Improving Asthma Outcomes Through Stress Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 217
- Locations
- 2
- Primary Endpoint
- Symptom-free Days in the Last 14 Days
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •We plan to enroll parent-child dyads that meet the following criteria:
- •Inclusion criteria (Parent):
- •self-identify as African-American
- •both the legal guardian and primary asthma caregiver of an eligible child.
Exclusion Criteria
- •unable or unwilling to sign informed consent document
- •exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment
- •enrolled in another asthma research study.
- •Inclusion criteria (Child):
- •parent-identified as African-American
- •age 4-12 years inclusive at recruitment
- •physician diagnosis of persistent asthma
- •publicly financed insurance
- •Exclusion criteria (Child):
- •chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.
- •In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.
Arms & Interventions
Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Intervention: Usual Care (Other)
Intervention
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Intervention: Parental stress management (Behavioral)
Outcomes
Primary Outcomes
Symptom-free Days in the Last 14 Days
Time Frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
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
Secondary Outcomes
- Asthma Morbidity - Nighttime Asthma Symptoms(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Asthma Severity and Control(Repeated Measures at 3, 6, and 12 months)
- Asthma Medication Adherence(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Health Care Utilization - Emergency Department Visits for Asthma(12 months after enrollment)
- Parental Stress(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Parental Depression(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Caregiver Smoking Behavior(Repeated Measures at 6 and 12 months)
- Asthma Exacerbations - Courses of Systemic Steroids(Assessed at 6m and 12m following enrollment)
- Parental Resilience(Repeated Measures at 6 and 12 months)
- Exacerbations - Hospital Admissions(Assessed at 6m and 12m after enrollment)
- Symptom-free Days in the Last 14 Days(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(Repeated measures at 6 and 12 months (3m data collected for repeated measures))
- Number of Participants With AEs and SAEs(12m follow up period)
- Economic Outcomes(12m follow-up period)
- Coping Strategies(Repeated measures at 12m FU (6m data used for repeated measures))
- Mindfulness(Repeated Measures at 6 and 12 months)
- Child Anxiety(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Child Depression(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
- Caregiver Quality of Life(Repeated Measures at 6 and 12 months (3m data collected for repeated measures))
Investigators
Stephen J. Teach, MD, MPH
Chair, Pediatrics
Children's National Research Institute