Skip to main content
OpenTrials
Completed

NCT Number: NCT05137223

BREATHE-Peds Pilot - I Focus Group Interviews

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urban Health Plan: Adolescent Health and Wellness, The Bronx, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2021
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.