Clinical trial NCT05004714: Y of Central Maryland Head Start Asthma Implementation
Official title: Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma in Children
Implementation
Preschool Children
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-08-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma

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

Primary outcomes:
measure: School Absences due to asthma symptoms
timeFrame: 5 years
Secondary outcomes:
measure: Implementation evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: District Heights
country: United States
facility: Easter Seals Head Start Prince George's County
state: Maryland
city: Nottingham
country: United States
facility: Y of Central Maryland Head Start
state: Maryland
Study officials:
affiliation: JHU
name: Michelle Eakin, PhD
role: PRINCIPAL_INVESTIGATOR
References: