Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence (CASCADE)

May 8, 2024 updated by: University of Chicago
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Significant health disparities persist in childhood asthma prevalence and morbidity despite existing evidence-based asthma guidelines that have been shown to improve outcomes. Schools are an integral partner in asthma management. Prior literature has outlined various targeted school-based interventions with some positive outcomes; however, these programs focus on individual components of the guidelines and take place transiently without integration into school processes for sustainability. To more comprehensively impact asthma care, schools have enacted policies to support guideline-based practices; however, implementation falls short and thus these policies have not led to effective, systemic practices. Therefore, this project aims to bridge the gap in the implementation of asthma guidelines and policies by developing and evaluating a pragmatic, multicomponent school-directed, child-centered asthma program that builds upon existing targeted interventions and is integrated in the school to foster sustainability. This innovative project contributes beyond existing school-based programs by simultaneously and pragmatically implementing multiple components of the asthma guidelines through school-wide systems and streamlined processes led by lay health workers.

A multi-level program will be put in place for all students and families within the school. Intervention components will include: in-depth training for current school staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to create integrated tracking 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • University of Chicago Charter Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Children will be recruited from two UCCS elementary schools. Children with a diagnosis of asthma and their parents will be eligible for inclusion in the study. 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: Years 1 and 2
Childhood Asthma Control Test
Years 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missed work days in parents
Time Frame: Years 1 and 2
Parent reports, logs
Years 1 and 2
Asthma knowledge - parents
Time Frame: Years 1 and 2
Asthma Knowledge Scale
Years 1 and 2
Asthma knowledge - child
Time Frame: Years 1 and 2
Asthma Knowledge Scale
Years 1 and 2
Asthma quality of life - child
Time Frame: Years 1 and 2
Pediatric Asthma Quality of Life Questionnaire
Years 1 and 2
Caregiver quality of life
Time Frame: Years 1 and 2
Pediatric Asthma Caregiver's Quality of Life Questionnaire
Years 1 and 2
Asthma impact - parent
Time Frame: Years 1 and 2
Parent Proxy Asthma Impact Scale
Years 1 and 2
Missed school days
Time Frame: Years 1 and 2
School records, parent report, logs
Years 1 and 2
Healthcare utilization
Time Frame: Years 1 and 2
Parent report and logs of ambulatory visits, emergency department visits, hospitalizations
Years 1 and 2
Asthma impact - child
Time Frame: Years 1 and 2
Pediatric Asthma Impact Scale
Years 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Anna Volerman, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB19-1308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma in Children

Clinical Trials on Multicomponent program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe