School-based Asthma Care for Teens (SB-ACT)
Phase: NA
Conditions: Asthma
Sponsor: University of Rochester

 
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Protocol 
School Based Asthma Care for Teens (SB-ACT)  
 
 
 
 
 
   Revised 2.1.2021 
1 
 
 
 
School Based Asthma Care for Teens (SB-ACT): 
A Randomized Control Trial to  
Improve Preventive Asthma Care for Urban Adolescents 
 
 
 
Investigators: 
Jill S. Halterman, MD, MPH 
Belinda Borrelli, PhD 
Kristin Riekert, PhD 
Ekaterina Noyes, PhD, MPH 
 
 
ClinicalTrials.gov#: NCT02206061 

 
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Protocol 
School Based Asthma Care for Teens (SB-ACT)  
 
 
 
 
 
   Revised 2.1.2021 
2 
School Based Asthma Care for Teens – SB-ACT 
A Randomized Control Trial to  
Improve Preventive Asthma Care for Urban Adolescents 
 
Investigators: 
 
Jill S. Halterman, MD, MPH 
Belinda Borrelli, PhD 
Kristin Riekert, PhD 
Ekaterina Noyes, PhD, MPH 
 
 
Background: 
Asthma is the most common chronic illness of childhood,1,2 affecting more than 10% of 
children in the city of Rochester.  Despite current advances in asthma therapies, morbidity and 
mortality continue to increase.  While evidence-based national guidelines recommend effective 
preventive medications for all children with moderate to severe asthma,3,4 studies indicate that 
many children in the U.S. who should receive preventive medications are not receiving them.5-7    
Low-income, minority teenagers have disproportionately high rates of asthma morbidity, 
including excess risk of emergency department care, hospitalization, and death from asthma, 
compared to white adolescents.8,9 Although urban children suffer the largest burden from 
asthma, they are the least likely group to receive adequate preventive care,10,11 and this poor 
adherence plays a significant contributing role in asthma morbidity. Inner city adolescents with 
asthma are at particular risk of non-adherence. Thus, there is a substantial amount of suffering 
that could be prevented with improvements in care.   
Preventive medicines for asthma, if used properly, reduce symptom and prevent asthma 
hospitalizations.12   Current national guidelines specifically recommend the use of these 
evidence-based daily preventive medications for all children with persistent asthma.4    However, 
many children in the U.S. and in Rochester who should receive these medications are not 
receiving them.5-7  We found that 74% of children nationally with significant asthma symptoms 
were not receiving daily preventive medications for asthma.  
Adolescents, as a group, tend to have poorer medication adherence than younger 
children or adults. Early adolescence is a developmental period that involves changes in 
cognitive processes, social influences, and biological factors that may be significant contributors 
to the decrease in medication adherence seen in this age group.  During early adolescence, 
parents typically grant their child increased independence and responsibilities.  When the child 
has a chronic illness, age 7-8 years is the time that parents often begin the transition of 
responsibility for illness management from parent to child, and by age 15 the child typically 
assumes more responsibility than the parent for day-to-day management tasks. This transition 
in responsibility is often marked by decreased adherence.10 Not surprisingly, poor adherence is 
associated with worse disease-related outcomes. 
The goal of this study is to evaluate the widespread implementation of a developmentally 
appropriate preventive asthma care intervention for urban teens. The School Based Asthma 
Care for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed 
therapy (DOT) to allow the teen to experience the potential benefits from adhering to guideline-
based asthma treatment, and 2) a developmentally appropriate Motivational Interviewing (MI) 
Counseling Intervention to help the teen transition to independent long-term medication 
adherence. We hypothesize that teens receiving the SB-ACT program will 1) experience less 
asthma-related morbidity than the asthma education (AE) attention-control comparison group, 

 
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Protocol 
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and 2) have improved adherence, less urgent healthcare use, less absenteeism, improved 
quality of life, and reduced FeNO compared to AE. We also hypothesize that participants 
receiving DOT-only will have improved asthma-related outcomes immediately following their 
DOT trial vs. teens receiving AE, but will not have sustained, clinically significant improvement 
in outcomes once the DOT phase is complete. This represents a unique opportunity to build 
upon existing community relationships with an innovative and developmentally focused program 
to improve asthma outcomes for urban teens. 
 
Study Objectives: 
This study has the following objectives: 
1. To identify and recruit an urban sample of adolescents (12-16 year olds) with mild 
persistent to severe persistent asthma from approximately 30 schools throughout the 
Rochester City School District and surrounding school districts. 
2. To enroll subjects into a 3-group randomized trial of the School-Based Asthma Care for 
Teens (SB-ACT) program; 1) the SB-ACT program, which includes a 6-8 week trial of 
DOT plus 3 MI counseling sessions; 2) DOT-only (6-8 week grail of DOT alone); and 3) 
an asthma education (AE) attention-control comparison group. 
3. To collect baseline morbidity data to characterize this group of teens with asthma and 
determine risk factors for the frequency and severity of recurrent symptoms.  
4. To follow these subjects prospectively through the year following enrollment for clinical 
outcomes (symptom severity, health care use, exhaled nitric oxide) and functional 
outcomes (functional limitations, school absenteeism, quality of life). 
5. To assess the effectiveness of the SB-ACT intervention in reducing asthma morbidity. 
6. To explore potential mediators (motivation, confidence, and beliefs about medication) 
and moderators (demographics, depressed mood, school/neighborhood variables) of the 
intervention effect.  
7. To perform an economic sustainability analysis (health and economic benefits of SB-
ACT, DOT-only and AE using cost-effectiveness methodology).  
8. To evaluate the process of program implementation using RE-AIM metrics.  
 
