutes routine school-
based services for ADHD other than attending the assessment sessions. The assessment 
sessions entail four collections of ratings of ADHD and indices of parent and adolescent 
functioning. The research team has an established process for timely collection of these data 
that minimizes the burden on families utilizing RedCap secure data collection tools. 
Participants will be able to opt out of any assessment that they so choose. We will work with 
the school to conduct the assessments during times that are least invasive to the student such 
as elective periods. 
Risk: Students who receive stimulant medication (estimated: 25% of student participants) will 
be asked to refrain from taking their medication on days that they will complete a study 
assessment because computer tasks are invalid when students complete them while on 
medication. Students may have difficulty focusing in school on the day of assessments. 
Removing medication during clinical assessment is standard practice in the field of ADHD to 
allow for observation of symptoms when unmitigated by medication. Therefore, this risk does 
not exceed the risks included in standard clinical care. To further minimize this risk, we will 
work with parents, teens, and school staff to avoid scheduling assessments on days with high 
stakes activities that benefit from medication such as tests and quizzes.   
Risk: Discomfort providing personal information about the student’s level of functioning or 
parenting techniques. Procedure: This risk is similar to  risk associated with clinical/school 
treatment (i.e., motivation, organization skills, ADHD symptoms). The same staff member will 

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meet with the subject and parents each time to minimize subject anxiety and provide continuity 
of care. Though it will not be directly queried in this trial, students will be informed that 
information disclosed about risk or rule-breaking behaviors will not be shared with their 
parents unless it represents a medical emergency. 
Risk: Some students or parents may not be interested in attending treatment sessions (i.e., 
parents may feel the program is for the teen and that they should not need to attend parenting 
classes). Procedure: We recognize that by targeting a low motivation population, there may 
be cases where desire for the parent or student to engage with the intervention may be low. 
However, the psychosocial intervention is designed to address motivational deficits and 
includes engagement-specific activities such as a recreation period. It is expected that the 
majority of students will be willing to participate in these activities as attendance and 
engagement in our similar treatment programs is typically strong. Attendance is not required 
and will be measured as an index of engagement. If a student expresses a desire to 
discontinue participation, the option of withdrawing from the study will be discussed with the 
student and the parent and the family will be permitted to remove themselves from the project. 
Study treatments are also designed to address areas of impairment that the students and 
parents self-identify. Our team is experienced at training community and school staff to deliver 
psychosocial interventions for ADHD and will provide adequate training and supervision to 
interventionists to address these concerns. In addition, students and parents will be permitted 
to discontinue treatment, but complete study assessments (if they desire)—which maintains 
trial retention even if intervention attendance is suboptimal. Parents will be permitted to 
continue the parent skills components without the student’s participation (and vice versa) 
should one member of the dyad refuse to participate. 
Risk: Loss of confidentiality. Procedure: All information gathered is treated under the Seattle 
Children’s guidelines for confidentiality of subject records. All data will be stored at the main 
research site and not at the schools (beyond routine school records that will be collected 
according to study protocol and later obtained by study staff for data collection purposes). No 
study data will be entered into the participant’s permanent school records. All data will be 
transmitted only in encoded form. Most data will be gathered and stored electronically through 
RedCap. In few cases, physical data will be collected (i.e., IQ test, diagnostic interview). In 
these cases, data will be locked in a secure file cabinet behind double locked doors in CHBD. 
All computers in the laboratory are password protected. All stored data will be linked to a 
participant ID number, rather than the name of the participant. All the research notes only 
contain the accession number and no other identifiers such as a participant's name. 
Confidentiality also may be compromised by intervention activities that occur in school, where 
peers may observe students participating and ask questions. Peer interventionists will 
participate in a training on maintaining confidentiality of research participants. In addition, 
students will be permitted to meet in private spaces throughout the school to minimize risk that 
other students will become aware of the nature of students’ participation in the study. This risk 
is not stronger than typical school services that may be observed by peers such as tutoring, or 
tier 2 interventions.
Risk: Sensitive information will be disclosed to the peer during intervention delivery. 
Procedure: As a part of their training, peers will receive instruction on how to identify different 
types of sensitive information (i.e., abuse, self-harm, depression, bullying, intent to harm 
others, ongoing trauma or deprivation, drug abuse) and what to do if the student participant 
discloses sensitive information to the peer. We will work with schools to develop a school-
specific protocol for disclosure of sensitive information that involves appropriate school-staff 
members (i.e., counselors, administrators).

