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SMART-School-based Asthma Therapy
SMART-School-based Asthma Therapy

NCT06796387

Not Yet RecruitingNA

Sponsor: University of Rochester

Conditions: Asthma in Children

Interventions: SMART-SBAT, Usual Care

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 overview

Sex: ALL

Age: 6 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Based on prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.