Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)
Phase: NA
Conditions: Asthma
Sponsor: Johns Hopkins University

 
 
  
  
COVER PAGE  
  
Official Title: Reducing Asthma Morbidity in High Risk Minority Preschool Children  
(Asthma Basic Care (ABC) at Head Start)  
  
NCT01519453  
  
January 26, 2017  
  
 
Protocol and Statistical Analysis Plan   
  

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 2 of 13  
  
JHMIRB eFormA  01  
Version 3 Dated:   8/15/05  
Page 1 of 12  
Johns Hopkins Medicine - eForm A  
  
  
  
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Use the section headings to write the eForm A, inserting the appropriate material in each. If a 
section is not applicable, leave heading in and insert N/A.  
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When submitting eForm A (new or revised), enter the date submitted to the field at the top of 
eForm A.  
  
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1.  
Abstract  
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research.  
Asthma has been identified as the most common chronic disease in early childhood and it places a 
higher burden on minority groups and the poor. Children ages 0-4 years have been identified as the 
driving force behind increased rates of hospitalization for children with asthma. Furthermore, black 
children are approximately 2.5 times likely to have an ED visit or hospitalization than white children. 
Reflecting this increased risk, the prevalence of asthma among low-income preschool children 
attending Head Start programs is high, ranging from 14% to 35%. For these reasons, asthma has 
been identified as a key health risk for Head Start children by the Department of Health and Human 
Services and the Environmental Protection Agency. Thus, Head Start programs offer a timely and 
important venue for reaching high-risk, low-income pre-school children and providing asthma 
education interventions. We therefore propose to draw on our established health and research 
partnership with Head Start programs in Baltimore City to test the effectiveness of a home-based 
asthma education intervention (ABC) with demonstrated efficacy. Specifically, we will conduct a 
randomized clinical trial of a culturally-tailored home-based asthma education intervention 
combined with a HS-level asthma education program in reducing asthma morbidity among low 
income minority children compared to a HS-level asthma education program alone. We will enroll 
406 HS students aged 2-6 years with caregiver-reported symptomatic asthma from all 16 Baltimore 
City HS programs. The primary study outcome measure will be symptom free days at six month 
follow-up. Secondary outcomes include caregiver-reported healthcare utilization for urgent (ED 
visits and hospitalizations) and non-urgent (primary and specialist care) asthma visits, 
caregiverreported oral steroid bursts, caregiver-reported asthma control and caregiver quality of life. 
In addition, at the HS level, we will assess overall HS participation in the HS-level asthma education 
program and any additional programs or institutional changes that would indicate adoption, 
implementation and maintenance of asthma education as a core HS health goal and changes in HS 
staff knowledge, attitudes and practices related to asthma management.   
   

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 3 of 13  
  
2. 
Objectives (include all primary and secondary objectives)  
Primary Objectives: Assess the relative effectiveness of the ABC intervention combined with Head 
Start (HS)-level asthma education (ABC group) in improving asthma morbidity compared to HSlevel 
asthma education alone (Control group) in preschool children with symptomatic asthma.  Primary 
Hypothesis (#1): Participants receiving the ABC intervention will have more symptom     free days 
at the 6-, 9-, and 12-month evaluations when compared with participants in the control group. (#2): 
Participants receiving the ABC intervention will have reduced morbidity, including decreased urgent 
care utilization (hospitalizations/ED visits measured by caregiver report as well as insurance payer 
data), improved quality of life, improved asthma control, and fewer courses of oral steroids, when 
compared with participants in the Control group at the 6-, 9-, and 12-month evaluations.   
  
Secondary Objectives: Assess the degree to which HS program-level adoption, implementation and 
maintenance of asthma education activities (stratified as high implementation vs. low 
implementation) moderates the impact of child-level treatment assignment (ABC vs. Control) on 
measures of asthma morbidity, including symptom-free days, urgent care, quality of life, asthma 
control and oral steroids.   
Secondary Hypothesis (#3): Participants receiving the ABC home-based intervention combined with 
high implementation of HS-level asthma education will have reduced asthma morbidity, including 
decreased urgent care utilization, improved quality of life, improved asthma control, and fewer 
courses of oral steroids, when compared with participants receiving the ABC intervention in low 
implementation of HS-level asthma education, or  Control group participants at the 6-, 9-, and 
12month evaluations. The secondary outcome measures include other measures of asthma morbidity 
(i.e., ED visits and hospitalizations, oral steroid bursts, asthma control and caregiver quality of life).  
  
