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NCT05371665 · ClinicalTrials.gov registry record · NA
Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT05371665 is a NA study that has completed, run by Montana State University. The registered enrollment target is 28 participants.
The verdict
NCT05371665, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the potential negative effects of these conditions across the lifespan (substance use, suicide). Available culturally adapted prevention and early interventions (PEIs) for anxiety and depression in AI youth are limited. Thus, there is a critical need for the development and evaluation of a culturally consonant, brief PEI for anxiety and depression in AI youth. The investigators' goal is to provide the community with a potentially successful PEI to mitigate AI youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research were to 1) culturally adapt a PEI program for AI youth living on a Northern Plains tribal reservation (chosen by the Cultural Advisory Board; CAB), 2) evaluate the feasibility and acceptability of the culturally-adapted program with AI youth living on the reservation, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted program with the AI youth. The investigators built upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators partnered with the CAB to culturally adapt the PEI program for AI youth in year 1 and 2 using a CBPR framework, including AI youth and parents. In year 2, the investigators trained an AI school counselor from the tribal community and a white school counselor from the two tribal serving schools on the reservation to implement the adapted PEI program. We pilot tested the 6-week program (one 20-30 minute session per week) with 28 AI 3rd-6th graders in two schools serving youth from the reservation in year 3. The investigators will partner with the tribal community to further refine and tailor the adapted PEI program using the results of this study. Moreover, further testing of the refined program's efficacy and sustainability will be conducted using a
Interventions
- BEHAVIORAL Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2024-05-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05371665
The ClinicalTrials.gov registry entry for NCT05371665 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montana State University, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program is the first listed.
NCT05371665 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05371665 about?
NCT05371665 is a clinical study titled "Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children". American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the potential negative effects of these conditions across the lifespan (substance use, suicide). Available culturally adapted prevention and early interventions (PEIs) for anxiety and depress...
What is the current status of trial NCT05371665?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2022-03-28. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT05371665?
The interventions under investigation include: Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05371665?
This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.
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