School-supervised asthma therapy for children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster randomized controlled trial aims to evaluate the effectiveness of the Asthma Link program, which provides school-supervised asthma therapy, compared to an educational workbook for children aged 5-14 with poorly controlled asthma. The intervention focuses on improving medication adherence and asthma symptoms, particularly among low-income and racial/ethnic minority children. By partnering pediatric practices, schools, and families, the program seeks to enhance asthma management in a real-world setting. The study builds on previous pilot findings that indicated improved asthma outcomes with this approach.

Why it matters

Who can join: the full rules

STUDY INCLUSION/EXCLUSION CRITERIA:

Child Inclusion Criteria:

* Meet the eligibility criteria for Asthma Link (as described below)
* Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
* Able and willing to provide informed assent

Child Exclusion Criteria:

* Unable or unwilling to provide informed assent
* Developmental delay that would prevent study participation.

Parent Inclusion Criteria:

* Parent/guardian to patient
* 18 years or older
* Able to understand and communicate in English or Spanish
* Able and willing to provide informed consent.

Child eligibility for children enrolled in Asthma Link:

* children aged 5-14 years (enrolled in grade K-8)
* prescribed daily inhaled corticosteroid (ICS) for asthma
* Asthma Control Test (ACT) score ≤19 OR 1 or more of ANY of following in the past 1 year: course of oral steroids, hospitalization, Emergency Department visit, sick visit for asthma
* parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
* able and willing to assent
* parental permission
* English or Spanish speaking

Where it's running

• University of Massachusetts Chan Medical School
  Worcester, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Michelle Trivedi, MD — UMass Chan Medical School
• Study coordinator: Michelle Trivedi, MD
• Email: Michelle.Trivedi3@umassmed.edu
• Phone: 7744418086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.