The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
Phase: NA
Conditions: Asthma in Children
Sponsor: Columbia University

 
 
 
 
The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making 
Intervention to Improve Asthma in Urban Youth 
IRB Protocol Number: AAAT8015 
Clinical Trial.gov (CTG) Number:  NCT05832437 
Multiple Principal Investigators: Maureen George PhD, RN (contact PI) & Jean-Marie Bruzzese, PhD 
Sponsor: National Institutes of Health   
Grant Number:  1R21NR019668 
Funded by: National Institute of Nursing Research  
Version Number:  v.10 2023- Dec 1

 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  

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PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
The Development and Pilot Testing of a Caregiver-Child Shared 
Decision-Making Intervention to Improve Asthma in Urban Youth 
 
Grant Number: 
 
1R21NR019668 
 
Study Description: 
 
This is a feasibility trial of a brief shared decision-making intervention 
that primary care providers will deliver to caregivers and their children 
aged 10-14 during a routine office visit, focusing on improving self-
management. Brief shared decision-making will be compared to a dose-
matched attention control; providers will be randomized to deliver either 
the active (n = 43) or control (n = 42) intervention to  dyads (N = 85) 
who will be followed for 3-months. The trial will be informed by focus 
groups (caregivers separately (n =20) ; early adolescents separately n 
=20) and dyads (n =20) (N=60).  
 

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Objectives: 
 
1. To develop BREATHE-PEDS  in a pediatric population (dyads of 
caregivers and their 10- to 14-year-old early adolescents with 
uncontrolled asthma) receiving asthma care in FQHCs; 
2. To evaluate the feasibility and acceptability of intervention 
procedures; and  
3. To assess intervention effects on asthma outcomes (monthly x 3 
months post-intervention). 
To accomplish these aims the proposed study includes two phases: (1) a 
development phase where we will develop BREATHE-PEDS using focus 
groups. Participants (N = 60)  will include  early adolescents (n = 20), 
caregivers (n = 20) and dyads (n=10 dyads) to adapt BREATHE-PEDS, 
and (2) a pilot validation phase where we will conduct a group-
randomized trial in two FQHCs with 85 dyads treated by 8 PCPs (10 
dyads/PCP) randomized to 1 of 2 study arms: (a) BREATHE-PEDS (n=42 
dyads), or (b) dose-matched attention control (n=43 dyads). We will 
conduct post-trial interviews with PCPs, caregivers, and their children to 
evaluate satisfaction with the intervention; we will follow caregiver-
child dyads for 3 months post-intervention to assess the impact of 
BREATHE-PEDS on asthma outcomes. 
Hypotheses: 
1. The intervention will be feasible and acceptable as evidenced by: 
high rates of dyad recruitment and retention; PCP fidelity to the 
intervention protocol; and PCP and caregiver-child dyad 
satisfaction. 
2. Over 3-months post-intervention, relative to controls, BREATHE-
PEDS children will have improvement (a) in asthma control as 
measured by the Asthma Control Questionnaire63-65 (primary 
outcome), higher perceived SDM, and (b) on other asthma 
outcomes (secondary outcomes), including quality of life, school 
absences, lung functioning, and exacerbation. 

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Endpoints: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NAME: Asthma Control Questionnaire  
TYPE: Primary 
TIME FRAME: Focus groups, Baseline and 1-, 2-, and 3-months post 
intervention 
DESCRIPTION: 6-item validated and widely used measure of asthma 
control 
WHO COMPLETES: Child with help from caregiver as needed 
 
NAME: Shared Decision-Making Questionnaire– 9 items 
TYPE: Secondary 
TIME FRAME: Focus groups, Immediately after the medical visit (i.e., 
immediate post-intervention) 
DESCRIPTION: 9-item validated measure of the decisional process in 
medical visits from both patients' and physicians' perspectives 
WHO COMPLETES: Child AND Caregiver (PATIENT version) and PCP 
(clinician version) 
 
NAME: Medication Adherence Record Scale-Asthma 
TYPE: Secondary 
TIME FRAME: Focus groups, Baseline and 1-, 2-, and 3-months post 
intervention 
DESCRIPTION: 10-item validated measure of inhaled corticosteroid 
adherence (ICS) (dichotomized as high or not). Scores have been shown 
to predict Self-management as measured by objective electronic 
monitoring and prescription refill rates.  
WHO COMPLETES: Child with help from caregiver as needed 
 
NAME: Conventional and Alternative Management for Asthma 
TYPE: Secondary 
TIME FRAME: Focus groups, Baseline and 3-months post intervention 
DESCRIPTION: 17-item validated measure of erroneous asthma 
management beliefs (9 items) and ICS beliefs (8 items) 
WHO COMPLETES: Child with help from caregiver as needed AND 
Caregiver 
 
NAME: Pediatric Asthma Quality of Life Questionnaire 
TYPE: Secondary 
TIME FRAME: Focus groups, Baseline and 1- and 3-months post 
intervention 
DESCRIPTION: 23 questions in 3 domains (symptoms, activity limitation 
and emotional function). The activity domain contains 3 ‘patient-
specific’ questions. Children are asked to think about how they have 
been during the previous week and to respond to each of the  
questions on a 7-point scale (7 = not bothered at all - 
1 = extremely bothered). The overall PAQLQ score is the mean of all 23 
responses and the individual domain scores are the means of the items 
in those domains 
WHO COMPLETES: Child with help from caregiver as needed 

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NAME: Pediatric Asthma Caregiver’s Quality of Life Questionnaire  
TYPE: Secondary 
TIME FRAME: Focus groups, Baseline and 1- and 3-months post 
intervention 
DESCRIPTION: 13-item in two domains (activity limitation and 
emotional function). Parents recall the impact that their child’s asthma 
has had during the previous week and score each question on a 7-point 
scale. 
WHO COMPLETES: caregiver  
 
NAME: Asthma Impairment and Risk Questionnaire (AIRQ) BASELINE 
TYPE: Secondary 
TIME FRAME: Focus groups, Baseline and 1-, 2-, and 3-months post 
intervention 
DESCRIPTION: 10-item valid and reliable survey that measures both 
domains of control: symptom impairments and risk for uncontrolled 
asthma  
WHO COMPLETES: Children aged 12 and older 
 
NAME: Asthma Impairment and Risk Questionnaire (AIRQ) FOLLOWUP 
TYPE: Secondary 
TIME FRAME: 1-, 2-, and 3-months post intervention 
DESCRIPTION: 10-item valid and reliable survey that measures both 
domains of control: symptom impairments and risk for uncontrolled 
asthma 
WHO COMPLETES: Children aged 12 and older  
 
NAME: Brief debriefing survey  
TYPE: Secondary 
TIME FRAME: Immediately after the medical visit 
DESCRIPTION: 10-item (caregiver) and 5-item (PCP) yes/no/short 
answer survey that asks the participant to recount what happened at 
the visit  
WHO COMPLETES: Three versions Caregiver, Patient AND PCP 
 
NAME: Asthma exacerbation 
TYPE: Secondary 
TIME FRAME: 1-, 2-, and 3-months post intervention 
DESCRIPTION: Oral steroid use 1 year pre- through 1-year post-
intervention; report of asthma-related acute care visits, ED visits, and 
hospitalizations; or Intensification of bronchodilators (to be defined by 
SMC). All self-reported and/or extracted from provider notes in the 
electronic health record, confirmed by claims data where available. 
WHO COMPLETES: Child and Caregiver  
 
 
NAME: Asthma Responsibility Questionnaire 

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Miscellaneous:  
TYPE:  Secondary 
TIME FRAME: Focus groups, Baseline and 1- and 3-months post 
intervention 
DESCRIPTION: 10-item validated measure assessing who is responsible 
for various asthma care tasks 
WHO COMPLETES: Child and Caregiver  
 
NAME: Newest Vital Sign 
TYPE:  Other 
TIME FRAME: Focus groups,  Baseline  
DESCRIPTION: 6-item validated and widely used measures of health 
literacy 
WHO COMPLETES: Caregiver  
 
NAME: Short Assessment of Health Literacy-Spanish and English 
TYPE: Other 
TIME FRAME: Focus groups, Baseline  
DESCRIPTION: Validated measures of health literacy 
WHO COMPLETES: Caregiver  
 
NAME: Asthma Prevention Index 
TYPE: Other 
TIME FRAME: Baseline and 1-, 2-, and 3-months post intervention 
DESCRIPTION:  11 item index measuring how many steps and the 
regularity in which the steps are taken to prevent symptoms from 
occurring.  
WHO COPLETES:  Child and Caregiver 
 
Asthma history (e.g. age at diagnosis); Demographics  
TYPE: Other 
TIME FRAME Baseline 
WHO COMPLETES: Caregiver 

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Study Population: 
Aim 1: Focus groups (pre-trial). We will enroll caregivers (n =20) ; early 
adolescents (n =20) and dyads (n =10) (N=60) into separate focus 
groups.  
Aims 2 & 3: Group-randomized trial. We will recruit 85 dyads and 8 
clinicians to the trial.  
Aims 2 & 3:  Post-trial interviews. We will do post-trial interviews with 
a purposive sample of ~6 participating clinicians, ~10 early adolescents, 
and ~10 caregivers.  
 
Inclusion of Women.  
Caregiving participants in focus groups and the group-randomized trial. 
We anticipate enrolling more female caregivers than men because 
more women serve in the caregiving role. We therefore estimate that 
~75% of our caregiving participants in this trial will be female. We will 
explore if there is a differential intervention effect by sex. 
 
Provider participants (group-randomized trial). Based on the sex of the 
clinicians working at these sites, we anticipate that 75% of our 16 
clinicians will be female. 
 
Inclusion of Minorities.  
Patient participants in focus groups and the group-randomized trial.  
Asthma prevalence and morbidity is increased in Latino (defined as a 
person of Cuban, Mexican, Puerto Rican, Cuban, South or Central 
American, or other Spanish culture or origin, regardless of race) and 
Black (defined as a person having origins in any of the black racial 
groups of Africa) youth. They also have more asthma-related 
emergency department (ED) visits and hospitalizations. To address 
these health disparities, we have partnered with Urban Health Plan, 
Inc. (UHP), a federally qualified health center (FQHC) that serves a 
predominantly Latino and/or Black community. Based on demographic 
data provided by UHP we anticipate that 95% of the adolescents will be 
ethnic-racial minorities with 85% Latino and 10% non-Hispanic Black; 
the racial/ethnic distribution of their caregivers is expected to be 
similar. Our team has extensive experience working in ethnically 
diverse populations, particularly in the context of asthma intervention 
research.  
 
