Co-design and evaluation of an implementation strategy to support pre-adolescents and families’ linkage to substance use prevention services in pediatric primary care (SPARC): study protocol

Family-based substance use prevention programs are effective but underutilized, particularly among low-income populations. Federally Qualified Health Centers (FQHCs) are uniquely positioned to reach underserved and low-income populations. Pediatric primary care settings within federally qualified health centers (FQHCs) offer a promising platform to expand access to these interventions, but multilevel barriers limit implementation. This study aims to co-design and evaluate an implementation strategy tailored to FQHCs—Support Pre-Adolescents and Families’ Linkage to pRevention Services in Primary Care (SPARC)—to improve the reach and adoption of a family-based substance use prevention program, Guiding Good Choices. This study will be conducted in two phases. In phase 1, we will use participatory co-design methods with caregivers, clinicians, and leaders of FQHCs to develop the SPARC implementation strategy that includes clinician recommendations, an electronic health record–embedded clinical decision support tool, and a referral process. Data will be collected through interviews, advisory boards, and iterative prototyping. In phase 2, we will conduct usability testing to refine the strategy followed by an 8-week pilot implementation among clinicians and caregivers to assess System Usability Scale scores, Feasibility- and Acceptability of Intervention measures, and qualitative feedback. The study will generate a co-designed implementation strategy tailored to FQHC workflows, including a refined clinical decision support tool, recommendation, and referral pathway. Feasibility and acceptability data will inform readiness for a future randomized controlled trial. This study will provide a novel implementation strategy to integrate substance use prevention into pediatric primary care. Findings will inform scalable approaches to improving access to family-based prevention programs in FQHC populations. N/A.