Considerations in Developing a Feasibility Study of a Mixed-Methods Pragmatic Randomized Controlled Trial of Navigation for Youth With Mental Health and/or Addiction Concerns and Their Families

Abstract

Despite the promising early indication of system navigation as an effective approach to assist entire families with complex needs, these data come from anecdotal reports and open studies. Navigation is a support service aimed at bridging gaps in health care, which involves helping patients and families through the barriers they are experiencing in the health care system; making well-informed, expert service matches based on the needs and goals of patients and families; and engaging with patients and families throughout their care journeys to ensure they access and receive needed care. Navigation is an innovation in mental health and/or addictions care, supporting whole families and often indirectly supporting the recipient of eventual treatment by working with the caregiver. Navigation is also a complex intervention that is directly responsive to individuals’ and families’ needs and goals. Thus, positive outcomes vary in accordance with goals and with the multiple pathways available to families seeking care. Designing a randomized controlled trial that responds to complex and flexible interventions such as navigation often requires creative methods and novel approaches to determining outcomes. This case study will be based on a mixed-methods feasibility RCT of navigation versus self-navigation, where participants were randomly assigned to receive navigation (through an existing youth and family navigation service) or self-navigation (using an online list of resources). In this trial, participants (caregivers of youth ages 13–26 with a mental health and/or addictions concern) completed online surveys assessing outcomes for the whole family (i.e., caregiver functioning, youth functioning, family functioning, and health services utilization) as well as qualitative interviews conducted by phone, assessing their experiences in accessing care for their loved one and barriers and facilitators encountered in the system. Although there is a small but growing literature on navigation for mental health and/or addictions, a structured outcome evaluation that assesses the impact of navigation for youth with mental health and/or addictions concerns and their families has not yet been published.

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