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Risk: Students may feel uncomfortable disclosing information on the Youth Self report form 
about whether they have had intrusive thoughts about sex or experimented with substances. 
The Youth Self Report form is among the most common broadband psychopathology scale 
scales in use in clinical practice and is routinely administered to youth with ADHD as a part of 
clinical assessment. Therefore, the risk of administering this questionnaire is no more than 
would typically be administered in a routine ADHD assessment, where questions like these 
are commonly asked to screen for possible thought disorders or behavioral health concerns.
Procedure: Students will be permitted to decline answering these questions. We will not force 
answers to these questions on the YSR and instead will put in an option that says “choose not 
to answer” as a fourth choice to the response option for the items on these topics. 
  
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:
  
Teachers will be asked to give their time to assist with research procedures and provide 
information about the students.  
  
12.5. Procedures performed to lessen the probability or magnitude of risks:
  
See Section 12.1.
 
13. Potential Benefits to Subjects
13.1. Potential benefits that individual subjects may experience from taking part in the research:32
  
The benefits of this study to the student and his/her parent are several. First, the parent will 
receive a free assessment of the student’s ADHD symptomatology. Second, parent and 
students in the intervention group will receive specialized psychosocial treatment designed to 
improve the transition to high school. The information gained from the study may also help 
participating schools develop effective interventions for their students with ADHD. Peers will 
receive community service hours for their experience and an enriching service-learning 
leadership opportunity. Serving as a summer STRIPES peer interventionist will also 
strengthen their college application.
  
14. Data Analysis/Management
14.1. Data analysis plan, including statistical procedures:
  
Analyses will be performed using Mplus 7. We will assess missing data prior to analyses. The 
proposed analysis methods (i.e., multilevel regression with maximum likelihood estimation) are 
robust to MAR (missing at random) or MCAR (missing completely at random) mechanisms, 
which will minimize impact of missingness and attrition. If there is evidence of MNAR (missing 
not at random) patterns, we will use appropriate methods. We will assess whether data meet 
all assumptions of analysis (multivariate normality, outliers). We will adjust for any violations 
using robust methods (such as using bootstrap standard errors). We will evaluate group 
differences in covariates and include in models as needed. Aim 2a is to test the effect of 
summer STRIPES (compared to SSU plus) on the primary outcome measures. The direct 

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effect of summer STRIPES on proximal outcomes (ADHD symptoms, GPA, class attendance, 
disciplinary incidents) at FU3 will be evaluated using latent growth models (Preacher, 2008). 
BL measure of the outcome, group, and their interaction will be used as predictors to evaluate 
the improvement in the outcome from BL to FU3. In longitudinal analyses, time will be 
modeled as a person-specific variable representing months since BL. We will explore non-
linear and piecemeal models to consider that summer STRIPES orientation and its school 
year follow-up components may enact unique influences on slope over time. Aim 2b: The 
mechanisms by which summer STRIPES leads to improvement in outcomes will be evaluated 
through mediation growth models in an SEM framework using full information maximum 
likelihood (FIML) estimation. Three sets of models will be assessed, according to the three 
theoretical mechanisms (intrinsic motivation, extrinsic motivation, EFs). The models will 
assess the effect of summer STRIPES on primary outcomes via indices of intrinsic motivation, 
extrinsic motivation, and goal-directed EFs. For all models, the effect of STAND-YA on change 
in the mediator (e.g., extrinsic motivation) from BL to FU2 will be assessed by controlling for 
BL values of the mediator; the effect of the mediator on change in the outcome across the 
three visits will be assessed by examining the relationship between FU2 mediator and the 
slope of the outcome to FU3. Current recommendations (e.g., MacKinnon, Coxe, & Baraldi, 
2012) advise evaluating mediators individually before considering combining them into a 
model with multiple simultaneous mediators. Aim 3. The effect of summer STRIPES on 
measures of engagement and school fit (Table 4) will be evaluated descriptively (e.g., 
treatment fidelity).
  
