School-based Approaches to Help Pre-teens Manage Asthma (DMSP)
January 16, 2013 updated by: Noreen M. Clark, University of Michigan
This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI.
The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes.
Outcomes of interest are symptom experience, quality of life, self-management, and school grades.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed.
DESIGN NARRATIVE:
If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys.
Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance.
Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.
Study Type
Interventional
Enrollment (Actual)
1292
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Open Airways Educational Intervention
Children in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator.
|
Other Names:
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Active Comparator: Open Airways and Peer Asthma Action Intervention Education
Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.
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Other Names:
Other Names:
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No Intervention: Control Arm
Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Care Use Data
Time Frame: At Baseline, 12 month and 24 months
|
health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
|
At Baseline, 12 month and 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Noreen M. Clark, PhD, University of Michigan School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
September 19, 2005
First Submitted That Met QC Criteria
September 19, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 288
- R01HL068654-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.