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NCT04201184

Wakȟáŋyeža (Little Holy One)

Completed NA Last updated 30 January 2026
What this trial tests

NA trial testing Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules in Suicide in 124 participants. Completed in 25 November 2025.

Timeline
18 November 2019
Primary endpoint
25 November 2025
25 November 2025

Quick facts

Lead sponsorJohns Hopkins University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment124
Start date18 November 2019
Primary completion25 November 2025
Estimated completion25 November 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Suicide or Trauma, Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Brockie T, Haroz EE, Nelson KE, Cwik M, et al · · 2021 · cited 11× · PMID 34922510 · DOI 10.1186/s12889-021-12272-9
  2. Feasibility, acceptability and effectiveness of a culturally informed intervention to decrease stress and promote well-being in reservation-based Native American Head Start teachers.
    Wilson DH, German D, Ricker A, Gourneau H, et al · · 2023 · cited 5× · PMID 37880677 · DOI 10.1186/s12889-023-16913-z
  3. The Pre-implementation Process of Adapting a Culturally Informed Stress Reduction Intervention for Native American Head Start Teachers.
    Wilson DH, Nelson KE, Gresh A, Ricker A, et al · · 2023 · cited 2× · PMID 36644672 · DOI 10.1007/s43477-022-00070-3
  4. The process of adapting a culturally informed stress reduction intervention for Native American Head Start Teachers using participatory research
    Wilson DH, Nelson KE, Gresh A, Ricker A, et al · · 2022 · DOI 10.21203/rs.3.rs-1727821/v2

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Data sources for this page

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