Study Overview: 
A. Study Design 
We propose a 3-group randomized trial of the School-Based Asthma Care for Teens 
(SB-ACT) program.  430 teens with persistent asthma will be randomized to either: 1) the SB-
ACT program, which includes a 6-8 week trial of DOT plus 3 MI counseling sessions; 2) DOT-
only (6-8 week trial of DOT alone); and 3) an Asthma Education (AE) attention-control 
comparison group.  Families and teens will be followed prospectively for one calendar year, with 
systematic assessments completed at 3-, 5-, 7-, and 12-months post-enrollment.   
 
B.  Subjects and Setting 
 
Adolescents 12-16 years of age attending secondary school in the Rochester City 
School District (RCSD) and surrounding school districts will be screened for eligibility at the start 
of the school year.  A total of 430 teens will be recruited over 4 years from approximately 20 
schools.  School-based screening, used successfully in our past programs, will identify teens for 
the program.  In compliance with the Family Education Rights and Privacy Act, our study has 
access to the RCSD medical alert forms that include whether or not the teen has a breathing 
problem.  For the surrounding school districts, school nurses or administrators will contact 
caregivers of potentially eligible families, and if the family is interested, will connect the 
caregiver with the study team for an eligibility assessment.  Additionally, we will review 
potentially eligible teens from Dr. Halterman’s Future Contact Database (RSRB# 31010) to 
inquire if prior study participants are eligible and interested in the current study.  We will assess 

 
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Protocol 
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eligibility for the study by a telephone survey with the primary caregiver.    
Eligibility requirements include:  
1) Physician-diagnosed asthma (based on caregiver report). 
2) Persistent asthma severity or poor asthma control (based on national guidelines4 and 
caregiver report). Per NHLBI EPR-3 criteria, any 1 of the following: 
a. In past month, >2 days/week with daytime asthma symptoms 
b. In past month, >2 days/week with rescue medication use 
c. In past month, >2 times/month with nighttime awakening due to asthma 
symptoms 
d. >2 asthma exacerbations during past year that required oral systemic 
corticosteroids 
3) Age >12 and <16 years 
4) Attending secondary school in the Rochester City School District or surrounding 
school districts. 
 
Exclusion Criteria: 
1) Inability to speak and understand English. 
2) No access to a working phone for follow-up surveys (either at home or an accessible 
alternate location). 
3) Diagnosed developmental or intellectual disability. 
4) Other significant medical conditions, including congenital heart disease, cystic 
fibrosis, or other chronic lung disease, that could interfere with the assessment of 
asthma-related outcome measures. 
5) Teens in foster care or other situations in which consent cannot be obtained from a 
legal guardian. 
Based on our previous studies, we anticipate <10% of subjects to be excluded based on 
these criteria.  
 
C.  Study Procedures 
 
1. Screening procedures 
Screening will occur from late summer (as soon as school enrollment forms are 
available to the team) until the end of January (since new screening information becomes 
available during the first few months of school).  To evaluate subjects for eligibility, 
screening procedures occur up to 4 weeks prior to the baseline assessment and 
randomization.  The baseline assessment includes symptom questions to be assessed for 
all teens and will be reviewed for teens that we are unable to complete the baseline within 4 
weeks of the screening survey.  
We will identify teens through school “medical-alert” forms that include whether or not 
the child has a breathing problem or referral from school nurse. All teens who have a 
breathing problem indicated on their medical-alert forms will be identified.  We will conduct a 
telephone screening survey with the caregiver to assess eligibility, and only teens with 
persistent symptoms or poor asthma control will be eligible.  Enrollment and randomization 
occur in a rolling fashion from the first day of school until the end of February (since 
enrollment can occur up to 4 weeks after screening survey completion). 
 
2. Baseline 
Home visits will be used to explain the study, elicit informed consent from the parent and 
assent from the teen, and obtain baseline measurements.  Baseline evaluations include: 
confirmation of inclusion/exclusion criteria, assessment of baseline severity, collection of 
demographic and health history variables, measurement of pulmonary function (using a 

 
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Protocol 
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portable spirometer), exhaled nitric oxide (FeNO – for airway inflammation), salivary 
cotinine, height, and weight.  All surveys questions will be read aloud to caregivers and 
teens.  We will give a symptom diary to the teen and caregiver for symptom tracking, assist 
in finding a prominent location for it, and review its use. For home interviews in which the 
child is not present, we will determine another time to come to the home to obtain the teen’s 
assent, conduct the baseline surveys, and collect samples and measurements. If it becomes 
difficult to reach the child at home we will ask the parent’s permission to meet with the child 
at the school nurse’s office to obtain assent, and collect the cotinine, FeNO, spirometry, and 
height and weight measurements. We will then contact the child by phone to complete the 
baseline survey. (Note: If teen refuses to assent to the study, the study subject will be 
withdrawn and all study materials will be destroyed.) 
We will use portable spirometers and FeNO machines to measure the teen’s pulmonary 
function and airway inflammation. Some teens may have difficulty with these procedures; we 
will only include data for teens able to perform the procedures accurately.  We will use a 
portable scale and stadiometer to take objective measurements for height and weight.  
Exposure to Secondhand Smoke will be assessed by both interview survey and cotinine 
measurements. A member of the research team will collect salivary fluid samples from each 
child using a small sterile swab. Collection will be made according to a standard protocol 
developed for use with children and adolescents. Salivary samples will be stored frozen and 
shipped via courier to Salimetrics, LLC in State College, PA for analysis. The Environmental 
Assessment will include a survey inquiring about environmental exposures and an 
observation checklist that a member of the study team will perform. 
 
3. Randomization 
Following the baseline assessment, each teen will be randomly assigned to one of 3 
groups: 1) the SB-ACT program, which includes a trial of DOT plus a self-management MI 
counseling intervention; 2) DOT-only; or 3) an asthma education (AE) comparison group.  
Randomization will be stratified by school and preventive medication at baseline. Since 
enrollment will occur over a period of 1-5 months at the start of the school year, a permuted 
block design will be used to assure approximately equal allocation of teens in each group 
over time.  The randomization scheme will be independently developed by a programmer in 
the Biostatistics Center.  After baseline completion, the interviewer will call the study 
coordinator who will provide the subject’s ID number and treatment assignment. 
 
4. SB-ACT Intervention: 
School Nurse Assisted Preventive Medication Use (Directly Observed Therapy)  
We will communicate with the child’s healthcare provider about the child’s 
symptoms and if child is not already taking a preventive medication, to determine an 
appropriate preventive medication for the teen. We will facilitate the child receiving their 
preventive medication at school. If needed, new prescriptions will be sent to pharmacies 
for parent pick-up or delivery (several local pharmacies provide delivery services) with 
instructions indicating one canister of preventive medication to be dispensed for the 
home and a second canister for the teen’s school.  This system has been successfully 
implemented in our prior studies. The school nurse and teen will meet at the beginning 
of the program to develop an individualized plan for the timing of DOT in the school to 
avoid disruption of classes and allow the teen choice in this process. For the first 6-8 
weeks after enrollment the teen will visit the school nurse once a day to receive a daily 
dose of preventive asthma medication. Study personnel will review the DOT protocol 
and proper administration technique with the school nurse.  The purpose of this 
intervention component is for teens to establish a relationship with the school nurse, 
learn proper medication technique, and experience potential benefits of consistent 

 
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preventive therapy.  As in our prior studies, most teens will receive once daily dosing 
since it is effective and allows for administration of medication during school hours; if 
more frequent dosing is needed additional doses will be taken at home.  The teen will 
use his/her home inhaler for doses on weekend days and other days in which he/she 
does not attend school. 
While many schools do not have a full time nurse, all schools are prepared for 
medication administration as many teens have daily medication needs (e.g., medications 
for attention deficit disorder).  In our prior study, medications were administered >95% of 
the time the teen was in school, even in schools with only part-time nurse coverage (the 
majority of schools).  All teens will be instructed to rinse their mouth with water after 
each medication dose.  A medication dispensing log will be used for tracking purposes, 
and contacts with the nurse will be tracked.  While adherence will be assured by the 
nurse on the days the teen attends school, adherence will simply be encouraged on 
days the teen does not attend school.  Guideline-based medication adjustments (‘step-
up’) will be recommended to the child’s provider after the first follow-up if persistent 
symptoms continue. 
Since the goal of SB-ACT is to ultimately support the teen’s transition to 
independent, sustained use of preventive medications, MI counseling, the second 
component of the intervention, will start 4-6 weeks after the commencement of DOT.  A 
brief survey tool will be administered by the school nurse weekly, following the first 6 
weeks of DOT, to help determine collaboratively with the teen if they are ready to 
transition to independent medication use. The teen will report their motivation to use 
preventive medications independently (1-10 scale, ‘readiness’ = score >8), their 
confidence in adhering to the treatment plan, and whether they have obtained needed 
refill medications for ongoing use.13   While the goal of the counseling sessions is to help 
the teen move towards autonomy with medications, some teens may request to continue 
DOT for a longer time period.  We deliberately provide this choice to support teens’ 
autonomy in decision-making, which is appropriate for this developmental stage.  We will 
track any contacts with the school nurse throughout the school year. 
 
Motivational Interviewing (MI) to Transition the Teen to Independent Use of Preventive 
Medications:   
This intervention component consists of an evidence-based self-management 
program to help the teen begin to transition to independence with preventive medication 
use.  A trained community nurse or counselor will conduct three in-person MI sessions 
with the teen at school to enhance the teen’s motivation to adhere to their guideline-
based asthma treatment plan (developed during the DOT phase).  All sessions will take 
place in a quiet location at a mutually agreed upon time that limits interference with 
classes and activities.  The three sessions consist of an initial 40 minute counseling 
session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 
weeks later.  The teens will also have the option of calling the nurse for reinforcement 
after the 3rd session if they desire additional support.  We will systematically track the 
number and length of contacts. 
a. Initial MI visit 
The focus of this intervention component is to build motivation for and to resolve 
ambivalence regarding asthma medication adherence.  Within the context of MI 
counseling delivery, asthma education (based on the same content used for the AE 
group) will be provided in a non-prescriptive manner using the MI technique of “elicit-
provide-elicit”.14   The counselor will first elicit the teen’s knowledge about the 
importance and health effects of proper medication adherence. The counselor then 
will offer recommendations in a non-confrontational manner that supports and 

 
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respects the teen’s autonomous decision-making.  Teen-endorsed goal setting, 
problem solving and other behavior change strategies will be utilized.  This approach 
does not regard the teen as a passive recipient of information, but rather an active 
collaborator in the change process.  Using MI, the counselor will use open-ended 
questions and reflections to explore the teen’s ambivalence towards taking 
medications (e.g., pros and cons).  The counselor will empathize with the teen’s 
struggles, elicit concerns about changing and not changing medication taking 
behavior, and explore ways for the teen to communicate their needs (e.g., with the 
PCP).  The teen will be encouraged to reflect on his/her experience with DOT in 
school, and the benefits gained from taking medicines consistently.  The counselor 
will inquire about things the teen feels are important (values, goals, interests), and 
where appropriate address discrepancies between the teen’s current behaviors (e.g., 
not taking medicine) and goals (e.g., being on basketball team). 
The MI sessions are targeted towards the adolescent.  However, we recognize 
that the caregiver can provide valuable information about the impact the teen’s 
asthma has on the teen and the family. It will be important, particularly when the 
parent maintains significant influence over the teen’s asthma management (e.g., 
getting medications/refills), for caregivers to provide input and consensus with the 
change plan that is developed.  The counselor will call the caregiver following each 
session. Using MI-compatible strategies, he/she will assess asthma control from the 
caregiver perspective, and the caregiver’s role in supporting or hindering the teen’s 
asthma self-management. 
b. Follow-up MI sessions  
Follow-up sessions will occur approximately 2 and 6 weeks following the initial 
session.  These sessions will focus on understanding the teen’s perspectives and 
choices regarding asthma management, offering continued support for autonomous 
decision making around medication adherence, discussing barriers to independent 
adherence, and identifying any benefits associated with ongoing preventive asthma 
care.  The teens will be asked about any anticipated obstacles (e.g., getting 
medication refills, making a follow-up visit with the provider).  If the teen is not using 
preventive medications daily, the nurse will continue to explore ambivalence and 
address discrepancies between the teen’s behavior and his/her current goals. 
 
Supervision of MI sessions will be provided by an investigator (B. Borrelli) and 
coordinator to assure fidelity to the MI intervention; all sessions will be audiotaped 
and a minimum of 20% will be reviewed.   
 
5. DOT-Only Group: 
As with the teens in the combined SB-ACT group, we will communicate with the child’s 
provider of those in the DOT-only group to assure each teen has preventive medications at 
home and school.  Teens in the DOT-only group will receive a trial of 6-8 weeks of directly 
observed administration of preventive asthma medications from the school nurse (with dose-
adjustments as needed), but will not receive MI counseling.  The school nurse will use the 
same survey tool as for the SB-ACT group to help determine with the teen if they are ready 
to transition to independent medication use, and will encourage the teen to reflect on their 
experience using these medications.  As in the SB-ACT group, teens may ask the nurse to 
continue DOT beyond the initial trial period; contacts will be tracked.  Outcomes from this 
group will help determine whether a trial of DOT alone is sufficient to promote sustained 
adherence and reduced morbidity. 
 
SB-ACT and DOT-Only:  The medications and spacers (if needed) will be purchased 
through the child’s health insurance.  Based on our prior research, we anticipate that most of 

 
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the children will have some form of either private or public health insurance, with most being 
insured by Medicaid.  If a family does not have insurance or insurance coverage status is 
uncertain, if there is an unexpected expense despite insurance coverage, and when a family 
informs us they are unable to pay for the co-payment, we will pay for medications or 
medication supplies (e.g., spacer, nebulizer mask, etc.).   In all instances we will also assist 
the family in getting insurance, help them to proactively plan for refills of medications, as well 
as link them with services to help them afford co-payments. 
 
6. Asthma Education (AE) Comparison Group: 
  
We will notify the teen’s healthcare provider that teens in the AE group have persistent 
asthma symptoms that warrant use of effective guideline-based preventive medications.  We 
also will provide an in-school asthma education program,15 provided by community asthma 
educators or nurses. The program will include asthma management instruction and will be 
geared toward teens living in underserved neighborhoods. The program will match the time 
and attention of the MI counseling portion of SB-ACT.  Sessions will be delivered at school 
by a trained health educator, in a similar structure and time-schedule to the MI intervention 
(i.e., each teen will receive three 1-on-1 educational sessions at school).  Sessions will 
cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and 
warning signs, and 3) medications and self-advocacy.  As in SB-ACT, caregivers will be 
called after each session to reinforce key points and answer questions.  Bi-monthly 
supervision will be provided by the PI and research coordinator to assure fidelity to the AE 
intervention; all sessions will be audiotaped and 20% will be reviewed.   
 
  
Teens will not be blinded to group allocation; they will be told they are randomly 
assigned to different ways of approaching asthma management.  As in our prior work, to 
avoid differential attrition we assure sessions are interactive and provide flexible scheduling 
and reminders.  
 
7. Asthma Control Status at Follow-Up 
Criteria for a preventive medication adjustment recommendation at the 3 month Follow-
Up assessment for the DOT-only and SB-ACT treatment groups: 
1. Caregiver 3mo. FU; one (or both) below evidencing poor control status: 
a. NHLBI criteria 
b. ACT score ≤ 19 
AND 
2. Teen 3mo. FU; one (or both) below evidencing poor control status: 
a. NHLBI criteria 
b. ACT score ≤ 19 
AND 
3. Caregiver and/or teen reports making any effort to take/continue the 
prescribed preventive medication at school/home 
If the above conditions hold true, a step-up adjustment recommendation (and/or a 
change to once daily dosing) will be made.  This will happen regardless of whether school DOT 
is continuing or the teen has already transitioned to independent use. 
 
Medication Adjustment Procedure: Generate a NHLBI symptom report to justify a 
preventive medication action and draft a prescription recommendation for PCP to consider and 
authorize (possibly with edits). After receipt of PCP decision, caregiver will be contacted to 
explain recommendation and obtain consent.  Submit new prescription to pharmacy and deliver 

 
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Protocol 
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to school/home as needed.  If medication adjustment is NOT agreed to by caregiver then notify 
PCP of decision not to adjust. 
Note: If caregiver and teen both report NO attempt to be adherent and asthma control is 
poor then Asthma Care Coordinator will encourage caregiver/teen to restart the previously 
prescribed preventive medication and no adjustment recommendation will be initiated. 
 
For AE-only subjects who meet the criteria above: Send caregiver a poor control 
follow-up notification letter encouraging family to pursue preventive asthma care due to teen’s 
continuing persistent symptoms.  Send PCP a notification letter calling attention to teen’s 
continuing persistent symptoms.  
 