14.2. Quality control procedures for collected data:33
  
Research staff will monitor all data for accuracy as they are collected through RedCap, which 
includes an option to require responses to all items. During assessments, research assistants 
will screen responses entered into RedCap forms to ensure that participants are completing 
forms thoroughly. Remote electronic assessments will receive data screening immediately 
after they are completed (staff receive an electronic notification when a new form has been 
completed by a participant). For any data that requires manual entry (i.e., student transcripts, 
IQ test results), research assistants will enter data on a rolling basis as the ratings are 
collected, and check these entries by comparing raw data ratings with computer printouts of 
the data sets, checking for and correcting any discrepancies. 
 
15. Confidentiality34
15.1. Procedures to secure the data and/or biospecimens during storage, use, and transmission:
  
Only the research staff performing the assessments, training, and supervision will have access 
to subjects’ identities (approximately 5 staff). All information gathered is treated under Seattle 
Children’s guidelines for confidentiality of subject records. All data will be coded and entered 
into a secure database on the center server that is only accessible to study staff. Hard copies 
of data will be stored in a locked data storage room at CHBD. The sheet linking study code 
numbers to individuals will be stored in a separate electronic database interface than 
participant data (RedCap). No data disclosed by the youth in the assessments (including the 
YSR) will be shared with the parent or anyone outside the research team without the youth’s 
explicit permission. This will only be done in cases where concerns about safety are disclosed. 
YSR data will be collected through a redcap form that is sent in a private link to the youth and 
will not be shared with the parent or others outside the research team. The data is also 
protected by a Certificate of Confidentiality so it cannot be requested by non-research team 
members. 
  
15.2. Location where the data and/or biospecimens will be stored:
  

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Redcap. Physical data (i.e., IQ tests) will be stored in a locked file cabinet in CHBD.
  
15.3. Length of time data and/or biospecimens will be stored:
  
Indefinitely to allow for secondary data analysis.
  
15.4. Individuals with access to data and/or biospecimens:
  
Study team members listed in Click.
  
15.5. Process for the transmission of data and/or biospecimens outside Seattle Children’s:
15.5.1.
List of data and/or biospecimens that will be transmitted:
  
Not applicable.
  
15.5.2.
Individual(s) who will transmit data:
  
Not applicable.
  
16. Provisions to Monitor Data to Ensure the Safety of Subjects35
16.1. Plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe:36
  
Study treatments are variations of established evidence based academic interventions, so it is 
not expected that serious safety concerns will arise. No study staff will be administering 
pharmacological treatments; however participants are permitted to continue use of previous 
pharmacological treatments, and medication use will be tracked and analyzed. Due to the 
minimal risks involved in this treatment, a formal Data Safety Monitoring Board was not 
deemed necessary for this protocol. To ensure the safety of all study participants, a Data 
Safety Monitoring Plan will be enacted. Dr. Sibley, Dr. Stefany Coxe (outside consultant with 
expertise on statistical design--will not be engaged in research or handle data), and Dr. 
William French, a board certified Child and Adolescent Psychiatrist, will comprise the Data 
Monitoring Committee (DMC). Dr. French has previous experience working on NIH clinical 
trials and will oversee monitoring of psychiatric emergencies during the trial. 
Prior to the start of the study, the DMC will meet to review the protocol and will give input on 
augmentation. They will also determine data fields to be included in quarterly reports. In 
quarterly reports, the groups will be de-identified and information will be prepared Dr. Sibley’s 
staff and shared with Dr. Coxe and Dr. French in a group level format. 
  
16.2. Data reviewed to ensure safety of subjects:
  
Examined outcomes will include adverse events, dropouts, enrollment, and attendance at the 
school-based intervention. The DMC will review these summaries on a quarterly basis and 
determine if any adjustments need to be made to study protocol or other study methodology 
as result of these data.
  
16.3. Safety information collection procedures:
  
At each assessment, the student self-report form will be given, which includes two items about 
self-harm behaviors and ideation. Research assistants will be trained to screen these 
questionnaires for endorsement of either item. If endorsement is present a licensed clinical 
psychologist (Sibley or Sasser) will be contacted to perform an immediate risk assessment. 
Other than the possibility of existing self-harm behaviors (unrelated to intervention but possible 
in our population of teenagers with ADHD), we do not expect any safety concerns to stem 

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from an academic intervention delivered by members of a school community (rather than the 
SCH team).
  
16.4. Frequency of cumulative data review:
  
Quarterly.
  
