Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05004714
Other study ID # IRB00244099
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2025

Study information

Verified date August 2023
Source Johns Hopkins University
Contact Michelle Eakin, PhD
Phone 410-550-0487
Email meakin1@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States Easter Seals Head Start Prince George's County District Heights Maryland
United States Y of Central Maryland Head Start Nottingham Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary School Absences due to asthma symptoms Child Level Outcome 5 years
Secondary Implementation evaluation Adoption and penetration 5 years
See also
  Status Clinical Trial Phase
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Recruiting NCT05734261 - Forced Oscillations Technique During a Metacholine Test in Children N/A
Recruiting NCT06044051 - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma N/A
Completed NCT04896502 - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers N/A
Completed NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT06003569 - Reducing Asthma Attacks in Disadvantaged School Children With Asthma N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT04388098 - Oral Health Status of Asthmatic Children
Terminated NCT03586544 - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity Phase 4
Recruiting NCT04821908 - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting NCT03277170 - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations Phase 2
Enrolling by invitation NCT06239844 - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English N/A
Not yet recruiting NCT05974917 - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting NCT05366309 - Performance and Adherence in Children Using Spacers N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Recruiting NCT04166344 - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma N/A
Completed NCT03673618 - Soluble Corn Fiber Supplementation for Asthma Phase 2
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma