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Reducing Asthma Morbidity In High Risk Minority Preschool Children (ABC-HS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Johns Hopkins University
Information provided by (Responsible Party):
Cynthia Rand, Ph.D., Johns Hopkins University Identifier:
First received: January 24, 2012
Last updated: September 17, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Behavioral: Home Based Asthma Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Asthma Morbidity In High Risk Minority Preschool Children

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Symptom Free days [ Time Frame: 30 days ]
    Number of days within the past 30 days the child reports not having asthma symptoms

Secondary Outcome Measures:
  • Emergency Department (ED) visits [ Time Frame: 3 months ]
    Number of ED visits for asthma in past 30 days

  • Hospitalizations [ Time Frame: 3 months ]
    Number of hospitalizations in last 3 months due to asthma

Estimated Enrollment: 406
Study Start Date: September 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Based Asthma Education
Families will receive 4 home and 3 phone asthma education sessions with a community asthma outreach worker
Behavioral: Home Based Asthma Education
4 home and 3 phone sessions with community asthma outreach worker to provide families with asthma education
No Intervention: Control


Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01519453

United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michelle Eakin, Ph.D.    410-550-0487   
Principal Investigator: Cynthia Rand, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Cynthia Rand, Ph.D. Johns Hopkins University
  More Information

Responsible Party: Cynthia Rand, Ph.D., Professor, Johns Hopkins University Identifier: NCT01519453     History of Changes
Other Study ID Numbers: HL-107223
Study First Received: January 24, 2012
Last Updated: September 17, 2015

Keywords provided by Johns Hopkins University:
Health Disparities

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on March 27, 2017