HealthSpark 2: Improving Asthma Care for Preschool Children

This study has been completed.
Sponsor:
Collaborators:
Health Foundation of South Florida
Ounce of Prevention Fund
The Early Childhood Initiative Foundation
Early Learning Coalition
Information provided by (Responsible Party):
Jeffrey P. Brosco, University of Miami
ClinicalTrials.gov Identifier:
NCT00304304
First received: March 16, 2006
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their "asthma-friendly" rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the "asthma-friendliness" of each center. We will use a wait-list control, with all centers eventually receiving the intervention.


Condition Intervention
Asthma
Behavioral: Asthma education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Community - Based Asthma Intervention in Subsidized Preschools

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 6 month post-intervention: quality of CCC asthma policy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Did CCC have appropriate policy


Secondary Outcome Measures:
  • 6 month post-intervention changes in asthma outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Parent-report of fewer asthma symptoms


Estimated Enrollment: 2000
Study Start Date: February 2006
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention - asthma education
CCC received asthma education in the first 6 months of the study
Behavioral: Asthma education
Research assistant worked with CCC staff on asthma prevention
Placebo Comparator: Wait-list control
CCC received asthma education in second 6 months of study
Behavioral: Asthma education
Research assistant worked with CCC staff on asthma prevention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers

Exclusion Criteria:

  • Children under the age of 1 year
  • Children whose parents do not want to participate
  • Children whose child care centers do not want to participate
  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 ClinicalTrials.gov identifier: NCT00304304

Locations
United States, Florida
University of Miami Mailman Center for Child Development
Miami, Florida, United States, 33101
Sponsors and Collaborators
University of Miami
Health Foundation of South Florida
Ounce of Prevention Fund
The Early Childhood Initiative Foundation
Early Learning Coalition
Investigators
Principal Investigator: Jeffrey P Brosco, MD PhD University of Miami
  More Information

No publications provided

Responsible Party: Jeffrey P. Brosco, Professor, Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT00304304     History of Changes
Other Study ID Numbers: 20057395
Study First Received: March 16, 2006
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
child care centers
asthma triggers
community-based research

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014