Testing the effectiveness of Family Spirit Strengths (FSS) – a culturally informed intervention designed to prevent mental health and substance misuse for Indigenous families through home visiting

Background: Families represent the foundation of health for many Indigenous communities. Yet, Indigenous women, particularly women of the age who are starting families, face profound challenges related to mental health and substance use. These challenges are rooted in historical trauma, ongoing discrimination, systemic racism, and chronic underfunding of mental health and substance use services, and result in significant gaps in access to care. Family-based home visiting has the potential to address multiple types of mental health and substance use concerns in a way that is more accessible and culturally acceptable. However, to date, there are no empirically supported family-based home visiting interventions designed to specifically to address these concerns in Indigenous communities. Family Spirit Strengths is a culturally tailored intervention developed to help fill this gap. Methods: This study is a Hybrid Type I Effectiveness-Implementation randomized controlled trial with the primary goal is to test the effectiveness of Family Spirit Strengths (FSS) at reducing poor mental health days, symptoms of depression, anxiety, and substance use, among N = 188 primary caregivers across three diverse Tribal settings and contexts. Participants will be randomized 1:1 to receive FSS or a beneficial control, an evidence-based nutritional support program. FSS is a transdiagnostic secondary-prevention intervention that was adapted from the evidence-based Common Elements Treatment Approach. The FSS intervention consists of 4-16 lessons (average 6-8 lessons), tailored to participant needs, delivered weekly or bi-weekly by a trained home visitor. Primary outcomes will be measured 6-9 months post-enrollment. We will also seek to characterize heterogeneity and mechanisms of FSS effects by using mixed methods and exploring moderators and mediators of impact. We will also estimate FSS costs, cost-effectiveness, and budget impact. Discussion: Serious mental health and substance use issues have long been challenges home visitors encounter with few tools to help, beyond screening and referral to clinical services, which are often hard to access if available at all. This has been particularly true when working with Indigenous families due to the profound mental health and substance use inequities they face. This trial will inform the evidence base for transdiagnostic interventions delivered through early childhood home visiting. Trial Registration: NCT050836090