Provider participants (group-randomized trial). The racial and ethnic 
distribution of the PCP sample is expected to be approximately 50% 
Black, 45% White, 5% Asian, and 10% Hispanic; this is based on our 
prior experience with research involving FQHCs. 
 
Post-trial interviews with clinicians, patients and caregivers. We will 
purposively sample to ensure a racial and ethnic diversity among our 
participants.  
 
Other Vulnerable Populations.  

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Pregnant women will be eligible to participate since improving asthma 
control for their early adolescent children would benefit the family. 
 
Description of 
Sites/Facilities Enrolling 
Participants: 
 
Participants will be recruited from 3 Urban Health Plan sites. 
They include: 
El Nuevo San Juan 1065 Southern Blvd Bronx, NY 10459 
Adolescent Health and Wellness 960 Southern Blvd Bronx, NY 10459 
Bella Vista 822 Hunt’s Point Ave Bronx, NY 10474 
 
Description of Study 
Intervention/Experimental 
Manipulation: 
 
BREATHE-PEDS utilizes Primary Care Providers (PCPs) to deliver a brief 
tailored , shared decision-making intervention using motivational 
interviewing in a one-time 9-minute intervention during medical visits 
for asthma. PCPs will follow a 4-step script that was created by and 
tailored to black adults’ asthma and inhaled corticosteroid beliefs, as 
well as their Asthma Control Questionnaire (ACQ) score, measured just 
prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: 
Provide feedback (1½ minutes). Step 3: Enhance engagement (3 
minutes). Step 4: Shared decision-making (3 minutes).  
Dose-matched Attention Control Condition. Control participants will 
receive a PCP-led 9-minute scripted discussion of healthy lifestyles 
(e.g., diet) following principles of Teach to Goal. Review of BMI, current 
diet and exercise: (3 minutes). Diet/exercise counseling: (3 minutes). 
Plan for goal attainment (3 minutes). 
 
Study Duration: 
 
Three months post intervention. 
Participant Duration: 
Pre-trial focus groups.  One 2-hour session 
Group-randomized trial:  
Patient participants – 3 months 
Clinician participants = ~ 6 months (delivering the intervention one 
time to 12-13 patients during a single office visit)  
Post-trial interviews. One hour.  
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Uncontrolled asthma is an appropriate target for shared decision-making (SDM) interventions that 
support disease self-management as it is associated with higher asthma burden and worse clinical 
outcomes. To date, the application of SDM and community-based interventions targeting underserved 
communities have failed to address these disparities. Therefore, we will use patient and caregiver input 
to develop BREATHE-PEDS - Brief intervention to Evaluate Asthma Therapy in Pediatrics – a 9-minute 
SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and 
established its efficacy in this health disparity population. Our intervention is unique in that is a one-time 
brief, tailored intervention integrated into office visits, using the patient’s own provider as the 
interventionist (e.g. scalable). Our pilot trial demonstrated high fidelity to BREATHE-PEDS delivery and 

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improved asthma control and reduced symptoms among adults compared to a dose-matched attention 
control condition. 
This study addresses the important problem of uncontrolled asthma among a group at high risk for asthma 
and its adverse effects – urban minority children. Stakeholder-informed pragmatic trials are essential but 
are lacking in asthma intervention research. Our proposal addresses these weaknesses in the prior 
research. 
2.2 
BACKGROUND  
 
A.1. Asthma’s Impact is Significant in Minorities and Early Adolescents. Asthma is the most common 
chronic illness affecting 6 million US children1. Prevalence and rates of uncontrolled asthma are highest 
among Black and Hispanic youth1-5. Early adolescents (ages 10-14) have high asthma prevalence relative 
to younger children and adults1. Disability-adjusted life years (DALYs), a measure of asthma burden, 
peaks at ages 10-146-8, making asthma the third leading cause of DALYs7 in this age group6.  
A.2. Early Adolescents have Poor Asthma Self-Management. Our team, and others, have demonstrated 
that early adolescents have sub-optimal asthma self-management, including trigger management and 
using medication preventively and when symptomatic10-14. Their poor self-management occurs in the 
context of unique developmental transitions that add challenges to self-management, including 
vulnerability to stress13 and increased independence and autonomy10,29,67, as well as opportunities to 
render them good self-managers due to the developmental gains they also make68. Yet, few 
interventions specifically target this age group. A.3. Caregiver Engagement is Critical to Self-
Management but is Lacking. Despite the fact that a gradual transfer of responsibility to youth is 
recommeded71, caregivers often prematurely expect their child to assume responsibility for their asthma 
self-management72, with some transferring care as early as age 1073.  Early adolescents often report 
having more responsibility for their asthma care than their caregivers10,13, despite a desire to share 
responsibility72. Thus, caregiver engagement is critical for optimal asthma management during early 
adolescence10,24,25. Therefore, interventions are needed to engage caregivers to support their child’s 
transition to independent self-management. Intervening with early adolescent-caregiver dyads has the 
potential for a synergistic effect improving asthma control beyond what an intervention for either alone 
might have. 
A.4. Federally-Qualified Health Centers (FQHCs) are Optimal Settings for Asthma Interventions. Most 
(80%) asthma care is delivered by primary care providers (PCPs)9, and uncontrolled asthma is more 
common in these settings compared to specialty care74. FQHCs are unique primary care settings 
providing asthma care for a greater proportion of minority patients with uncontrolled asthma54. There 
are unique challenges to achieving asthma control in FQHCs: their clients live in - or near - the US 
poverty level54 and PCPs in FQHCs have limited time and resources75 to evaluate asthma control and to 
identify suboptimal self-management. This speaks to the pressing need for novel brief interventions 
integrated into clinical care. 
A.5. Tailored SDM Interventions Can Promote Asthma Self-Management. The study is guided by the 
evidence-based model, Shared Decision-Making (SDM)76, which posits that the best treatment decisions 
are informed by patients’ preferences, the best available scientific evidence, and clinician expertise. PCPs 
facilitate discussions of risks and merits associated with options in the context of patient’s goals and 
preferences, and in a manner that activates patients to engage in self-management51. The goal of SDM is 
to reach mutually agreed upon higher quality decisions that align patient’s self-management decisions 
with guideline-directed evidence-based care77,78. We have shown that SDM improves asthma control in 
adults30,53, and SDM has been used in other areas of pediatric health55-60. Yet, there has been limited 
application in asthma61. A Cochrane review has shown some benefits of SDM in pediatric asthma, 
although confidence in findings was rated low-to-moderate because of the lack of suitable controls and 
high risk of performance and detection bias62.  
A.6. Brief Dyadic SDM Interventions Can be Effective and Scalable. Brief interventions are effective in 
changing adults’ health behaviors79-84. Non-asthma caregiver-child dyadic interventions resulted in 

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children reporting less anxiety85, less disordered eating86 and safer driving87. Although less is known 
about brief asthma interventions targeting caregiver-youth dyads, one dyadic intervention was shown to 
improve caregiver-youth shared asthma management85. These data suggest that targeting caregiver-
child dyads may amplify, not dilute, intervention effects. Brief interventions (<20 minutes) make up for 
their brevity by including tailored advice, motivational interviewing (MI)52 and a plan for follow-up. A 
directed, patient-centered strategy for eliciting behavior change, MI helps patients explore and resolve 
ambivalence about recommended health behaviors while not confronting or seeking to change the 
health beliefs that underlie these behaviors52. The synergistic effects of tailoring, SDM, and MI “power” 
brief interventions in a way that more time- and labor-intensive generic interventions cannot match79-81. 
Since implementation of SDM interventions has been restricted, in part, by burdensome protocols 
requiring multiple sessions, lengthy engagement and/or time-intensive training for PCPs – protocols ill-
suited for FQHCs – we propose to develop BREATHE-PEDS, a brief (one-time, 9-minute) SDM 
intervention that utilizes MI delivered to caregiver-early adolescent dyads by PCPs during office visits for 
uncontrolled asthma.  
A.7. Impact. This study will increase potential access to an asthma intervention for racial/ethnic minority 
early adolescents, an especially vulnerable group for poor asthma control. The impact of utilizing a brief, 
one-time FQHC-based intervention and intervening with caregiver-early adolescent dyads could be 
dramatic. 
A.8. Strengths and Weaknesses in the Rigor of Prior Research. The scientific premise for this proposal is 
strong. Despite high asthma prevalence and morbidity among early adolescents and their unique 
developmental needs, the field is limited by a lack of developmentally appropriate interventions for this 
at-risk group. More specifically, most (76%) pediatric SDM interventions exclude children in decision-
making60, even though expert recommendation is that children be involved in health decision-making 
commensurate with their developmental age and maturity69,88. Brief tailored dyadic SDM interventions 
delivered by PCPs during office visits for asthma directed at fostering evidence-based guideline-directed 
asthma self-management behaviors (e.g., trigger management, symptom monitoring, medication 
adherence) has great potential to improve asthma control. Other major limitations of prior research that 
we improve on include: time-intensive interventions focused on a single aspect of asthma self-
management (i.e., medication adherence); intervention visits that occurred outside of clinical care; 
reliance on highly-trained interventionists; not tailoring interventions; failure to monitor intervention 
fidelity; lack of an attention control comparator; and a lack of formative process evaluations. We 
address these limitations and maximize the likelihood of sustaining our intervention and building 
capacity (scalability) by developing a brief (one-time 9-minute) tailored caregiver-early adolescent 
dyadic SDM intervention to effect early adolescent’s asthma self-management behaviors, using PCPs as 
interventionists, and implementing rigorous fidelity monitoring protocols (see C.2.a) and an attention 
control group. Integrating self-management SDM discussions into clinical care offers several advantages, 
such as keeping PCPs more informed regarding their patients’ status and health needs, offering them 
requisite knowledge to improve their asthma self-management. In addition, while prior pediatric SDM 
interventions often focused only on the caregiver60,89, intervening simultaneously with caregivers can 
support the early adolescent’s growing autonomy to self-manage asthma37, and thus asthma control.  
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
Asthma carries with it some inherent risk (morbidity and, rarely, mortality). Our intervention, however, 
is educational and behavioral and does not mandate (or prevent) changes in drug therapy or medical 
management by the study staff. All participants identified as having uncontrolled asthma on screening, 
regardless of whether they decide to enroll in the trial, will be scheduled for a visit with their PCP who 
will be notified at the time of screening that their patient’s screening indicated uncontrolled asthma. 
Every attempt will be made to schedule the visit within 14 days of screening; patients will be instructed 
to seek immediate medical care if their condition deteriorates prior to that visit. While the behavioral 

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intervention itself is low risk, participants must have uncontrolled asthma to be eligible for enrollment. 
Because of this, we will ask the Safety Monitoring Board (SMC) to establish a threshold for asthma 
exacerbations and if we need stop rules, with the team’s input.  
Because the evaluation utilizes self-reported data, loss of confidentiality of study data is a potential risk. 
It is also possible that the participants will experience some inconvenience, embarrassment, distress, or 
fatigue while answering focus group questions/completing surveys. We will allow participants to skip 
questions and rest as needed. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Complex behavioral interventions should be informed by stakeholders. Thus, focus group participants 
will contribute important data that will help us develop a tailored intervention.  
The proposed research aims to help early adolescent patients with uncontrolled asthma improve their 
asthma control thus reducing asthma disparities. Given the minimal risks associated with our 
behavioral/educational intervention, we believe the benefits outweigh the risks, benefitting the 
participants. Specifically, those in the BREATHE-PEDS group will receive a one-time brief SDM 
intervention that is expected to improve communication about asthma control and erroneous beliefs, 
improving symptoms and SDM. Those in the control group may benefit from having a tailored discussion 
of healthy lifestyles.  
We also believe this program will provide benefits to the FQHC personnel. Providers in both the active 
and control groups will have patients with uncontrolled asthma identified by research staff thereby 
giving them an enhanced understanding of uncontrolled asthma in their patient population. In addition, 
those in the BREATHE-PEDS arm may learn about erroneous beliefs that are barriers to asthma control 
and will learn how to deliver a brief behavioral intervention to enhance their patients’ motivation to 
improve disease control. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Research staff will collect data at the designated time points and the PI will conduct the post-trial 
interviews. To minimize the risk of inconvenience, embarrassment, distress, or fatigue while completing 
surveys or interviews, we will allow participants to skip questions and rest as needed. Our team will be 
trained in all aspects of data collection, procedures for interviewing, and handling sensitive topics in 
data collection; they will also complete IRB training. Participants can discontinue participation at any 
time. Weekly team meetings will be used to discuss reactions to the surveys/interviews; we will provide 
re-training if needed.  
3 
OBJECTIVES AND ENDPOINTS  
 
Objectives 
We propose a feasibility trial to: 1) develop BREATHE-PEDS in a pediatric population (dyads of caregivers 
and their 10- to 14-year-old early adolescents with uncontrolled asthma) receiving asthma care in 
FQHCs; 2) evaluate the feasibility and acceptability of intervention procedures; and 3) assess 
intervention effects on asthma outcomes (monthly x 3 months post-intervention). 
 
 
 

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Endpoint  
Primary Outcomes:  asthma control as measured by improvements in Asthma Control Questionnaire 
(ACQ) score. 
 
Secondary outcomes: (a) shared-decision-making as measured by scores the Shared Decision-making 
Questionnaire – 9 items, (b) Self-management as measured by the Medication Adherence Report Scale – 
Asthma (MARS-A), (c) asthma and ICS beliefs as measured by the Conventional and Alternative 
Management for Asthma, (d) asthma quality of life as measured by the Pediatric Asthma Quality of Life 
Questionnaire (PAQLQ) and Pediatric Asthma Caregiver’s Quality of Life Questionnaire; and asthma 
exacerbations. We will also follow (l) Asthma Impairment and Risk Questionnaire (12 and older) and (m) 
and Asthma Responsibility Questionnaire scores over time.  
 
Other measures: (1) demographics (age, sex); (2) health literacy as measured by the Newest Vital Sign and 
the Short Assessment of Health Literacy-English and Spanish. 
 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
 
STUDY DESCRIPTION.  
Our overall goal is to develop and test BREATHE-PEDS (BRief intervention to Evaluate Asthma THErapy-
Pediatrics), a shared decision-making intervention, among low-income urban minority adolescents with 
uncontrolled asthma.  
 
AIMS. 1) develop BREATHE-PEDS in a pediatric population (dyads of caregivers and their 10- to 14-year-
old early adolescents with uncontrolled asthma) receiving asthma care in FQHCs; 2) evaluate the feasibility 
and acceptability of intervention procedures; and 3) assess intervention effects on asthma outcomes 
(monthly x 3 months post-intervention). 
 
HYPOTHESES. 
1. The intervention will be feasible and acceptable as evidenced by: high rates of dyad recruitment 
and retention; PCP fidelity to the intervention protocol; and PCP and caregiver-child dyad 
satisfaction. 
2. Over 3-months post-intervention, relative to controls, BREATHE-PEDS children will have 
improvement (a) in asthma control as measured by the Asthma Control Questionnaire63-65 
(primary outcome), higher perceived SDM, and (b) on other asthma outcomes (secondary 
outcomes), including quality of life, school absences, lung functioning, and exacerbation. 
STUDY PHASE.  Phase 1 development and testing a behavioral intervention 
 
STUDY DESIGN. This is a group-randomized clinical trial. 
 
 
STUDY PROCEDURES.  
 

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Aim 1:  Focus Groups. 
Focus groups. Prior to recruiting for the trial, we will hold focus groups with caregivers (n =20); early 
adolescents (n =20) and dyads (n =10) (N=60), separately .  
 
Aims 2 & 3:  Group-randomized trial. This is a trial of a behavioral/educational intervention comparing 
the active condition BREATHE-PEDS (BRief intervention to Evaluate Asthma THErapy-Peds) to a dose-
matched attention control condition (see below for detailed description of conditions). Active and control 
interventions are delivered once in 9-minutes by the participants’ PCP during a single office visit. In each 
condition there are matched data collection points after baseline: 1-month 2-month, 3-month post-
intervention. Considering the potential for visit disruptions due to Covid-19, we offer an alternative plan 
for the delivery of the intervention at a single telehealth visit (baseline) by phone or HIPAA-compliant 
videoconferencing platform.   
 
Aim 2: Post-Trial Interviews. The PI will conduct post-trial semi-structured interviews with a purposive 
sample of ~6 participating clinicians, ~10 patient participants, and ~10 caregivers to ascertain their 
satisfaction with, and acceptability of, the active and control interventions. As part of our implementation 
evaluation, attempts will also be made to interview patient participants and PCPs who withdraw from the 
study (or PCPs who decline to enroll, if we have any), to better understand what it was that prevented 
their continued participation. 
 
RANDOMIZATION.  
We will randomly assign all eligible clinicians equally into the BREATHE-PEDS and the dose-matched 
attention control condition stratified for provider type (physician vs. nurse practitioner [NP]/physician 
assistant [PA]) using a computer-generated randomization list in advance of the trial. The first four 
physicians and first four NPs/PAs in each condition (BREATHE-PEDS and control) will then be invited to 
enroll (N=8). Those not selected (i.e., those remaining on the list) will be placed on “standby” if a 
replacement is needed. Invited PCPs signing consent will then be trained on the condition to which they 
were randomized. Each PCP will then enroll ~10 dyads meeting inclusion/exclusion criteria (N =85). 
STATISTICAL ANALYSES. 
Development and Intervention Feasibility. We will document recruitment, randomization and retention 
success, as well as process and implementation assessments.  
Intervention Effects. Intervention effects will be assessed using linear mixed models (LMM) and 
generalized linear mixed models (GLMM) for continuous and categorical outcomes, respectively132. All 
hypothesis tests will be two-sided at level α=0.05. The key outcome will be ACQ63-65 score; secondary 
measures will be examined to inform the future RCT. Separate models will be fitted for different 
outcome measures. If y_ijt is the outcome for patient j of provider i at time t, without loss generality 
then the following LMM will be used: y_ijt=β_0+β_1*Group+β_2*t+β_3*INT+β_4*X_ij+μ_i+μ_ij+ε_ijt, 
where group, t, and INT are design variables. Group is an indicator for intervention arm and INT is an 
indicator for pre- or post-intervention. X_ij is a vector of possible PCP- and patient-level covariates. The 
random term μ_i  iid~N(0,σ_1^2) is a PCP-specific random effect and μ_ij  iid~N(0,σ_2^2) is a patient-
specific random effect; ε_ijt  iid~N(0,σ_ε^2) is the model random error. To examine the effect of 
intervention on the outcome, we will conduct hypothesis test of H_o:β_3=0. We will explore differential 
intervention effect by sex (early adolescent and/or caregiver) and conduct exploratory analyses to 
determine if seasonality or differences in disease severity108 between groups provide alternative 
explanations for findings.  
Power & Sample Size. With a sample size of 10 dyads/PCP and 4 PCPs in each intervention arm (total 
n=10*4*2=80), and 20% attrition, we calculated the power to test the effect of intervention on ACQ. 
Power calculations were based on: (1) 4 repeated observations over the 3-month follow-up with a 
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account for clustering of patients from the same PCP; and (3) LMMs to estimate pre- and post-
intervention differences. We estimated an 80% power to detect a small effect size (d=0.15). For ACQ, 
this is equivalent to detect a post-intervention difference of 0.15 (assuming SD=0.9).  
Qualitative Data. Two or three coders will independently perform conventional content analysis133. To 
enhance rigor, we will use multiple data sources (credibility), rich contextual descriptions 
(transferability), codebook and saturation tables (dependability) and audit trail (confirmability)134-137.  
NVivo 12 will manage data.  
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
The control intervention will meet the requirements for a comparison control for testing behavioral 
interventions125, which are equivalent in contact time, credible and interesting, and exert limited 
treatment effects. 
 
5 
STUDY POPULATION 
 
Sixty participants (~30 early adolescents with asthma and 30 caregivers of early adolescents with asthma)  
will take part in pre-trial focus groups. 85 dyads and 8 primary care providers (PCPs) will participate in the 
trial. Post-trial interview will be conducted We will do post-trial interviews with a purposive sample of ~6 
participating clinicians, ~10 patient participants, and ~10 caregivers.  
 
5.1 
INCLUSION CRITERIA 
 
Aim 1: Focus groups. Focus group participants will be informal caregivers (e.g., parent, grandparent, 
older sibling) and children (ages 10-14) with physician-diagnosed asthma. We will conduct focus groups 
as follows: (a) children aged 10-14 with asthma; (b) caregivers of the children in group a; and (c) dyads 
who did not participate in group a or b. 
 
Aims 2 & 3: Trial.  Clinician participants will be eligible if they manage a panel of adult asthma patients. 
We will enroll eight primary care providers (PCPs) who manage a panel of asthma patients at UHPs two 
participating sites (4 PCPs / FQHC site). We will enroll 80 children (10- to 14-year-olds) with uncontrolled 
asthma and their caregivers – 10 dyads per PCP. Based on our prior studies and the data provided to us 
from the FQHCs, we anticipate 55% of the children aged 10-14 with asthma will be male and 95% will be 
ethnic-racial minorities (85% Latino; 10% non-Hispanic Black); we anticipate that 95% of the caregivers 
will be female.  
 
