Improving Asthma Outcomes Through Stress Management
Phase: NA
Conditions: Asthma
Sponsor: Stephen J. Teach, MD, MPH

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CHILDREN'S NATIONAL HEALTH SYSTEM 
Center for Translational Science 
111 Michigan Avenue, NW 
Washington, DC 20010 
(202) 476-6224 
 
RESEARCH PROTOCOL 
 
TITLE:  Improving Asthma Outcomes through Stress Management  
 
SHORT TITLE: Breathe With Ease: A Unique Approach to Managing Stress (BEAMS) 
 
PRINCIPAL INVESTIGATOR: Stephen Teach, MD, MPH 
CO-INVESTIGATOR: Randi Streisand, PhD 
 
A. SPECIFIC AIMS 
 
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain 
adherent to their management plans.1  Adherence to inhaled corticosteroids (ICS), when indicated for 
persistent or uncontrolled asthma, is a critical component of most asthma management plans,2 and 
other self-management practices such as trigger avoidance are similarly related to improved asthma 
outcomes.  Adherence to self-management practices is mediated by multiple factors, including 
psychosocial stress of parents∗and their children.3   
 
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of 
young, African American, and socioeconomically disadvantaged urban children with asthma who are 
receiving guideline-based care may improve asthma self-management, and therefore asthma 
outcomes.   
 
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally 
appropriate and community-based asthma intervention to augment existing guideline-based best 
practice. The intervention will target the parents of at-risk, urban, African American youth, and will 
employ individualized psychosocial stress management and peer support.  
 
We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC 
Asthma Clinic’s existing intervention of guideline-based clinical care, education, and short-term care 
coordination (usual care) to usual care plus parental stress management in a cohort of up to 250 
parent-child dyads of AA youth aged 4-12 years.  
 
Specific Aim 1. To measure the uptake of each intervention component by participants.  This aim is 
not hypothesis driven, however it is an important aspect of our research question, as we have designed 
a multi-modal intervention based on input from a broad group of stakeholders, including parents, 
                                                          
∗ We recognize that the actual home caregivers of young patients with asthma may be biologic parents, adoptive 
parents, foster parents, and other relatives and legal guardians. For simplicity, we will use the term “parents” to 
refer to all potential home caregivers and to distinguish the group from clinicians and other school and 
community-based caregivers. 

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community-based clinicians and service providers, as well as national experts in asthma and stress 
management. 
 
Specific Aim 2. To determine the effect that a stress management intervention has on the primary 
measured outcome: symptom free days.  Other patient/family-centered outcomes will include parent 
stress, quality of life, asthma morbidity, healthcare utilization, and medication adherence.  
 
Hypothesis 1: The principal hypothesis is that the number of symptom-free days over a two 
week period (primary outcome) at 6 month follow-up will be significantly higher among parents 
in Arm 2 (usual care plus the intervention) than in Arm 1 (usual care alone).  
 
Impact of Study on Health Decisions: The proposed study will provide novel insights into the 
contribution of parent stress to family difficulties in child asthma management and control. The primary 
goal of this project is to address the need for a multi-dimensional approach to a multi-faceted problem 
in asthma care and address disparities facing families, particularly in the area of stress management.  
This knowledge will inform the decisions of parents, in addition to health systems, clinicians, and 
community-based programs that seek to improve pediatric asthma outcomes and reduce disparities.  
Results of the study will be disseminated to a broad range of stakeholders, including parents of children 
with asthma, clinicians, and other service providers.  The dissemination strategy will be developed in 
partnership with representatives of these key stakeholders.  
 
B. BACKGROUND AND SIGNIFICANCE 
 
Background: Burden of Pediatric Asthma on the Health of Children 
 
Asthma is the most common chronic pediatric disease in the 
United States, affecting 7 million children <18 years in 2010.4  
Despite effective NIH guidelines for care, overall morbidity 
among youth with asthma, whether measured by attack rates, 
emergency department (ED) visits, hospitalizations, or deaths, 
have not decreased.4  Further, striking disparities persist among 
youth with asthma, as socio-economically disadvantaged, 
urban, and minority children throughout the United States incur 
a disproportionate burden of asthma-related morbidity.5,6  The 
overall ED visit rate for asthma, for example, among non-
Hispanic African Americans (AAs) aged 0-17 years is 4.1 times 
greater than that among non-Hispanic whites. Similarly, the 
asthma death rate among non-Hispanic AAs aged 0-17 years is 
7.3 times greater than that among non-Hispanic whites, while 
the death rate among Hispanics in the same age group is 1.2 
times greater than non-Hispanic whites.7 
 
Washington, DC provides a useful local case study of these 
disparities. Like highly urbanized areas elsewhere, the city has 
both high prevalence and high morbidity rates that 
disproportionately affect at-risk, minority youth. In 2008, the 
Figure 1: 2010 ED visit rates for 
asthma by DC zip code, ages 5-14y 
www.impact-dc.org 

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current asthma prevalence was 3.0 times greater among non-Hispanic AA youth than among non-
Hispanic whites.8   
Disparities in morbidity due to pediatric asthma are even more dramatic (Figure 1).  ED visits and 
hospitalizations are heavily concentrated among AA children residing in the socioeconomically 
disadvantaged northeast and southeast neighborhoods of the District, especially those lying east of the 
Anacostia River. In 2010, the ED visit rates for asthma among youth residing in the most disadvantaged 
zip codes of southeast DC were >10 times greater than the more advantaged zip codes of northwest 
DC.9 While AAs and Hispanics make up only 60.0% of DC residents,10 over 95% of all pediatric ED 
visits for asthma in DC are made by AA and/or Hispanic youth.9 
 
Significance: The Knowledge Gap  
 
Existing studies provide evidence of a link between psychosocial stress and asthma severity in both 
adults and children. This relationship is complex, and a model such as that of Lazarus and Folkman11 
provides a means to conceptualize stress as a multi-dimensional construct with at least three domains: 
1. Stress-provoking factors (traumatic life events, domestic and/or neighborhood violence, 
substance abuse, financial strain, racial or ethnic discrimination) 
2. Stress-mediating factors which may interact with or modify the effects of stress-provoking 
factors (self-coping mechanisms, peer, family, or professional social support) 
3. Stress-resulting factors which reflect the possible psychological sequelae (depression, anxiety). 
 
Together, these factors work through the parent-child dyad (Figure 2) to mediate a wide range of 
asthma outcomes, including physiologic parameters (immune response to allergens and infections, 
lung function), daily symptomatic impairment, exacerbations, responses to therapy, and 
choices/behaviors regarding adherence to medical care. Specifically, higher stress levels may directly 
increase airway inflammation and reactivity (through immunologic, autonomic, and neuro-endocrine 
effects) and/or decrease the effect of asthma controller and reliever medications. In addition, stress 
may alter a parent’s perception and management of their 
child’s asthma symptoms,12 accentuating or down-playing 
them. It may also affect their perceptions, expectations, and 
interpretations of asthma health outcomes, affecting 
subjective outcome measures such as quality of life 
measures.13,14 Finally, and crucially from the perspective of 
our proposed intervention, parental stress (and its 
psychological correlates such as depression15 and anxiety) 
may worsen their child’s adherence to asthma medications 
(including ICS) and other management strategies, resulting in 
more asthma symptoms and exacerbations. Bartlett et al,16 for 
example, studied mothers of minority children with asthma in 
Baltimore and Washington, DC and found that maternal 
depressive symptoms were strongly associated with risk for 
non-adherence. 
 
