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

Not Applicable

Completed

Conditions: Asthma

Interventions: Behavioral: Parental stress management
Other: Usual Care

Registration Number: NCT02374138

Lead Sponsor: Stephen J. Teach, MD, MPH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 217

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Parental stress management	Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Usual Care	Usual Care	IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Primary Outcome Measures

Name	Time	Method
Symptom-free Days in the Last 14 Days	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 Outcome Measures

Name	Time	Method
Number of Participants With AEs and SAEs	12m follow up period	Safety data: Number of Participants with AEs and SAEs
Economic Outcomes	12m follow-up period	Analysis of costs of care in both groups
Asthma Morbidity - Nighttime Asthma Symptoms	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	Nights of asthma symptoms in prior 14d
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)	Reported use of inhaled corticosteroids and LTRA in past two days
Health Care Utilization - Emergency Department Visits for Asthma	12 months after enrollment	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
Parental Stress	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	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.
Parental Depression	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	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.
Caregiver Smoking Behavior	Repeated Measures at 6 and 12 months	parent report of cigarettes smoked per day
Asthma Exacerbations - Courses of Systemic Steroids	Assessed at 6m and 12m following enrollment	Courses of systemic steroids over 12m follow up period
Parental Resilience	Repeated Measures at 6 and 12 months	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.
Exacerbations - Hospital Admissions	Assessed at 6m and 12m after enrollment	Number of participants with hospital admissions due to exacerbations
Symptom-free Days in the Last 14 Days	Repeated Measures at 12 months (with data also assessed at 3m and 6m)	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
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)	Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Coping Strategies	Repeated measures at 12m FU (6m data used for repeated measures)	Brief COPE
Mindfulness	Repeated Measures at 6 and 12 months	Interpersonal Mindfulness in Parenting
Child Anxiety	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	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.
Child Depression	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	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.
Caregiver Quality of Life	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)	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.