Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06320210

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Interventions

Multicomponent program

Study Details

Brief summary:

Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level.

Conditions

Asthma in Children

Study ID

NCT06320210

Start date

Aug 31, 2023

Status verified date

May, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Participants will be included in the study if:

1. The participant either works at, attends, or is the legal guardian of a child who attends one of the two elementary schools included in the study from the University of Chicago Charter Schools - North Kenwood Oakland and Donoghue.
2. The child participant has a diagnosis of asthma OR the parent participant is legal guardian of a child with asthma.
3. The adult stakeholder is 18 years or older.

Participants will be excluded from the study if:

1. The participant declines or is unable to provide consent/assent
2. The participant does not speak or read English
3. The participant has already enrolled in the study

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Children with asthma, parents/guardians of children with asthma, school staff

Children will be recruited from two University of Chicago Charter elementary schools. Children with a diagnosis of asthma and their parents will be eligible for inclusion in the study and will specifically be targeted for study recruitment. Staff and administrators at each school will also be recruited through in-person, phone, and email communication, primarily through word of mouth and professional development days. UCCS teachers, staff, and administrators will also be included in the program evaluation and we will obtain appropriate consent.

Up to 400 families with a child/children with asthma from two UCCS schools will be added to a registry database. A total of 68 children with a diagnosis of asthma and their parents will be recruited for evaluation of the multi-component program, resulting in a total of 136 children and parents. We will also recruit 24 teachers, staff, and administrators across the two schools to participate in the evaluation of the overall program.

Interventions

Multicomponent program

The intervention is a multi-component program that includes in-depth training for current school teachers/staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to support integrated systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.

Primary outcome measure

  • Asthma control [ Time Frame: Years 1 and 2 ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago Charter Schools

Recruiting

Chicago, Illinois, United States, 60640

More Information

Sponsor

University of Chicago

Last update posted

May 10, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2024-05-10.