Clinical trial NCT02374138: Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)
Official title: Improving Asthma Outcomes Through Stress Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: psychosocial stress
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-27
Enrollment: 217
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Symptom-free Days in the Last 14 Days
timeFrame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Secondary outcomes:
measure: Asthma Morbidity - Nighttime Asthma Symptoms
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Asthma Severity and Control
timeFrame: Repeated Measures at 3, 6, and 12 months
measure: Asthma Medication Adherence
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Health Care Utilization - Emergency Department Visits for Asthma
timeFrame: 12 months after enrollment
measure: Asthma Exacerbations - Courses of Systemic Steroids
timeFrame: Assessed at 6m and 12m following enrollment
measure: Parental Stress
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Parental Depression
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Child Anxiety
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Child Depression
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Caregiver Quality of Life
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Number of Participants With AEs and SAEs
timeFrame: 12m follow up period
measure: Economic Outcomes
timeFrame: 12m follow-up period
measure: Caregiver Smoking Behavior
timeFrame: Repeated Measures at 6 and 12 months
measure: Coping Strategies
timeFrame: Repeated measures at 12m FU (6m data used for repeated measures)
measure: Mindfulness
timeFrame: Repeated Measures at 6 and 12 months
measure: Parental Resilience
timeFrame: Repeated Measures at 6 and 12 months
measure: Exacerbations - Hospital Admissions
timeFrame: Assessed at 6m and 12m after enrollment
measure: Symptom-free Days in the Last 14 Days
timeFrame: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
measure: Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
timeFrame: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Other outcomes:
measure: Sociodemographics
timeFrame: Baseline
measure: Number of Participants With Positive Smoke Exposure
timeFrame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
measure: Parental Health Literacy
timeFrame: Baseline
measure: Use of Existing Ancillary Services
timeFrame: Assessed at 6m and 12m following enrollment
measure: Parental Resilience
timeFrame: Baseline
measure: Intervention Component Uptake
timeFrame: 6 month intervention period
measure: Intervention Satisfaction
timeFrame: 6 month intervention period
measure: Intervention Fidelity
timeFrame: 6 month intervention period
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Stephen Teach, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.