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

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PROJECT SUMMARY / ABSTRACT Background and Rationale: Minority children experience high asthma prevalence and morbidity. Asthma self- management can achieve and sustain disease control. However, urban early adolescents have sub-optimal self-management. Notably, critical health behaviors that emerge at this age affect lifelong patterns. Therefore, early adolescence offers a unique opportunity to intervene, allowing the youth to become effective self- managers. Successful self-management requires the right division of responsibility between caregivers and adolescents. Thus, intervening simultaneously with early adolescent and their caregivers who can help support the early adolescent’s growing autonomy to self-manage asthma has the potential for a synergistic effect, further facilitating the adolescents’ self-management, and thus asthma control. Objective: We propose to develop and pilot test BREATHE-Peds (BRief intervention to Evaluate Asthma THErapy for Pediatrics), a novel dyadic (caregiver-early) shared decision-making (SDM) intervention, to improve asthma control in 10- to 14- year-old youth with asthma in federally-qualified health centers (FQHCs). Hypotheses: Hyp 1: The intervention will be feasible and acceptable as evidenced by: high rates of dyad recruitment and retention; primary care provider (PCP) fidelity to the treatment protocol; and PCP and caregiver-child dyad satisfaction. Hyp 2. Over 3-months post-intervention, relative to controls, BREATHE-Peds children will have improvement in asthma control as measured by the Asthma Control Questionnaire (primary outcome), higher perceived SDM, reduced symptoms, missed school days and other secondary outcomes. Methods: The proposed study includes two phases: (1) a development phase where we will develop BREATHE-Peds using focus groups with caregiver-early adolescent dyads (n=30) and expert input, and (2) a pilot validation phase where we will conduct a group-randomized trial in two FQHCs with 80 caregiver-early adolescent dyads treated by 8 PCPs (4/FQHC; 10 dyads/PCP) randomized within FQHCs to 1 of 2 study arms: (a) BREATHE-Peds (n=40 dyads), or (b) dose-matched attention control (n=40 dyads). We will follow caregiver-child dyads for 3 months post- intervention to assess the impact of BREATHE-Peds on asthma outcomes; we will conduct post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention. Significance: The study has high public health significance because it (1) tests the application of SDM to pediatric asthma; (2) targets caregiver-early adolescent dyads, which may have a synergistic effect, (3) tests a sustainable and scalable real-world pragmatic approach to improving asthma in FQHCs, unique primary care settings that provide safety net services for vulnerable populations, and (4) contributes to the scientific foundation for clinical practice and managing symptoms, thus addressing an important health inequity issue.