School-based Approaches to Help Pre-teens Manage Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 1,292
- Primary Endpoint
- Health Care Use Data
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 11 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Open Airways Educational Intervention (Behavioral)
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.
Intervention: Open Airways Educational Intervention (Behavioral)
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.
Intervention: Peer Asthma Action Educational Intervention (Behavioral)
Control Arm
Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Noreen M. Clark
Principal Investigator
University of Michigan