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

Improving Asthma Outcomes Through Stress Management

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Usual Care; Behavioral: Parental stress management

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 Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographics	Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history	Baseline
Number of Participants With Positive Smoke Exposure	Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Health Literacy	Single Item Literacy Screener (SILS)	Baseline
Use of Existing Ancillary Services		Assessed at 6m and 12m following enrollment
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.	Baseline
Intervention Component Uptake	Completion of intervention sessions	6 month intervention period
Intervention Satisfaction	Brief survey of satisfaction with intervention components.	6 month intervention period
Intervention Fidelity	Checklist of staff's fidelity to individual components of intervention protocol	6 month intervention period

Collaborators and Investigators

• Sponsor: Stephen J. Teach, MD, MPH
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Stephen Teach, MD, MPH, Children's National Health System

Publications and helpful links

General Publications

• Teach SJ, Shelef DQ, Foushee N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2021 Jan;58(1):121-132. doi: 10.1080/02770903.2019.1665063. Epub 2019 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: psychosocial stress
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 5819