Actively Recruiting

Phase Not Applicable
Age: 5Years - 12Years
All Genders
NCT06003569

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Led by University of Colorado, Denver · Updated on 2026-04-13

300

Participants Needed

13

Research Sites

201 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.

CONDITIONS

Official Title

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Who Can Participate

Age: 5Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Students with poor asthma control or indicators of excess burden on school Asthma Intake Form
  • Children aged 5 to 12 years
  • Attending a participating school in rural Colorado with high socioeconomic need based on free-and-reduced lunch rates or rural status
Not Eligible

You will not qualify if you...

  • Children younger than 5 years or older than 12 years
  • Students with no asthma or well-controlled asthma

AI-Screening

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Trial Site Locations

Total: 13 locations

1

Ault-Highland RE-9 school district

Ault, Colorado, United States, 80610

Actively Recruiting

2

Colorado Springs 11

Colorado Springs, Colorado, United States, 80907

Actively Recruiting

3

Harrison 2 school district

Colorado Springs, Colorado, United States, 80916

Actively Recruiting

4

Ellicott 22 school district

Ellicott, Colorado, United States, 80808

Actively Recruiting

5

Fountain 8 school district

Fountain, Colorado, United States, 80817

Actively Recruiting

6

Granada school district

Granada, Colorado, United States, 81041

Actively Recruiting

7

Greeley 6

Greeley, Colorado, United States, 80631

Actively Recruiting

8

East Otero R1 school district

La Junta, Colorado, United States, 81050

Actively Recruiting

9

Lamar RE2 school district

Lamar, Colorado, United States, 81052

Actively Recruiting

10

Las Animas school district

Las Animas, Colorado, United States, 81054

Actively Recruiting

11

Manzanola school district

Manzanola, Colorado, United States, 81058

Actively Recruiting

12

Weld County RE1

Platteville, Colorado, United States, 80651

Actively Recruiting

13

Wiggins RE-50(J)

Wiggins, Colorado, United States, 80654

Actively Recruiting

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Research Team

M

Michaela Brtnikova, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

3

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