Clinical Trials Directory

Trials / Completed

CompletedNCT01676896

Asthma in Central Texas Project

Enhancing Children's and Parents' Asthma Management

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
292 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
6 Years – 13 Years
Healthy volunteers
Accepted

Summary

Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.

Detailed description

Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).

Conditions

Interventions

TypeNameDescription
BEHAVIORALAsthma in-school class
BEHAVIORALAsthma Day Camp
BEHAVIORALHealth Promotion in-school class

Timeline

Start date
2008-12-01
Primary completion
2013-09-01
Completion
2014-11-01
First posted
2012-08-31
Last updated
2015-04-24
Results posted
2015-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01676896. Inclusion in this directory is not an endorsement.