Wakȟáŋyeža (Little Holy One) - an Intergenerational Intervention for Native American Parents and Children: a Protocol for A randomized Controlled Trial with Embedded single-case Experimental Design

Background: Trauma within Native American communities compromises parents' parenting capacity; thus, increasing childrens' risk for substance use and suicide over the lifespan. The objective of this manuscript is to describe the Wakȟáŋyeža (Little Holy One) intervention and evaluation protocol, that is designed to break cycles of intergenerational trauma, suicide, and substance use among Fort Peck Assiniboine and Sioux parents and their children.

Methods: A randomized controlled trial with an embedded single-case experimental design will be used to determine effectiveness of the modular prevention intervention on parent-child outcomes and the added impact of unique cultural lesson-components. Participants include 1) Fort Peck Assiniboine and Sioux parents who have had adverse childhood experiences, and 2) their children (3-5 years). Parent-child dyads are randomized (1:1) to Little Holy One or a control group that consists of 12 lessons taught by Indigenous community health workers. Lessons were developed from elements of 1) the Common Elements Treatment Approach and Family Spirit, both evidence-based interventions, and 2) newly created cultural (intervention) and nutrition (control group only) lessons. Primary outcomes are parent (primary caregiver) trauma symptoms and stress. Secondary outcomes include: Parent depression symptoms, parenting practices, parental control, family routines, substance use, historical loss, communal mastery, tribal identity, historical trauma. Child outcomes include, externalizing and internalizing behavior and school attendance. Primary analysis will follow an intent-to-treat approach, and secondary analysis will include examination of change trajectories to determine impact of cultural lessons and exploration of overall effect moderation by age and gender of child and type of caregiver (e.g., parent, grandparent).

Discussion: Many Native American parents have endured adverse childhood experiences and traumas that can negatively impact capacity for positive parenting. Study results will provide insights about the potential of a culturally-based intervention to reduce parental distress - an upstream approach to reducing risk for childrens' later substance misuse and suicidality. Intervention design features, including use of community health workers, cultural grounding, and administration in Head Start settings lend potential for feasibility, acceptability, sustainability, and scalability.

Trial Registration: ClinicalTrials.gov: NCT04201184 . Registered 11 December 2019.