N/A N=217 Randomized Single-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02374138 ↗

Enrolled (actual)

217

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Symptom-free Days in the Last 14 Days — 11.4; 11.6 days in prior 14d — p=0.93

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Parental stress management (Behavioral); Usual Care (Other)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Stephen J. Teach, MD, MPH
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Symptom-free Days in the Last 14 Days	10.9; 11.8	0.35
SECONDARY Asthma Morbidity - Nighttime Asthma Symptoms	1.7; 1.9; 2.1; 1.5	0.87
SECONDARY Asthma Severity and Control	—	—
SECONDARY Asthma Medication Adherence	68; 68; 55; 61; 14; 16	0.35
SECONDARY Health Care Utilization - Emergency Department Visits for Asthma	0.32; 0.32; 0.33; 0.42	0.63
SECONDARY Asthma Exacerbations - Courses of Systemic Steroids	0.30; 0.29; 0.26; 0.30	0.98
SECONDARY Parental Stress	10.4; 11.4; 10.3; 12.6	0.32
SECONDARY Parental Depression	6.8; 7.4; 7.6; 8.0	0.32
SECONDARY Child Anxiety	42.5; 40.4; 43.1; 41.5	0.70
SECONDARY Child Depression	41.1; 40.6; 42.3; 41.2	0.53
SECONDARY Caregiver Quality of Life	57.6; 58.9; 58.1; 57.8	0.53
SECONDARY Number of Participants With AEs and SAEs	0; 0; 0; 0	1.0
SECONDARY Economic Outcomes	—	—
SECONDARY Caregiver Smoking Behavior	—	—
SECONDARY Coping Strategies	—	0.58
SECONDARY Mindfulness	—	—
SECONDARY Parental Resilience	16.1; 16.2	0.90
SECONDARY Exacerbations - Hospital Admissions	5; 4; 7; 9	—
SECONDARY Symptom-free Days in the Last 14 Days	10.9; 11.8	0.35
SECONDARY Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use	1.64; 1.83; 2.31; 1.57; 1.42; 1.04	0.54

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02374138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.