Completed
Enhancing Children's and Parents' Asthma Management
What is being tested
Asthma in-school class
+ Asthma Day Camp
+ Health Promotion in-school class
Behavioral
Who is being recruted
Bronchial Diseases+6
+ Hypersensitivity
+ Hypersensitivity, Immediate
From 6 to 13 Years
+4 Eligibility Criteria
How is the trial designed
Placebo-Controlled
Interventional
Study Start: December 2008
Summary
Principal SponsorUniversity of Texas at Austin
Last updated: April 24, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2008
Actual date on which the first participant was enrolled.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).
Principal SponsorUniversity of Texas at Austin
Last updated: April 24, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
292 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma
Criteria
3 inclusion criteria required to participate
has had asthma symptoms in the previous 12 months
parent reports the child has a diagnosis of asthma made by a medical provider
speaks either English or Spanish
1 exclusion criteria prevent from participating
has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalProvided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Group II
ExperimentalThe asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff.
The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g.
teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Group III
ShamThe mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The University of Texas at Austin
Austin, United StatesOpen The University of Texas at Austin in Google MapsCompletedOne Study Center