OveRcoming Adverse ChiLdhood Experiences (ORACLE): A Mixed Methods Intervention Co-design Study to Improve Outcomes for Children and Young People Experiencing or at Risk of Adversity.

Childhood exposures to adversity are common and increase risk for negative health and social outcomes throughout the life course. There is limited evidence regarding interventions to prevent or reduce the impact of adverse childhood experiences (ACEs), particularly for families with multiple adversities. Here we present the findings of mixed methods research to co-design a complex intervention to prevent adverse childhood experiences, and their impacts. Using established research methods, and the framework of the Medical Research Council (MRC) complex interventions development guidance, the work was conducted in four stages, shaped by stakeholder engagement and input at every stage. The first stage, Discover, was exploratory and employed evidence synthesis and quantitative (n = 11,564) and qualitative (n = 31) research methods to understand needs, experiences, and evidence gaps. The Define stage developed three intervention principles and identified intervention options, through a series of six co-design workshops with 41 participants and an academic research team workshop. The Develop and Deliver stages were undertaken through a Policy Lab (22 participants), and developed options for intervention design, before converging on a defined intervention that could be delivered and tested. Through this process, we developed a 'village-style' intervention, which functions at three levels: individual service users, operational, and system/strategy. Central to this are link or community health workers who would build relationships with family members, and act as a single point of contact. They should develop an understanding of family needs and the interaction of multiple complex adversities, and advocate for families, facilitating access to services. Crucially, they should use this understanding to work at and feed into operational and strategic levels to reshape services and enhance access for all families at risk of or experiencing adversity. Entry into the intervention through assessments at existing universal touch points, for example at routine perinatal or newborn appointments, should provide a prevention focus and follow the principles of proportionate universalism. Sensitive enquiry regarding financial stress may be a component of the assessment, in response to the findings of this work regarding the contexts created through the interaction of poverty and other adversities. The proposed intervention is designed to improve individual and family outcomes, and generate positive system-level changes. A feasibility study and evaluation will be required in future work, to assess the effects, costs and benefits. The processes and frameworks we developed and used may provide an adaptable template for future intervention co-design work.