8. Participant Follow-up 
Outcome measures will be assessed at 3, 5, 7 and 12 months after baseline for all 
subjects by an independent group blinded to treatment allocation.  We will use structured 
telephone interviews with both the teen and caregiver for follow-up surveys.  We may also 
send reminders and schedule appointments through text messages and emails.  Text 
messages will be formatted in a manner that provides research relevance in the absence of 
personal health information (PHI).  We may use a limited data set when sending text 
messages that can include dates and times for visits or telephone call reminders.  FeNO, 
spirometry, cotinine, height, weight and adherence measurements will be conducted through 
home or school visits at specific time-points (see below). Medical record review also will be 
performed. 
 
Measures (see below for Measurement Table with scales and timing of administration) 
Symptom Severity:   
a) The primary outcome measure will be the number of symptom-free days (SFDs) at the 
3, 5, and 7 mo. follow-ups.  This outcome measure is consistent with the symptom 
monitoring suggested by the national guidelines,16 and we collected prospective data on 
SFDs in our prior studies, enabling a realistic calculation of sample size requirements.  At 
each follow-up, parents and teens will report the number of days the teen experienced no 
symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, 
and no need for rescue medicine) in the past 2 weeks.  Symptom diaries will assist with 
recollection.  
b) Secondary measures: Parents and teens will be asked to report the number of “steroid 
bursts” for asthma, as well as urgent (ED visits, hospitalizations, school exacerbations 
requiring treatment) and non-urgent (primary and specialist care) visits.  With parent 
permission, we can access charts at each medical practice and will review medical records 
to verify visits.  We also will measure the number of nights with asthma symptoms, days 
needing rescue medications, days with limited activity, and asthma control with the asthma 
control test (ACT).17,18  
Adherence:  We will use Horne’s adherence scale,19 and also will ask teens to report doses 
missed in the prior 2 weeks. To provide objective adherence data for teens in each group, 
we will monitor dose counters that are integrated into medication canisters.  Almost all 
inhaled steroids now include counters, and in our prior study 99% of children used 
medication that included integrated counters.  At baseline, 5-months, and 7-months, we will 
use home visits to document the number of doses on the teens’ preventive medication 
inhaler (or count remaining pills for oral medications, i.e.; Singulair), and return 2 weeks later 
to re-measure the doses used.  Based on the prescribed regimen, we will calculate 
adherence (#actuations / #prescribed) over the prior 2 wks.  For teens in the SB-ACT and 
DOT-only groups, we will also collect school medication administration logs and will record 
the time to transition to independent medicine use. 

 
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Protocol 
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Functional Outcomes and Services Utilization:  We will measure adolescent and 
caregiver quality of life using the Pediatric Asthma Quality-of-Life Questionnaire and the 
Pediatric Asthma Caregiver's Quality of Life Questionnaire.20,21 School absenteeism will be 
assessed by teen/caregiver report and school records, and we will assess caregiver’s 
workdays missed for teen’s medical visits or illness. We will also assess other utilization, 
caregiver time costs, and out-of-pocket expenses (e.g., visits to the nurse’s office for 
exacerbations, loss of activities, urgent care utilization, medication costs, visit co-pays, and 
transportation costs). 
Airway Inflammation:  We will obtain exhaled nitric oxide (FeNO) measurements at 
baseline, 5 month follow-up, and 7-month follow-up.  We will use a NIOX VERO Airway 
Inflammation Monitor; a portable device that measures FeNO using the electrochemistry 
method (range 5-300ppb).  Teens exhale into the device for 10 seconds.   FeNO is elevated 
in inflammatory diseases and decreases with inhaled steroid treatment.22 
Pulmonary function: At baseline, 5 month follow-up, 7-monthfollow-up teens will blow into 
a portable spirometer to assess lung function.  
Height & Weight: At baseline, 5, month, 7 month follow-up, a portable scale and 
stadiometer will be used to take objective measurement of the teen’s height and weight. 
Independent Variables/Potential Moderators: We will collect caregiver-reported measures 
of demographic, personal, and community factors known to be associated with asthma 
morbidity in high risk children or influence response to interventions.  These include 
demographics age,7,23  race/ethnicity,5,24,25  gender, insurance,5,7,26 caregiver’s education7, 
and caregiver and teen-reported depressed mood,27,28 using the Center for Epidemiologic 
Studies-Depression Scale29 and the Center for Epidemiological Studies Depression Scale 
for Children.30,31  Since smoke exposure is associated with asthma morbidity,32,33 we will 
measure teens’ salivary cotinine levels (baseline, final).34,35 For school/community variables, 
we use the Neighborhood Social Cohesion scale,36 school size, graduation rate, % 
free/reduced price lunch, and racial composition.   
Potential Mediators: To explore potential mediators related to the conceptual model, we 
will use a Motivation and a Confidence Rating37 to assess teens’ motivation to improve their 
asthma medication use, and the teens’ perceived confidence in “how sure they are that they 
can take their medication every day,” (scale 1-10).  We will measure beliefs using the Beliefs 
about Medications Questionnaire.38  The Beliefs About Medication Scale - Intent to Adhere 
Subscale (BAMS-IA)39 will assess the teens’ intention to adhere to their medication regimen 
independently during the subsequent two weeks.  The Asthma Readiness to Change 
Questionnaire40 will assess readiness to change their medication use.  We also will use the 
Health Care Climate Questionnaire41-43 to assess the teen’s relationship with the school and 
MI nurses and health educators.  
   
9. Measures 
The table on the following page summarizes the use of all instruments used for this 
study including how the data is collected and the times of administration.  
 
