Reducing Asthma Morbidity In High Risk Minority Preschool Children

Study Overview
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Brief Summary
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Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.

Detailed Description
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Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies 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 young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, Emergency Department visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.

Official Title
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Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Home Based Asthma Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in Head Start Physician diagnosed asthma or reactive airway disease Resides in Baltimore City or Baltimore County English Speaking Exclusion Criteria: Enrolled in another pulmonary research study Sibling enrolled in study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Based Asthma Education<br>Families will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker | Behavioral: Home Based Asthma Education<br>* 4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education<br>|
| No Intervention: Control<br>There is no control arm specific intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control. | Baseline, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Emergency Department (ED) Visits [Child] | Aggregate number of ED visits for asthma in past 90 days for all participants. | Baseline, 3, 6, 9 and 12 months | 
| Total Number of Hospitalizations [Child] | Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Preschool, Health Disparities, Implementation