Clinical trial NCT05137223: BREATHE-Peds Pilot - I Focus Group Interviews
Official title: The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Asthma in Children
Keywords: Asthma
Adolescents
Dyads
Shared decision-making
Minority health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-11-30
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who successfully complete the focus group
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Urban Health Plan: Adolescent Health and Wellness
state: New York
city: Bronx
country: United States
facility: Urban Health Plan: El Nuevo San Juan
state: New York
city: Bronx
country: United States
facility: Urban Health Plan: Bella Vista
state: New York
Study officials:
affiliation: Columbia University
name: Maureen George, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
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