Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05004714

Conditions

Asthma in Children

Implementation

Preschool Children

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05004714

Start date

Aug 1, 2020

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • School Absences due to asthma symptoms [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Easter Seals Head Start Prince George's County

Recruiting

District Heights, Maryland, United States, 20747

Y of Central Maryland Head Start

Recruiting

Nottingham, Maryland, United States, 21236

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-13.