 
Outcomes 
Measurement Strategy 
Time of Administration 
Symptom Severity 
Teen and caregiver report, NHLBI guideline-
based items 
Asthma Control Test (ACT) 
Baseline, each follow-up 
Airway Inflammation 
Objective Measurement:  FeNO 
Baseline, 5 months, 7-month,  
Lung Function 
Objective Measurement: Spirometry 
Baseline, 5 months, 7-month,  

 
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Height and Weight 
Objective Measurement: Scale, Stadiometer 
Baseline, 5 months, 7-month,  
Medication Adherence 
Teen and caregiver report, Horne adherence 
scale 
 
Objective Measurement:  Monitoring of 
integrated medication counters 
Baseline, each follow-up 
 
 
Baseline, 5 months, 7-month,  
Functional Outcomes and 
Service Utilization 
 
 
Quality of Life 
Teen – Juniper PAQLQ 
Caregiver – Juniper PACQLQ 
Baseline, each follow-up 
School Absenteeism 
Teen and caregiver interview 
School record review 
Baseline, each follow-up 
Health Care Utilization 
Teen and caregiver interview  
Medical record review 
Baseline, each follow-up 
Additional Cost Measures 
Caregiver interview (caregiver missed work, out 
of pocket expenses, transportation costs, etc.) 
Baseline, each follow-up 
Independent Variables 
 
 
Demographic, Medical Variables 
Teen and caregiver interview 
Baseline 
Depressed Mood* 
Caregiver – CES-D 
Teen – CES-DC 
Baseline, 7- month 
Baseline, 7- month 
 
Secondhand Smoke 
Teen and caregiver interview 
Objective Measurement: Salivary Cotinine 
Baseline, each follow-up 
Baseline, 7-month 
Potential Mediators
Motivation 
Teen - Medication Adherence Motivation and 
Confidence 
Baseline, each follow-up 
Beliefs about Medications 
Teen and caregiver – Beliefs about 
Medications Questionnaire (BMQ) 
Teen – Beliefs About Medications – Intent to 
Adhere Subscale (BAMS-IA), Asthma 
Readiness to Change Questionnaire  
Baseline, 7-month 
 
Baseline, 7-month 
 
Process Evaluation 
 
 
RE-AIM  Summary Measures 
See detailed table in Process 
Evaluation section below 
RE-AIM Dimensions and Questions for 
Evaluating Health Education and Health 
Behavior Research 
At end of each study year 
* Parents and teens whose scores indicate they may be suffering from mild to severe depression will be provided a 
list of mental health services and providers in the community, and will be referred to their primary care provider. 
 
10. Compensation 
 
Teens and caregivers will each receive a $20 gift card following baseline survey, $10 
after the 3- and 5- month follow-ups, and $30 after the 7- and 12- month follow-ups.  
Payment to participants will be in the form of a prepaid Visa debit card from Bank of 
America.  The use of these cards allows for tracking the use of lost or stolen cards and 
provides flexible options for participant use.   
 
11. Process Evaluation 
We will consider both individual and institutional level impacts and resources available in 
‘real world’ schools and communities. We will use RE-AIM44 metrics to assess :1) the 

 
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proportion of eligible subjects who participate and the representativeness of participants 
compared to non-participants (Reach), 2) the intervention’s impact on primary outcomes and 
quality of life (Effectiveness), 3) characteristics of schools and program support by school 
administration, nurses, providers, and teens/caregivers (Adoption), 4) the consistency in 
delivery of each intervention component (including the efficiency of the delivery of 
medication to the schools, the % of days teens receive medications in school, % completed 
counseling sessions, and whether additional contacts with the nurses occur beyond the 
intervention period) (Implementation), and 5) the extent to which intervention components 
continued or were modified post-study completion and its long-term effects (Maintenance). 
The final interview will also include Likert-scale and open-ended questions to teens, parents, 
PCPs, school nurses and administrators about convenience, scheduling, and satisfaction.   
 
 
 
 
 
 
12. Data Storage and Confidentiality 
To maintain the integrity, security, and confidentially of study data, the data will be 
maintained in a secure and encrypted web-based database and/or a password protected 
database on a secure university network drive. No subject data will be stored on the internal 
hard drives of any Strong Health computers. After data validation and analysis, subject 
information will be de-identified.  All consent forms, paper surveys and additional 
correspondence will be locked in an office or filing cabinet and will only be accessible by the 
study staff.  
 
Baseline, follow-up, and chart review data will be entered into a password-protected 
database.  This database is stored on a secure university network drive that is only 
accessible by the research team whom must use their NetID and password to access the 
database.  Data may also be collected and stored using RedCap, a secure, password 
protected database (using University NetID’s and passwords) hosted through the University 
of Rochester. 
 
The counseling and education sessions will be audio recorded.  These recordings will be 
saved on Box.net, a secure and University supported database that will only accessible by 
investigators and study personnel.  These recordings will be used for supervision of the 
counseling and education sessions to ensure the protocol is being followed correctly. 
RE-AIM METRICS
RE-AIM 
QUESTIONS
ASSESSMENT METHOD
Reach 
(Individual Level) 
What percent of eligible participants: a) were 
excluded, b) took part and c) how 
representative were they? 
Response rate and 
demographics  
Effectiveness 
(Individual Level) 
Effect of intervention on primary outcomes 
and QOL? Were pre-determined NHLBI 
guideline-based targets achieved?   
Primary analysis (symptoms, 
quality of life; economic 
evaluation)  
Adoption  
(Setting/Staff 
Level) 
Characteristics of participating secondary 
schools, time and resource burden on school 
and community personnel.   
School characteristics, 
demographics, staff surveys  
Implementation  
(Setting Level) 
To what extent were the various intervention 
components delivered as intended by school 
and community staff members? 
Medication delivery log, session 
completion rate, contacts with 
nurses, surveys 
Maintenance  
(Individual Level) 
Long term effects at 12 months? Attrition 
rate? Were drop-outs representative; how 
did attrition impact conclusions? 
Analysis of long-term outcomes 
(12 month assessment), 
attrition, demographics 
Maintenance 
(Setting Level) 
a)To what extent were intervention 
components continued post-study 
completion, b)how was the program modified 
Survey and semi-structured 
interviews with school nurses, 
administrators, ALA leadership 