16.5. Conditions that trigger an immediate suspension of the research:
  
Because this is an academic intervention, we cannot think of any foreseeable conditions that 
could trigger a need to suspend the research.
  
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:37
  
NA
  
17.3. Types of communications that will be submitted to the IRB for review:38
  
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 Injury39  
18.1. Available compensation in the event of research related injury:
  
None
  
19. Recruitment Methods40
19.1. When, where, and how potential subjects will be recruited:
  
During the spring of participants’ 8th grade year, study staff will work with high 
schools to distribute nomination forms and study information to feeder middle school 
counselors and administrators, inviting the schools to nominate students. 
Based on procedures that our team has used in two previous federally funded studies 
(Sibley et al., 2018; 2020), the following process occurs. 
First, an informational meeting about the study will be held for staff at each feeder 
middle school. The research team will explain the study and ask school staff 
members to contact parents of students who may be a good candidate for the 
program, based on their profile of school difficulties. A nomination packet will be 
distributed at this meeting.
The nomination packet contains the parent written informed consent form for the 
student’s participation, written permission form for the school and SCH to exchange 
information about the student, a demographic survey to collect basin information 
about the student and the family, and parent informant rating scales that query the 

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presence of ADHD symptoms and related impairment. Interested parents may 
complete the packet and return it to the teacher. Once the teacher has the parent 
packet (which includes the information exchange form and the written parental 
consent form), the teacher may complete their portion of the nomination packet (brief 
surveys about classroom performance) and return the packet to the research team, 
who will be regularly visiting the schools to collect completed packets from teachers. 
As part of the nomination form, the parents of rising ninth grade students who are 
nominated will be sent a cover letter (see attachments) that describes the study and 
invites them to schedule a phone call with the research team should they be 
interested in discussing study details with the researchers prior to completing the 
consent form. 
Assent will be pursued for all rising ninth grade students whose parents consent to 
their participation in the research study. The student will be approached at school, 
informed about the study and that their parent has signed a consent form for their 
participation, should they assent. The study will be described in detail and student’s 
will have the opportunity to assent on the written form that was signed previously by 
their parents.  
Peers will be selected by school staff members. The research team will ensure that 
they meet study criteria after they have been selected by the school stakeholders 
(i.e., at least a 3.0 and no suspensions from school in the past year). However, there 
will be school choice in the process that is used to select the peers—some schools 
have elected to invite particular students directly, while others have decided to open 
applications to the program to the entire school. The research team will hold a group 
information session for peers to describe the opportunity and will deliver to peers a 
parental consent form (for those under 18) and youth assent form that must be signed 
prior to being considered for participation. 
Parents of ninth grade students will complete a separate consent form for their own 
participation after it has been determined that the student meets study eligibility. 
Parents will be emailed a link to a written informed consent form that they can sign 
using a digital signature pad on a touch screen (i.e., on their smart phone). The 
consent form will reiterate how the parent can contact the research team to discuss 
their opportunities to be involved. Parental involvement is not a requirement in this 
study, it is a measured outcome. Therefore, all activities will be offered to the parent, 
but none will be required (i.e., parent intervention components). The link will also 
contain the parent rating scale battery.
The school staff members who will help to deliver the intervention will also be 
participants in this study because we will be measuring their fidelity to intervention 
procedures. An information sheet will be used to consent these individuals into the 
study, as their primary role is as an individual engaged in research, not as a research 
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Teachers who will complete rating scales of student performance and who will pass 
along study information to parents are not considered participants in research. They 
are considered informants. We will collect no personal information from these 
teachers and will collect no information on the teachers’ attitudes or behavior. As 
students have four to five core academic teachers, there is no pressure for a single 
teacher to serve as an informant so that the student can participate. Any single core 
academic teacher can complete a rating scale on the adolescent’s performance to 
evaluate inclusion criteria and performance. We will only collect the teacher’s 
information related to reimbursing them for their time completing the informant rating 
scale at each assessment. Teachers are not paid for nominating (i.e., recruiting 
students). They are only reimbursed for their time once the student is already in the 
study and study measures are being collected at each time point.
There are no differences in recruitment methods for Spanish speaking parents, as the 
students are referred by the school. We will make parent application packets available 
to the school in both English and Spanish so the school staff can send home the 
appropriate packet based on parent needs.
  
