Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support. We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
217
The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Children's National Medical Center
Washington D.C., District of Columbia, United States
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Asthma Morbidity - Nighttime Asthma Symptoms
Nights of asthma symptoms in prior 14d
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Asthma Severity and Control
Time frame: Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Reported use of inhaled corticosteroids and LTRA in past two days
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Health Care Utilization - Emergency Department Visits for Asthma
Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
Time frame: 12 months after enrollment
Asthma Exacerbations - Courses of Systemic Steroids
Courses of systemic steroids over 12m follow up period
Time frame: Assessed at 6m and 12m following enrollment
Parental Stress
Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Depression
Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Anxiety
PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Depression
PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Caregiver Quality of Life
Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Number of Participants With AEs and SAEs
Safety data: Number of Participants with AEs and SAEs
Time frame: 12m follow up period
Economic Outcomes
Analysis of costs of care in both groups
Time frame: 12m follow-up period
Caregiver Smoking Behavior
parent report of cigarettes smoked per day
Time frame: Repeated Measures at 6 and 12 months
Coping Strategies
Brief COPE
Time frame: Repeated measures at 12m FU (6m data used for repeated measures)
Mindfulness
Interpersonal Mindfulness in Parenting
Time frame: Repeated Measures at 6 and 12 months
Parental Resilience
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Time frame: Repeated Measures at 6 and 12 months
Exacerbations - Hospital Admissions
Number of participants with hospital admissions due to exacerbations
Time frame: Assessed at 6m and 12m after enrollment
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time frame: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Time frame: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
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