  
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug 
or device, and any other relevant information to justify the research)  
Previous efficacy studies have suggested that asthma education programs can be effective in 
improving overall management of asthma for preschool children. Multiple studies have 
demonstrated that home asthma educational interventions can increase the number of symptom free 
days, decrease frequency and severity of asthma flares, decrease ED visits and hospitalizations, and 
improve quality of life. Asthma education interventions have been shown to reduce asthma morbidity 
across diverse populations, including in preschool age and low-income minority children. 
Schoolbased asthma programs are a promising strategy for asthma education because of the potential 
to reach large numbers of children and directly teach them asthma self-management skills. School 
programs offer the further advantage of being able to deliver asthma education to low-income 
children who may not be seen for regular asthma medical care. Most of these programs, however, 
have been conducted in elementary schools and focused on the child's efforts to self-manage and are 
of limited application in a pre-school age population. In a prior study we found that our Asthma 
Basic Care (ABC) intervention led to significant short-term improvements in symptom free days, 
along with a greater rate of reduction in courses of oral steroids over 18 months, relative to usual 
care in low-income, minority children. However, for these promising asthma intervention strategies 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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to have sustainable public health impact for low-income, minority children, they must be integrated 
within those medical, educational and social structures that serve these high risk children. We 
therefore propose to draw on our established health and research partnership with Head Start 
programs in Baltimore City to test the feasibility of implementing the ABC home-based asthma 
education intervention with demonstrated efficacy into a Head Start venue.  
  
4.  
Study Procedures  
a. Study design, including the sequence and timing of study procedures  (distinguish research 
procedures from those that are part of routine care).  
  
This study is designed to evaluate the effectiveness of a home-based asthma education intervention (ABC) 
with demonstrated efficacy in combination with a Head Start level intervention (ABC + HS) to improve 
asthma morbidity compared to a Head Start level intervention (HS Only) containing asthma education 
implemented in the Head Start Programs. The study design is a two group randomized clinical trial (N=406). 
Participants will be children with symptomatic asthma enrolled in Baltimore City Head Start Program Sites 
(age 2-6) and their families. Participants will be recruited from Head Start and randomly assigned to ABC 
combined with HS asthma education or HS asthma education alone. The ABC intervention is home- asthma 
education intervention that was tailored, based on our prior research and that of others, to reflect known 
cultural barriers to effective asthma management among low-income minority families, including 
underutilization of asthma primary care, overestimation of asthma control, perceptions that asthma is an 
episodic illness that only needs acute treatment, negative beliefs about controller medications, and 
environmental risk factors in the home. All intervention visits will be audio-taped. Outcome measures will 
be collected at 3-, 6-, 9- and 12-months. The primary outcome measure will be symptom free days at six 
month follow-up. Secondary outcome measures include other measures of asthma morbidity (i.e., ED visits 
and hospitalizations, oral steroid bursts, asthma control, and caregiver quality of life). In addition, at the Head 
Start level, we will evaluate over five years the overall HS participation in the HS-level asthma education 
program and any additional programs or institutional changes that would indicate adoption, implementation 
and maintenance of asthma education as a core HS health goal and changes in HS staff knowledge, attitudes 
and practices related to asthma management.  
  
Staff Safety  
  
In order to assure safety for our study team we do the following: (1) All of our study team members are 
provided with a cell phone to be kept with them at all times.  (2) We conduct annual safety training with a 
member of the police department. (3) We request that our study team members not conduct home visits at 
night. (4) All study team members are encouraged to request a second team member attend any home visit 
that makes them feel uncomfortable.   
  
  
Screening  
Potentially eligible families will be identified from Baltimore City Head Start Programs. Specifically, we will 
distribute an initial screening survey (ISS) to the primary caregiver of all Head Start students (N=4000/year) 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 5 of 13  
  
enrolled in a Baltimore City Head Start program. This screening questionnaire will assess asthma diagnosis, 
presence of asthma symptoms as well as questions pertaining to study eligibility. Data from the ISS will be 
stored without personal identifiers to track Head Start level rates of these variables. Four hundred and six 
children (ages 2-6 years) whose caregiver reports asthma diagnosis and presence of asthma symptoms will 
be enrolled in a twelve month study of a home-based asthma education intervention (ABC).   
  
