N/A
Completed N=430
School-based Asthma Care for Teens (SB-ACT)
Source: ClinicalTrials.gov NCT02206061 ↗Enrolled (actual)
430
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months) — 11.5; 11.4; 11.6 Days — p=<.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months) |
11.5; 11.4; 11.6 | <.05 sig |
Eligibility Criteria
Inclusion Criteria
- Physician-diagnosed asthma
- Persistent asthma or poor asthma control (based on NHLBI guidelines).
- Attending secondary school in Rochester City School District
Exclusion Criteria
- Inability to speak and understand English
- No access to a phone for follow-up surveys
- Diagnosed developmental or intellectual disability
- Other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- Teens in foster care or other situations in which consent cannot be obtained from a guardian.
Data sourced from ClinicalTrials.gov (NCT02206061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.