19.2. Steps that will be taken to protect potential subjects’ privacy interests:41
  
To protect privacy during the recruitment process, all teachers will be given a non-descript 
envelop to send the nomination packet home to parents, so that others in the school will not 
know the contents of the envelope. The envelope will be returned to the teacher who will bring 
it to the counselor once they have added their teacher rating form. The research team will visit 
the counselor several times a week to pick up completed envelopes. Once all the nomination 
paperwork is complete, the next step is to hold the assessment. 
All assessments will be held in private rooms at the school. Parent and teacher ratings will be 
conducted electronically through secure links sent to their emails. These links expire after one 
use and do not contain the participant’s name.
Students will meet in private spaces throughout the school to minimize risk that other 
students will become aware of the nature of students’ participation in the study. This risk is 
not stronger than typical school services that may be observed by peers such as tutoring or 
tier 2 interventions.
  
19.3. Sources of subjects:42
  
High schools
  
19.4. Methods that will be used to identify potential subjects:
  
Collecting nomination forms from teachers. We will meet with staff at all feeder middle schools 
to explain the opportunity to participate in the study and the procedure for selecting students.
Once the nomination forms are obtained, as well as appropriate parental consent and youth 
assent, we will hold an initial  visit with the youth at the school to assess additional eligibility 
criteria (i.e., IQ test). 
  
19.5. Materials that will be used to recruit subjects:43 

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See information provided above within this section.
  
19.6.
Recruitment methods not controlled by Seattle Children’s:
  
The study team will not have complete control over Peer Interventionist recruitment.  Peers will 
be nominated by teachers and will participate in an interview facilitated by the school.  The 
study team will confirm eligibility.
  
20. Consent/Assent Process
Consent process overview:44
Once a student is referred, active informed consent will be obtained by sending the consent 
form home to parents. SCH staff and investigators will be available by phone to discuss the 
research with parents as part of the consent process. The consent form will contain phone 
numbers to call to discuss the consent form with investigators. Student assent will also be 
obtained at the school during an intake meeting with study staff and after the parent has 
already provided written consent for their participation.  The staff member will instruct the 
parent/student to read the consent/assent and will provide a summary of the most important 
points listed in the document. The staff member will also answer any questions that the parent 
and/or student has during the consent process. The risks and benefits of participating in the 
study will be carefully discussed and all participants will be allowed to decline participation in 
the study.  
Written parental consent and assent will be required prior to peer interventionist participation 
and will be obtained using the procedures above. Students will receive an in-person assent 
(as well as peers) that will allow them to answer any questions they may have about the 
research. It will be emphasized to the students and peers that at any time, if they wish to 
discontinue their involvement in the research, they may approach a study team member to do 
so. The students and peers will have regular contact with the study team throughout the study 
and so they will the opportunity to do so. In addition, parents will have the contact information 
of the investigators, and so they can telephone the team at any time to express concerns or 
ask additional questions.  
Discussion of the consent form will not occur unless the parent contacts the study team.  We 
do not want to require a consent conference in order for the student/peer to participate in the 
study because we would end up with a biased sample of only students with actively involved 
parents—and we are deliberately studying students who are known to have disengaged 
parents—the purpose of the parenting components of this project are to boost parent 
motivation.  If the parent also agrees to participate in the research, they study team would 
have regular contact with them to complete study procedures. —
20.1. Where the consent process will take place:
  
For students and peers it will take place at the school in a private room, individually (students) 
or group administered (peers). For parents, it will take place over a phone call as requested by 
parents.
  
20.2. Steps that will be taken to protect prospective subjects’ privacy interests:45
  
Study team members will conduct any consent discussions in a private room. Parents will be 
able to place the signed parental permission/assent form in manila folder sent home with the 
student/peer. 
  

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20.3. Waiting period available between approaching a prospective subject and obtaining consent:
  
. There will be between three to six months between recruitment and receipt of intervention. 
Practically, a potential participant needs to decide if they want to participate before the end of 
their eighth grade year.
  
20.4. Process to ensure ongoing consent:
  
Parents and students will be regularly monitored throughout the study by the research team 
(at least monthly) through intervention activities and assessments. At each point in time the 
participant will have an opportunity to express concerns about participation.
  
