Asthma in Central Texas Project

NCT ID: NCT01676896

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2014-11-30

Brief 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

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Asthma in-school class

Provided 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 Type: EXPERIMENTAL

Asthma in-school class

Intervention Type: BEHAVIORAL

Asthma Day Camp

The 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 Type: EXPERIMENTAL

Asthma Day Camp

Intervention Type: BEHAVIORAL

Health Promotion in-school class

The 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.

Group Type: SHAM_COMPARATOR

Health Promotion in-school class

Intervention Type: BEHAVIORAL

Interventions

Asthma in-school class

Intervention Type: BEHAVIORAL

Asthma Day Camp

Intervention Type: BEHAVIORAL

Health Promotion in-school class

Intervention Type: BEHAVIORAL

Other Intervention Names

Asthma Plan for Kids

Eligibility Criteria

Inclusion Criteria

• parent reports the child has a diagnosis of asthma made by a medical provider;
• has had asthma symptoms in the previous 12 months;
• speaks either English or Spanish.

Exclusion Criteria

• has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

R01NR007770

Identifier Type: NIH

Identifier Source: secondary_id

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R01NR007770

Identifier Type: NIH

Identifier Source: org_study_id

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