Early adolescent participants: We will enroll early adolescents, informal caregivers and primary care 
providers. Early adolescents (ages 10-14) will have physician-diagnosed asthma  and screen positive for 
uncontrolled asthma as measured by the Asthma Control Questionnaire. Early adolescent participants 
must be English-speaking individuals. Caregivers will be informal caregivers (e.g., parent, grandparent, 
older sibling). Caregivers can be English or Spanish-speaking individuals. Primary care provider 
participants will be eligible if they manage a panel of pediatric patients. 
 
Aim 2  Post-trial interviews. Post-trial interviews will be conducted with a purposive sample of dyads 
and PCPs enrolled in the clinical trial.  

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5.2 
EXCLUSION CRITERIA 
Exclusion criteria across the study are: 1) serious mental health conditions (caregiver and/or child) or 
developmental delays (child) that preclude completion of study procedures or confound analyses. Focus 
group participants will NOT be eligible to participate in the pilot. 
5.3 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened.  
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
AIM 1:  FOCUS GROUPS 
Recruitment of participants. We will recruit using three methods.   
(1) Opt-out Letter:   The FQHC administrator/data analyst at each site will create a list of potential 
participants using a combination of ICD-10 Asthma 493-specific queries of electronic membership 
records, age, and prescription profile. As in our BREATHE trial, we will employ IRB-approved opt-out 
letters signed by the federally-qualified health center (FQHC) medical director and mailed to all potential 
participants. The opt-out letter will identify two active responses and one passive option. The active 
responses include requesting not to be contacted or calling the research team directly to request 
screening. The passive response allows the research team to contact the patient if they have not 
responded within the specified timeframe (i.e., 2 weeks from letter receipt). CU staff will be provided 
the contact information of eligible patients who were sent letters and did not actively opt out; CU staff 
and/or UHP staff will then call families to recruit them, explaining the study and collecting consent from 
those who wish to participate. 
(2) UHP Provider/Staff Referral:  UHP providers and staff will explain the study to eligible dyads who 
present at the clinic on a given day; they will either consent interested families or refer them to CU staff 
for consent.  UHP may also call their patients; interested patients can be consented orally following the 
already IRB approved oral script for consenting, or if granted permission to share the caregiver’s contact 
information with CU, pass their information to CU staff who will consent orally using the approved oral 
consent script. 
(3) Self-referral:  We will also accept participants who respond to recruitment materials. UHP staff will 
post and/or distribute IRB approved flyers and include the IRB approved slide summarizing the study in 
their electronic advertising at the clinics; interested patients will contact the CU staff to learn more 
about the study. Interested families can be consented orally using the approved oral consent script, or in 
person at the clinic if they have an upcoming appointment. 
AIMS 2 & 3:  TRIAL 
Recruitment of primary care provider (PCPs) participants for pilot trial 

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Enrolling 8 PCPs participants to the trial. We will recruit 4 primary care providers (PCPs) per site. The 
clinic will identify PCP participants and trained CU staff will complete a written consent form if done in 
person or an verbal consent if done orally over the phone. The participating sites have 5 to 14 PCPs who 
manage a panel of pediatric asthma patients.  
Enrollment feasibility  
We will enroll 30 dyads (caregiver-child) for focus groups and 85 dyads for the trial (trial dyads cannot 
have participated in focus groups).   
Aim 1: Focus Groups: Participants will be informal caregivers (e.g., parent, grandparent, older sibling) 
and children (ages 10-14) with physician-diagnosed asthma.  
Aims 2 & 3 Clinical Trial – Dyads: We will enroll early adolescents, informal caregivers and primary care 
providers. Early adolescents (ages 10-14) will have physician-diagnosed asthma (and screen positive for 
uncontrolled asthma as measured by the Asthma Control Questionnaire. Caregivers will be informal 
caregivers (e.g. parent, grandparent, older sibling). Primary care provider participants will be eligible if 
they manage a panel of pediatric patients. 
Data provided by Urban Health Plan Inc. indicates that they follow a panel of 1,896 children aged 10-14 
with asthma who are prescribed controller in the past year; of these 596 have uncontrolled asthma as 
indicated by an asthma control test score administered at their last appointment. Considering our 60% 
success rate for enrolling dyads in our previous trial, this would yield 358 dyads for enrollment (we need 
only 30 dyads for focus groups and 40 dyads for the trial). 
 
Aims 2 & 3 Clinical Trial – PCPs:  Based on the strong FQHC support for this project and the fact that in our 
pilot BREATHE study, all PCPs approached agreed to participate, we do not anticipate difficulty in 
recruiting PCPs. Moreover, we will replace a PCP should a PCP decline to enroll or drops out before end 
of study; we have a sufficiently large waitlist of PCPs (and additional sites) from which to replace PCPs, if 
needed. 
 
Vulnerable Subjects 
Asthma’s impact is significant among minority populations. Erroneous beliefs impede asthma control. To 
date, community-based asthma interventions have not reduced the burden of asthma. For this reason, 
we adapted an evidence based brief SDM intervention used in acute care settings to FQHC settings with 
input from black adult asthma patients and their loved ones. We will develop this intervention by 
adapting our prior work in our adults which found several positive short-term effects on asthma control, 
SDM, and symptom burden.   
Pregnant women will be eligible to participate since improving asthma control for their early adolescent 
children would benefit the family. 
 
 
 
Retention of patient participants 

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UHP has retained 72-90% of participants in clinical trials requiring data collection of 12 months (Personal 
communication, F. Barsanti). To retain 80% of dyads over 3 months post-intervention for this trial, we 
will use the retention strategies proven successful in our previous trials in FQHCs requiring 3+-months of 
follow-up: 
1. Assigning one Research Assistant (RA) to a dyad: Data collection by RAs that have a history of 
working at these FQHCs will facilitate rapport and retention. RAs are often members of the community; 
all have received training on the delivery of patient-centered care.  
2. Confirming contact information at each assessment; obtaining contact information of two or 
more people who will know how to contact the participant: We will update contact information (e.g., 
name, address, phone numbers, emails) for the participants and two or more of their contacts at each 
study visit; participants will be asked to indicate preferred mode of communication (email, text or 
phone). 
3. Frequent data collection points: There are 4 assessment points over the 3-month follow-up. 
Participants will receive monthly communication from our study team to confirm upcoming visits. If they 
fail to respond after three attempts using multiple modes of contact over varying day/evening hours and 
weekday/weekend attempts, we will contact their alternative contacts.   
4. Graduated incentives: Participants will be compensated using a graduated incentive plan. We 
will pay the dyad: baseline=$25; 1-month=$30; 2-month=$40; 3-month=$50 (total $145). A portion of 
each incentive will be made directly to the child. 
Retention of PCP participants 
Since we have FQHC administrative buy-out of PCP time and strong support for this project and because 
each PCP delivers the intervention only one-time to small number of their patients , we do not 
anticipate difficulty with PCP retention. We will replace a PCP should a PCP drop out and we have a 
sufficiently large waitlist of PCPs (and additional sites) from which to choose, if needed. 
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
DESCRIPTION OF STUDY INTERVENTIONS. 
 
BREATHE-PEDS Intervention. BREATHE, grounded in shared decision-making (SDM) theory and 
developed with input from black adults with asthma, utilizes PCPs to deliver a brief intervention using 
motivational interviewing in a single brief (9-minute) intervention during an office visit. Using data we 
collect from our focus groups we will develop BREATHE-Peds by adapting BREATHE. PCPs follow a 4-step 
script developed in partnership with patients and tailored to specific erroneous beliefs measured by the 
Conventional and Alternatives Management for Asthma (CAM-A) survey, as well as to their Asthma 
Control Questionnaire (ACQ) score. A lab coat pocket-sized laminated action card will supplement the 

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web-based application that the  PCPs follow prompting them through the intervention. The tailored 
script is automatically generated based on  the RA inputting the CAM-A and ACQ responses. We will 
randomize providers to one of two intervention arms. Neither intervention alters the clinical care study 
participants receive. Our intervention involves training providers on communication methods/topics; it 
does not involve our changing or modifying patient medication in any way. Patients in both arms receive 
the same asthma care from the providers. 
• 
Step 1: Raise the subject (1½ minute). PCP establishes rapport using persuasive communication 
techniques and assesses the dyad’s asthma knowledge, perception of asthma control, quality of 
life, self-care preferences, and motivation for enhanced asthma control, exploring specific 
asthma and ICS beliefs that they have endorsed and that are known to be associated with 
uncontrolled asthma.  
• 
Step 2: Provide feedback (1½ minutes). PCP provides feedback to the dyad based on 
assessments made in the prior step. The PCP candidly discusses the patient’s uncontrolled 
asthma and erroneous beliefs in the context of gaps in asthma self-management, drawing a 
connection between current self-management and uncontrolled asthma.  
• 
Step 3. Enhance engagement (3 minutes).  The PCP attempts to enhance the dyad’s motivation 
to increase Self-management using motivational interviewing techniques such as collaboration, 
empathy, concern, and acceptance of ambivalence about self-care. In this step, the PCP may 
elicit the dyad’s beliefs regarding the benefits, and negative sequelae, of their current degree of 
self-management (pro/con).  
• 
Step 4: Shared decision-making (3 minutes). The PCP and dyad jointly consider treatment 
options. The PCP will actively attempt to build consensus around self-management, reconciling 
conflicts to better align asthma and ICS beliefs with evidence-based guideline-directed 
treatment. For example, if the patient uses ICS intermittently (rather than twice daily as 
required) because of an erroneous belief that tolerance to ICS develops with daily dosing, then 
the PCP will attempt to counter that belief using the tailored script, as well as information from 
national asthma guidelines. This will likely include encouraging the patient to use ICS once a day 
(50% adherence) as an initial short-term plan to be followed by a return visit and re-evaluation 
of asthma control. If the patient declines to engage in SDM or declines attempts at negotiating 
ICS use, then the PCP and the patient agree to disagree.  
 
Dose-matched Attention Control Intervention. The control intervention will meet the requirements for a 
comparison control for testing behavioral interventions, which are equivalent in contact time, credible 
and interesting, and exert limited treatment effects. Control participants will receive a PCP-led 9-minute 
scripted discussion tailored to healthy lifestyles (e.g., diet, exercise) following Teach to Goal principles: 
• 
Review of weight, diet and exercise: (3 minutes). PCP and patient review current weight/fitness, 
current diet and/or current exercise in the context of goal-setting.  
• 
Exercise counseling: (3 minutes). PCP describes benefits of exercise and options for 
starting/increasing exercise.  
• 
Plan for goal attainment (3 minutes). PCP explores barriers and facilitators to goal attainment. 
 
