Y of Central Maryland Head Start Asthma Implementation

NCT ID: NCT05004714

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma in Children Implementation Preschool Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head Start Staff

Head Start staff including teachers, family advocates, directors, and others

No interventions assigned to this group

Head Start Children with Asthma

Children enrolled in Head Start program with physician diagnosed asthma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Eakin, PhD

Role: PRINCIPAL_INVESTIGATOR

JHU

Locations

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Easter Seals Head Start Prince George's County

District Heights, Maryland, United States

Site Status RECRUITING

Y of Central Maryland Head Start

Nottingham, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Eakin, PhD

Role: CONTACT

410-550-0487

Other Identifiers

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R01HL146785-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00244099

Identifier Type: -

Identifier Source: org_study_id

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