Wakȟáŋyeža (Little Holy One)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2025-11-25

Brief Summary

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The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.

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Detailed Description

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The scientific premise of this work is rooted in understanding that high rates of historical and current trauma in Native communities compromise caregivers' mental health and parenting, which in turn affect early childhood behavior problems and adverse events that increase children's risk for suicide and substance use in adolescent and young adulthood.

Wakȟáŋyeža will combine adapted elements of: 1) Common Elements Treatment Approach (CETA), an evidence-based intervention proven effective to reduce stress, depression and trauma-related symptoms, 2) Family Spirit, an evidence-based parent training program to promote positive early child development in Native American communities, and 3) cultural components informed by tribal-specific risk and protective factors for suicide and substance abuse identified in community-based studies that led to this proposal. The intervention will consist of 12 weekly individual lessons taught to parents and children (ages 2 to 5) at Head Start facilities by indigenous community health workers, a delivery strategy selected to enhance participant engagement, local acceptability and sustainability.

This study will use a randomized control trial (RCT) with an embedded single-case experimental design (SCED) to determine the effectiveness of the intervention on mental health and behavioral outcomes among N=120 parent-child dyads, while empirically exploring the added benefit of specific cultural components on parent/caregiver outcomes. The study plan is situated within a well-established trust relationship with tribal communities, innovative formative research that led to this proposal, and an experienced, multi-disciplined study team led by an Indigenous Principle Investigator.

A supplement has been added to this clinical trial, the goal of the supplement is to add to our understanding of opioids and other substance use and suicide risk in Native communities by analyzing individual social network data to understand the relational factors that may increase both risk of suicide and opioid use and the relational characteristics of networks that act as protective factors for suicide and opioid use.

Conditions

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Suicide Trauma, Psychological Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be enrolled in one of two groups; active control or intervention groups. Participants in the control group will be provided with food boxes weekly for 12 weeks. Participants in the intervention group will be taught the 12 lessons on parenting, culture, and stress over a 12-week period in individual sessions with their community health worker.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Little Holy One intervention

The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks.

Group Type EXPERIMENTAL

Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules

Intervention Type BEHAVIORAL

Caregivers will receive 12 lessons, weekly, over a period of 12 weeks. Full curriculum contains: 4 lessons on cultural connection and traditions, 4 lessons on parenting adapted from Family Spirit intervention, and 4 lessons on stress and trauma adapted from CETA. modules

Nutrition control

The active control condition will receive nutrition information, weekly food boxes and recipes based on seasonal foods, as well as a shopping list for making future meals.

Group Type ACTIVE_COMPARATOR

Active nutrition control

Intervention Type BEHAVIORAL

The active control condition will receive nutrition information, weekly food boxes and recipes. Recipes will be developed based on seasonal foods and a shopping list for making future meals will be included.

Interventions

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Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules

Caregivers will receive 12 lessons, weekly, over a period of 12 weeks. Full curriculum contains: 4 lessons on cultural connection and traditions, 4 lessons on parenting adapted from Family Spirit intervention, and 4 lessons on stress and trauma adapted from CETA. modules

Intervention Type BEHAVIORAL

Active nutrition control

The active control condition will receive nutrition information, weekly food boxes and recipes. Recipes will be developed based on seasonal foods and a shopping list for making future meals will be included.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parent or caregiver of 2-5-year-old child
* Parent or caregiver must be willing to participate in all aspects of the study including random assignment
* Parent or caregiver has been exposed to at least 1 adverse childhood event or historical trauma
* Child is an enrolled member of Fort Peck Tribes or the descent of an enrolled member