Parents will be asked to complete the Asthma Head Start Initial Screening Survey (ISS). Forms will be sent 
home with children in informational packets for the family. Each teacher will be given $50 in the form of a 
gift card as an award for 80% form return for his/her classroom, regardless of recruitment or eligibility status 
of the students. The ISS has an option that allows the family to refuse to fill out the form but still return it to 
the teacher. This reward plan is necessary to ensure comprehensive and timely screening of the HS sites. This 
reward plan has been used by numerous researchers and has been successful in screening up to 98% of 
children.  On the ISS, families will indicate if they give permission to be contacted to determine eligibility 
and interest in participation in the proposed study. To facilitate recruitment at the Head Start sites, we will 
be working closely with the HS site Family Service Coordinators (FSCs). They will be assisting us with 
distribution and completion of the Initial Screening Survey (ISS). They will also be providing student roster 
information and serve as a communication liaison with the teachers. Therefore we will compensate their time 
by offering a $50 check for completion of 80% of the forms at their assigned sites, regardless of recruitment 
or eligibility status of the students. This IRB approved screening approach allowed us to successfully screen 
87% of the children during our current study NA_00019089.  
  
Participant Recruitment  
Families who report an asthma diagnosis on the ISS who give permission to be contacted will be contacted 
by phone to confirm eligibility and interest in participation in the proposed study. During this phone contact, 
eligible families will have the study described in detail and will be informed of the  $190 total financial 
incentive for completing each of the data collection visits. An appointment will be made with interested 
families to obtain consent and do the baseline assessment in the home. Because of the age of the children, 
written assent is not possible.   
  
OPTIONAL ABC FAMILY STUDY: During the baseline visit, the consented parent/guardian will be invited 
to answer an additional survey regarding patterns of health care use and personal health concerns among 
family members. They will be compensated $50 for the additional time and effort. Parents/ guardians will be 
asked to nominate up to 5 family members to be recruited to complete the Family Health Questionnaire. 
Parents will be given IRB approved postcards and/ or emails to pass on to their family members. Each 
postcard/email will provide an option to respond either by mail (i.e., returning the postcard by mail) or by 
email (i.e., contact information listed on card or in email). Each postcard/email will have a unique code which 
links family members to the parent who initially passed them out. For each family member that either returns 
the postcard or responds by email, the parent who referred the participant will receive compensation of $20. 
In total, parents who complete the additional family survey and refer up to 5 family members, who 
subsequently contact the research team, can earn up to $150. Caregivers will be provided the additional 
compensation regardless of recruitment or eligibility status of the family members.   
  

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 6 of 13  
  
Family members referred by the initial parent/ guardian who contact research staff will have the study 
described in detail over the phone and will be informed of the $50 compensation for completing the survey. 
Oral consent will be obtained prior to  the survey will be completed either in the home or over the phone.    
  
Asthma Outreach workers: Interested Asthma Outreach Workers will have the study described to them in 
detail by a JHARC study team member on an individual basis. Asthma Outreach Workers will be told 
about the study, given an opportunity to ask questions about participation and informed that participation is 
voluntary and has no effect on their employment status at Johns Hopkins University. Staff participation 
consists of Asthma training by JHARC staff and a brief knowledge and satisfaction survey pre and post 
training.   
  
Randomization  
Randomization will occur after baseline data collection and the group assignment will be recorded. Children 
will be individually randomized to either the ABC + HS intervention or HS intervention alone. Blocked 
randomization will be used so that staff cannot predict which treatment will follow. We will stratify 
randomization by Head Start program to control for clustering within Head Start programs.  
  
Baseline and Follow-up Assessments  
Baseline measures will be collected prior to intervention delivery. The baseline assessment consists of an 
environmental home assessment, skills checklist, weight and height of the child and a survey, will be 
completed in the family’s home by a research assistant (RA) before randomization. Families who are unable 
to locate their spacer or state they do not have a spacer, will be provided one at this time. Participants will 
receive $50 for completing this home visit.   
  
Follow-up assessments will be completed 3-, 9-, and 12- months and will consist of a survey that will be 
completed over the phone. Participants will receive $30 for completing these phone visits.  6-month followup 
assessments will be conducted in the home and consist of an environmental home assessment, skills checklist, 
weight and height of the child and a survey. Participants will receive $50 for completing this home visit.  
  