Control PCPs will use study the web-based app to access the healthy lifestyle scripts and patient 
participant’s ACQ score but will not have access to CAM-A results or BREATHE-PEDS scripts. While 
control participants will receive important nutrition and lifestyle information, the control intervention is 
not designed to be specific enough to change strategies related to ICS adherence. Further, the control 
group offers a similar format as BREATHE-PEDS, namely PCP-led discussions in which PCPs use tablets to 
review ACQ scores and initiate a tailored discussion. 

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6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Intervention Training, Supervision and Fidelity.  We have extensive experience training clinicians to deliver 
interventions, as well as monitoring treatment fidelity. Procedures used in this study will mirror 
established procedures employed in our BREATHE-PEDS pilot.  
• 
BREATHE-PEDS Training. The core training for PCPs delivering the BREATHE-PEDS intervention will 
be conducted by our consultant, Dr. Pantalon, and will consist of one, 2-hour instructional session 
comprised of: didactics - 30 minutes; role-playing common clinical scenarios - 10 minutes; SDM 
role-playing - 50 minutes; question & answers – 30 minutes. Immediately after training, PCPs will 
be tested using a standardized patient scenario to demonstrate that he/she can deliver the 
intervention in 9 minutes or less, the average length obtained in our feasibility trial. If the PCP 
fails to achieve 100% proficiency, she/he will receive additional instruction and retested. Prior 
studies demonstrated that remediation re-training results in 100% proficiency. 
• 
Attention Control Training. PCPs assigned to the attention control condition will be trained using 
a 15-minute self-guided instructional manual followed by an in-person question and answer 
period with the PI.  
• 
Supervision and fidelity. We will audio record all participants’ intervention) visits (BREATHE-PEDS 
and control). The Research Assistant (RA) will set up two digital recorders at the beginning of the 
visit and upload audio files to a secure HIPAA-compliant site within 24 hours of the visit. Within 
24 hours of recording, files will be uploaded and 2-3 trained raters, working independently of one 
another, will review the sessions. We will evaluate fidelity the first time a PCP delivers their 
intervention and then at ~20% of randomly selected visits, a protocol successfully used by the 
consultant. At least one additional file per PCP will be reviewed prior to enrollment of their 5th 
participant, to evaluate drift and the length of sessions. For BREATHE-PEDS we will determine 
whether the critical elements of the brief intervention were completed in 9 minutes using the 
validated Brief Negotiation Interventions Adherence Scale adapted to asthma. For the control 
sessions, raters will note the length and content of the healthy lifestyle discussion. Within 24 
hours of the rating, the PCPs will receive a summary of their performance (free of personal health 
identifiers) via email. PCPs will receive additional training to enhance intervention fidelity and 
dose (length) if problems are identified (by Dr. Pantalon for BREATHE-PEDS group and Dr. George 
for control group). PCPs will not be excluded from the study if they fail to deliver all elements of 
their respective intervention. PCPs will not be excluded if they require more (or less) than 9 
minutes to deliver the intervention. Control PCPs will not be excluded if they teach asthma self-
care; these metrics will be tracked.  
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
DESCRIPTION OF RANDOMIZATION PROCEDURES:  Prior to trial initiation, all eligible clinicians will be 
randomized equally into the BREATHE and the attention control condition stratified for provider type, 
using a computer-generated randomization list. We will obtain informed consent from the first eight 
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randomized to BREATHE; two physicians and two NPs randomized to control. Those remaining on the list 
will be placed on “standby” if replacement is needed. 
 
CONTAMINATION. 
Contamination will be minimized by (1) training only BREATHE-PEDS clinicians to deliver the active 
intervention and (2) encouraging confidentiality regarding training and intervention content. 
 
MASKING. 
Dyads, data collectors, and the statistician will be blinded to assignment. Consent materials will inform 
dyads that the focus of the trial is on the communication they have with their clinician about asthma 
management and control. Immediately after the intervention, dyads will be asked to guess the condition 
to which their clinician had been randomized.  At the end of participants’ final data collection visit, data 
collectors will be asked to guess whether participants had received the active or control intervention at 
the visit. These data will provide some measurement of the success of masking.  
 
 
 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL 
MANIPULATION 
Stop rules. If the PI, IRB and/or SMC determines that stop rules are warranted for serious adverse events 
then data collection and study enrollment will be stopped. The SMC and the IRB will be asked to review 
the study and suggest modifications of the protocol, the threshold limit or other changes. If the SMC and 
the Chairperson of the IRB believe that these modifications are adequate for resumption of the study, 
then the study will resume. NINR will receive a written report within three days of any such suspension 
and/or resumption of data collection. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for TBD  number of scheduled 
visits and study staff are unable to contact the participant after more than 3 attempts.  
 
The following actions must be taken if a participant fails to return for a required study visit: 
 
• 
The site will attempt to contact the participant, reschedule the missed visit, counsel the 
participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study 

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• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
Caregivers and children will complete assessments at four timepoints:  baseline, immediately after the 
medical visit, and 1-, 2-, and 3-months following the child’s asthma visit. The baseline and 1 
 
The measures completed at each time point by each participant are detailed in the table below as well 
as in the endpoints section on pages 3-5. 
 
 
MEASURE 
TIMEPOINT 
COMPLETED BY 
Screening 
Base 
Immed 
1-Mon 
2-Mon 
3-Mon 
Caregiver 
Child  
Clinician 
Asthma Control 
Questionnaire 
X 
X 
 
X 
X 
X 
X 
X 
 
Shared-Decision-
Making 
Questionnaire 
 
 
X 
 
 
 
X 
X 
X 
Medication 
Adherence 
Record Scale-
Asthma 
 
X 
 
X 
X 
X 
X 
X 
 
Conventional & 
Alternative 
Management for 
Asthma 
X 
X 
 
X 
X 
X 
X 
X 
 
Pediatric Asthma 
Quality of Life 
Questionnaire 
 
X 
 
X 
 
X 
 
X 
 
Pediatric Asthma 
Caregiver’s 
Quality of Life 
Questionnaire 
 
X 
 
X 
 
X 
X 
 
 
Asthma 
Impairment & 
Risk 
Questionnaire 
(AIRQ)  
 
X 
 
X 
X 
X 
 
X 
(>12-
years
-old) 
 
Brief debriefing 
survey 
 
 
X 
 
 
 
X 
X 
X 

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Asthma 
exacerbation 
 
 
 
X 
X 
X 
X 
 
 
Asthma 
Responsibility 
Questionnaire 
 
X 
 
X 
X 
X 
 
X 
 
Newest Vital 
Sign 
 
X 
 
 
 
 
X 
 
 
Short 
Assessment of 
Health Literacy  
 
 
 
 
X 
 
 
 
 
X 
 
 
Asthma 
Prevention Index 
 
X 
 
X 
X 
X 
X 
X 
 
Asthma history 
& demographics 
 
X 
 
 
 
 
X 
X 
 
 
8.1 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.1.1 DEFINITION OF ADVERSE EVENTS 
Adverse events are defined as unanticipated problems involving risks to study participants or others, or 
as any untoward medical occurrence that may present itself during the study time period which may or 
may not have a causal relationship with the treatment.  
8.1.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
Serious adverse events result in any of the following outcomes: death, a life-threatening experience, 
inpatient hospitalization, or a significant disability/incapacity. Such events also include breeches of 
confidentiality. 
8.1.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.1.3.1 SEVERITY OF EVENT 
 
All AEs should be assessed by the principal investigator, and if necessary, another professional with clinical 
Moderate adverse events are those discomforts severe enough to cause interference with usual activities 
or requiring treatment by a health care provider. Such events also include the loss of participants from 
the study for reasons related in any way to a deviation from procedures for ensuring confidentiality. 
 
Mild adverse events are those events that are easily tolerated signs or symptoms of discomfort; minor 
irritants that cause no loss of time from normal activities; symptoms that require no medication or a 
medical evaluation; and transient signs and symptoms. 
 
 
 

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8.1.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
The SMC will then determine how an AE is to be categorized using standard taxonomy: Unrelated (clearly 
not related to the research), Unlikely (doubtfully related to the research), Possible (may be related to the 
research), Probable (likely related to the research) and Definite (clearly related to the research).  
8.1.3.3 EXPECTEDNESS  
 
Unexpected adverse events are those events, the specificity or severity of which is not consistent with the 
risk information described in the general investigative plan or the IRB proposal. "Unexpected" refers to 
an adverse event that has not been previously observed. 
 
Expected adverse events are those events, the specificity or severity of which is consistent with the risk 
information described in the general investigative plan or IRB proposal.  
Any ED visit or hospitalization associated with primary ICD-10-CM Diagnosis Code 493. Asthma (493.00 
asthma atopic unspecified; 493.01 asthma atopic asthmaticus; 493.02 asthma atopic acute exacerbation; 
493.10 intrinsic asthma unspecified; 493.11 intrinsic asthma asthmaticus; 493.12 intrinsic asthma acute 
exacerbation; 493.20 asthma chronic obstructive pulmonary disease copd; 493.21 asthma chronic 
obstructive pulmonary disease copd; 493.22 asthma chronic obstructive pulmonary disease copd; 493.81 
exercise induced bronchospasm; 493.82 cough variant asthma; 493.91 asthma bronchial allergic nos 
asthmaticus; 493.92 asthma bronchial allergic nos acute exacerbation) will be characterized as a Probable 
or Definite SAE. 
8.1.4 ADVERSE EVENT REPORTING  
 
AEs and SAEs will be systematically assessed at all data collection points via review of the medical record 
and/or patient interview. Subjects will be instructed to report AEs and SAEs to the study team within 48 
hours of their occurrence. 
 
During the trial, subjects will be instructed to notify the study team within 48 hours of any Emergency 
Department (ED) visit or hospitalization, regardless of its cause, and to notify the study team within 48 
hours of initiating oral corticosteroids (OCS), each event representing the standard definition of asthma 
exacerbation. Because not all exacerbations cause individuals to seek acute care, we will track OCS use 
and intensification of beta-agonist use as those who manage an exacerbation outside of the ED or hospital 
will manage their exacerbation in this manner. We will also ask subjects to report these at monthly data 
collection points in an attempt to capture any exacerbations that might otherwise go unreported. In this 
manner we will not miss any exacerbations. Subjects’ answers will then be compared to the medical 
record and/or claims data, as available.  
8.1.5 SERIOUS ADVERSE EVENT REPORTING  
 
SAE reporting.  
Any SAE whether related to study intervention, will be reported to the IRB and the SMC. The PI will inform 
the IRB and SMC immediately and jointly decide whether the reported event is a SAE that must be 
reported to NINR due to the unexpectedness and/or the severity of the event. If it is determined that it is 
either unexpected and/or the severity, the SAE will be reported to NINR within two days.  