 
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Portions of the final assessments with caregivers, nurses, and healthcare providers may be 
tape recorded too.  These recordings will be saved on a university network drive that is only 
accessible by study personnel whom must use their NetID and password to access these 
tape recordings.  Once the recordings have been transcribed, they will be deleted from the 
network drive. 
 
The Rochester City School District has partnered with the University of Rochester study 
team for this study, and all of the procedures follow the school district’s rules of privacy and 
confidentiality, as outlined in the letter from Dr. Jeanette Silvers, Chief of Accountability for 
the Rochester City School District.  As deputies of the school district, the study team is 
granted permission to review limited student information and contact families to inquire 
about their willingness to participate in the study. 
For surrounding school districts, the study team will not have access to student data until the 
family has consented to the study procedures. 
 
  
13. Safety 
This is not a drug investigational study since the effectiveness and safety of the drugs 
are not being tested.  The randomized trial proposed will pose minimal risk to the teens, 
since the medications used by the teens (and delivered at school for the teens in the SB-
ACT and DOT-only groups) are FDA approved preventive medications that are 
recommended as the standard of care45 for children and adolescents with the degree of 
symptom severity required for enrollment into the program. The most common side effects 
of inhaled corticosteroids, including yeast infection of the mouth and facial rash, will be 
assessed during each follow-up interview.  Any significant concerns will be relayed promptly 
to the study coordinator, the principal investigator, the teen’s health care provider, the 
Institutional Review Board, the DSMB and the NIH.  There is a potential risk of adverse 
effects on linear growth from the use of inhaled steroids;46 however, this risk is felt to be 
outweighed by the benefits for children and adolescents with persistent asthma.  In general, 
these medications are well tolerated and safe. Health care providers will prescribe all 
medications and will follow the teen for any potential side effects and monitor the teen’s 
growth during the course of the study.   
The frequency and severity of all reported adverse events will be systematically 
recorded. Telephone interviewers will inquire about any adverse events, and specifically ask 
about any yeast infections of the mouth and facial rash.  Any teen experiencing an acute 
asthma exacerbation at the time of a home visit or follow-up phone call will be referred 
immediately to their health care provider for care, and their caregiver will be notified.  In 
addition, school nurses will be instructed to contact the caregiver of any teen presenting to 
the nurses office with acute symptoms and refer them promptly to their health care provider. 
There is a risk that the study team may discover an unknown medical condition.  If this is 
to occur, we will refer the family to their health care provider or another appropriate health 
care professional for evaluation and treatment. 
 
Data Safety Monitoring Plan (DSMP):   
This study also includes a Data Safety Monitoring Plan as submitted to and approved by 
the study sponsor: National Institutes of Health and National Heart, Lung, and Blood 
Institute.  A formal Data Safety and Monitoring Board has been assembled for this project. 
The plan for safety and monitoring is as follows. 
 
14. Data and Safety Monitoring 

 
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Data Quality Monitoring 
Principal investigator, Dr. Halterman, will take responsibility that the study is 
adequately monitored and that the data are secure.  Co-investigators, Dr. Borrelli and Dr. 
Riekert each have human subject protection certifications through their institutions.  All UofR 
recruitment staff will have human subject protection certifications prior to recruiting subjects 
into the study and will be included in the IRB application. Recruitment will only occur at the 
University of Rochester.  There will be no enrollment of subjects at the University of Boston 
Medical Center or Johns Hopkins University.  
Research assistants/interviewers will be responsible for all assessments, and will 
receive training from key study personnel regarding asthma terminology, symptoms, and 
medication understanding. They will be trained by the study coordinator on the use of the 
spirometer, FeNO machine, scale, stadiometer, and salivary collection methods.  
Data forms will be completed at each study home visit or telephone interview and will 
be returned with a cover sheet and other source documentation support materials (informed 
consent, contact information, etc.).  Pre-intervention training of study staff will be conducted 
to increase knowledge about asthma, asthma medications, and other important information 
in order to reduce the number of “real-time” data collection errors.  Through this training, 
staff will note any inconsistencies in parent reported data and will discuss them with the 
parent at the time of the interview. 
Once forms have been collected, errors that can be corrected over the telephone 
(legibility, incorrect dates, etc.) will be done using telephone interviews with the parents.  
Forms will be keypunched into the database using a double-entry system technique and 
checklists will be used to ensure that all data forms have been received and entered into the 
database.  Simple range checks as well as cross-form validation checks will be performed to 
ensure the accuracy and completeness of the data.  A list of all data checks performed will 
be maintained and any errors detected by this method will be noted on the form (initials and 
date of change).  In addition, data forms, valid informed consent documents for each 
enrolled patient, and supporting source documentation materials will be reviewed by the 
information analysts for accuracy.  Required regulatory documents (IRB approval, updates 
to the protocol, data monitoring documents) will be maintained by the study coordinator.  All 
events during the course of the trial including study enrollments, adverse events and study 
terminations will be reported to the study coordinator (see Safety Monitoring section below). 
   