Current Medication Treatment Plan (CMTP)   
A CMTP for each participant will be obtained from the child’s asthma care providers at Baseline and 12 
month follow-up vists. The CMTP will contain information about start and end dates for asthma 
medications as well as drug name, dose and prescribed frequency.   
  
Pharmacy Refill History  
Medication refill data will be obtained by faxing all family-identified pharmacies and their pharmacy 
benefits managers or insurance payer. We will get the refill records for one year before joining the study 
and following their 12 month phone survey (or 12 months after randomization if the 12 month visit is not 
completed) .   
  

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 7 of 13  
  
Health Outcome data  
When available, healthcare utilization data will be obtained from insurance payers to validate caregiver 
report of utilization. This information includes: hospitalizations, ED visits, and PCP visits.  
  
Head Start Staff Assessments  
Prior to the delivery of the HS-level asthma education program at a HS program, all staff members (Family 
Service Coordinators, Teachers, Administrators) at HS centers (N=500) will be asked to complete a survey 
about knowledge, attitudes and practices related to asthma management. The survey will also include 
questions about personal knowledge about asthma management and Head Start policies about asthma 
management, their own health beliefs about asthma management, asthma beliefs about barriers to asthma 
management, and how often they engage in professional activities related to asthma management either 
directly with the children or indirectly in parent or staff trainings. The questionnaire will explicitly indicate 
that survey data will be maintained without personal identifiers and that completion of the survey indicated 
consent. Staff members who complete and return the survey will receive $10 compensation each year. This 
survey will also be completed immediately prior to initiation of the HS asthma educational staff workshops 
and materials distribution and in years 2 and 5. Staff may return the survey to a locked box at the site or by 
mail (envelope provided). Surveys will be distributed a second time to nonresponders.  
  
Intervention  
We propose to conduct a randomized controlled trial of a home-based asthma education intervention for Head 
Start students, nested within the context of a HS-level asthma education program. We will partner with 
Baltimore City Head Start to assist them in implementing this HS-level asthma education program across all 
Head Start programs. We describe below the randomized trial and our role in the HS-level asthma education 
program.   
  
Control Condition (CC).   
All participants who enroll in the trial and are randomized to the control condition will receive (along with 
all other Head Start students) Head Start-based asthma educational activities and materials. CC participants 
will be contacted for follow-up assessment at 3, 6, 9, and 12 months.   
  
Intervention Condition (IC).   
Participants randomized to the intervention condition will also receive the HS-level asthma education 
program activities and materials. In addition, participants will receive a culturally-specific home-based 
asthma education intervention, specifically designed to reflect known cultural barriers to effective asthma 
management among low-income minority families .Over the course of the intervention the family will 
receive  four weekly home visits (30-45 minutes each; approximately 1-, 2- 3-, and 4- weeks 
postrandomization) and  three quarterly phone sessions (20-30 minutes each, after the completion of each 
follow-up assessment) by a trained asthma educator. The asthma educator has the knowledge, comfort and 
experience with the community. The asthma educator overarching goals for intervention are to address 
known cultural barriers including underutilization of asthma primary care, overestimation of asthma 
control, perceptions that asthma is an episodic illness that only needs acute treatment, negative beliefs 
about controller medications, and environmental risk factors in the home. The intervention will begin by 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 8 of 13  
  
assessing the family’s asthma control and management practices. The asthma educator will review the 
direct, measurable benefits of preventative asthma care, home environmental risk factors, steps to take 
during an asthma exacerbation, providing low-literacy written asthma education materials and training on 
using medication devices, if prescribed. The asthma educator will also provide feedback on the child’s 
current level of control following NAEPP guidelines, using a validated asthma control measure.  
Additionally, the asthma educator will discuss the caregiver’s barriers and facilitators to accessing regular 
asthma care and daily self-management. The caregiver will be encouraged to set a personally relevant 
asthma goal (e.g., attending a PCP visit, giving the child medicine once a day), and problem solving will be 
used to collaboratively develop a plan to achieve the goal. A core component of the educational 
intervention is empowering and supporting caregivers to more effectively communicate with the child’s 
PCP about their child’s asthma.. Asthma education will be presented using strategies recommended by the 
Joint Commission for working with low literacy patient populations. The asthma educator will be trained 
to use plain language and to avoid medical jargon, and will limit information presented to two or three key 
elements. The asthma educator will use the “Tell me back/show me” strategy whereby the caregiver is 
asked to repeat the information provided in his/her own words or demonstrate a skill, and additional 
teaching is provided until there is full comprehension of the concept. As much as possible the asthma 
educator will use drawings, models, or diagrams. All intervention visits will be audio-taped. Some families 
will be asked to have their visits videotaped. If families agree to have their visits videotaped, they will be 
asked to sign another consent form. If they refuse to have their visits videotaped it will not affect their 
ability to participate in this study.   
  
