BREATHE-Peds Pilot - I Focus Group Interviews

November 5, 2024 updated by: Maureen George, Columbia University

The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth

The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase I only.

Study Overview

Status

Completed

Conditions

Detailed Description

Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect.

Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase I) attempts to build on these promising results by adapting BREATHE to caregiver-early adolescent dyads. Phase I of the study will involve conducting up to 6 focus groups to identify components of BREATHE that are relevant to racial and ethnic minority early adolescents with uncontrolled asthma receiving care at FQHCs in urban communities and their caregivers. Focus groups will be composed of ~10 participants each: (a) two groups of early adolescents aged 10-14 with asthma; (b) two groups of the caregivers of the youth in Group A; and (c) two groups of adolescent-caregiver dyads who did not participate in Group A or B. Investigators will use the focus group results to write BREATHE-Peds, making modifications based on feedback from two primary care providers and two pediatric pulmonologists.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10459
        • Urban Health Plan: Adolescent Health and Wellness
      • Bronx, New York, United States, 10459
        • Urban Health Plan: El Nuevo San Juan
      • Bronx, New York, United States, 10474
        • Urban Health Plan: Bella Vista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Early adolescents (aged 10-14 years) with persistent uncontrolled asthma receiving care in federally-qualified health centers and their caregivers

Description

Inclusion Criteria (adolescents):

  • Aged 10-14 years
  • Physician-diagnosed persistent asthma (defined as being prescribed a controller medication)

Exclusion Criteria (adolescents):

  • Serious mental health conditions
  • Developmental delay

Inclusion Criteria (caregivers):

  • Informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma

Exclusion Criteria (caregivers):

  • Serious mental health conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adolescent Only Focus Groups
20 early adolescents (ages 10-14) with physician-diagnosed persistent asthma (i.e., prescribed a controller medication) receiving care at a FQHC
Caregiver Only Focus Groups
20 informal caregivers (e.g., parent, grandparent) of early adolescents with physician-diagnosed persistent asthma receiving care at a FQHC
Adolescent and Caregiver Focus Groups
10 adolescents with physician-diagnosed persistent asthma receiving care at a FQHC and their caregivers (both of whom did not participate in either previous group for a total of 20 participants in the group cohort)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who successfully complete the focus group
Time Frame: up to 12 months
Focus groups will be held with early adolescents and caregivers to identify relevant components of a pre-existing intervention (i.e., BREATHE) for a new intervention (i.e., BREATHE-Peds). Information collected during these focus groups will aid in the design/implementation of the intervention to be pilot-tested in Phase II.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Maureen George, PhD, Columbia University
  • Principal Investigator: Jean-Marie Bruzzese, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

September 19, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT8015-I
  • 1R21NR019668-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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