Y of Central Maryland Head Start Asthma Implementation

NCT05004714 | Recruiting

• 2 other identifiers: IRB00244099R01HL146785-01A1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma in Children; Implementation; Preschool Children

Outcome Measures

Primary Outcomes (1)

• School Absences due to asthma symptoms

  Child Level Outcome

  5 years

Secondary Outcomes (1)

• Implementation evaluation

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Easter Seals Head Start Prince George's County

District Heights, Maryland, 20747, United States

RECRUITING

Y of Central Maryland Head Start

Nottingham, Maryland, 21236, United States

RECRUITING

Study Officials

• Michelle Eakin, PhD

  JHU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Eakin, PhD

CONTACT

410-550-0487; meakin1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 13, 2021
• Study Start: August 1, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)