Y of Central Maryland Head Start Asthma Implementation

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05004714
Collaborator
(none)
500
2
60
250
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers
    Actual Study Start Date :
    Aug 1, 2020
    Anticipated Primary Completion Date :
    Jul 31, 2025
    Anticipated Study Completion Date :
    Jul 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. School Absences due to asthma symptoms [5 years]

      Child Level Outcome

    Secondary Outcome Measures

    1. Implementation evaluation [5 years]

      Adoption and penetration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Easter Seals Head Start Prince George's County District Heights Maryland United States 20747
    2 Y of Central Maryland Head Start Nottingham Maryland United States 21236

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Michelle Eakin, PhD, JHU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05004714
    Other Study ID Numbers:
    • IRB00244099
    First Posted:
    Aug 13, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022