Clinical trial NCT01519453: Reducing Asthma Morbidity In High Risk Minority Preschool Children
Official title: Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Preschool
Health Disparities
Implementation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 404
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.

Detailed description: Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, Emergency Department visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.

Eligibility criteria: Inclusion Criteria:

* Enrolled in Head Start
* Physician diagnosed asthma or reactive airway disease
* Resides in Baltimore City or Baltimore County
* English Speaking

Exclusion Criteria:

* Enrolled in another pulmonary research study
* Sibling enrolled in study

Primary outcomes:
measure: Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
timeFrame: Baseline, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Total Number of Emergency Department (ED) Visits [Child]
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Total Number of Hospitalizations [Child]
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cynthia Rand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callaghan-Koru JA, Riekert KA, Ruvalcaba E, Rand CS, Eakin MN. Home Medication Readiness for Preschool Children With Asthma. Pediatrics. 2018 Sep;142(3):e20180829. doi: 10.1542/peds.2018-0829. Epub 2018 Aug 7.
citation: Ruvalcaba E, Chung SE, Rand C, Riekert KA, Eakin M. Evaluating the implementation of a multicomponent asthma education program for Head Start staff. J Asthma. 2019 Feb;56(2):218-226. doi: 10.1080/02770903.2018.1443467. Epub 2018 Mar 15.
citation: Sadreameli SC, Riekert KA, Matsui EC, Rand CS, Eakin MN. Family Caregiver Marginalization is Associated With Decreased Primary and Subspecialty Asthma Care in Head Start Children. Acad Pediatr. 2018 Nov-Dec;18(8):905-911. doi: 10.1016/j.acap.2018.04.135. Epub 2018 May 3.
citation: Eakin MN, Zaeh S, Eckmann T, Ruvalcaba E, Rand CS, Hilliard ME, Riekert KA. Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial. JAMA Pediatr. 2020 Dec 1;174(12):1191-1198. doi: 10.1001/jamapediatrics.2020.3375.
citation: Lu MA, Eckmann T, Ruvalcaba E, McQuaid EL, Rand CS, Riekert KA, Eakin MN. Family management of asthma in Head Start preschool children. Ann Allergy Asthma Immunol. 2022 Feb;128(2):178-183. doi: 10.1016/j.anai.2021.11.002. Epub 2021 Nov 10.