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In the event that a patient either withdraws from the study or the investigator decides to discontinue a 
patient due to SAE, the patient will be monitored by the investigator via ongoing status assessment until 
1) a resolution is reached, i.e., the problem requiring hospitalization has resolved or stabilized with no 
further changes expected; 2) the SAE is determined to be clearly unrelated to the study intervention; or 
3) the SAE results in death.  A summary of the SAEs that occurred during the previous year will be included 
in the annual progress report to the IRB and the SMC. The report will include the participants’ 
sociodemographic characteristics, expected versus actual recruitment rates, treatment retention rates, 
any quality assurance or regulatory issues that occurred during the past year, summary of AEs and SAEs, 
and any actions or changes with respect to the protocol. 
8.2 
UNANTICIPATED PROBLEMS 
 
8.2.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.] 
8.2.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the DSMP/lead principal investigator (PI). The UP report will include the following 
information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 

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Specific Aims: 
1. 
To develop BREATHE-Peds in a pediatric population (dyads of caregivers and their 10- to 14-year-
old early adolescents with uncontrolled asthma) receiving asthma care in FQHCs; 
2. 
To evaluate the feasibility and acceptability of intervention procedures; and  
3. 
To assess intervention effects on asthma outcomes (monthly x 3 months post-intervention). 
Hypotheses: 
1. 
The intervention will be feasible and acceptable as evidenced by: high rates of dyad recruitment 
and retention; PCP fidelity to the intervention protocol; and PCP and caregiver-child dyad satisfaction. 
2. 
Over 3-months post-intervention, relative to controls, BREATHE-Peds children will have 
improvement (a) in asthma control as measured by the Asthma Control Questionnaire (primary outcome), 
higher perceived SDM, and (b) on other asthma outcomes (secondary outcomes), including quality of life, 
school absences, lung functioning, and exacerbation. 
MEASURES / ENDPOINTS.   
Primary Outcomes: asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) 
score. 
Secondary outcomes: (a) shared-decision-making as measured by scores the Shared Decision-making 
Questionnaire – 9 items, (b) Self-management as measured by the Medication Adherence Report Scale – 
Asthma (MARS-A), (c) asthma and ICS beliefs as measured by the Conventional and Alternative 
Management for Asthma, (d) asthma quality of life as measured by the Pediatric Asthma Quality of Life 
Questionnaire (PAQLQ) and Pediatric Asthma Caregiver’s Quality of Life Questionnaire; and significantly 
lower rates of (e) asthma exacerbations, (f) symptoms days, (g) nights woken, (h) activity limitations, (i) 
shortness of breath, (j) wheeze, and (k) rescue medicine use. We will also track Asthma Impairment and 
Risk questionnaire and Asthma Responsibility Questionnaire scores over time.  
Other measures: (1) demographics (age, sex); (2) health literacy as measured by the Newest Vital Sign and 
the Short Assessment of Health Literacy-English and Spanish; (3) asthma history and (4) lung function as 
measured by spirometry (COVID permitting). 
9.2 
SAMPLE SIZE DETERMINATION 
Power & Sample Size. With a sample size of 10 patients/PCP and 4 PCPs in each intervention arm (total 
n=10*4*2=80), and 20% attrition, we calculated the power to test the effect of intervention on 
outcomes. Power calculations were based on: (1) 4 repeated observations over the 3-month follow-up 
with a correlation of ρ=0.8 between repeated measures; (2) intra-cluster correlation among PCPs=0.2 to 
account for clustering of patients from the same PCP; and (3) LMMs to estimate pre- and post-
intervention differences. We estimated an 80% power to detect a small effect size (d=0.15). For ACQ, 
this is equivalent to detect a post-intervention difference of 0.15 (assuming SD=0.9). 
9.3 
POPULATIONS FOR ANALYSES 
 
INTENTION-TO-TREAT (ITT) ANALYSIS POPULATION (i.e., all randomized participants) 

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QUALITATIVE ANALYSIS AND RIGOR. Analysis of Qualitative Data. Guided by Qualitative Descriptive 
methodologies, 2-3 coders working independently of each other will systematically read the focus group 
transcripts to identify codes and categories using conventional inductive content analysis. An iterative 
codebook will be developed, and a data saturation table will be created and maintained in tandem with 
updates to the codebook. Data saturation, a measure of data adequacy, will signal the end of data 
collection (focus groups) and analysis. The creation of saturation data tables adds transparency to the 
process. Saturation can be reached with a small number of focus groups when the scope of the project is 
narrow and there is sample homogeneity (e.g., minority dyads from the same community), as in this 
proposal.  
 
Directed content analysis will be used to summarize satisfaction at post-trial interviews  using constructs 
from the Theoretical Framework of Acceptability (e.g., burden, user experience, attitudes towards the 
intervention and intention to participate). 
 
Various methods of enhancing the rigor of qualitative methods will be used. Credibility will be enhanced 
by having disagreements about codes reconciled by consensus and by returning our findings to a small 
group of participants who will perform a “member check” to determine if the categories resonate with 
them. We will also use triangulation, a method in which multiple data sources (e.g., dyads, primary care 
providers) describe their perspectives. Investigators with disparate expertise (e.g., nurse scientists, public 
health and behavioral scientists) will serve as coders and have collaborated on the design of the trial, 
providing additional triangulation. Our purposive sample fosters transferability, the ability to translate 
findings to similar communities. Dependability and confirmability criteria will be met by the creation of 
an audit trail documenting data collection and analysis decisions. NVivo 12 will be used to manage 
qualitative data 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Participants will be described with respect to baseline characteristics (e.g., means, standard deviations, 
ranges, etc.) Descriptive data analysis will precede formal hypothesis testing to understand the data 
distribution and to check for outliers to determine the need for transformations of variables or special 
analytic techniques. We will also examine the patterns of missing data paying special attention to the 
balance of missing data in the study arms; linear and generalized linear mixed models provide unbiased 
estimates for data with missing at random when likelihood of missing is not related to the missing data 
and can be fully accounted for by variables where there is complete information. Intention-to-treat 
analyses will be conducted which requires data to be analyzed as randomized, regardless of whether 
participants completed some or none of the intervention.. Based on our feasibility trial and the high 
retention rate in our previous trials, we anticipate 90% will provide baseline, 1-, 2-, and 3-month data.  
 
9.4.2 ANALYSIS OF THE PRIMARY AND SECONDARY ENDPOINT(S) 
 

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Analytic Plan.  
 
Aims 1 & 2: Development and Intervention Feasibility. We will document our success in meeting 
recruitment and randomization goals, as well as process (recruitment outreach and numbers meeting 
eligibility criteria who accept or decline enrollment) and implementation assessments (retention 
rates, data completion rates, as well as fidelity, contamination and masking in the clinical trial arm).  
 
Randomization. This is a group-randomized trial in which the primary care providers (PCPs) will be 
randomized within sites to the active and control conditions. We will utilize a stratified block 
randomization plan, stratifying by provider type (physician vs. nurse practitioner/physician assistant), 
to insure equal numbers of PCPs within each PCP type are assigned to each condition. Randomization 
lists will be computer-generated in advance by our biostatistician. Outcomes will be analyzed at the 
level of the early adolescent and/or caregiver. 
 
 
Masking. Participants and data collectors will be masked to study hypotheses and group assignment; 
the investigators will be blinded to group assignment. PCPs in both intervention conditions will use 
tablets as part of their respective interventions and have sessions audio-recorded, facilitating masking 
of participants and data collectors.  
 
Aim 3: Intervention Effects. Intervention effects will be assessed using linear mixed models (LMM) or 
generalized linear mixed models (GLMM) for continuous and categorical outcomes, respectively. All 
hypothesis tests will be two-sided at level α=0.05. The key outcome will be ACQ score; secondary 
measures will be examined to inform the future RCT. Separate models will be fitted for different 
outcome measures. If y_ijt is the outcome for patient j of provider i at time t, without loss generality  
then the following LMM will be used:  
y_ijt=β_0+β_1*Group+β_2*t+β_3*INT+β_4*X_ij+μ_i+μ_ij+ε_ijt, where group, t, and INT are design 
variables. Group is an indicator for intervention arm and INT is an indicator for pre- or post-
intervention. X_ij is a vector of possible PCP- and patient-level covariates. The random term μ_i  
iid~N(0,σ_1^2) is a PCP-specific random effect and μ_ij  iid~N(0,σ_2^2) is a patient-specific random 
effect; ε_ijt  iid~N(0,σ_ε^2) is the model random error. To examine the effect of intervention on the 
outcome, we will conduct hypothesis test of H_o:β_3=0. We will explore differential intervention 
effect by sex.  
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
Consent forms will describe in detail the study intervention, study procedures, and risks and 
documentation of informed consent will be completed prior to starting the study intervention. These 

