View Clinical Trial (Medical Research Study)
Reducing Asthma Morbidity In High Risk Minority Preschool Children
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21224 |
| Conditions: |
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Asthma |
| Purpose: |
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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, ED 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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Enrolled in Head Start
- Physician diagnosed asthma or reactive airway disease
- resides in Baltimore City
- English Speaking
- Asthma symptoms on 4 days/nights in the last four weeks or use of albuterol one time
in the last week or ED visit in the last 6 months
Exclusion Criteria:
- Enrolled in another pulmonary research study
- sibling enrolled in study
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| NCT ID: |
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NCT01519453 |
| Primary Contact: |
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Principal Investigator
Cynthia Rand, Ph.D.
Johns Hopkins University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21224
United States
Michelle Eakin, Ph.D.
Phone: 410-550-0487
Email: meakin1@jhmi.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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