Trials / Completed
CompletedNCT02206061
School-based Asthma Care for Teens (SB-ACT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 430 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to evaluate the widespread implementation of a developmentally appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed therapy (DOT) to allow the teen to experience the potential benefits from adhering to guideline-based asthma treatment, and 2) a developmentally appropriate Motivational Interviewing (MI) Counseling Intervention to help the teen transition to independent long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT program will 1) experience less asthma-related morbidity than an asthma education (AE) attention-control comparison group, and 2) have improved adherence, less urgent healthcare use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The investigators also hypothesize that participants receiving DOT-only will have improved asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but will not have sustained, clinically significant improvement in outcomes once the DOT phase is complete. This represents a unique opportunity to build upon existing community relationships with an innovative and developmentally focused program to improve asthma outcomes for urban teens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | School-Based Asthma Care for Teens (SB-ACT) | |
| BEHAVIORAL | Directly Observed Therapy | |
| BEHAVIORAL | Asthma Education |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2020-03-01
- Completion
- 2021-02-01
- First posted
- 2014-08-01
- Last updated
- 2021-05-14
- Results posted
- 2021-02-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02206061. Inclusion in this directory is not an endorsement.