SMART-School-based Asthma Therapy
ConditionAsthma in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Rochester
About this trial
The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize effectiveness outcomes and inform future scale-up.
Eligibility criteria
Qualifiers
Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria
Age >=6 and =<12 years
Attending school in Rochester City School District
Caregiver >=18 years, and is able to understand and speak English or Spanish
Disqualifiers
Caregiver inability to speak and understand English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.)
Having 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.
In foster care or other situations in which consent cannot be obtained from a guardian.
Trial design
Treatments tested in this trial
- SMART-SBAT
- Usual Care
Treatment groups
330 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Rochester
Lead sponsor
Michigan State University
Collaborator
Source ClinicalTrials.gov