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A+ Asthma Early Intervention in Asthma Management
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00217906
  Purpose

This project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Condition Intervention
Asthma
Behavioral: A+ Asthma early intervention program

MedlinePlus related topics: Asthma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: October 1999
Estimated Study Completion Date: March 2004
Detailed Description:

BACKGROUND:

While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children.

DESIGN NARRATIVE:

Head Start sites will be randomized to either a minimal intervention control group or the A+ Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to: optimize classroom management of asthma, educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children.

The primary outcome that the study was designed to evaluate Head Start absences/days enrolled, determined by review of Head Start attendance records.

The secondary outcomes specified in the protocol are health care utilization (emergency department visits, hospitalizations, primary care visits), asthma symptoms (restricted activity, symptom-free days, day and nighttime symptoms), asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practices.

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Children aged 3 and 4 years who have asthma that is currently active

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217906

Sponsors and Collaborators
Investigators
Investigator: Cynthia Rand Johns Hopkins University
  More Information

Publications:
Study ID Numbers: 299
Study First Received: September 19, 2005
Last Updated: December 21, 2005
ClinicalTrials.gov Identifier: NCT00217906  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009