BREATHE-Peds Pilot - I Focus Group Interviews

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma, Asthma in Children

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescent Only Focus Groups<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who successfully complete the focus group | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Adolescents, Dyads, Shared decision-making, Minority health