In spite of this emerging understanding of the multidimensional pathways linking high psychosocial 
stress and worsened airway obstruction in asthma, few studies have directly studied the efficacy of 
interventions utilizing psychosocial stress management on patient-centered measures of 
asthma care and outcomes.17,18,19,20,21,22 Even fewer have focused on the parents of at-risk, urban, 
AA and/or Hispanic children.23 In fact, a comprehensive search of ClinicalTrials.gov in mid-September 
Figure 2 

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2013 revealed no ongoing registered trials of interventions targeting stress reduction in parents of 
children with asthma.  A single ongoing trial (NCT1445015) targets inner-city adolescents themselves. 
The role of increased psychosocial stress as a mediator of poor asthma outcomes and the 
paucity of studies of interventions employing stress management have been identified as 
concerns by federal agencies, national academic figures, clinicians, and parent/patient groups. 
In its discussion of barriers to the implementation of guidelines-based asthma care, for example, the 
2012 Coordinated Federal Action Plan to Reduce Racial and Ethnic Asthma Disparities24 highlighted 
the importance of psychosocial factors, specifically noting the following: 
a. Lack of family resources and community support for appropriate asthma self-management 
behaviors. 
b. Higher levels of chronic stress and acute exposures to violence, which exacerbates asthma 
and impedes adherence to therapy. 
c. Competing priorities, such as food/housing insecurity, that impact a family’s ability to 
address asthma. 
 
In addition, the most recent Guidelines for the Diagnosis and Management of Asthma from the 
NAEPP/NHLBI/NIH2 (EPR-3) make repeated note of the incompletely understood role of psychosocial 
stress in asthma morbidity and urge clinicians to assess levels of stress and, when appropriate, to 
make referrals to appropriate support services. Of note however, no specific references are provided in 
EPR-3 for the effectiveness of stress management in asthma management, and the Panel explicitly 
states that “Clinical trials are needed to evaluate the effect of stress and stress reduction on 
asthma control...” 
 
Independent expert reviews of the role of stress in chronic disease in general, and asthma in particular, 
have repeatedly called for more studies of interventions to mitigate stress and improve disease 
outcomes. In a recent comprehensive review of parenting stress among caregivers of children with 
chronic disease, Cousino and Hazen,25 for example, explicitly concluded that “Parenting stress is an 
important target for future intervention.” In a recent monograph published as part of the Asthma 
Outcomes Workshop convened by the leadership of multiple Institutes of the NIH, Rand and Wright et 
al3 emphasized the importance of measuring and addressing stress as a mediator of asthma outcomes. 
 
Through parental focus groups, parents of at-risk urban children with asthma both nationally 
and locally have cited psychosocial stress as a potent barrier to the management of their 
children’s asthma.26 In a 2005 review of patient-identified barriers to asthma treatment adherence, 
Bender and Bender found that low-income and minority patients repeatedly noted “daily life hassles” as 
an important barrier, suggesting that “…information from patients’ perspectives indicates the need to 
reappraise current strategies for the management of asthma…”27  Results from our own pilot efforts 
in DC assessing barriers to care for inner-city families are illustrative as well. Through a series of 
focus groups funded by the Kellogg Foundation and performed in conjunction with the Urban Institute, 
we repeatedly found social stress (manifest as coping with job loss, safety concerns, parental poor 
health, housing insecurity, and food insecurity) reported as a potent and consistent barrier to caring for 
their children.28 
 
Finally, expert reviews of possible interventions to address asthma disparities have stressed 
the importance of multi-dimensional approaches to the multi-factorial problem. Canino et al29 
recently noted, for example, that, “Given that the causes of asthma disparities are complex and 
multilevel, clinical strategies to address these disparities must therefore be comparably multilevel and 
target many aspects of asthma care.” Through this framework, interventions may leverage 

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innovations in mobile technology. In a recent review of the use of technology among young people 
with asthma, Nickels and Dimov30 noted that “The positive attitude toward use of social media or mobile 
technology opens the possibility for future studies to further explore the potential benefits of such 
interventions.” The penetration of electronic connectivity among disadvantaged inner-city families is 
remarkable. In a recent study of 509 largely minority and publicly insured families seen in an urban 
pediatric ED,31 nearly 100% reported access to the Internet.  However, our own focus groups have 
shown mixed receptivity to technological interventions in context of a stress management program.32 
 
C. PRELIMINARY STUDIES 
 
C.1. Validation of the IMPACT DC Intervention 
 
The IMPACT DC Asthma Clinic is a unique program of asthma care, education and care coordination at 
Children’s National Health System that targets children who are heavily dependent on emergency 
departments for episodic care, and is designed to transition patients to more effective longitudinal 
asthma care in their primary medical care homes. 
 
In its pivotal randomized controlled trial, the IMPACT DC intervention improved outcomes in multiple 
domains (Figures 3a and 3b).33  Of note, it increased adjusted adherence to ICS by greater than 100% 
at six month follow-up [adjRR 2.03, 95% confidence intervals (1.57, 2.63)] and reduced the rate of ED 
visits for asthma by over 40% [adjRR 0.54, 95% confidence intervals (0.40, 0.72)]. The intervention also 
improved multiple other proximal and distal measures of adherence and health outcomes, including 
asthma-related quality of life. 
 
 
Figure 3a 
Figure 3b 
Rate of ED Visits for Asthma per 1000 At-risk DC Residents 
Aged 1-17y
0.0
50.0
100.0
150.0
200.0
250.0
300.0
350.0
400.0
450.0
2003
2004
2005
2006
2007
2008
2009
2010

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While demonstrating the efficacy of IMPACT DC’s intervention within a clinical trial is impressive, 
IMPACT DC’s existence has also been associated with a dramatic and sustained 40% drop in the rate 
of ED visits for asthma among all DC youth with asthma. This drop has occurred at a time when the 
overall rate of ED visits for all reasons by DC youth has been steadily rising (Figures 4a and 4b). 
 
These improvements in care and outcomes among at-risk DC youth with asthma are impressive, 
but significant work remains.  Even within the context of IMPACT DC’s tightly scripted and guideline-
based program of care, adjusted ICS adherence declined to nearly 50% within the intervention group 
by six months.  Similarly, the rate of ED visits for asthma among DC youth in 2009 was still nearly three 
times the national rate.4 The guideline-based IMPACT DC intervention, like validated interventions 
everywhere that target asthma disparities, needs to improve further.  
 
C.2. Stress Management 
 
Existing psychosocial support interventions for parents of young children with T1D have demonstrated 
increased perceived support, decreased family burden, and improved coping.34 Dr. Streisand’s 
recently completed NIH-funded RCT (NIH, DK080102) directly addressed stress management 
among parents by comparing 5 telephone sessions of diabetes education (control condition) to 
5 sessions of parental support and stress management. Preliminary findings revealed that such an 
intervention is highly feasible, can favorably impact parental stress, and is well received by parents.35 
Another effort has generated extensive preliminary data demonstrating the feasibility, 
satisfaction, and preliminary efficacy for using a parent-focused behavioral intervention to 
reduce distress in parents, and promote parents’ management of their child’s illness. 
Specifically, Dr. Streisand (R01DK0700118) is completing a 
multi-site RCT evaluating parental management of young 
children’s T1D. In this study, 134 parents were randomized 
in a trial in which intervention participants completed a 
phone-based 5-session intervention, including access to an 
Internet message board and group call. A total of 89% of 
participants completed all 5 sessions, and retention at one 
year was excellent (>89%). Preliminary findings suggest 
high intervention satisfaction, with significant improvements 
for intervention families in mealtime distress, one of the key 
areas targeted by intervention (Figure 5). These data 
demonstrate the research team’s ability to successfully 
execute a phone-based psychosocial intervention with high 
levels of satisfaction and retention, as well as favorable 
outcomes on eating behavior and control of blood sugar.  
 
