Trial Summary
What is the purpose of this trial?
This trial tests a program called 'Wakȟáŋyeža' for Native American caregivers and their young children. It aims to reduce stress and trauma, improve parenting skills, and support children's development using culturally relevant methods. The program includes lessons on managing stress, better parenting, and promoting healthy child growth. The Wakȟáŋyeža program is an intergenerational intervention designed for Native American parents and children, incorporating unique cultural lesson-components to improve parent-child outcomes.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Cultural-Based Intervention for Psychological Trauma in Native American Caregivers is an effective treatment?
The available research shows that Cultural-Based Intervention for Psychological Trauma in Native American Caregivers is effective because it focuses on healing through traditional knowledge and culturally based practices. One study highlights the importance of addressing historical trauma and current stressors like poverty and violence, suggesting that these interventions help build resilience and survival skills. Another study emphasizes the healing process through reclaiming indigenous heritage and spirituality, which helps neutralize the negative effects of colonization. These approaches are seen as beneficial in promoting mental health and well-being among Native American communities.12345
What safety data exists for the Wakȟáŋyeža (Little Holy One) intervention?
The available research does not provide specific safety data for the Wakȟáŋyeža (Little Holy One) intervention. However, the intervention is being evaluated through a randomized controlled trial with an embedded single-case experimental design, as described in the protocol for the trial. Additionally, the intervention has been adapted for Native American Head Start teachers using a systematic process within a participatory framework, which included community input and iterative feedback. The safety and feasibility of this adapted intervention will be reported in a future publication.15678
Is the treatment Wakȟáŋyeža (Little Holy One) a promising treatment for psychological trauma in Native American caregivers?
Research Team
Teresa Brockie, PhD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for Native American caregivers on a Northern Plains reservation with children aged 2-5. Participants must have experienced trauma or stress and be willing to join all study parts, including random assignment. Children should be members or descendants of the Fort Peck Tribes.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Wakȟáŋyeža (Little Holy One) (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Theodore DeWeese
Johns Hopkins University
Chief Executive Officer since 2023
MD from an unspecified institution
Allen Kachalia
Johns Hopkins University
Chief Medical Officer since 2023
MD from an unspecified institution
National Institute of Mental Health (NIMH)
Collaborator
Dr. Joshua A. Gordon
National Institute of Mental Health (NIMH)
Chief Executive Officer since 2016
MD, PhD
Dr. Shelli Avenevoli
National Institute of Mental Health (NIMH)
Chief Medical Officer
PhD
Annie E. Casey Foundation
Collaborator