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Randomized Controlled Trial
. 2025 Nov;13(11):2980-2990.e4.
doi: 10.1016/j.jaip.2025.07.022. Epub 2025 Aug 22.

A Pilot Pragmatic Cluster Randomized Trial of School-Supervised Therapy to Improve Pediatric Asthma Control

Michelle Trivedi  1 , Michelle Spano  2 , Christine Frisard  3 , Sybil Crawford  4 , Grace Ryan  3 , Melissa Goulding  3 , Sonia Radu  2 , Juliana Arenas  5 , Sarah Becker  2 , Layana Al-Halbouni  6 , Jordan Alter  7 , Nancy Byatt  8 , Wanda Phipatanakul  9 , Milagros C Rosal  3 , Stephenie C Lemon  3 , Lynn B Gerald  10 , Lori Pbert  3
Affiliations
Randomized Controlled Trial

A Pilot Pragmatic Cluster Randomized Trial of School-Supervised Therapy to Improve Pediatric Asthma Control

Michelle Trivedi et al. J Allergy Clin Immunol Pract. 2025 Nov.

Abstract

Background: Although school-supervised inhaled corticosteroid administration has potential to improve asthma morbidity, there has yet to be an evaluation of the pediatric practice as a setting to identify children with asthma and connect them to school-supervised asthma therapy.

Objective: Conduct a pragmatic pilot trial of Asthma Link, a model that connects children with asthma seen in pediatric practice to supervised asthma therapy in the school setting.

Methods: Four pediatric practices were pair-matched and randomized to (1) Asthma Link plus an asthma educational workbook or (2) Enhanced Usual Care, the same workbook alone. We recruited children 6 to 17 years old with poorly controlled asthma, prescribed a daily inhaled corticosteroid. Parent-child dyads completed surveys at baseline and 3, 6, and 12 months.

Primary outcomes: recruitment/retention of pediatric practices and parent-child dyads and intervention fidelity.

Secondary outcomes: asthma symptoms, medication adherence, emergency room visits, hospital admissions, oral steroid use, missed schooldays.

Results: Four pediatric practices and 66 parent-child dyads were recruited (average child age 9 y, 44% female, 65% Hispanic, 23% Black, 62% low income). All (4 of 4) practices were retained throughout the study and retention of parent-child dyads was 95%, 91%, and 89% at 3, 6, and 12 months, respectively. All (31 of 31) Asthma Link families brought their child's preventive inhaler into school; children received school health staff-supervised therapy on more than 95% of schooldays over 12 months. Children in the Asthma Link group had greater improvement in Asthma Control Test scores, longer time to first asthma exacerbation, less oral steroid use, and better medication adherence compared with the Enhanced Usual Care group.

Conclusions: Extending the reach of pediatric practices to facilitate the delivery of daily asthma prevention medication at school was feasible and improved pediatric asthma morbidity.

Keywords: Asthma; Clinical; Cluster randomized trial; Community trial; Community-clinical linkage; Pediatric; Practice; School; Sustainable.

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Conflict of interest statement

Dr. Byatt has received salary and/or funding support from Massachusetts Department of Mental Health via the Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms). She is also the Medical Director of Research and Evaluation for MCPAP for Moms and the Executive Director of the Lifeline for Families Center at UMass Chan Medical School. She has served as a consultant for The Kinetix Group, VentureWell, and JBS International.

Figures

Figure 1a.
Figure 1a.
Consolidated Standards of Reporting Trials (CONSORT) Diagram
Figure 1b.
Figure 1b.
CONSORT Diagram with Individual-Level Participant Flow
Figure 2:
Figure 2:
Intervention Fidelity by Study Month (Asthma Link Condition Only)
Figure 3.
Figure 3.
Crude Asthma Control Test Score at Each Time Point by Study Condition
Figure 4.
Figure 4.. Time to First Asthma Exacerbation over the 12-month Study Period
EUC= Enhanced Usual Care Asthma Exacerbation= oral steroid use, emergency room visit, or hospital admission for asthma
See this image and copyright information in PMC

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