Mobile technologies show promise in augmenting Dr. Streisand’s approach. Telephone 
counseling has already been demonstrated as an effective and acceptable format for promoting 
positive psychological adjustment of parents across a broad range of pediatric medical 
conditions.36,37,38,39,40 Research regarding the feasibility of mHealth technology as a mode of 
intervention indicates promising results among a variety of adult populations.41,42,43 Further, several 
interventions that are theoretically grounded in social cognitive theory have incorporated text message 
components into their larger intervention.44,45,46,47 Dr. Streisand’s team has already demonstrated 
Figure 4a 
Figure 4b 
Figure 5: Change in Mealtime 
Distress Post-Intervention 

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that such technologies are a feasible means for reaching families affected by a medical 
condition as part of behavioral interventions to improve adherence in T1D.48  
C.3. mHealth Technology 
 
Mobile technologies are now pervasive among residents of disadvantaged urban communities.31 AAs 
and Hispanics are more likely to own smartphones than whites, and are more likely to use their mobile 
phones to access health information online.49  The latest Nielsen report indicates that 54% of AAs own 
a smartphone, and that they are more likely than other racial groups to use their phones for texting, 
email, Internet access, and social media.50  
 
While national data suggests that low-income minorities frequently send/receive text messages and are 
receptive to receiving health information via text, Dr. Ivor Horn and her team sought to understand 
patterns of cell phone use and interest in mHealth technology among the general patient pool at 
Children’s National. Her team conducted a survey with 266 parents of children (1-12 years old, covered 
by public insurance) receiving care at three pediatric primary care centers in Washington, DC. The 
survey included questions about demographics, cell phone use, Internet use, and social networking 
based on the Pew Internet and American Life Project Poll. This sample was composed primarily of AA 
(93%) and single (78%) mothers. Half had more than a high school education and incomes above 
$25,000 per year (58%). 96% of participants indicated they use a cell phone, and over two-thirds 
use their cell phones for functions other than calls (90% text). Almost 20% send more than 50 
texts per day. Those with incomes less than $25,000 were more likely to send text messages sharing 
information about their health than those with higher incomes. Over 80% are interested in getting health 
information online, via email or text message. We are therefore confident that mHealth technology 
will be a feasible and valuable tool to increase the efficacy of our intervention.  
 
C.4. Qualitative Research in Target Population 
 
The study team conducted formative qualitative research under IRB Pro00004728 to investigate 
parental report of key stressors, intervention preferences, and receptivity to mHealth interventions.  A 
series of focus groups and one-on-one interviews were conducted with parents of children receiving 
asthma care in the IMPACT DC Asthma Clinic or Emergency Department.  These interviews achieved 
thematic saturation regarding preferred intervention content and format, but showed greater variability 
in responses to the incorporation of technologies into the intervention. 
 
The focus groups and interviews found that asthma is a primary stressor in many parents’ lives, and the 
parents need coping skills to help them deal with stress on an ongoing basis rather than just letting it 
build up.  In addition, the participants expressed a desire for more knowledge about asthma and ways 
to keep their children healthy.  Participants highlighted the importance of relationships with 
interventionists and peers, and preferred face-to-face approaches for the intervention.  In addition, 
multi-modal approaches are desired, including the opportunity to role play and learn from peers. There 
were highly varied preferences regarding the incorporation of mHealth communication, with some 
participants indicating no interest in using technology to communicate or learn, and others identifying 
many ways in which mHealth could be helpful.  Furthermore, participants expressed that any 
communication via texting or other mHealth tools should be personalized and grounded in 
relationships, rather than impersonal or general.   
 
In addition, the study investigators have convened a Stakeholder Engagement Core (SEC) to 
participate in the development of this study.  Members were selected based on either professional 

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expertise in social, medical, legal and educational services, or experience as the parent of one or more 
children with asthma.  The SEC has guided the study team in refining the research questions, 
determining patient-centered outcomes, and developing the intervention.  The SEC will remain highly 
engaged as the study shifts from development to implementation and ultimately dissemination. 
 
D. RESEARCH DESIGN AND METHODS 
 
D.1. Overview of Study Design and Procedure 
 
This study is a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma 
Clinic intervention of guideline-based clinical care, education, and short-term care coordination (usual 
care) to usual care plus parental stress management in a cohort of up to 250 parent-child dyads.  
 
This study will employ a parallel-groups RCT design. Outcomes data will be collected by interviews at 
enrollment (baseline), 3 months post-enrollment, 6 months post-enrollment, and 12 months post-
enrollment.  The 12 month follow-up data will be collected only for a subset of participants. 
 
D.2. Usual Care  
 
All participants in both the usual care and intervention arms of the study will receive guideline-
based asthma care in the IMPACT DC Asthma Clinic, supplemented by three months of limited 
care coordination services to address barriers to care. 
 
The IMPACT DC Asthma Clinic is a fully validated and bilingual clinical intervention33 that has operated 
at Children’s National since 2004. It focuses on at-risk youth with an over-dependence on EDs for 
episodic care. It provides care to approximately 1000 new patients per year, and has won multiple 
national and local awards, including the EPA’s 2006 National Environmental Leadership Award in 
Asthma Management, the 2012 DC Chartered Healthcare “Making a Difference” Health Disparities 
Award, and the 2012 DC Hospital Association Haynes Rice Community Service Award. 
 
IMPACT DC’s conceptual model begins with the premise that effective longitudinal asthma care is a 
broad continuum involving the child surrounded by his/her family, primary medical care home, hospital, 
ED, community pharmacist, insurance case manager, and school nurse.  The vision continues with the 
novel idea that the ED can and should be a critical and proactive part of this continuum, particularly for 
children who use the ED frequently and/or are poorly connected with their medical homes. The 
IMPACT DC Asthma Clinic therefore targets children who are heavily dependent on EDs for episodic 
care.  It provides a comprehensive source of asthma education, medical care, and care coordination 
designed to transition patients to more effective longitudinal asthma care in their primary medical care 
homes. Patients are referred for consultative care from EDs, inpatient units, primary clinicians, and 
school nurses. 
 
By seeing the majority of children within two weeks of referral, the IMPACT DC Asthma Clinic leverages 
the “teachable moment.” While educating families about the physiological and environmental basis of 
asthma, IMPACT DC stresses the importance of managing asthma as a chronic disease and 
emphasizes the effectiveness of combining preventative measures and longitudinal care.  This, in turn, 
promotes self-efficacy among the child and caregivers, giving them the confidence to manage their 
child’s asthma effectively. Each family meets with an asthma educator, clinician, and case manager. 
While highly individualized and based on a shared dialogue with the family and patient, the clinic’s 

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curriculum has three fully-scripted components, as detailed the table below, which are highly 
reproducible and based on the NIH guidelines. Participating families report a high level of satisfaction 
with the Clinic.   
 
IMPACT DC Asthma Clinic Curriculum 
KEY COMPONENTS 
EDUCATION PROVIDED 
Asthma Education: 
Environmental Triggers 
and their Control 
-Basic pathophysiology of asthma with emphasis on its chronic nature 
-Role of the environment in asthma 
-Specific, individualized environmental triggers (i.e. tobacco smoke, mold, pests) 
-Creation of a safe sleep zone minimizing triggers 
Medical Care 
-Symptom recognition 
-Disease control with controller medications 
-Management of exacerbations with quick relief medications 
-Proper device use (i.e. spacer, diskus, nebulizer) 
-Completion of an  Asthma Action Plan 
Care Coordination 
-The role and importance of longitudinal asthma care with a primary care 
provider 
-Counseling on communication strategies with PCP about asthma 
-Ensure school-based care through school nurses and coordinate with managed 
care organizations 
-Provision of booster calls after clinic visit to address barriers to ongoing care  
 
 
D.3. Intervention  
 
The intervention for this study is a multi-dimensional stress management program designed to be 
responsive to parent and other stakeholder preferences, as described in Section C.4: Qualitative 
Research in Target Population. 
 