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forms include: adult (caregiver) consent for their own participation and their child’s participation, and 
adolescent assent  for participation.   
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
The informed consent process includes reading the informed consent to the dyad and answering 
questions. Oral explanations provided to both children and caregivers will convey who is conducting the 
study, the purpose of the study, the procedures (e.g., the number of surveys), study risks and benefits, a 
discussion of compensation, and a statement that participation is voluntary; all oral explanations and 
written consent/assent forms will be IRB and HIPAA compliant. Those who remain interested after review 
of the consent/assent form and after questions have been answered will be asked to sign the 
consent/assent form.  
Consent will be obtained several ways, which correspond to the methods of recruiting. 
(1) Opt-Out Letter:  Following the two-week period allocated to allow participants to actively opt out, CU 
and/or UHP staff will contact eligible families by phone who have if not opted out. We explain the study 
to them providing all the details needed for families to make an informed decision to participate and will 
obtain their oral consent and assent if they wish to participate using the already approved IRB oral script 
for consenting. We will document oral consent in study logs, including the date/time of consent/assent, 
the name of the caregiver and adolescent, and the staff member collecting the consent/assent.  
(2) UHP Provider/Staff Referral:  UHP providers and staff will explain the study to patients who present 
at the clinic on a given day; they will either obtain written consent from  interested families using our 
IRB approved consent forms. Or they may refer them to CU staff for consent. If CU staff are at the clinic, 
they will explain the study to patients in person and obtain written consent. Otherwise, they will call the 
family and obtain oral consent as detailed in recruiting option #1 above. UHP staff may also call eligible 
patients to explain the study to them and if interested consent them orally. 
(3) Self-referral: We will also accept participants who respond to recruitment materials, such as posted 
flyers and the slide that is part of UHPs electronic messaging. Interested patients will contact the CU 
staff to learn more about the study. CU staff or UHP staff will consent the family in person when 
possible and obtain written consent; otherwise consent will be obtained via phone and oral 
consent/assent will be obtained as detailed in #1. 
The consent form includes HIPAA authorization. Copies of signed consent form will be secured in 
electronic form behind the Columbia firewall or in hardcopy in a locked cabinet in a locked office at 
CUSON. Trained research assistants will answer questions in the same manner as if the consent was 
being obtained in-person. 
COVID-19 CONSIDERATIONS. If social distancing mandates prevent us from obtaining informed consent 
or study visits/procedures in-person, we will follow an IRB-approved script to obtain oral consent using 
telephone or secure web-based videoconferencing platform that is HIPAA-compliant, documenting name, 
date and time of oral consent.  
PHASE 2 only. We will use the same IRB approved screening protocol from our prior trials that allowed us 
to obtain screening data by phone (asthma control score) with an initial verbal consent from the caregiver 

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and child assent. Those children whose asthma control score indicates that they have uncontrolled asthma 
will have their baseline visit scheduled within ~14 days. If at any time the children experience a loss of 
asthma control, they will be told to seek immediate medical attention. Written consent/assent will be 
obtained as previously described. 
10.1.2 CONFIDENTIALITY AND PRIVACY  
 
We will ensure confidentiality is protected by taking several steps. All members of the study staff complete 
training in human participants’ protection, HIPAA requirements, as well as ongoing training by the PI and 
the investigators in all aspects of human subject protection. The formal training program will include a 
course on Good Clinical Practices. For purposes of the research database, individuals seen at participating 
sites will be assigned a unique identifier that bears no systematic relation to their health records. 
Information to be excluded from the research database includes names of study participants (and their 
contacts), as well as addresses, telephone numbers, FQHC, clinician(s), and other information that has the 
potential to identify individuals. Data managers and the research staff will be responsible for data 
management of the information collected and will be supervised by the MPIs George & Bruzzese. Data 
will be stored on a password-protected webserver, which Columbia University staff can access for data 
entry; files stored on the webserver are also encrypted. All research participants will be identified on all 
research forms and logs other than consent forms by coded identifiers. Codebooks relating ID codes to 
names will be personally maintained only by Dr. George in a locked cabinet and/or in an electronic file 
that is password-protected and stored behind the Columbia firewall. Confidentiality of all participants will 
be optimized by housing all paper records in locked files in locked offices. Electronic data will be 
maintained on a computer in password-protected computer files with limited access to data by staff – 
different levels of access will depend on the person’s specific level on the staff, and server security 
safeguards that in the aggregate provide a high degree of protection from unauthorized users. All the 
information will be coded by identification number so that no names are associated with any of the data. 
The identity of participants will not be revealed in the presentation or publication of any results from the 
project. All personnel working on the project will be regularly educated about the importance of strictly 
respecting participants’ rights to confidentiality.  
10.1.3 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data collected for this study will be analyzed and stored, with the participant’s approval and as approved 
by local Institutional Review Board (IRB). No specimens will be collected.  
 
10.1.4 SAFETY OVERSIGHT 
 
DATA SAFETY AND MONITORING PLAN (DSMP) 
 
Institutional Review Board (IRB) Oversight 
 
The Columbia University Human Research Protection Office (HRPO) and Institutional Review Board (IRB) 
has determined that Columbia University IRB will serve as the single Reviewing IRB for this research. This 
is designated in the application and in accordance with the Department Health and Human Services 
regulation for the use of a single IRB for federally funded collaborative research under the Revised 
Common Rule. The applicant organization (Columbia University) and Multiple Principal Investigators 
(MPIs) (George [contact PI] and Bruzzese) are responsible for overseeing all research activities and 

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remaining compliant with applicable regulations, grant requirements, and the terms of the IRB approval. 
The DSMP will be reviewed and approved by the IRB prior to any human participants’ research and 
renewed annually.  
 
Data and Safety Monitoring Board (DSMB)/Safety Monitoring Committee (SMC) 
 
At the initiation of this study, we will create a three-member DSMB/SMC of persons not affiliated with 
the research project, which will include one person outside of the institution, one person with statistical 
expertise, and one person with medical expertise in adolescent asthma. Names were submitted to the 
NINR and approved on October 18, 2021.  The approved SMC are: 
 
Chair Jonathan Feldman PhD. Clinical Associate Professor, Department of Pediatrics, Albert Einstein 
College of Medicine & Professor of Psychology, Ferkauf Graduate School of Psychology Yeshiva University.  
jonathan.feldman@yu.edu Dr. Feldman has a federally funded program of research using behavioral 
interventions to improve asthma symptom perception and medication adherence in children and adults 
with asthma; psychological treatment of anxiety in patients with asthma; anxiety, depression, and food 
allergy.  
 
Member Shing Lee, PhD. Associate Professor Biostatistics at the Columbia University Medical Center. 
sml2114@cumc.columbia.edu Dr. Lee's research interest is in the implementation of novel designs for 
early stage trials. Lee has over ten years of experience in statistical consulting. She has assisted numerous 
investigators from a variety of medical disciplines in the design, conduct and analysis of clinical studies. 
 
Member Tina Tolomeo, DNP, MBA, APRN, FNP-BC, AE-C.  Senior Director, Patient Access Yale Medicine 
and Nurse Practitioner in the Department of Pediatrics. Tina joined the Section of Pediatric Respiratory 
Medicine at Yale in 1995. Her academic and clinical interests include, but are not limited to, asthma, 
general pediatric pulmonary medicine, patient access, and patient self-management. 
 
The approved DSMB/SMC members will review and finalize the DSMP that the MPIs draft. The finalized 
DSMP will be sent to the IRBs and the NINR Program officer prior to the onset of study enrollment.  
 
The purpose of the DSMB/SMC is to protect participant safety and to monitor study performance and the 
quality and integrity of all study-related activities. As such, the DSMB/SMC will review informed 
consent/assent procedures, any modifications to the study protocol, and all adverse events (AEs). The 
DSMB/SMC will be privy to statistical data and case reports required for its deliberations. The DSMB/SMC 
will meet twice per year by phone/videoconferencing and more if needed. Official minutes will be taken 
and will be available to NINR after upon request. 
 
The DSMB/SMC will provide recommendations to the MPIs about starting, continuing, altering, and 
completing each of the studies. In addition, the DSMB/SMC will: 
• 
Review and finalize the Data Safety Monitoring Board/ Safety Monitoring Committee Charter; 
• 
Review informed consent/assent procedures, protocols, and any modifications to protocols, and 
all AE reporting forms and procedures prior to initiating any of the studies; 
• 
Approve the definition of AEs, including serious adverse events (SAE); and 
• 
Review and finalize the plan for reporting AEs to organizations with oversight responsibilities. 
 
The purpose of the DSMB/SMC is to protect participant safety and monitor study performance and the 
quality and integrity of all study-related activities. As such, the DSMB/SMC will review informed consent 

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procedures, any modifications to the study protocol, and all AEs. The DSMB/SMC will define AEs, which 
are expected to include oral steroid bursts, excessive rescue medicine use, Emergency Department (ED) 
visits and hospitalizations, as well as SAEs, which are expected to include any life-threatening 
exacerbations, admissions to ICU, events that result in permanent disability, or deaths. AEs and SAEs can 
be related to the study intervention or not and can be expected or unexpected. The DSMB/SMC will also 
establish a plan for reporting AEs to agencies. All staff will be instructed to report any AE or problems 
involving risk to the MPIs. The MPIs or Dr. Kattan, our pediatric pulmonologist co-investigator, will review 
the AE with the participant, and in compliance with the plan, the MPIs will report AEs to appropriate 
agencies. Based on the Safety Monitoring Committee and DSMPs in our prior studies, we anticipate deaths 
and formal study complaints will be reported in real time to the DSMB/SMC, IRBs, and NINR if study-
related; other SAEs are reported bi-annually. The NIH Program Officer will also be informed if action is 
taken by the DSMB/SMC or IRB. The DSMB/SMC will also define thresholds for participant safety, rules 
for stopping protocols, and nature/frequency of reports for its review. The DSMB/SMC could stop the trial 
if there were a disproportionate number of ED visits or hospitalizations, oral corticosteroids (OCS) bursts, 
or excessive intensification of rescue medication use attributed to study participation. 
 
Data and Safety Monitoring Procedures 
 
The MPIs will be responsible for ensuring that any risks to study participants are minimized. In their weekly 
team meetings, the MPIs and the Co-Investigators will review data reports regarding all study-related 
activities. This will include screening, consent/assent, intervention activities, and surveys/interviews. 
Because this study involves testing a behavioral intervention and does not involve dispensing medication, 
it does not pose a serious health risk to study participants. Despite this, all study personnel will report any 
study-related AEs and/or unanticipated problems (UPs) involving risks to participants to the MPIs. After a 
prompt, careful review of the events, the MPIs will report the event to the IRBs and the DSMB/SMC if 
deemed necessary. The contact PI (George) will also inform her NINR Program officer in writing of any 
actions taken by the IRBs because of such AEs, cc’ing Dr. Bruzzese. 
 
While we anticipate the intervention will improve asthma control and reduce asthma morbidity, it is 
possible that study participants have more AEs than controls because of an increased awareness of the 
role of their suboptimal self-management in uncontrolled asthma. Therefore, the DSMB/SMC will also 
monitor for reverse effects.  
 
During the trial, participants will be instructed to notify the study team within 48 hours of any ED visit or 
hospitalization, regardless of its cause, and to notify the study team within 48 hours of initiating OCS or 
excessive intensification of rescue medication (to be defined by the DSMB/SMC), each event representing 
the standard definition of asthma exacerbation. We will also ask participants to report these events within 
48 hours of their occurrence, but we will also query about these events at each data collection point to 
capture any exacerbations that might otherwise go unreported. Participants’ answers will then be 
compared to the medical record and/or claims data, as available. Exacerbation rates more than the 
threshold set by the DSMB/SMC may trigger an immediate study shutdown. 
 