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:46
20.6.1.
Role of the individuals listed in the application as being involved in the consent 
process:
    
The to be named study coordinator will be available to conduct consent discussions 
with the parent by phone. However, because this is a naturalistic school-based 
intervention study (interventions delivered by school members), with optional 
parental involvement (measured as a study outcome), we may have limited contact 
with parents. As we have done in our previous school-based trials, parents will be 
sent a consent form home by the teacher who wants to nominate the student, must 
sign a permission to nominate form, an exchange of information form for the 
school/SCH, and the consent form. They will also be given a cover letter asking 
them to please call the study coordinator if they have any questions about the 
information on the consent form. If the parent signs the consent form, but does not 
request a consent discussion, a consent discussion will not occur.  
  
20.6.2.
Time that will be devoted to the consent discussion:
  
As much time as is requested by the parent.
  
20.6.3.
Steps that will be taken to minimize the possibility of coercion or undue influence:
  
The student and peer will participant in an assent discussion once parent written 
consent is obtained. The student and peer will be free to decline participation in the 
study after he/she learns of the study activities. 
  
20.6.4.
Steps that will be taken to ensure the subject’s understanding:
We will ask the student and peer a series of comprehension questions to make sure 
they fully understand the nature of study activities.
  
20.7. Non-English Speaking Subjects47
20.7.1.
Anticipated preferred language(s) for subjects or their representatives: 
  
Because all students will be in regular education classrooms, we do not anticipate 
any non-English speaking students or peers.
We will also include parents who speak a language other than English. At this point 
we have only identified Spanish as a language which will need accommodation for 

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parents. Others may be added through a future modification if additional non-
English language needs are identified for parents.
All consent procedures will be identical for non-English speaking parents. Mercedes 
Ortiz, who is a certified bilingual staff member on our research team, will conduct all 
consent discussions (and assessments) with parents who speak Spanish instead of 
English. Spanish translated consent forms are appended to this application.
  
20.7.2.
Presentation of Research Information and Documentation:
☐  Appendix A-10 of the Investigator Manual will be followed48 
☐  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.
  
20.7.3.
Justification if non-English speaking subjects will be excluded from the research:49
See Section 20.7.1.
   
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):50
  
We will only be enrolling rising ninth grade students, who by definition, are minors. 
Peers may be under or over 18 and so we will ask peers to share their date of birth 
in order to determine whether parental consent is needed (for those under 18).
  
20.8.2.
Parental permission will be obtained from:51
☐  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child.
☒ One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child.
☐ Neither parent.52
  
20.8.3.
Process used to determine an individual’s authority to consent to each child’s 
general medical care if permission will be obtained from someone other than 
parents:53
  
There is no general medical care involved in this study. The school has on file the 
name each student’s legal guardian and we will double check with school 
administrators that the correct adult provided consent. 
  
20.8.4.
Assent will be obtained from:54
☒
All children.  
☐
Some children.  Specify:  
Click here to enter text.
☐
None of the children.  Explain: Click here to enter text.

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20.8.5.
Procedures for obtaining and documenting assent:
  
We will follow the consent procedrues above for obtaining assent. This will be 
individual for the rising ninth grade students in a private location with an assent 
discussion held to ensure the students understand the research procedrues and 
assent. For the peers, we will hold this discussion in a group format at an 
information meeting about the opportunity to participate. We will have all peers who 
are interested take a parental consent form home to their parents. They must return 
it to the research team prior to engaging in any research activities.
  
20.8.6.
Plan for re-approaching children who have reached the age of majority to obtain 
consent:55
  
This will only be applicable to peers. We will keep the dates of their 18th birthday on 
file and will approach them to reconsent (will be regularly interacting with them at 
the school) upon their 18th birthday.
Re – approach for long-term follow – up will be addressed with the Modification 
adding long-term follow-up procedures.
  
20.9. Cognitively Impaired Adults/Adults Unable to Consent56
20.9.1.
Process used to determine whether an individual is capable of consent:
  
Not applicable
  
20.9.2.
Individuals from whom permission will be obtained in order of priority:57
  
Not applicable.
  
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:58
  
Click here to enter text.
  