The intervention will have two separate yet coordinated components:  
 
Intervention Component 1: One-on-one stress management sessions  
Four sessions as summarized below will be delivered by a trained community wellness coach.  We will 
aim to conduct the first two sessions in person, and to offer subsequent sessions on a weekly basis by 
phone.  The interventionist and participant will jointly determine the optimal timeframe for completing 
the four sessions within 12 weeks of enrollment. 
 
One-on-One Sessions 
Session Content 
1 
Challenges of asthma in children and families; the role of stress and introduction of tools for 
stress management; breathing exercise 
2 
Introduction to mindfulness; meditation 
3 
Positive thinking, self-nurturing and relaxation exercises 
4 
Working together with your child in deep breathing and mindfulness 
Wrap up: Encourage continuing utilizing peer support. 
 
Intervention Component 2: Peer Support 
 

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Participants will also be invited to participate in support groups conducted on a rolling basis, for up to 
six months after enrollment.  The community wellness coaches will facilitate these sessions.  A portion 
of each session will be devoted to content related to stress management and/or asthma management, 
to be provided by a clinician or community-based expert as appropriate, with the remainder of the time 
used for facilitated discussion and support.  Topics will be announced in advance so that participants 
know what to expect and can bring questions if desired.   
 
Content from the intervention sessions will be reinforced by periodic text messages and calls from the 
coaches, who will also encourage ongoing participation in the support groups. 
 
Certificates will be provided to participants who complete core intervention activities to foster a sense of 
accomplishment and expertise. 
 
Once control group participants have completed all study activities, they will be offered the opportunity 
to receive the intervention content. 
 
D.4. Participants 
 
We will consent a cohort of up to 400 parent-child dyads, with the goal of randomizing up to 250 dyads.  
Parents will be the primary targets of the intervention, and both parent and child outcomes will be 
assessed, as described in D.6. Outcomes. 
 
Eligible parents will meet the following criteria: 
- 
self-identify as African-American  
- 
be both the legal guardian and primary asthma caregiver of an eligible child 
- 
not have an exclusionary psychiatric condition, including but not limited to psychosis, based on 
the screening form at recruitment 
- 
not be enrolled in another asthma research study 
 
To be eligible, a child must meet the following criteria: 
- 
parent-identified as African-American 
- 
age 4-12 years inclusive at recruitment 
- 
physician diagnosis of persistent asthma 
- 
publicly financed insurance  
- 
absence of a chronic medical condition (other than asthma) including but not limited to diabetes, 
sickle cell disease, heart disease, lung disease or neurological disorder 
- 
not be enrolled in another asthma research study 
In addition, the PI may choose to not include a participant if he does not believe it is in the family’s best 
interest to participate. 
D.5. Recruitment, Consent and Randomization  
 
Trained clinical research staff will recruit eligible families from the IMPACT DC Asthma Clinic. The 
Clinic currently operates in the two locations of the Children’s National Emergency Department – at 
United Medical Center in Southeast DC, and at the Sheikh Zayed campus in Northwest DC.  By using 
the IMPACT DC Asthma Clinic as the recruitment site for this study, we will ensure that the children and 
families of all trial participants receive guideline-based asthma care.  
 

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After consulting with the Clinic team, study staff will approach parents to determine their interest in the 
study and to confirm eligibility.  
 
In order to minimize selection bias and ensure representativeness of participants, all potentially eligible 
participants will be screened.  Reasons for ineligibility will be tracked rigorously to allow for a clear 
description of the study population.  In addition, parents choosing to decline participation will be asked 
to provide simple demographic data and reason for declining so that participation bias analyses can be 
conducted. 
 
The study team has a strong record in study recruitment within our target population of disadvantaged 
African American families, and routinely achieves or exceeds enrollment targets.  The study team will 
meet regularly to assess recruitment progress, and to identify and address barriers as needed.  A 
summary of solutions to recruitment challenges is included below: 
 
Obstacle 1: Ineligibility.  Higher than expected ineligibility may prove challenging to enrolling at the 
target rate.  Solutions include: 
- 
Reassess recruitment sources and engage collaborators as needed to maximize availability of 
potentially eligible participants 
- 
Reassess eligibility criteria to ensure appropriateness 
 
Obstacle 2: Refusals.  Families vary in their willingness to participate in research.  Solutions include: 
- 
Train research staff to appropriately present studies to families and to partner with investigators 
to respond to questions. 
- 
Engage the Research Subject Advocate to empower families to make informed choices 
regarding research participation. 
 
Informed Consent:  Written consent will be obtained from interested study participants prior to the 
initiation of study activities.  A single document will be used to document consent for the parents’ own 
participation, as well as their permission for their child’s participation.  In addition, children age 7 and 
older will provide assent in accordance with Children’s National’s policy.  The Informed Consent form 
that will be approved by the Children’s National Health System IRB, and will supplement but not replace 
the dialogue between participants and research personnel. Additional requirements include: 
- 
The Consent Form will be prepared at approximately an 8th grade reading level, with 
appropriate lay descriptions of technical terms wherever used. 
- 
Participants will be allowed ample time to review the document and ask staff questions prior to 
deciding whether or not to participate. 
- 
Copies of the Consent Form will be given to participants for their records. 
 
After obtaining informed consent, study staff will administer a baseline questionnaire as described in 
Section D.6. Outcomes.  The baseline questionnaire will be completed within ten days of consent.   
 
Randomization: After completion of the baseline measure, the participant will be randomized to one of 
the study’s two arms using RedCap.  
 
Participants randomized to the intervention arm will then be provided with an orientation to the 
intervention, and instructed on when they will be contacted by the intervention team.  These 
participants will also receive short-term care coordination by the IMPACT DC Asthma Clinic team 

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according to the Clinic’s standard protocol, and will receive periodic requests for updated contact 
information. 
 
Participants randomized to the control arm will receive short-term care coordination by the IMPACT DC 
Asthma Clinic team according to the Clinic’s standard protocol, but will not receive any additional 
contact by the study team until the follow-up phone interviews with the exception of periodic requests 
for updated contact information.  
 
D.6. Outcomes 
 
The following domains will be assessed.  Data sources will include parent report and review of the 
child’s medical records. 
 
Follow-up interviews will be conducted by phone by trained research assistants who are blinded to the 
participant’s group assignment.  In order to maintain this blind, the research assistants will not be 
involved in the randomization process, will not have access to the randomization status of participants, 
and will not participate in meeting during which intervention sessions are discussed with participant-
specific details.  Critical unblinding issues will be reported to the IRB as protocol deviations, including 
any instance where a follow-up interview is completed by a research staff member with prior knowledge 
of the participant’s group assignment. 
 
Domain 
Target: Child or Parent 
Parent/Child/Family Psychosocial Outcomes  
Family Stress 
Parent 
Parental Stress 
Parent 
Parental Depression 
Parent 
Child Anxiety 
Child 
Child Depression 
Child 
Quality of life 
Parent 
Caregiver smoking behavior 
Parent 
Coping strategies 
Parent 
Mindfulness 
Parent 
Resilience 
Parent 
Mediators/Moderators 
Sociodemographics 
Parent, Child 
Health Literacy 
Parent 
Home exposure to ETS 
Child 
Resilience 
Parent 
Use of existing ancillary services 
Parent, Child 
BMI 
Child 
Asthma Management/Outcomes 
Symptom-free days (primary outcome) 
Child 
Asthma morbidity 
Child 
Asthma severity  
Child 
Asthma control 
Child 

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Asthma medications and adherence 
Child 
Healthcare utilization  
Child 
Exacerbations (measured by courses of systemic 
steroids) 
Child 
Process Outcomes 
Satisfaction 
Parent 
 
In addition, study staff will assess intervention fidelity, as well as participant uptake of the different 
intervention components.  And we will conduct a qualitative evaluation, asking open-ended questions 
regarding the intervention. 
 