 
Safety Monitoring 
A Data Safety Monitoring Board (DSMB) including a pediatric allergy and immunology 
specialist (Tamara Perry, MD; Arkansas Children’s Hospital Research Institute), an 
epidemiologist (Susan Fisher, MS, PhD; Temple University), and a human subjects 
specialist (Nicholas Ferraio, MS, MPA; Department of Pediatrics, University of Rochester), 
has been assembled to provide ongoing oversight of the study. The DSMB will meet bi-
annually or more frequently as needed to review study procedures and data.  Potential risks 
related to participation in this study are minimal since the medications delivered through this 
program are routinely recommended by national guidelines for asthma care.  In our previous 
school-based asthma program, which included 530 children, there were no reports of 
significant adverse events.  The frequency and severity of all reported adverse events will 
be systematically recorded at each follow-up interview.  Telephone interviewers will inquire 
about any adverse events, and specifically ask about any yeast infections of the mouth and 
facial rash.  Any significant adverse events will be flagged by the follow-up research 
associates and relayed promptly to the senior study coordinator, the principal investigator, 
the child’s health care provider, the Institutional Review Board, the DSMB, and the NIH 
within 24 hours.  We will hold bi-weekly research review meetings with the study team to 

 
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provide an additional layer of monitoring to ensure subject safety as well as treatment 
integrity.   
All records will be kept strictly confidential as required by the policies and procedures of 
the University of Rochester where data are collected, processed, and reported.   
 
15. Potential Benefits 
Adolescents may or may not benefit from the study.  They may experience improved 
asthma morbidity due to the additional time and attention they receive around their asthma 
and asthma care.  Additionally, teens in the groups receiving preventive medications may 
experience reduced symptoms due to taking their medication daily.  In addition, the teen’s 
health care provider will be alerted of their asthma severity, and families will receive 
telephone calls in order to assess the teen’s ongoing symptoms.  It is possible that an 
increased awareness of symptoms and enhanced communication with the health care 
provider will occur, and will result in improved asthma care and reduced morbidity for these 
adolescents.  
 
16. Analysis 
Sample Size and Power Justification: 
This study is designed to have adequate power to test the primary hypothesis that teens 
receiving SB-ACT will have more symptom-free days at the 3, 5, and 7 -month evaluations 
compared to AE.  Previous asthma interventions, including the SBAT trial, have 
demonstrated that improvements of 0.9 SFD/2 weeks are feasible and clinically 
meaningful.47,48 Based on our prior data, we estimate a pooled standard deviation (SD) of 
SFD to be 2.6 and within-subject correlation (ICC) of 0.3-0.4. We calculated power for the 
intervention effect on SFD while justifying repeated assessments for outcomes (5, 7, 12 
months). A sample size of 123 subjects per group will obtain 94-96% power to detect a 
difference of 0.9 in SFD at a two-sided 5% significance level (assuming ICC: 0.3-0.4).  We 
anticipate <15% attrition, as attrition was minimal (<5%) in the prior study, and therefore 
plan to enroll 430 teens. To test the short term intervention effect of DOT-only vs. AE, the 
sample size of 123 per group will obtain 80% power to detect a difference of 0.93/2 weeks at 
3-month assessment with a two-sided 5% significance.  We expect the DOT-only 
intervention won’t sustain the effect at long term follow-up compared with AE. To test this, 
the proposed sample size will have 86% power at a one-sided 5% significance level, using a 
non-inferiority test with a margin of equivalence of 0.9 and a SD of 2.6.  To compare the 
long-term effect of DOT-only vs. SB-ACT, we will have 80% power to detect an effect size of 
0.4 at a two-sided 5% significance level.   
To evaluate the intervention effect within each study arm, we anticipate in the SB-ACT 
group the rate of asthma control, asthma exacerbation and no absences will reach a 
guideline-based target of 80%. 123 subjects will have 80% power to claim a rate >80% with 
a non-inferiority margin to be 10%, at a one-sided significance level of 5%. 
There are 10,900 teens in 7th-10th grade in the city school district and >6,000 entering 7th 
graders in a 3 yr. period.  Conservatively assuming an asthma prevalence of 10%,1 >1,690 
of these students have asthma, and approximately ½ have persistent asthma.  In our prior 
study, we enrolled 74% of eligible subjects.  We can conservatively enroll 126 subjects/year 
(60%); which is more than adequate for sample size requirements.   
 
Primary Analysis: 
We will use graphs and descriptive statistics to summarize outcomes by intervention 
group at each time point.  We will assess for differences between groups at baseline despite 
randomization (e.g., demographics, depressed mood, school/neighborhood factors) to 
enable the identification of covariates to be controlled in later analyses. If distributional 

 
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assumptions associated with a particular statistical procedure are violated, we will use 
appropriate transformations or non-parametric alternatives. Analysis will be performed under 
the intent-to-treat principle.49 Hypothesis-driven comparisons will be made to control the 
family-wise type I error rate at 0.05 (2-sided) for primary hypotheses.  
We expect minimal loss to follow-up.13,47,50 Inferences are valid if missing data follows 
the missing completely at random (MCAR) assumption.51 However, the occurrence of 
missing data may depend on the observed response, thus we will perform sensitivity 
analysis to examine the MCAR assumption. If it is severely violated, we will report treatment 
effects using weighted GEE to address MCAR. Biased estimates may also arise in the case 
of non-ignorable non-response (NINR).  Although unanticipated, we will examine NINR 
using the joint modeling approach.52 For SEM, the maximum likelihood estimates (MLE) are 
valid under MAR, if the posited distribution models are satisfied.  In the presence of missing 
data, estimates from LMM and SEM may be biased if parametric assumptions are not met, 
even with the use of robust variance estimates. If this arises, we will change the distribution 
models and/or use clustered bootstrap methods for inference.53 
 
 
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