  
“ABC Report”. After enrollment, the child’s caregiver-identified PCP will be faxed a letter describing the 
study and informing them of their patient’s participation. They will be invited to call the research team if they 
have any questions. They will be asked to complete the Current Asthma Treatment Plan (CATP) form. The 
asthma educator may contact the PCP as a part of study interventions; such contacts are integral components 
of the intervention and reflect the appropriate partnering and inclusion of the physician. After the first 
intervention session, the asthma educator will prepare the “ABC Report” which will include collected 
information relevant to asthma management, including: (1) feedback on the child’s level of asthma control, 
medication reconciliation if necessary (e.g., an indication if the medications in the home and family reported 
regimen do not match the CATP), environmental triggers (from the home assessment), and psychosocial 
concerns affecting asthma management; and (2) information the asthma educator has provided to the family 
(e.g., smoking cessation referral). The “ABC Report” will be faxed to the PCP with the family’s knowledge 
and permission.   
  
Asthma Outreach Workers education program  
In order to learn what skills work well to train asthma outreach workers we would like to conduct pre-post 
assessments with our hired asthma outreach workers. We will administer an assessment prior to any training 
and after training is completed. Training will include didactic lectures, hands-on practice with devices, role 
plays and supervised intervention sessions. We hope to learn if we are able to effectively train community 
workers to provide asthma education to families.   
  

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 9 of 13  
  
HS-level asthma education program  
In order to enhance the efficacy, reach, integration and sustainability of the proposed home-based asthma 
education intervention, we will train and facilitate Head Start staff to implement and deliver the HS-level 
asthma education program, utilizing existing community resources whenever possible. The HS-level 
asthma education program will consist of the following four components: 1) bi-annual Staff Training 
Workshops (for which HS staff will receive continuing education credit), 2) provision of relevant asthma 
educational materials drawn from public resources, 3) identification and facilitation of community 
resources relevant for achieving goals, and 4) ongoing expert facilitation of Head Start initiated asthma 
education activities (e.g. parent workshops, health fairs, newsletters)  
  
a. Study duration and number of study visits required of research participants. The study duration 
is 12 months for each participant. All participants will complete 5 surveys. The intervention 
condition will also receive 3 home visits and 4 phone calls. Head Start staff will be offered the 
opportunity to attend asthma education workshops which contain 8 modules and a 
postevaluation two times a year.   
b. Blinding, including justification for blinding or not blinding the trial, if applicable. N/A  
c. Justification of why participants will not receive routine care or will have current therapy 
stopped.    
All subjects will receive an asthma educational program within the Head Start setting which is 
not currently provided. Participants in the intervention condition will receive additional 
intervention.  
d. Justification for inclusion of a placebo or non-treatment group.  
Both groups will receive a Head Start level educational intervention, thus there is no nontreatment 
group. The intervention group will receive additional intervention sessions.  
e. Definition of treatment failure or participant removal criteria.   
Any participant can leave the study at any time. Participants will be removed from the study 
prior to randomization if the baseline assessment is not complete. Treatment failure is defined 
as subjects not completing the home visits. After the participant is randomized, subjects will 
not be removed from the study by investigators.  
f. 
Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely.   
  
This study does not provide experimental medical care for the participants but does encourage the 
families to keep all appointments with the child's PCP. The child's medical care will not be affected 
if the family ends their participation in the study prematurely. There are no known risks of exiting the 
study prematurely.  
  
