School-based Approaches to Help Pre-teens Manage Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Open Airways Educational Intervention; Behavioral: Peer Asthma Action Educational Intervention

• Registration Number: NCT00217776
• Lead Sponsor: University of Michigan

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.

Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Airways Educational Intervention	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.
Open Airways and Peer Asthma Action Intervention Education	Open Airways Educational Intervention	Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.
Open Airways and Peer Asthma Action Intervention Education	Peer Asthma Action Educational Intervention	Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.

Primary Outcome Measures

Name	Time	Method
Health Care Use Data	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.