Asthma in ChildrenNCT05004714
Y of Central Maryland Head Start Asthma Implementation
An observational study of Asthma in Children and Implementation, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma in Children, Implementation, Preschool Children
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2020to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma
Who may be able to join
- Aged 18 or older
- Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma
- Cognitive ability to provide consent
- Willing to be audio recorded
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Easter Seals Head Start Prince George's County
District Heights, Maryland, 20747
- Recruiting
Y of Central Maryland Head Start
Nottingham, Maryland, 21236
About this study
Official title: Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers
Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.
- Conditions
- Asthma in Children, Implementation, Preschool Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head Start Staff | Head Start staff including teachers, family advocates, directors, and others | |
| Head Start Children with Asthma | Children enrolled in Head Start program with physician diagnosed asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Absences due to asthma symptoms
Child Level Outcome
Measured: 5 years
Secondary outcomes (1)
Implementation evaluation
Adoption and penetration
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle Eakin, PhD, Principal investigator, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004714
- Sponsor's protocol ID
- IRB00244099
- Other IDs
- R01HL146785-01A1
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers
- ClinicalTrials.gov ID
- NCT05004714
- Acronym / sponsor ID
- IRB00244099
- Conditions
- Asthma in Children, Implementation, Preschool Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Aug 2021 (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.
Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Start Staff | – | –Head Start staff including teachers, family advocates, directors, and others |
| Head Start Children with Asthma | – | –Children enrolled in Head Start program with physician diagnosed asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma
Key inclusion criteria (4 listed)
- Aged 18 or older
- Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma
- Cognitive ability to provide consent
- Willing to be audio recorded
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
School Absences due to asthma symptoms
Time frame: 5 years
Child Level Outcome
1 secondary outcome
Implementation evaluation
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
Not yet recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Not yet recruiting
Effects of Respiratory Muscle Strength Training in Children With Asthma
Asthma (Diagnosis)
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.
Michelle Eakin, PhD principal investigator
JHU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Implementation, run by Johns Hopkins University at 2 sites 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?
The sponsor lists 4 inclusion and 0 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Eakin, PhD (410-550-0487, meakin1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Absences due to asthma symptoms (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.