The primary outcome of symptom-free days was selected in consultation with a wide range of parents 
and other stakeholders, including our SEC.  Being healthy and able to participate fully in activities is a 
patient-centered goal for asthma care.  
 
Other asthma outcomes were selected for their importance to both parents/patients and decision 
makers.  Asthma morbidity, control, and exacerbations are of primary importance to parents, while 
clinicians and other decision-makers also focus on medication adherence, healthcare utilization, and 
exacerbations. 
 
In addition, this study includes psychosocial outcomes of key importance to both parents and decision 
makers.  Parents indicated a particular interest in the psychological well-being of their children, and 
clinicians and service providers have indicated interest in parental well-being, as this impacts a wide 
range of child-centered outcomes. 
 
Analysis of the following variables is planned: 
Outcome 
Measure 
Primary Outcome 
Symptom-free days 
Days with no symptoms of asthma in prior 14d  
Secondary Outcomes 
Asthma morbidity 
Daytime and nighttime symptoms in prior 14d, 
missed school in prior 14d 
Asthma severity 
Asthma symptoms in prior 1m, and oral steroid 
use in prior year 
Asthma control 
Asthma symptoms in prior 1m, and oral steroid 
use in prior year 
Asthma medications and adherence 
Use of medications in prior 2d, and beliefs 
regarding asthma medications 
Healthcare utilization 
Utilization in 12m prior to enrollment and during 
follow-up period, including emergency department 
visits, hospital and ICU admissions, primary care 
visits, and urgent care visits. 
Exacerbations 
Courses of systemic steroids 
Family stress 
Stressful events in prior 30d 
Parental stress 
Perceived Stress Scale (PSS) 
Parental depression 
Center for Epidemiologic Studies Depression 

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Scale (CES-D)  
Child anxiety 
PROMIS Parent Proxy Anxiety 
Child depression 
PROMIS Parent Proxy Depressive Symptoms 
Quality of life 
Pediatric Asthma Caregiver Quality of Life 
Questionnaire (PACQLQ) 
Caregiver smoking behavior 
Cigarettes smoked per day 
Coping strategies 
Brief COPE 
Mindfulness 
Interpersonal Mindfulness in Parenting 
Resilience 
Revised Life Orientation Test (LOT-R) 
Covariates 
Sociodemographics 
Race, ethnicity, family history, parent education 
attainment, household income 
Home exposures 
Exposure to environmental tobacco smoke 
Health literacy 
Single Item Literacy Screener (SILS) 
Use of existing ancillary services 
Use of other social services and participation in 
stress management activities 
Resilience 
Revised Life Orientation Test (LOT-R) 
Intervention component uptake 
Staff data collection 
Intervention satisfaction 
Satisfaction survey, qualitative evaluation 
Intervention fidelity 
Staff data collection 
BMI 
Height and weight 
 
Additional information regarding validated measures is included below: 
 
 
Validated Measure 
Characteristics and References 
Perceived Stress Scale 
(PSS) 
The Perceived Stress Scale (PSS) is a widely used psychological 
instrument for measuring the perception of stress. It is a measure of the 
degree to which situations are perceived as stressful, including how 
unpredictable, uncontrollable, and overloaded respondents find their lives. 
The questions are of a general nature and hence are relatively free of 
content specific to any subpopulation group.  
  
Cohen, S. and Williamson, G. Perceived Stress in a Probability Sample of 
the United States. Spacapan, S. and Oskamp, S. (Eds.) The Social 
Psychology of Health. Newbury Park, CA: Sage, 1988. 
Stressful Life Events—
Rochester Youth 
Development Study 
Stern SB, Smith CA. Family processes and delinquency in an ecological 
context. Social Service Review 1995;69:703-731 
 
PROMIS Parent Proxy 
Depressive Symptoms 
and Anxiety 
The Parent Proxy Depressive Symptoms and Anxiety measures were 
developed from the existing PROMIS pediatric self-report content domains, 
for use by proxy respondents when the child is unable to complete a patient 
reported outcome instrument. 
 
Irwin, D. E., Gross, H. E., Stucky, B. D., Thissen, D., DeWitt, E. M., Lai, J. 
S., Amtmann, D., Khastou, L., Varni, J. W., & DeWalt, D. A. (2012). 
Development of six PROMIS pediatrics proxy-report item banks. Health and 

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Quality of Life Outcomes, 10 (1): 22. 
Pediatric Asthma 
Caregiver Quality of Life 
Questionnaire 
(PACQLQ) 
This is a short, readily administered instrument for assessing the impact of 
asthma on caregivers’ and not children’s QOL, which has been used in 
many pediatric asthma studies of diverse populations. Domain subscales 
include activity limitations and emotional function. The PACQLQ is very 
reproducible with a low within-subject variance that results in a high degree 
of reliability in being able to detect differences in quality of life between 
caregivers with different degrees of quality of life impairment. 
 
Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. 
Measuring quality of life in the parents of children with asthma. Qual Life 
Res 1996;5(1):27-34, Epub 1996/02/01. 
Center for Epidemiologic 
Studies Depression 
Scale (CES-D) 
This standardized questionnaire measures severity of depressive 
symptoms.  Items are rated on a 4 point Likert scale. CES- D has adequate 
test-retest reliability and correlates well with clinical ratings of depression 
severity. The tool is not intended as a clinical diagnostic tool, and group 
averages should be interpreted in terms of level of symptoms which 
accompany depression, not in terms of rates of illness.  The CES-D has 
been found to have very high internal consistency and adequate test-retest 
repeatability. Reliability, validity, and factor structure are similar across a 
wide variety of demographic characteristics in the general population 
samples tested. 
 
Radloff L. The CES-D scale: a self-report depression scale for research in 
the general population. Appl Psych Meas 1977;1(3):385-401. 
 
Single Item Literacy 
Screener (SILS) 
The Single Item Literacy Screener (SILS) is a simple instrument designed to 
identify patients with limited reading ability who need help reading health-
related materials. The SILS is able to determine limited reading ability in 
adults and allows providers to target additional assessment of health literacy 
skills.   
 
Morris NS, MacLean CD, Chew LD, Littenberg B.  The Single Item Literacy 
Screener: Evaluation of a brief instrument to identify limited reading ability. 
BMC Family Practice 2006, 7:21. 
Revised Life Orientation 
Test (LOT-R) 
The LOT-R is a brief measure to assess individual differences in 
generalized optimism vs pessimism.  This has been used in research on the 
behavioral, affective and health consequences of this personality variable.  
It has been used as a continuous dimension of variability.  
 
Scheier, M. F., Carver, C. S., & Bridges, M. W. (1994). Distinguishing 
optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): 
A re-evaluation of the Life Orientation Test. Journal of Personality and 
Social Psychology, 67, 1063-1078.     
Brief COPE 
The Brief COPE assesses coping strategies, including several responses 
known to be relevant to effective and ineffective coping.  The Brief COPE 
has been used in studies of a wide range of health conditions, and 
examines coping in naturally occurring situations. 

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Carver, C. S.  (1997).  You want to measure coping but your protocol’s too 
long:  Consider the Brief COPE. International Journal of Behavioral 
Medicine, 4, 92-100. 
Interpersonal 
Mindfulness in Parenting 
This measure assesses mindful parenting, which is conceptualized as a 
construct encompassing parent social cognitions and emotions within the 
parenting context.  Factors include non-judgmental receptivity, nonreactivity, 
present-centered awareness and attention.  The measure has demonstrated 
reliability and validity. 
 
Duncan LG, Coatsworth JD, Gayles JG, Geier MH, Greenberg MT. Can 
mindful parenting be observed? Relations between observational ratings of 
mother-youth interactions and mothers' self-report of mindful parenting. J 
Fam Psychol. 2015 Apr;29(2):276-82.  
 
Coatsworth JD, Duncan LG, Greenberg MT, Nix RL. Changing 
Parent's Mindfulness, Child Management Skills and Relationship Quality 
With Their Youth: Results From a Randomized Pilot Intervention Trial. J 
Child Fam Stud. 2010 Apr 1;19(2):203-217. 
 
 
 
 
D.7. Retention and Compensation 
 
The study team has a strong record of retention, and Dr. Teach’s completed studies have had >89% 
success rates of phone follow-up at six months.  The study team will utilize the following procedures 
developed for prior studies, which have been essential for high retention rates.  At enrollment, the 
research staff will request multiple phone numbers and an email address from each participant, and will 
also request information on an alternate person that we may contact if we have difficulty reaching them 
for follow-up.   This is necessary due to both the transient nature of our target population, and the fact 
that phone numbers are frequently disconnected and/or changed. In addition, the study team will 
maintain a high frequency of contact with all study participants, and regularly request updated contact 
information.  In addition, the study team will engage families at recruitment and emphasize the 
importance of their ongoing participation.  Finally, we will aim to minimize barriers to participation and 
assure that all research activities are patient- and family-centered.  
 
Participants will receive total compensation of up to $150 for participation in the study to be dispensed as: 
$25 after enrollment and baseline interview, $35 after the follow-up interview at month 3 and $40 after the 
final interview at month 6.  In addition, the subset of participants that complete an additional follow-up 
interview at 12 months will receive $50 in compensation. Based on previous studies conducted in our 
research center with similar populations, this amount should be sufficient to compensate participants for 
their time, but it will not be coercive, minimizing participation solely based on financial gain. Compensation 
will be provided in the form of gift cards.  In addition, we will provide reimbursement for transportation in the 
form of parking vouchers or metro cards for study-related activities.  
 
D.8. Data Management  
 

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All study data will be collected via systems created by the Biostatistics and Study Methodology Division 
at Children’s National, and will comply with all applicable guidelines regarding research participant 
confidentiality and data integrity.  
 
We will collect and manage study data using the Research Electronic Data CAPture System (REDCap) 
(https://redcap.vanderbilt.edu) which has been used to successfully support more than 800 single and 
multi-centered clinical research studies at Children’s National and George Washington University as 
part of the collaboration between these two institutions for the Clinical and Translational Research 
Institute at Children's National (CTSI-CN). Data can be captured either on paper source documentation 
and then entered into the REDCap system or entered directly. The web-based transmission of data is 
encrypted and enclosed within a fire-wall.  
 
Data will be entered into REDCap by site study staff and will then check electronically for validity 
against data specifications. Data exceptions (i.e., invalid values, outliers) or missing data are flagged 
and described to give the site coordinator an opportunity to review and make corrections or complete 
the data, and regular data queries will be conducted.  
 
D.9 Staff Training and Quality Assurance 
 
All members of the study team will complete training in human subject protections prior to participating 
in research activities.  Required training modules accessed through the web-based Collaborative IRB 
Training Initiative (CITI) program have been completed by all study staff.  
 
In addition, the principal investigator will provide his research team with ongoing training on the 
responsible conduct of research, with emphasis on adherence to protocol and protecting each 
participant’s safety, rights, and welfare. As for all of the PI’s studies, an atmosphere of openness and 
accountability is maintained, and all staff have been instructed to immediately speak with a coordinator 
and/or investigator if they encounter a situation in which they are unsure how to follow protocol or they 
identify a potential compromise to patient safety or well-being. 
 
When protocol deviations occur, the PI and study staff will work closely with the IRB to determine the 
best procedure for addressing the deviation and preventing further occurrences. Regular team 
meetings will provide opportunities for process improvement, ongoing training and education of staff, 
refinement and standardization of processes, identification of potential problems, and fostering of open 
communication among study team members. 
 
In addition, the principal investigator will always be available to address any problems that occur. 
 
The community wellness coaches that implement the intervention will be selected based on prior 
experience promoting healthy lifestyle behaviors in community settings, including individuals with 
experience as a community health worker, a practitioner of complementary and integrative heath 
therapies.  They will be employed by Children’s National, and will participate training activities and 
ongoing supervision with our research team staff. Training will be led by Drs. Streisand and Teach, and 
topics will include:  
- 
human subjects research, privacy protections, and informed consent,  
- 
socialization with other coaches,  
- 
an overview of this study and the role of coaches,  
- 
coach interaction guidelines (e.g., confidentiality, rapport building, active listening, 

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crisis/emergency situations),  
- 
role-playing mentorship skills, and 
- 
an overview of participant assignment, call structure, and supervision 
 
Emphasized throughout the training will be the supportive role of the coach, and the distinction between 
their role and that of a health care team provider. Coaches will be trained to not give any medical 
advice and to refer participants requesting asthma management information to their medical team. 
Participants will also be informed of the limitations of the role of their assigned coach.  
 
Supervision will occur on a monthly basis with Dr. Streisand and/or Dr. Teach. This training system 
worked well with prior studies conducted by Dr. Streisand. 
 
D.10. STATISTICAL ANALYSES 
 
General Considerations 
 
All analyses will be conducted on an intention-to-treat paradigm using all data collected. All analyses 
will be conducted with two-tailed α=0.05 for significance. 
 
To address aim 1: To measure completion of the intervention’s components by participants randomized 
to the intervention. Summary statistics of all variables will be described. For continuous variables, we 
will calculate the mean, median, standard deviation, minimum and maximum. For categorical variables, 
we calculate the count and the percentage.  
            
To address aim 2: To determine the effect that the stress management intervention has on the primary 
measured outcome: symptom free days. Other patient/family-centered outcomes will include parent 
stress, quality of life, asthma morbidity, healthcare utilization, and medication adherence. Baseline 
demographic characteristics will first be compared in univariate fashion between the two groups using 
the chi-squared test for categorical variables and the t-test for continuous variables. If any variable is 
not balanced by randomization, it will be used as a covariate in all secondary analyses. To test the 
hypothesis that the time average of number of symptom-free days over a two week period (primary 
outcome) at 3 and 6 month follow-up will be significantly higher among parents in Arm 2 (intervention) 
than in Arm 1 (usual care), a two sample t-test will be used to compare difference of mean symptom-
free days over a two week period between the two arms with point estimates, 95% CI and p values 
being reported.  Depending on the degree of dispersion, we may need to employ a Poisson or negative 
binomial model. 
 
In secondary analysis, we will further explore the effect of the intervention by fitting random effect mixed 
models that (1) adjust for baseline covariates of interest, considered a priori or that differ between 
groups at baseline and are relevant to change in symptom-free days; (2) test for interaction between 
treatment effects and other covariates; and (3) examine patients who complete intervention and follow-
up (per protocol analysis).  
 
For continuous secondary outcomes, we will use the same approach as described above. For the 
categorical secondary outcomes, we will use the chi square test of whether relative rates between 
groups differ from 1. All subsequent estimates of relative rates (RR) will be adjusted (at the minimum) 
for age, sex, race/ethnicity and other covariates using generalized estimating equations (GEE). All 
estimates of RR will be reported with 95% confidence intervals (CIs).  For measures of healthcare 

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utilization, the analysis will compare adjusted rates and RRs at 3 and 6 follow up. Depending on the 
degree of dispersion in the rates, these models will be based on either Poisson or negative binomial 
regression models.  
 
Sensitivity analyses will be conducted to account for missing data.  These will estimate the highest and 
lowest potential treatment effect for primary and secondary outcomes. 
 
