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

• ClinicalTrials.gov Identifier: NCT02374138
• Recruitment Status: Completed
• First Posted: February 27, 2015
• Results First Posted: September 23, 2019
• Last Update Posted: September 23, 2019
• Sponsor: Stephen J. Teach, MD, MPH
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Stephen J. Teach, MD, MPH, Children's National 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

• 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 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 Outcome Measures :

1. Asthma Morbidity - Nighttime Asthma Symptoms [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
   Nights of asthma symptoms in prior 14d
2. Asthma Severity and Control [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
3. Asthma Medication Adherence [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
   Reported use of inhaled corticosteroids and LTRA in past two days
4. Health Care Utilization - Emergency Department Visits for Asthma [ Time Frame: 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
5. Asthma Exacerbations - Courses of Systemic Steroids [ Time Frame: Assessed at 6m and 12m following enrollment ]
   Courses of systemic steroids over 12m follow up period
6. Parental Stress [ Time Frame: 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.
7. Parental Depression [ Time Frame: 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.
8. Child Anxiety [ Time Frame: 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.
9. Child Depression [ Time Frame: 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.
10. Caregiver Quality of Life [ Time Frame: 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.
11. Number of Participants With AEs and SAEs [ Time Frame: 12m follow up period ]
    Safety data: Number of Participants with 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 12m FU (6m data used for repeated measures) ]
    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 ]
    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.
17. Exacerbations - Hospital Admissions [ Time Frame: Assessed at 6m and 12m after enrollment ]
    Number of participants with hospital admissions due to exacerbations
18. Symptom-free Days in the Last 14 Days [ Time Frame: 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
19. Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use [ Time Frame: 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

Other Outcome Measures:

1. Sociodemographics [ Time Frame: Baseline ]
   Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
2. Number of Participants With Positive Smoke Exposure [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
   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.
3. Parental Health Literacy [ Time Frame: Baseline ]
   Single Item Literacy Screener (SILS)
4. Use of Existing Ancillary Services [ Time Frame: Assessed at 6m and 12m following enrollment ]
5. Parental Resilience [ Time Frame: Baseline ]
   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.
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 of satisfaction with intervention components.
8. Intervention Fidelity [ Time Frame: 6 month intervention period ]
   Checklist of staff's fidelity to individual components of intervention protocol

Eligibility Criteria

• 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

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

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

  Study Documents (Full-Text)

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

Statistical Analysis Plan  [PDF] November 25, 2016

Study Protocol  [PDF] April 26, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Teach SJ, Shelef DQ, Fousheé 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.

• Responsible Party: Stephen J. Teach, MD, MPH, Chair, Pediatrics, Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT02374138
• Other Study ID Numbers: 5819
• First Posted: February 27, 2015
• Results First Posted: September 23, 2019
• Last Update Posted: September 23, 2019
• Last Verified: August 2019

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

psychosocial stress

Additional relevant MeSH terms:

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