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

NCT ID: NCT02374138

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Intervention

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

Group Type: EXPERIMENTAL

Parental stress management

Intervention Type: 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."

Interventions

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."

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• self-identify as African-American
• both the legal guardian and primary asthma caregiver of an eligible child.

• parent-identified as African-American
• age 4-12 years inclusive at recruitment
• physician diagnosis of persistent asthma
• publicly financed insurance

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Stephen J. Teach, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Teach, MD, MPH

Chair, Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Teach, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Medical Center

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31545115 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

5819

Identifier Type: -

Identifier Source: org_study_id