 
 

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Missing Data 
 
Clinical research staff will be trained in the importance of completing all data fields. Based on our prior 
studies, we anticipate a rate of missing data for the primary outcome of <5%.  All efforts will be made to 
minimize patient dropout.  Frequent data queries will allow us to track missing data and retrain staff as 
needed.  Sensitivity analyses will be conducted as described above.  Reasons for participant drop out 
will be collected and reported.  In cases of missing data, we will use multiple imputation (MI) to impute 
the missing values. 
 
Sample Size Considerations: Power Analysis 
 
This study is designed to detect the smallest 
clinically significant difference in mean symptom 
free days (SFD) between the intervention and 
control groups.  
 
The initial sample size calculation was based on 
previous data from other studies, the improvements 
of 0.9-1.0 SFD per 14 days are feasible, the 
standard deviation of SFD is 2.7, and the within 
subject correlation is 0.3. Power analysis was 
calculated for the intervention effect on SFD while 
justifying two assessments for each subject. The 
table shows the total sample size needed to detect 
differences in SFD from 0.9 to 1.0 with different 
within subject correlation. The sample size of 152 
is needed to detect the difference of 1.0 SFD with 
standard deviation of SFD of 2.7, within subject 
correlation of 0.3, power of 0.8 at alpha level of 
0.05. With anticipation of attrition rate of 10%, we 
initially planned to enroll 168 children. 
 
The sample size was recalculated on September 
14, 2015, based on the baseline data collected 
from the first 60 participants, which showed the 
following: mean was 10.25 days, median was 11.5 
days, standard deviation was 4.12.  The sample 
distribution is not normal and approximated a Poisson distribution. Based on this distribution, the 
calculated sample size is 188, as can achieve 80% power at a 0.05 significance level to detect a 
response rate ratio of 1.15 with baseline response rate 0.8. Therefore, with 10% percent attrition rate, 
we now plan to enroll 207 participants. 
 Feasibility 
 
The IMPACT DC Asthma Clinic sees approximately 1200 new patients per year.  Of these, we estimate 
that at least 30% of patients (n=360) will meet all eligibility requirements and that at least 70% of their 
Power Calculation with 
Standard Deviation of 2.7,  
Power of 0.8, Alpha level of 0.5 
Difference 
Correlation 
N 
N 
(with 10% 
attrition) 
0.9 
0.1 
158 
174 
0.9 
0.15 
166 
183 
0.9 
0.2 
172 
190 
0.9 
0.25 
180 
198 
0.9 
0.3 
186 
205 
0.9 
0.35 
194 
214 
0.9 
0.4 
200 
220 
0.95 
0.1 
142 
157 
0.95 
0.15 
148 
163 
0.95 
0.2 
156 
172 
0.95 
0.25 
162 
179 
0.95 
0.3 
168 
185 
0.95 
0.35 
174 
192 
0.95 
0.4 
180 
198 
1 
0.1 
128 
141 
1 
0.15 
134 
148 
1 
0.2 
140 
154 
1 
0.25 
146 
161 
1 
0.3 
152 
168 
1 
0.35 
158 
174 
1 
0.4 
164 
181 

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parents will agree to participate. These estimates yield a rate of enrollment of approximately 250 
participants per 12 months.   
 
Proposed Timeline 
 
The timeline below shows the progression of each participant through the trial activities.  Shaded cells 
apply only to the intervention group.  The 12 month interview will only be conducted for a subset of 
participants. 
 
Activity by Month 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
IMPACT DC Asthma Clinic Visit 
X 
  
  
  
  
  
  
  
  
  
  
  
  
Screening 
X 
  
  
  
  
  
  
  
  
  
  
  
  
Consent 
X 
  
  
  
  
  
  
  
  
  
  
  
  
Baseline Interview 
X 
  
  
  
  
  
  
  
  
  
  
  
  
Randomization 
X 
  
  
  
  
  
  
  
  
  
  
  
  
IMPACT DC Care Coordination 
(both study arms) 
  
X 
X 
X 
  
  
  
  
  
  
  
  
  
Intervention: One-on-One Sessions  
  
X 
X 
X 
  
  
  
  
  
  
  
  
  
Intervention: Peer Support 
  
X 
X 
X 
X 
X 
X 
  
  
  
  
  
  
Follow Up Interviews (Blinded) 
  
  
  
X 
  
  
X 
  
  
  
  
  
X 
 
 
 
HISTORICAL CONTROLS: 
To allow for additional comparisons of the study participants, we seek to collect data from the electronic 
medical record about a sample of participants as similar as possible to those enrolled in the trial.  
Specifically, we will identify a consecutive case series of participants seen in the IMPACT DC Asthma 
Clinic in the 12 months prior to the start of enrollment in this trial.  We will include English-speaking 
participants age 4-12y with public insurance and persistent asthma, and will use available data in the 
medical record to exclude those that are not African American or have significant medical comorbidities.  
We will compare their health care utilization before and after receiving care in the IMPACT DC Asthma 
Clinic to those participants enrolled in the trial. 
E. STUDY POPULATION –(GENDER AND MINORITY INCLUSIONS): 
 
Inclusion of Women and Minorities 
 
We will enroll without regard to gender.  Based on the population receiving care in the IMPACT DC 
Asthma Clinic, as well as prior studies, we anticipate that approximately 75% of parents will be female.   
 
We propose to enroll participants that self-identify as African-American. This population has been 
identified as a high-risk subgroup, and account for approximately 95% of the families receiving care in 
the IMPACT DC Asthma Clinic.  This study is specifically aiming to reduce racial health disparities. 

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Inclusion of Children 
 
This study will enroll parents-child dyads.  Parent participants must have children age 4-12y receiving 
care in the IMPACT DC Asthma Clinic. Parents are the target of the intervention, as parental stress has 
been demonstrated to impact pediatric asthma outcomes.  And we have deliberately chosen to include 
only parents of children age 4-12y for two reasons: 
1. Below the age of 4 years, the diagnosis of asthma can be uncertain, and many young children who 
wheeze have “transient wheezing of childhood” that later resolves. Further, the effectiveness of ICS 
is less certain in this age group.  
2. Above the age of 12 years, the locus of control for administration of medication has shifted from the 
parent to the adolescent, rendering our planned intervention targeting parents less impactful. 
 
 

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F. RISKS AND SIDE EFFECTS 
 
The primary risk to participation in this study is breach of confidentiality.   
 
In addition, while there are no known psychological risks to subjects when completing interviews or 
filling out standardized psychological questionnaires, the questions may make the subjects feel 
uncomfortable in that they ask about their physical and psychological health. It is possible that subjects 
could feel mental fatigue, embarrassment, a sense of invasion of privacy, and/or frustration from 
recalling traumatic or distressing events that relate to their personal stress experiences. 
 
The alternative to participation in this project is for parents to not participate.  
 
F.1. MEASURES TAKEN TO MINIMIZE RISKS AND SIDE EFFECTS: 
 
Protection Against Risk of Loss of Confidentiality: As the primary risk to study participation is 
breach of confidentiality, study staff is trained in procedures for maintaining the security and 
confidentiality of data. All paper files will be in a locked cabinet in a secure suite on a secure floor in the 
Children’s Research Institute. Any materials containing research subject names will always be stored 
separately from associated data to preclude the inadvertent linking of confidential or sensitive 
information to an individual research subject. All records will be stripped of names and be provided with 
a unique “research” ID.  Study databases will be password-protected and maintained on secure 
servers, and all staff will be trained on the importance of maintaining the confidentiality of study data. 
 
Project findings and reports prepared for dissemination will not contain information that could 
reasonably be used to identify an individual.  Individual data will not be shared outside of research staff, 
although data summaries will be made available to partners, including the Stakeholder Engagement 
Core and National Advisory Core, who will assist the study team in interpreting and disseminating the 
findings.  One exception is if a participant reports the intention to harm him or herself or others. 
Researchers will report any evidence of abuse or neglect to appropriate authorities. 
 
