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

• Sponsor: Stephen J. Teach, MD, MPH
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Stephen J. Teach, MD, MPH, Children's Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: Parental stress management; Other: Usual Care	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	217 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Improving Asthma Outcomes Through Stress Management
Actual Study Start Date :	May 2015
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	May 2017

Arms and Interventions

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."

Outcome Measures

Primary Outcome Measures :

1. Symptom-free days [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   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 :

1. Asthma morbidity [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
2. Asthma severity and control [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
3. Asthma medication adherence [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
4. Health care utilization [ Time Frame: 24 months (12 months before and after enrollment) ]
   Utilization in 12m prior to enrollment and during 12m follow up period, including emergency department visits, hospital and ICU admissions, primary care visits, and urgent care visits.
5. Asthma exacerbations [ Time Frame: 24 months (12 months before and after enrollment) ]
   Courses of systemic steroids or hospitalizations in 12m prior to enrollment and during 12m follow up period
6. Parental stress [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   Perceived Stress Scale (PSS) and Stressful Life Events—Rochester Youth Development Study
7. Parental depression [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   Center for Epidemiologic Studies Depression Scale (CES-D)
8. Child anxiety [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   PROMIS Parent Proxy Anxiety
9. Child depression [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   PROMIS Parent Proxy Depressive Symptoms
10. Quality of life [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ)
11. Safety data: AEs and SAEs [ Time Frame: 12m follow up period ]
    AEs and SAEs
12. Economic outcomes [ Time Frame: 12m follow-up period ]
    Analysis of costs of care in both groups
13. Caregiver smoking behavior [ Time Frame: Repeated Measures at 6 and 12 months ]
    parent report of cigarettes smoked per day
14. Coping strategies [ Time Frame: Repeated Measures at 6 and 12 months ]
    Brief COPE
15. Mindfulness [ Time Frame: Repeated Measures at 6 and 12 months ]
    Interpersonal Mindfulness in Parenting
16. Parental Resilience [ Time Frame: Repeated Measures at 6 and 12 months ]
    Revised Life Orientation Test (LOT-R)

Other Outcome Measures:

1. Sociodemographics [ Time Frame: Baseline ]
   Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
2. Environmental Smoke exposure [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
   environmental smoke exposure
3. Parental Health literacy [ Time Frame: Baseline ]
   Single Item Literacy Screener (SILS)
4. Use of existing ancillary services [ Time Frame: Baseline and follow-up (3, 6, and 12m) ]
5. Parental Resilience [ Time Frame: Baseline ]
   Revised Life Orientation Test (LOT-R)
6. Intervention component uptake [ Time Frame: 6 month intervention period ]
   Completion of intervention sessions
7. Intervention satisfaction [ Time Frame: 6 month intervention period ]
   Brief survey
8. Intervention fidelity [ Time Frame: 6 month intervention period ]
   Checklist of staff's fidelity to individual components of intervention protocol

Eligibility Criteria

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Ages Eligible for Study:	4 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 (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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Stephen J. Teach, MD, MPH

Patient-Centered Outcomes Research Institute

Investigators

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Principal Investigator:	Stephen Teach, MD, MPH	Children's National Health System

More Information

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Responsible Party:	Stephen J. Teach, MD, MPH, Chair, Pediatrics, Children's Research Institute
ClinicalTrials.gov Identifier:	NCT02374138 History of Changes
Other Study ID Numbers:	5819
First Posted:	February 27, 2015
Last Update Posted:	July 21, 2017
Last Verified:	July 2017

Keywords provided by Stephen J. Teach, MD, MPH, Children's Research Institute:

psychosocial stress

Additional relevant MeSH terms:

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Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases