16-year follow-up of Family Spirit intervention effects on Native American maternal-child outcomes: study protocol

BACKGROUND: Family Spirit is a culturally grounded home-visiting program, delivered by paraprofessional home visitors, which was designed for and has been proven effective with Native American families. A randomized controlled trial of the Family Spirit intervention was conducted between 2006 and 2011, yielding positive outcomes for young mothers and their children at 3 years post-partum. This 16-year long-term follow-up study, to be conducted between 2023 and 2028, aims to determine if Family Spirit's early impacts resulted in long-term protection against problematic substance use and suicide during peak risk periods. Both substance use and suicide are leading causes of death and despair for Native Americans, resulting in significant public health disparities for Native American communities. METHODS: This study will take place in the four communities that participated in the original Family Spirit trial. The study aims to recruit at least 75% (n = 242) of the mothers and their now adult children (n = 242) who participated in the original trial (n = 322). We will use an explanatory mixed-methods design, involving self-report questionnaires and electronic health record reviews to understand Family Spirit's long-term impacts on maternal and child substance use, suicide, and related consequences, as well as mediators and moderators of these outcomes. Additionally, semi-structured in-depth interviews with a purposively sampled group of participants will be used to understand the intervention's long-term impacts on individual and intergenerational experiences surrounding substance use, suicide, and related consequences. DISCUSSION: This study will address critical knowledge gaps in understanding the long-term effectiveness of early childhood home-visiting programs, especially among Native American communities. This is the first long-term follow-up study of a home visiting intervention to assess substance use and suicide impacts directly, and the first to document long-term efficacy of paraprofessional home visitors. In summary, this study presents a unique and important opportunity to assess whether a culturally grounded early childhood home-visiting intervention provides long-term protection during a timeframe of peak mortality risk. TRIAL REGISTRATION: ClinicalTrials.gov, TRN: NCT00373750; Registration date: 12 January 2015.