Y of Central Maryland Head Start Asthma Implementation

Asthma in Children Clinical Trial

Official title:

Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004714
• Other study ID #: IRB00244099
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Michelle Eakin, PhD
• Phone: 410-550-0487
• Email: meakin1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Implementation
• Preschool Children

Locations

Country	Name	City	State
United States	Easter Seals Head Start Prince George's County	District Heights	Maryland
United States	Y of Central Maryland Head Start	Nottingham	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	School Absences due to asthma symptoms	Child Level Outcome	5 years
Secondary	Implementation evaluation	Adoption and penetration	5 years