Asthma in ChildrenCASCADENCT06320210
Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence
A study testing Multicomponent program in people with Asthma in Children, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Multicomponent program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Participants will be included in the study if:
- 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.
- The child participant has a diagnosis of asthma OR the parent participant is legal guardian of a child with asthma.
- The adult stakeholder is 18 years or older.
Participants will be excluded from the study if:
- The participant declines or is unable to provide consent/assent
- The participant does not speak or read English
- The participant has already enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Charter Schools
Chicago, Illinois, 60640
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Multicomponent program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with asthma, parents/guardians of children with asthma, school staff | Experimental | 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. Receives: Behavioral: Multicomponent program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
Childhood Asthma Control Test
Measured: Years 1 and 2
Secondary outcomes (9)
Missed work days in parents
Parent reports, logs
Measured: Years 1 and 2
Asthma knowledge - parents
Asthma Knowledge Scale
Measured: Years 1 and 2
Asthma knowledge - child
Asthma Knowledge Scale
Measured: Years 1 and 2
Asthma quality of life - child
Pediatric Asthma Quality of Life Questionnaire
Measured: Years 1 and 2
Caregiver quality of life
Pediatric Asthma Caregiver's Quality of Life Questionnaire
Measured: Years 1 and 2
Asthma impact - parent
Parent Proxy Asthma Impact Scale
Measured: Years 1 and 2
Missed school days
School records, parent report, logs
Measured: Years 1 and 2
Healthcare utilization
Parent report and logs of ambulatory visits, emergency department visits, hospitalizations
Measured: Years 1 and 2
Asthma impact - child
Pediatric Asthma Impact Scale
Measured: Years 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start31 Aug 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Volerman, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320210
- Sponsor's protocol ID
- IRB19-1308
- Acronym
- CASCADE
- Status last verified
- May 2024
- First submitted
- 12 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013 Dec;(258):1-81.
PubMed 24784481National Surveillance of Asthma: United States, 2001-2010. Hyattsville, MD: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 2012.
Centers for Disease Control and Prevention. Asthma Data, Statistics, and Surveillance. Most Recent Asthma Data. 2017.
Centers for Disease Control and Prevention. Asthma-Related Missed School Days among Children Aged 5-17 Years.; 2015.
Quinn K, Shalowitz MU, Berry CA, Mijanovich T, Wolf RL. Racial and ethnic disparities in diagnosed and possible undiagnosed asthma among public-school children in Chicago. Am J Public Health. 2006 Sep;96(9):1599-603. doi: 10.2105/AJPH.2005.071514. Epub 2006 Feb 28.
PubMed 16507720Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.
PubMed 26712860Gupta RS, Zhang X, Sharp LK, Shannon JJ, Weiss KB. Geographic variability in childhood asthma prevalence in Chicago. J Allergy Clin Immunol. 2008 Mar;121(3):639-645.e1. doi: 10.1016/j.jaci.2007.11.036. Epub 2008 Feb 4.
PubMed 18243285Illinois Department of Public Health. The Burden of Asthma in Illinois, 2000-2011. State of Illinois; 2013.
Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
PubMed 19221156Volerman A, Kan K, Salem E, Prachand N, Warren CM, Sighoko D, Gupta RS. Disparities persist in asthma-related emergency department visits among Chicago children. Ann Allergy Asthma Immunol. 2019 Apr;122(4):417-419.e1. doi: 10.1016/j.anai.2019.01.011. Epub 2019 Jan 24. No abstract available.
PubMed 30684738National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 3. Washington, DC: US Department of Health and Human Services; 2007.
National Heart, Lung, and Blood Institute. Managing Asthma: A Guide for Schools. Washington, DC: US Department of Health and Human Services; 2014.
Asthma Management Policy. Chicago Public Schools Policy Manual; 2012.
Cloutier MM, Hall CB, Wakefield DB, Bailit H. Use of asthma guidelines by primary care providers to reduce hospitalizations and emergency department visits in poor, minority, urban children. J Pediatr. 2005 May;146(5):591-7. doi: 10.1016/j.jpeds.2004.12.017.
PubMed 15870660Grant EN, Malone A, Lyttle CS, Weiss KB. Asthma morbidity and treatment in the Chicago metropolitan area: one decade after national guidelines. Ann Allergy Asthma Immunol. 2005 Jul;95(1):19-25. doi: 10.1016/S1081-1206(10)61183-0.
PubMed 16095137
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence
- ClinicalTrials.gov ID
- NCT06320210
- Acronym / sponsor ID
- CASCADE / IRB19-1308
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with asthma, parents/guardians of children with asthma, school staff | Experimental | Behavioral: Multicomponent programChildren 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent programThe 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. | Behavioural | Children with asthma, parents/guardians of children with asthma, school staff |
Primary outcome
Asthma control
Time frame: Years 1 and 2
Childhood Asthma Control Test
9 secondary outcomes
Missed work days in parents
Time frame: Years 1 and 2
Asthma knowledge - parents
Time frame: Years 1 and 2
Asthma knowledge - child
Time frame: Years 1 and 2
Asthma quality of life - child
Time frame: Years 1 and 2
Caregiver quality of life
Time frame: Years 1 and 2
Asthma impact - parent
Time frame: Years 1 and 2
Missed school days
Time frame: Years 1 and 2
Healthcare utilization
Time frame: Years 1 and 2
Asthma impact - child
Time frame: Years 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 24784481Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013 Dec;(258):1-81.
- BackgroundNational Surveillance of Asthma: United States, 2001-2010. Hyattsville, MD: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 2012.
- BackgroundCenters for Disease Control and Prevention. Asthma Data, Statistics, and Surveillance. Most Recent Asthma Data. 2017.
- BackgroundCenters for Disease Control and Prevention. Asthma-Related Missed School Days among Children Aged 5-17 Years.; 2015.
- Background: PubMed 16507720Quinn K, Shalowitz MU, Berry CA, Mijanovich T, Wolf RL. Racial and ethnic disparities in diagnosed and possible undiagnosed asthma among public-school children in Chicago. Am J Public Health. 2006 Sep;96(9):1599-603. doi: 10.2105/AJPH.2005.071514. Epub 2006 Feb 28.
- Background: PubMed 26712860Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.
- Background: PubMed 18243285Gupta RS, Zhang X, Sharp LK, Shannon JJ, Weiss KB. Geographic variability in childhood asthma prevalence in Chicago. J Allergy Clin Immunol. 2008 Mar;121(3):639-645.e1. doi: 10.1016/j.jaci.2007.11.036. Epub 2008 Feb 4.
- BackgroundIllinois Department of Public Health. The Burden of Asthma in Illinois, 2000-2011. State of Illinois; 2013.
- Background: PubMed 19221156Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
- Background: PubMed 30684738Volerman A, Kan K, Salem E, Prachand N, Warren CM, Sighoko D, Gupta RS. Disparities persist in asthma-related emergency department visits among Chicago children. Ann Allergy Asthma Immunol. 2019 Apr;122(4):417-419.e1. doi: 10.1016/j.anai.2019.01.011. Epub 2019 Jan 24. No abstract available.
- BackgroundNational Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 3. Washington, DC: US Department of Health and Human Services; 2007.
- BackgroundNational Heart, Lung, and Blood Institute. Managing Asthma: A Guide for Schools. Washington, DC: US Department of Health and Human Services; 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Volerman, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent program in people with Asthma in Children, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Volerman, MD (773-702-5905, avbeaser@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: Years 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320210, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.