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OpenTrials
Completed

NCT Number: NCT00217776

School-based Approaches to Help Pre-teens Manage Asthma

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.

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Key information

Age range

11 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Airways Educational Intervention

Behavioral

Other names: A 6 week asthma educational self management program for middle school students.

Peer Asthma Action Educational Intervention

Behavioral

Other names: Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: DMSP

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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