Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Stephen J. Teach, MD, MPH, Children's National Research Institute

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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."




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374138


Locations
Layout table for location information
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
Layout table for investigator information
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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    Key Record Dates
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:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases