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Completed

NCT Number: NCT02374138

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parental stress management

Behavioral

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."

Usual Care

Other

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stephen J. Teach, MD, MPH

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Improving Asthma Outcomes Through Stress Management

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 27, 2015
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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