The DSMB/SMC will determine how an AE is to be categorized using standard taxonomy: Unrelated 
(clearly not related to the research), Unlikely (doubtfully related to the research), Possible (may be related 
to the research), Probable (likely related to the research) and Definite (clearly related to the research).  
They will also address Unanticipated Problems (UP). In this study we will also use the FDA definition of a 
SAE: deaths, hospitalization, toxicity, all life threatening or disabling/incapacitating events, and all 
congenital abnormalities or birth defects among research participants.  

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UPs, AEs, & SAEs 
 
The DSMB/SMC will adhere to the Office of Human Research Protections (OHRP) definitions for AEs, SAEs, 
and UPs using the following OHRP definitions: 
 
AEs are defined as UPs involving risks to study participants or others, or as any untoward medical 
occurrence that may present itself during the study period which may or may not have a causal 
relationship with the treatment. Such events may also include breaches of confidentiality. 
SAEs result in any of the following outcomes: death, a life-threatening experience, inpatient 
hospitalization, or a significant disability/incapacity.  
Moderate AEs are those discomforts severe enough to cause interference with usual activities or requiring 
treatment by a health care provider. Such events also include the loss of participants from the study for 
reasons related in any way to a deviation from procedures for ensuring confidentiality. 
Mild AEs are those events that are easily tolerated signs or symptoms of discomfort; minor irritants that 
cause no loss of time from normal activities; symptoms that require no medication or a medical 
evaluation; and transient signs and symptoms. 
Unexpected AEs are those events, the specificity or severity of which is not consistent with the risk 
information described in the general investigative plan or the IRB proposal. "Unexpected" refers to an AE 
that has not been previously observed.  
Expected AEs are those events, the specificity or severity of which is consistent with the risk information 
described in the general investigative plan or IRB proposal.  
An UP includes any incident, experience or outcome that meets all the following criteria: 
• Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the population being studied; 
• Related or possibly related to participation in the research; and 
• Suggests that the research places study participants or others at a greater risk of harm than was 
previously known or recognized. 
 
An incident, experience, or outcome that meets all three criteria above will warrant DSMB/SMC 
consideration of substantive changes in the research protocol or informed consent process/document or 
other corrective actions to protect the safety, welfare, or rights of participants or others. 
 
Collection and Reporting of Adverse Events 
 
Any event that meets the definition for an UP, AE, or SAE will be reported to the MPIs by research staff as 
soon as they learn about the event. Throughout the study, research staff will collect and document any 
UP, AE, or SAE using an Adverse Event Report that will include the following information: 
• Identifying information for the research protocol, including the project title, names of MPIs, and the 
IRB project numbers; 
• Participant study ID #; 
•   Date reported 
• Brief description of the event; 
• Date and method by which the MPIs were notified; 
• Whether the event was related to participation in the study; and 
• Action taken by the study team (instruction to inform PCP about the event) 
 

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SAEs will be reported to the IRBs within 48 hours by phone or email and a completed Adverse Event Report 
(Tables 1-3) will be submitted within 10 days of the initial IRB notification.  Any SAE, whether related to 
study intervention or not, will be reported to the IRB and the DSMB/SMC. The MPIs will inform the IRB 
and DSMB/SMC immediately and jointly decide whether the reported event is a SAE that must be reported 
to the appropriate Federal Agency. 
 
In the event that a participant either withdraws from the study or the investigator decides to discontinue 
them due to SAE, the participant will be monitored by the investigator via ongoing status assessment until 
1) a resolution is reached, i.e., the problem requiring hospitalization has resolved or stabilized with no 
further changes expected; 2) the SAE is determined to be clearly unrelated to the study intervention; or 
3) the SAE results in death. The outcomes of SAEs will be periodically reported to the IRB and to the 
funding agency. A summary of the SAEs that occurred during the previous year will be included in the 
annual progress report to the IRB and the DSMB/SMC. The report will include the participants’ 
sociodemographic characteristics, expected versus actual recruitment rates, treatment retention rates, 
any quality assurance or regulatory issues that occurred during the past year, summary of AEs and SAEs, 
and any actions or changes with respect to the protocol. 
 
 
 
Participant 
number 
AE 
Onset Date 
Asthma-
related 
*Severity 
*Relatedness to 
Study 
*Action 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*See Table 2  
 
Table 2. Adverse Events Coding 
Asthma-related 
Severity 
Relatedness 
Action Taken  
0 = No 
1 = Yes 
1/2=mild/moderate 
3/4=severe/ 
life threatening 
0=Definitely unrelated 
1=Unlikely 
2=Possibly related 
3=Probably related 
4=Definitely related 
0 = None 
 
1 = Referral to Health Center for 
evaluation  
2 = Referral to Emergency 
Evaluation 
 
 
Table 3. AE Reporting Timeline 

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What Event is Reported 
When is the Event Reported 
By Whom is Event 
Reported  
To Whom is Event Reported 
Fatal or life-threatening 
unexpected SAE 
Within 2 calendar days of 
initial receipt of information 
PI 
 
 
DSMB 
Institutional IRB 
NINR Program Officer 
Non-fatal, 
non-life-
threatening expected AE 
Within 7 calendar days of 
initial receipt of information 
PI 
DSMB 
Institutional IRB 
NINR Program Officer 
Unanticipated problem 
(UP) that is not a SAE 
Within 15 calendar days of the 
investigator becoming aware of 
the problem 
PI 
DSMB 
Institutional IRB 
 
 
 
We will register this trial with clinicaltrials.gov (https://clinicaltrials.gov/). 
 
Frequency of Data and Safety Monitoring 
 
The MPIs will be responsible for ensuring participants’ safety on a daily basis. The protocol will be 
overseen by the DSMB/SMC. The MPIs and/or other study Co-Investigators will review all data collection 
forms throughout the study for data completeness and accuracy as well as protocol compliance. The 
DSMB/SMC will act in an advisory capacity to the MPIs to monitor participant safety, evaluate the progress 
of the study, and review procedures for maintaining the confidentiality of data and the quality of data 
collection, management, and analyses.  
 
Reporting Mechanisms of IRB Actions to NIH 
 
The IRB has authority, under HHS regulations at 45 CFR 46.109(a), to require, as a condition of continued 
approval by the IRBs, submission of more detailed information by the MPIs about any AE or UP occurring 
in a research protocol. If the IRB determines that the incident, experience, or outcome does not meet the 
above criteria for a UP, further reporting to the NINR Program Official would not be required under HHS 
regulations. Any IRB action taken because of this study will be reported to the NINR Program Official within 
5 business days of notification. Any modifications to the Human Subject Research or Data Safety 
Monitoring Plan will be submitted for approval to the NIH Program Official prior to implementation of the 
change. 
 
Reporting Mechanisms of Protocol or Consent Changes 
 
Any proposed changes to a research study in response to an UP must be reviewed and approved by the 
IRB before being implemented, except when necessary to eliminate apparent immediate hazards to study 
participants. If the changes are more than minor, the changes must be reviewed and approved by the 
convened IRBs (45 CFR 46.103(b)(4) and 46.110(a)). Any IRB action taken because of this study will be 
reported to the NINR Program Official within 5 business days of notification.  

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Any protocol revisions or consent changes made in response to an UP must be approved by the IRB and 
the DSMB/SMC. As such, the MPIs will submit such changes to the IRB and DSMB/SMC for approval within 
3 business days of identification of required changes. Any revisions involving a change in the scope of the 
study (e.g., risk to study participants) require prior authorization by NINR. Therefore, the MPIs will report 
such revisions to the Program Officer for approval. Protocol revisions and consent changes must be 
implemented within 5 days of IRB approval. 
 
10.1.5 DATA HANDLING AND RECORD KEEPING  
10.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
The research material obtained from each participant includes paper and electronic surveys, paper 
diaries, lung function tests (if in-person visits are allowed), spreadsheets, and audio files. Data obtained 
for the research project will not become part of the participant’s health record. Only individuals who are 
members of the study team, or as mandated by the IRB or funding agency, will have access to coded or 
identifiable data. All materials will be collected specifically for the proposed research project. There is no 
planned collection of specimens.  
Due to the likelihood of low health literacy, all forms will be administered to the patient participants or 
actively assisted. Trained Research Assistants (RAs) will enter responses into REDCap, a web-based 
electronic data capture system that is compliant with all regulatory requirements, after the visit. Audio 
files from intervention visits and post-trial interviews will be uploaded to a secure web platform and 
deleted from the recording device once transcripts are verified. Lung function results will be deleted 
from the spirometer’s memory once a printout has been made and data has been entered and verified. 
10.1.6 PUBLICATION AND DATA SHARING POLICY  
Data Sharing Plan 
The Principal Investigator will ensure that all datasets provided will be prepared in accordance with 
National Institute of Nursing Research (NINR) requirements for data repository of Common Data 
Elements and associated documentation as outlined in the NIH Data Sharing. We will submit data sets 
and variable and scale dictionaries to the NINR Program Official no later than 3 years after the end of 
the clinical activity (e.g., final participant follow-up) or 2 years after the main paper of the trial has been 
published, whichever comes first. The proposed research will include data from 110 minority caregivers 
and 110 of their children (aged 10-14) from New York City federally qualified health centers (FQHCs). 
The final dataset will include repeated measures of self-reported data from surveys completed by the 
participants that assess demographics, asthma-related outcomes and behaviors, and intervention 
adoption and maintenance. We will maintain data in storage for six years after publication of main 
findings to be able to respond to any requests from the scientific community. We are not producing any 
reagents or obtaining specimens such as DNA or other tissues. Nevertheless, we will assist other 
investigators to the best of our ability to conduct replication studies or studies that may extend our 
findings by making available whatever measures we are able to provide without violating legal 
restrictions such as copyright, trademark, or patent laws. We will facilitate access to data, provided 
investigators are approved to receive data by their home Institutional Review Board (IRB), the Western 
IRB or and the Columbia University IRB.  

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We agree with the NIH data sharing policy that data must be provided in a manner that protects the 
identity and privacy of study participants. To that end, only data de-identified by HIPAA standards will 
be released, and we will do our best to facilitate provision of such data, subject to availability of 
resources to support such sharing. To further protect participants, we will make the data and associated 
documentation available to users only under a data sharing agreement that provides for (1) a 
commitment to using the data only for research purposes, (2) a commitment to securing the data using 
appropriate encryption technology, and (3) a commitment to destroying or returning the data after 
analyses are completed. We will participate in any NIH data repositories that may become available, 
which would request and accept the data to be obtained through this project to hasten the tempo of 
scientific inquiry. We will work closely with the NINR to ensure full compliance with all requirements 
while preserving the privacy of individual participants.  
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