Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Asthma Outcomes Through Stress Management

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Parental stress management
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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 (Parent): 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination | Other: Usual Care<br>* IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination<br>|
| Experimental: Intervention<br>Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. | Behavioral: Parental stress management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Repeated Measures at 6 months (3 month data collected to allow for repeated measures) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Morbidity - Nighttime Asthma Symptoms | Nights of asthma symptoms in prior 14d | 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 | Reported use of inhaled corticosteroids and LTRA in past two days | 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 | 12 months after enrollment | 
| Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids over 12m follow up period | 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. | 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. | 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. | 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. | 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. | 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 | 12m follow up period | 
| Economic Outcomes | Analysis of costs of care in both groups | 12m follow-up period | 
| Caregiver Smoking Behavior | parent report of cigarettes smoked per day | Repeated Measures at 6 and 12 months | 
| Coping Strategies | Brief COPE | Repeated measures at 12m FU (6m data used for repeated measures) | 
| Mindfulness | Interpersonal Mindfulness in Parenting | 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. | Repeated Measures at 6 and 12 months | 
| Exacerbations - Hospital Admissions | Number of participants with hospital admissions due to exacerbations | 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 | 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 | Repeated measures at 6 and 12 months (3m data collected for repeated measures) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial stress