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Reducing Asthma Morbidity In High Risk Minority Preschool Children

Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01519453
Acronym
ABC-HS
Enrollment
404
Registered
2012-01-27
Start date
2011-09-30
Completion date
2018-03-31
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Preschool, Health Disparities, Implementation

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.

Interventions

BEHAVIORALHome Based Asthma Education

4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment ToolBaseline, 3, 6, 9 and 12 monthsThe Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.

Secondary

MeasureTime frameDescription
Total Number of Emergency Department (ED) Visits [Child]Baseline, 3, 6, 9 and 12 monthsAggregate number of ED visits for asthma in past 90 days for all participants.
Total Number of Hospitalizations [Child]Baseline and 12 monthsAggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.

Countries

United States

Participant flow

Pre-assignment details

2 refused to complete a baseline assessment after consent 1 participant dropped due to no asthma after consent 3 families were pilot participants and their data is not represented in final outcomes except in sponsor reporting

Participants by arm

ArmCount
Home Based Asthma Education
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child. For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
199
Control
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child. Caregiver is not provided a control arm specific intervention.
199
Total398

Baseline characteristics

CharacteristicHome Based Asthma EducationTotalControl
Age, Categorical
Caregiver in caregiver-child pair
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Caregiver in caregiver-child pair
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Caregiver in caregiver-child pair
Between 18 and 65 years
199 Participants397 Participants198 Participants
Age, Categorical
Child in caregiver-child pair
<=18 years
199 Participants398 Participants199 Participants
Age, Categorical
Child in caregiver-child pair
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Child in caregiver-child pair
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous
Caregiver in caregiver-child pair
30.9 years
STANDARD_DEVIATION 7.8
31.4 years
STANDARD_DEVIATION 8.4
31.9 years
STANDARD_DEVIATION 8.9
Age, Continuous
Child in caregiver-child pair
4.2 years
STANDARD_DEVIATION 0.6
4.2 years
STANDARD_DEVIATION 0.7
4.2 years
STANDARD_DEVIATION 0.8
Ethnicity (NIH/OMB)
Child in caregiver-child pair
Hispanic or Latino
6 Participants14 Participants8 Participants
Ethnicity (NIH/OMB)
Child in caregiver-child pair
Not Hispanic or Latino
193 Participants384 Participants191 Participants
Ethnicity (NIH/OMB)
Child in caregiver-child pair
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child in caregiver-child pair
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child in caregiver-child pair
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child in caregiver-child pair
Black or African American
189 Participants379 Participants190 Participants
Race (NIH/OMB)
Child in caregiver-child pair
More than one race
2 Participants7 Participants5 Participants
Race (NIH/OMB)
Child in caregiver-child pair
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child in caregiver-child pair
Unknown or Not Reported
4 Participants4 Participants0 Participants
Race (NIH/OMB)
Child in caregiver-child pair
White
4 Participants8 Participants4 Participants
Region of Enrollment
United States
199 Participants398 Participants199 Participants
Sex: Female, Male
Caregiver in caregiver-child pair
Female
184 Participants371 Participants187 Participants
Sex: Female, Male
Caregiver in caregiver-child pair
Male
15 Participants27 Participants12 Participants
Sex: Female, Male
Child in caregiver-child pair
Female
76 Participants151 Participants75 Participants
Sex: Female, Male
Child in caregiver-child pair
Male
123 Participants247 Participants124 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3980 / 398
other
Total, other adverse events
2 / 3980 / 398
serious
Total, serious adverse events
8 / 39816 / 398

Outcome results

Primary

Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool

The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.

Time frame: Baseline, 3, 6, 9 and 12 months

Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.

ArmMeasureGroupValue (MEDIAN)
Home Based Asthma EducationAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool3 months85 score on a scale
Home Based Asthma EducationAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool9 months85 score on a scale
Home Based Asthma EducationAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool6 months85 score on a scale
Home Based Asthma EducationAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool12 months85 score on a scale
Home Based Asthma EducationAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment ToolBaseline70 score on a scale
ControlAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool12 months85 score on a scale
ControlAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment ToolBaseline75 score on a scale
ControlAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool3 months80 score on a scale
ControlAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool6 months85 score on a scale
ControlAsthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool9 months85 score on a scale
Secondary

Total Number of Emergency Department (ED) Visits [Child]

Aggregate number of ED visits for asthma in past 90 days for all participants.

Time frame: Baseline, 3, 6, 9 and 12 months

Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.

ArmMeasureGroupValue (NUMBER)
Home Based Asthma EducationTotal Number of Emergency Department (ED) Visits [Child]3 months34 ED visits
Home Based Asthma EducationTotal Number of Emergency Department (ED) Visits [Child]9 months37 ED visits
Home Based Asthma EducationTotal Number of Emergency Department (ED) Visits [Child]6 months28 ED visits
Home Based Asthma EducationTotal Number of Emergency Department (ED) Visits [Child]12 months31 ED visits
Home Based Asthma EducationTotal Number of Emergency Department (ED) Visits [Child]Baseline65 ED visits
ControlTotal Number of Emergency Department (ED) Visits [Child]12 months35 ED visits
ControlTotal Number of Emergency Department (ED) Visits [Child]Baseline50 ED visits
ControlTotal Number of Emergency Department (ED) Visits [Child]3 months42 ED visits
ControlTotal Number of Emergency Department (ED) Visits [Child]6 months32 ED visits
ControlTotal Number of Emergency Department (ED) Visits [Child]9 months38 ED visits
Secondary

Total Number of Hospitalizations [Child]

Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.

Time frame: Baseline and 12 months

Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.

ArmMeasureGroupValue (NUMBER)
Home Based Asthma EducationTotal Number of Hospitalizations [Child]Baseline6 asthma related hospitalizations
Home Based Asthma EducationTotal Number of Hospitalizations [Child]12 months7 asthma related hospitalizations
ControlTotal Number of Hospitalizations [Child]Baseline10 asthma related hospitalizations
ControlTotal Number of Hospitalizations [Child]12 months24 asthma related hospitalizations

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026