5.  
Inclusion/Exclusion Criteria 
Inclusion:  
• 
Age 2-6 years   
• 
Currently enrolled in Baltimore City HS program  
• 
Physician diagnosis of asthma or reactive airway disease (RAD)   

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 10 of 13  
  
  
Exclusion:  
• 
Current participation in another respiratory research study  
• 
Families unwilling or unable to participate  
• 
A sibling enrolled in the study  
• 
Non-English speaking  
• 
Plans to move out of the Baltimore area in the next year  Living in transitional housing  
  
  
6.  
Drugs/ Substances/ Devices  N/A  
a. The rationale for choosing the drug and dose or for choosing the device to be used.  
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed.  
Study Statistics  
a. Primary outcome variable.  
The primary outcome is symptom free days which is a well-recognized, accepted index of asthma 
morbidity often used to assess the effectiveness of new therapies in children. A measure of SFD 
is calculated by subtracting the numbers of days and/or nights with asthma symptoms (i.e., cough, 
wheeze, shortness of breath) in the past month from 30 days. Studies utilizing clinical and 
education interventions have demonstrated that improvements of 2-3 SFD /month are feasible and 
clinically meaningful.   
  
b. Secondary outcome variables.  
Secondary outcomes include caregiver-reported healthcare utilization for urgent (ED visits and 
hospitalizations) and non-urgent (primary and specialist care) asthma visits, caregiver-reported 
oral steroid bursts, caregiver-reported asthma control and caregiver quality of life. We will also 
collect objective data on healthcare utilization from insurance payers to validate caregiver 
report. In addition, at the HS level, we will assess overall HS participation in the HS-level 
asthma education program and any additional programs or institutional changes that would 
indicate adoption, implementation and maintenance of asthma education as a core HS health 
goal and changes in HS staff knowledge, attitudes and practices related to asthma management.  
  
c. Statistical plan including sample size justification and interim data analysis.  
The power analysis is based on differences in symptom free days between the ABC group and 
the control group. We expect to recruit 406 total families (203 each group) and anticipate up to 
15% of those enrolled will be lost to follow-up for a final sample of 346 families included in the 
analyses. We chose this sample size because under a variety of scenarios, discussed below, it is 
considered sufficient to detect a similar increase in symptom free days seen in our previous 
study. Symptom free days will be assessed at baseline, 3-, 6- 9- and 12-months 
postrandomization. Choices for treatment effects, variability, associations (to account for the 
longitudinal nature of the study), and loss to follow up rates were informed by our previous 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 11 of 13  
  
study, as well as from the literature. The power calculations were obtained using the software 
package SAS version 9.2 (SAS Institute, Cary NC). We expect that both groups will have a 
mean (SD) number of symptom free days 23.65 (6.85) in a month at baseline. In our previous 
study, the ABC group experienced a 23% increase in symptom free days over the no-contact 
control group at 6 months post-randomization. This application proposes to achieve a similar, if 
not higher, increase in symptom free days at 6 months. Table 1 gives a summary of the 
estimated total sample size that we will need to detect effect under different power assumptions 
(power = 0.8, 0.9) and within-subject association (parameterized as a latent effect inducing 
correlations of (ρ = 0.5, 0.6, or 0.7). Inspection of the table below reveals that we will have 90% 
power to detect an approximate 23% increase in symptom free days for the ABC group at 6 
months post-randomization.  
  
Table 1  
  
  
  
  
   
Data will be summarized by intervention group (blinded for any interim analyses).  Initially we 
will examine both groups (ABC and Control) for differences in baseline independent/covariate 
variables (i.e., age, gender, and maternal age). Standard goodness-of-fit tests will be used to 
determine the approximate normality of the continuous demographic data and response 
variables under each hypothesis. Data will be transformed as appropriate before hypothesis 
testing is performed. It is common in prospective studies for a non-trivial fraction of the 
participants to be lost to follow-up during the course of the study. All outcome analysis will be 
based upon the intent-to-treat principle (ITT). The sample size calculation and the analytic plan 
anticipate a 15% loss to follow-up. From a statistical perspective, dropouts can be classified into 
two major groups: ignorable and non-ignorable. For the former, the probability of dropping out 
depends upon measured variables, e.g., severity of disease, age and gender. Nonignorable 
dropouts occur when the probability of dropping out depends upon unobserved quantities, e.g., 
the outcome that would have been observed had the person not dropped out. We will use 
statistical methods (weighted Generalized Estimating Equations or likelihood methods) that 
provide consistent inferences about the intervention effect for ignorable dropout processes. 
However, all methods of inference can be biased by non-ignorable dropouts. We will conduct 
sensitivity analyses to determine how extreme the non-ignorable missingness must be to 
severely compromise the major substantive findings of this research. We will also conduct 
interclass correlations (ICC) among children recruited from the same HS program for all 
outcome variables to test if our randomization schema worked. Since we will stratify our 
randomization by HS program, we anticipate that an equal number of children will receive the 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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ABC intervention compared to the control. However, if the ICC values indicate a cluster effect, 
this will be included in our models as nested data models.  
  
Dr. Callaghan-Koru at University of Maryland-Baltimore County will be completing secondary data 
analysis. UMBC has requested that Johns Hopkins Medicine IRB serve as the site's IRB. De-identified 
data sets will be sent by Johns Hopkins via HIPAA and JHMI compliant protocols and study participants 
will not directly interact with UMBC.   
   
d. Early stopping rules.   
The DSMB will develop early stopping rules based on their review of the study protocol. Once 
these rules have been developed they will be shared with the IRB.  
  
7.  
Risks  
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. Parents 
may be uncomfortable discussing the child’s asthma. Some families may experience possible 
family discord if the asthma management practices change.  Asthma educators will be trained to 
interact with families in a positive, non-judgmental manner that encourages honest 
communication and a partnership approach to asthma education. Care will be taken to help family 
members discover ways that they can all work together to better manage the child’s asthma.  
  
Maryland law requires us to tell the local or state authorities if we suspect abuse or neglect of a 
child or dependent adult.  If anyone reports that they plan to harm someone, we are required to 
contact the police. We may also warn the person who is at risk. The caregiver will be informed 
of the limits of confidentiality during the informed consent process and reminded of this during 
the first home visit. There are no risks to HS staff completing the staff survey.  
  
b. Steps taken to minimize the risks.  
Asthma educators are trained to learn how to clinically address family conflict about asthma 
practices. The family may refuse to allow the home visits at any time. If this were to happen, the 
child would continue to be followed and we will categorize him/her as receiving low dose 
intervention.   
  
c. Plan for reporting unanticipated problems or study deviations.  
In the event that any adverse event occurs during the course of the study, the adverse event will 
be reported to the Johns Hopkins University School of Medicine IRB using the IRB's Protocol 
Event Report by PI Form with suporting documentation of the adverse event and will also be 
reported to the study DSMB.  
  
d. Legal risks such as the risks that would be associated with breach of confidentiality.  
The only legal risk associated with participating in this study is the breach of confidentiality for 
the family in disclosing the child's participation in the study or data provided about the child.  For 
confidentialty protection, the identify and personal information of each subject will not be used 
in communication of the data and each subject will be assigned a unique study number for 

Date: January 26, 2017  
Principal Investigator: Michelle Eakin, Ph.D.  
Application Number: NA_00046455  
  
  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
Page 13 of 13  
  
identification.  All data will be held confidential and stored in locked files, accessible to 
authorized staff and investigators only. All staff members have completed the IRB certification 
so they are all aware of the importance of patient confidentiality. All newly hired staff will not be 
allowed access to any study information until they have completed and passed all IRB human 
subjects research certification examinations.  
  
e. Financial risks to the participants. N/A  
  
  
8.  
Benefits  
 
a.  
Description of the probable benefits for the participant and for society.  
The family may learn strategies to manage asthma in chidlren and thereby reduce moribidities 
associated with asthma. Study findings may provide evidence on how to improve clinical care 
to this vulnerable population of young children.  
  
  
9.  
Payment and Remuneration  
a.  
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol.  
  
The child’s parent/legal guardian will be given $30 for completing each of the phone 
surveys and $50 for each home visit, totalling$190. The parent/ legal guardian will receive 
an additional $50 if they choose to complete the family survey and a $20 incentive for each 
referral, for a maximum total of $150.   
  
Head Start Staff members will be given $10 for completing each of the staff surveys for a total 
of $30.   
  
Head Start teachers and family service coordinators (FSCs) will be paid $50 each when they 
achieve 80% completion rate of the ISS forms for their class (teacher) or classes (FSC)  
  
Interested Family members will receive $50 for completing the Family Health Questionnaire.   
  
  
10.  
Costs  
a.  
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who 
will pay for them. N/A