Last reviewed · How we verify
NCT04201184
Wakȟáŋyeža (Little Holy One)
NA trial testing Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules in Suicide in 124 participants. Completed in 25 November 2025.
25 November 2025
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 124 |
| Start date | 18 November 2019 |
| Primary completion | 25 November 2025 |
| Estimated completion | 25 November 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules
- Active nutrition control
Conditions studied
- Suicide — all drugs for Suicide →
- Trauma, Psychological — all drugs for Trauma, Psychological →
- Parenting — all drugs for Parenting →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04201184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Suicide
Currently open trials in the same condition.
- NCT07404787 — Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Ho · NA · recruiting
- NCT07214233 — Youth Empowerment and Safety Intervention · NA · recruiting
- NCT07343258 — Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline · NA · recruiting
- NCT07523490 — Investigation on Suicide Risk Factors of Patients With Mood Disorders · recruiting
- NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting
Other Johns Hopkins University trials
Trials by the same sponsor.
- NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
- NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
- NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
- NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
- NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04201184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 30 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04201184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing