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

Stephen J. Teach, MD, MPH

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Parental stress management; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02374138

5819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

217 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

Intervention

Experimental group

Description:

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Treatment:

Behavioral: Parental stress management