20.10. Waiver or Alteration of Consent Process
20.10.1. Reasons for requesting a waiver or alteration of informed consent:59
  
n/a
  
20.10.2. Consent Waiver/Alteration Criteria justifications:60
20.10.2.1.
The research involves no more than minimal risk to the subjects 
because:
  
n/a
20.10.2.2.
The waiver or alteration will not adversely affect the rights or welfare 
of the subjects because:61
  
n/a
  
20.10.2.3.
The research could not practicably be carried out without the waiver 
or alteration because:62

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n/a
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:
n/a
  
20.10.2.5.
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
  
n/a
  
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:63
  
NA
  
21. Process to Document Consent in Writing
21.1. If consent 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:64
 
Click here to enter text.
  
21.2. If consent will not be documented in writing (check all boxes that apply):65
☒ 
A written statement/information sheet describing the research will be provided to 
subjects.66
☐ 
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.67
22. HIPAA Authorization and RCW Criteria
22.1. HIPAA Authorization (check all boxes that apply):
☐ 
The study does not involve the receipt, creation, use and/or disclosure of protected health 
information (PHI).68
☒ 
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).  See 
21.2 below for required HIPAA waiver/alteration criteria.
☐ 
Subjects will review a written statement/information sheet with the appropriate HIPAA 
language but will not provide a written signature.  See 21.2 below for required HIPAA 
alteration criteria.69
☐ 
Other.  Explain:70
Click here to enter text.
  
22.2. HIPAA Waiver/Alteration Criteria: Explain why:
22.2.1.
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:

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22.2.1.1.
An adequate plan to protect the identifiers from improper use and 
disclosure: 
  
Click here to enter text.
  
22.2.1.2.
An adequate plan to destroy identifiers at earliest opportunity consistent 
with conduct of research:
  
Click here to enter text.
  
22.2.1.3.
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:
  
Click here to enter text.
  
22.2.2.
The research could not practicably be conducted without the waiver or alteration of 
authorization:
  
Click here to enter text.
  
22.2.3.
The research could not practicably be conducted without access to and use of the 
PHI:71
  
Click here to enter text.
  
23. Payments/Costs to Subjects72
23.1. Amount, method, and timing of payments to subjects:73
  
Payment will be made based on the length of their assessment batteries. Parents will 
receive $50 for each assessment (approximately 30 minutes to complete), peers will 
receive $20 (10 minutes to complete), and ninth graders will receive $75 (one to two 
hours to complete). This will be given through Clincards (or a new procedure if that is 
what is in place by March 2021, when the first participants will be paid). 
  
23.2. Reimbursement provided to subjects:74
  
NA
  
23.3. Additional costs that subjects may be responsible for because of participation in the 
research:75
  
NA
  
24. Setting
24.1. Site(s) or location(s) where the research team will conduct the research:
  
Garfield and Roosevelt (Seattle Public Schools) High Schools.
  
24.2. Composition and involvement of any community advisory board:
  
NA
  
24.3. For research conducted outside of the organization and its affiliates:76
24.3.1.
Site-specific regulations or customs affecting the research:
  
NA
  
24.3.2.
Local scientific and ethical review structure:
  

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NA
  
25. Resources Available
25.1. Qualifications (e.g., training, education, experience, oversight) of investigator(s) to conduct 
and supervise the research:77
  
Dr. Sibley is a licensed clinical psychologist who has experience overseeing six 
clinical trials, including four federally funded ones (R01 MH106587, IES 
R305A150433, R34 MH092466, IES R324A120169). This includes trials of both the 
STRIPES and STP-A interventions that will be used to adapt the proposed 
intervention.
  
25.2. Other resources available to conduct the research:78
  
Click here to enter text.
  
26. Coordinating Center Procedures
26.1. Coordinating center institution:
  
Seattle Children’s
  
26.2. If Seattle Children’s is the coordinating center:
26.2.1.
Process to ensure communication among sites:79
  
The Seattle Children’s study staff will be in constant contact with staff at the high 
school sites.
  
26.2.2.
Process to ensure all site investigators conduct the study according to the IRB 
approved protocol and report all non-compliance:
    
The Seattle Children’s Study team will always be present when the two school staff 
members are engaged in study activities and will be able to monitor and provide 
feedback on adherence to procedures. Only the Seattle Childrens’ study team will 
have access to participant data.    
  
26.2.3.
Process to ensure all required approvals are obtained at each site:
    
Both school districts will approve the study formally. Neither have IRBs (FWA 
numbers) and so Seattle Children’s will be the single IRB and will govern the 
activities of the school staff members.
  
26.2.4.
Process to ensure all sites are informed of any problems and/or interim results:
  
We will provide annual reports to the school districts during the study. 
  
27. International Center for Harmonization of Good Clinical Practice (ICH-GCP)
27.1. If you have committed to conducting the described study per ICH-GCP, check this box: ☐80

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 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.
2 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.  
3 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 mobile medical applications may meet the definition of a device – see FDA Guidance.
4 See the Investigator Manual HRP-103 for sponsor requirements for FDA-regulated research.
5 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.
6 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.
7 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 
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. 
8 Be sure to indicate if controls will be included and include information about why control arms are ethically 
acceptable.
9 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.
10 Attach all surveys, scripts, and data collection forms to the “Supporting Documents” page.
11 Include information about the frequency of data collection.
12 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 (e.g. you will submit data to dbGaP, NDAR, FITBIR), indicate here.  
13 If applicable, include a list of identifiers that will be banked.
14 Be general (e.g., researchers’ lab, clinic, etc.)
15 Generally, data and/or biospecimens should be released in a coded, non – identifiable manner.

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16 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.
17 You can allow for use for broad purposes
18 This includes putting results and/or data in the subject medical records.
19 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.
20 If you check a box below, be sure to include the additional safeguards associated with the population.
21 Refer to HRP-416 CHECKLIST: Children.  
22 If the study is minimal risk, explain why. Must also 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).
23 This population may be wards of the state or any other agency, institution, or entity. Refer to HRP-416 
CHECKLIST: Children, Section 6, for additional guidance on required considerations for this population.
24 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.
25 Refer to HRP-413 CHECKLIST: Neonates and HRP-414 CHECKLIST: Neonates of Uncertain Viability.
26 Refer to HRP-412 CHECKLIST: Pregnant Women.
27 Refer to HRP-415 CHECKLIST: Prisoners
28 Indicate how you will ensure that there is no coercion or undue influence
29 A subject is considered “enrolled” when they consent to be in the study.
30 Only applicable for multisite studies.
31 i.e., numbers of subjects excluding screen failures.
32 Payment for participation is not considered a benefit.
33 For example, data will be double entered, data will be reviewed by another study team member to ensure 
accuracy, etc.
34 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.

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35 Applicable for studies that present more than minimal risk.
36 Include information about who (describe in terms of role or group) will review the data.
37 This should be specific to the social media you are using for the research.
38 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.  
39 Applicable if the research involves more than minimal risk to subjects.  If minimal risk, this section is N/A.
40 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.
41 “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal 
information.
42 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.
43 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.
44Include how you will ensure that subjects and/or their parent/legally authorized representative have sufficient 
opportunity to discuss and consider whether or not to participate in the research.  .
45 “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal 
information.
46 This section describes the way(s) in which the processes for this study will not follow Seattle Children’s SOP.
47 See HRP-090, HRP-091, and Investigator Manual HRP-103 for more information.  
48 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.
49 Seattle Children’s IRB prohibits the exclusion of non-English speaking populations from research unless there is 
sufficient justification for the exclusion.  See Investigator Manual HRP-103 for more information.  
50 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 

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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.
51 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.
52 If parental permission will not be obtained, please address this in the Waiver or Alteration of Consent Process 
below.
53 See HRP-013 for more information.
54 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.
55 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.
56 See “HRP-417 Cognitively Impaired Adults” for further information.  
57 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.
58 The IRB may allow the person obtaining assent to document assent on the consent document.
59 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.
60 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.  
61 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.

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62 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.
63 See “HRP 419: Waiver of Consent for Emergency Research” for further information.
64 This section describes the ways in which the procedures will not be following Seattle Children’s SOP.
65 See “HRP-411: Waiver or Written Documentation of Informed Consent” for further information.
66 An information sheet template 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.
67 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.
68 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.  
69 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).  
70 For example: altering HIPAA elements for international research.
71 Possible reason could be: the nature of the research is specific to individuals’ health and requires access to 
individuals’ health records.
72 See “HRP-316: Payments” for further information.
73 Methods of payment include check, ClinCard, gift cards, etc.  Provide details on who will be the recipient of the 
payment (parent or child).
74 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.  
75 This could include things like fuel/transportation costs, parking, and/or childcare.
76 Type N/A if this section does not apply.
77 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. 
78 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 

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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.
79 Including communication between sites of current study document versions and modifications.
80 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.