NCT05004714 Y of Central Maryland Head Start Asthma Implementation
| NCT ID | NCT05004714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Asthma in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-08-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-08-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Aim 1 Inclusion Criteria: * 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
Contact & Investigator
Michelle Eakin, PhD
PRINCIPAL INVESTIGATOR
JHU
Frequently Asked Questions
Who can join the NCT05004714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05004714 currently recruiting?
Yes, NCT05004714 is actively recruiting participants. Contact the research team at meakin1@jhmi.edu for enrollment information.
Where is the NCT05004714 trial being conducted?
This trial is being conducted at District Heights, United States, Nottingham, United States.
Who is sponsoring the NCT05004714 clinical trial?
NCT05004714 is sponsored by Johns Hopkins University. The principal investigator is Michelle Eakin, PhD at JHU. The trial plans to enroll 500 participants.
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