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Recruiting Not applicable Interventional

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

ClinicalTrials.gov ID: NCT06003569

Public ClinicalTrials.gov record NCT06003569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06003569
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Enrollment
300 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
5 Years to 12 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 20, 2023
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027
Last update posted
Apr 12, 2026

2023 – 2027

United States locations

U.S. sites
13
U.S. states
1
U.S. cities
12
Facility City State ZIP Site status
Ault-Highland RE-9 school district Ault Colorado 80610 Recruiting
Colorado Springs 11 Colorado Springs Colorado 80907 Recruiting
Harrison 2 school district Colorado Springs Colorado 80916 Recruiting
Ellicott 22 school district Ellicott Colorado 80808 Recruiting
Fountain 8 school district Fountain Colorado 80817 Recruiting
Granada school district Granada Colorado 81041 Recruiting
Greeley 6 Greeley Colorado 80631 Recruiting
East Otero R1 school district La Junta Colorado 81050 Recruiting
Lamar RE2 school district Lamar Colorado 81052 Recruiting
Las Animas school district Las Animas Colorado 81054 Recruiting
Manzanola school district Manzanola Colorado 81058 Recruiting
Weld County RE1 Platteville Colorado 80651 Recruiting
Wiggins RE-50(J) Wiggins Colorado 80654 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06003569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06003569 live on ClinicalTrials.gov.

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