Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules for Parenting
This trial will develop an intervention to help reduce historical trauma and stress among Native American caregivers and improve their children's emotional and behavioral development to reduce the risk for suicide and substance abuse.
- Psychological Trauma
4 Primary · 23 Secondary · Reporting Duration: Baseline, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months
Awards & Highlights
2 Treatment Groups
1 of 2
Little Holy One intervention
1 of 2
120 Total Participants · 2 Treatment Groups
Primary Treatment: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules · No Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Brockie, Teresa, Emily E. Haroz, Katie E. Nelson, Mary Cwik, Ellie Decker, Adriann Ricker, Shea Littlepage, et al.. 2021. “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”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-021-12272-9.
- Brockie T, Haroz EE, Nelson KE, Cwik M, Decker E, Ricker A, Littlepage S, Mayhew J, Wilson D, Wetsit L, Barlow A. Wakha engyeza (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. BMC Public Health. 2021 Dec 18;21(1):2298. doi: 10.1186/s12889-021-12272-9.
- 2019. "Wakȟáŋyeža (Little Holy One)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201184.
Frequently Asked Questions
What aims are being sought to be achieved by this research endeavor?
"Across the specified timeline of Baseline, 6 weeks, 12 weeks, 6 months, 12 months 18 months and 24 months; this trial will measure Change in Caregiver Parenting Stress with the assistance of the Parenting Stress Index - Short Form. Other metrics include Change in Caregiver Perceived Stress as assessed via a 10-item questionnaire that ranges from 0 to 40 scores (with mean scores between 12-14) and no diagnostic or cut off score. Additionally, tribal identity is measured through Orthogonal Cultural Identification Scale's six questions about closeness to different cultures each accompanied by four answer choices ranging from 'A lot' to" - Anonymous Online Contributor
How many subjects are participating in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, the study is currently enrolling participants and was initially posted on November 18th 2019 with its most recent update released on November 15th 2022. The trial requires 120 individuals at one research site." - Anonymous Online Contributor
Are individuals still being accepted for enrollment in this experiment?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively recruiting, having been first posted on November 18th 2019 and most recently updated on November 15th 2022. One site will be responsible for enrolling 120 participants in total." - Anonymous Online Contributor