Hybrid type 1 randomized controlled trial of technology-assisted stepped care behavioral health intervention for caregivers and children following pediatric traumatic injury.

Pediatric traumatic injury (PTI) has substantial physical and emotional health impacts, sometimes resulting in hospitalization and/or the development of posttraumatic stress disorder (PTSD) and depression in children. Caregivers are a key source of support for children following PTI; however, many caregivers experience their own distress and psychological reactions following injury. The CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) model is a technology-assisted, stepped care intervention to support the emotional and behavioral recovery of preadolescent children hospitalized after PTI and their caregivers. The CAARE model seeks to provide a systematic, evidence-based screening and intervention procedure that is feasible to implement within pediatric trauma centers. This protocol paper describes a study to evaluate the effectiveness of the CAARE model in improving quality of life, clinical and functional outcomes, and treatment engagement in children and their caregivers following PTI. We also aim to explore potential inequities regarding race, ethnicity, and injury type. This hybrid type 1 effectiveness-implementation trial design allows for the examination of contextual factors related to implementation of CAARE. This paper includes a description of the intervention and control conditions, participant selection and recruitment procedures, assessment measures, and planned quantitative and qualitative methodologies. Potential implications and future directions are discussed. This study was registered in ClinicalTrials.gov (NCT04579198).