Wakȟáŋyeža (Little Holy One)

Johns Hopkins University

Status: Completed

Conditions: Parenting; Trauma, Psychological; Suicide

Treatments: Behavioral: Active nutrition control; Behavioral: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04201184

1R01MH115840-01A1 (U.S. NIH Grant/Contract)

IRB00200073

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Parent or caregiver is under 18 years of age.
• Inability to participate in full intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Little Holy One intervention

Experimental group

Description:

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

Treatment:

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

Nutrition control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active nutrition control