School-based Approaches to Help Pre-teens Manage Asthma (DMSP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Noreen M. Clark, University of Michigan
ClinicalTrials.gov Identifier:
NCT00217776
First received: September 19, 2005
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Open Airways Educational Intervention
Behavioral: Peer Asthma Action Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Health Care Use Data [ Time Frame: At Baseline, 12 month and 24 months ] [ Designated as safety issue: No ]
    health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.


Enrollment: 1292
Study Start Date: February 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Open Airways Educational Intervention
Other Name: A 6 week asthma educational self management program for middle school students.
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.
Behavioral: Open Airways Educational Intervention
Other Name: A 6 week asthma educational self management program for middle school students.
Behavioral: Peer Asthma Action Educational Intervention
Other Name: Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
No Intervention: Control Arm
Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT00217776

Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Noreen M. Clark, PhD University of Michigan School of Public Health
  More Information

No publications provided

Responsible Party: Noreen M. Clark, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00217776     History of Changes
Other Study ID Numbers: 288, R01HL068654-04
Study First Received: September 19, 2005
Last Updated: January 16, 2013
Health Authority: United States: Federal Government

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 August 18, 2014