Y of Central Maryland Head Start Asthma Implementation

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Implementation; Preschool Children

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Michelle Eakin, PhD; Phone Number: 410-550-0487; Email: meakin1@jhmi.edu

Study Locations

• United States
  • Maryland
    • District Heights, Maryland, United States, 20747
      • Recruiting
      • Easter Seals Head Start Prince George's County
    • Nottingham, Maryland, United States, 21236
      • Recruiting
      • Y of Central Maryland Head Start

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
School Absences due to asthma symptoms	Child Level Outcome	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation evaluation	Adoption and penetration	5 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Michelle Eakin, PhD, JHU

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: IRB00244099; R01HL146785-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No