Observational trial of the preventive impact of a social risk factor focused program for co-occurring opioid and methamphetamine use disorders and suicide risk in parents: study protocol

Abstract Background Parents who experience adverse social risk factors of health (SRFOH) are at risk for child welfare involvement, and those with opioid and/or methamphetamine use (O/MU) and mental health (MH) disorders are at risk for escalating negative outcomes like intravenous (IV) drug use and suicide. Just Care for Families® is a continuum of preventive care program that targets parental SRFOH, including those with O/MU and MH disorders. This protocol describes an observational trial of Just Care, spanning five rural counties that will examine malleable individual SRFOH (e.g., employment) and systemic SRFOH (e.g., access to quality healthcare), and less malleable structural SRFOH (e.g., county-based health risk factors), along with the program’s impact on outcomes. Methods Parents referred to Just Care for Families (N = 250) across five rural Oregon counties will be recruited. County health metrics will be collected from the areas where participants live to examine structural SRFOH. Consenting parents will report their SRFOH needs weekly for 18 months, regardless of engagement in Just Care services. When engaged, Just Care coaches will report weekly on whether social risk factors were identified, intervened upon, or successfully addressed. Parents will be assessed for O/MU, including IV drug use, and MH symptoms, including suicide (ideation, intention, attempt) at Baseline, 9- and 18-months. Administrative health data will be collected from consent to 24–42 months post-Baseline to assess longer-term prevention of IV drug use and suicide. Cost data will focus on costs to deliver the intervention and costs reimbursed to clinics. An intensive, longitudinal, sequencing design will allow an analysis of how intervention components disrupt malleable individual SRFOH, malleable systemic SRFOH, and escalation of O/MU and MH disorders (Aim 1); how intervention effects are impacted by less malleable structural SRFOH (Aim 2); and how the relationship between SRFOH and both individual and system outcomes influences costs incurred by provider clinics delivering Just Care for Families (Aim 3). Discussion Outcomes will inform program scale-up by providing an empirical basis for targeting parent SRFOH throughout the course of treatment, as well as the impact of these clinical decisions on parent outcomes and clinic-borne costs. Trial registration NCT06560866 registered and released 7/10/2024.