Referrals for Depression or Concern for Other Serious Mental Health Issues: Given the high rate 
of depression in our target population, we will provide a list of mental health resources to all participants 
at enrollment.  For participants whose questionnaire responses indicate that they are experiencing a 
clinically significant level of depressive symptoms (CES-D 10 score ≥11 or PROMIS parent proxy 
depressive symptoms t-score ≥70), we will follow a protocol that has been effective in prior studies 
conducted by co-Investigator Randi Streisand, PhD. Specifically, all psychological forms will be 
reviewed by one of study staff or investigators within 24 hours of completion and flagged if the 
depression score is significant. The research staff reviewing scores will immediately alert the PI and Dr. 
Streisand.  If it is the first elevated score for a participant, Dr. Streisand or Dr. Teach will call the 
participant to explore referral for services. For subsequent elevated scores, Dr. Streisand and Dr. 
Teach will be notified, and will determine whether another call to the participant is needed.   
 
A similar process will be followed if the research staff identifies other mental health concerns or safety 
concerns. 
 
In addition, participants will be reminded at the time of the interview that they do not have to answer 
any questions that make them uncomfortable. 

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G. BENEFITS 
 
There are no clear direct benefits to participants for participating in this study. The study team may 
learn more about managing stress among parents of children with asthma that may benefit other 
parents in the future and improve child asthma outcomes. 
 
H. DATA AND SAFETY MONITORING PLAN 
 
Study monitoring 
Safety monitoring will be performed by the PI and the study coordinator on an ongoing basis. The PI 
will be responsible for evaluating any unanticipated problems and determining whether they affect the 
risk/benefit ratio of the study and whether modifications to the protocol and consent forms are required. 
Unanticipated problems to be assessed include adverse events, deviations from the study design or 
protocol, problems with informed consent, and confidentiality violations. The PI will report unanticipated 
problems to the Children’s National IRB in accordance with IRB policy. The IRB will review such cases 
and determine what actions must be taken to address or resolve the situation.  
 
In addition, as required by PCORI, the study’s funder, the principal investigator will convene a Data and 
Safety Monitoring Board (DSMB).   The DSMB will conduct safety monitoring and monitoring of data 
integrity issues for the study.  It will be the responsibility of the DSMB to review relevant safety data for 
each enrolled participant, and to make recommendations regarding the ongoing conduct and 
monitoring of studies. 
 
 
The DSMB will meet at least every six months, in person, by phone or by webinar, and will be comprised of 
at least four members who are independent from the study.  Membership will include two medical 
professionals, a trained patient or stakeholder representative and a statistician. Data will be compiled by 
the study data manager and presented to the DSMB in a format that allows for complete review of all 
safety data and study progress data (participant enrollment, data completion and quality).  The DSMB will 
also review any adverse event reports and make recommendations for follow-up or further action.  The 
DSMB will receive and respond to reports of any serious adverse events (SAEs) and will be immediately 
notified of fatal or life-threatening events.  Based on the review of safety, efficacy, and performance data, 
the DSMB will make recommendations regarding conduct of the study.  Biannual data and safety 
monitoring reports will be submitted to PCORI within two weeks of convening the DSMB 
 
Minimizing research-associated risk 
 
As described above, the primary risk to study participation is breach of confidentiality.  Study staff will 
be trained in procedures for maintaining the security and confidentiality of data, and protocols will be in 
place to minimize risk of breach of confidentiality from paper or electronic records.  Individual data will 
not be shared outside of research staff, and only data summaries will be made available to partners.  
One exception is if a participant reports the intention to harm him or herself or others. Researchers will 
report any evidence of abuse or neglect to appropriate authorities. 
 
In addition, protocols will be implemented to address any responses by participants indicating that they 
are experiencing a clinically significant level of depressive symptoms or if the research staff identifies 
other mental health concerns or safety concerns. 
 

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Participants will be reminded at the time of the interview that they do not have to answer any questions 
that make them uncomfortable. 
 
Identifying, reviewing, and reporting adverse events and unanticipated problems to the IRB 
 
All members of the study team will be trained in identifying adverse events and unanticipated problems.  
These will be reviewed by the principal investigator or co-investigator, both of whom have significant 
experience in patient-centered research.  The IRB will be provided with reports of all adverse events 
and unanticipated problems, including the resulting action plan if applicable. 
 
Any injury or harm to a study participant that is possibly related to the study intervention will be treated 
as an AE or SAE.  Emergency department visits and hospital admissions for asthma will not be 
considered AEs or SAEs, as they are expected in the target population and will be tracked as 
outcomes.  Suicide or attempted suicide will be considered an SAE.  Any death, regardless of 
relatedness to study intervention, will be reported as an SAE. 
 
Assuring data accuracy and protocol compliance 
 
The study team will regularly review study processes and determine whether retraining is needed in 
any areas.  Fidelity checklists will be utilized for both data collection and intervention protocols, and the 
principal investigator and co-investigator will provide ongoing supervision of staff.  Data queries will be 
addressed in a timely manner, and retraining in data collection and data entry will be conducted as 
needs are identified. Any challenges identified in assuring data accuracy and protocol compliance will 
be reported to both the DSMB and PCORI. 
 
I. 
OUTSIDE CONSULTANTS/COLLABORATORS 
 
This project will be conducted with a number of collaborator’s outside of Children’s National, including: 
 
Cynthia Rand, PhD: Dr. Rand is the Director of the Johns Hopkins Adherence Research Center, and a 
Professor of Medicine at the Johns Hopkins University.  She is a nationally recognized expert in stress 
and adherence, especially in asthma and in disadvantaged populations. 
 
Ivor Horn, MD, MPH: Dr. Ivor Horn is the Medical Director at the Center for Diversity and Health Equity 
and Professor of Pediatrics at the University of Washington School of Medicine.  Dr. Horn provides 
expertise in both disparities research and the use of mHealth in minority populations. 
 
Kabir Yadav, MD: Dr. Yadav is a board-certified Clinical Informaticist and Associate Professor of 
Emergency Medicine at the University of California Los Angeles. He provides expertise in the use of 
technology in clinical interventions.  
 
J. CONTRACTUAL AGREEMENTS 
 
None. 
 
K. COSTS TO SUBJECTS 

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There will be no costs to the subjects’ insurance for their participation. Some participants may incur 
financial costs of phone usage for the calls and/or text messages, which will be offset by compensation in 
the form of gift cards.  
 
L. CONFLICTS OF INTEREST 
 
None.   
 
M. CONFIDENTIALITY 
 
We will keep the records of this study confidential.  Only the people working on the study will be able to 
access patient information. Results from this study made public will be presented as a summary of data 
and no individual will ever be referred to specifically. All tracking sheets will be stored in locked offices 
and filing cabinets belonging to study staff. Electronic data will be available on individually secured PCs 
or by password only on central servers. Passwords will be distributed only to study staff. All paper data 
will be stored in secured fashion for a minimum of two years after study completion. 
 
N. SUBJECT REIMBURSEMENT 
 
Participants will receive total compensation of up to $150 for participation in the study to be dispensed as: 
$25 after enrollment and baseline interview, $35 after the follow-up interview at month 3 and $40 after the 
final interview at month 6.  In addition, the subset of participants that complete another follow-up interview 
at 12 months will receive $50 in compensation. Based on previous studies conducted in our research 
center with similar populations, this amount should be sufficient to compensate participants for their time, 
but it will not be coercive, minimizing participation solely based on financial gain. Compensation will be 
provided in the form of gift cards. 
 
O. FACILITIES AND EQUIPMENT 
 
The Center for Translational Science at Children’s National Medical Center provides office space and 
secure storage space for the study team. 
 
P. APPENDICES  
 
None. 
 
Q. REFERENCES & LITERATURE CITED 
 
 
 
                                                          
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