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Completed Not applicable Interventional Accepts healthy volunteers Results available

Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children

ClinicalTrials.gov ID: NCT05371665

Public ClinicalTrials.gov record NCT05371665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:17 AM EDT

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Official title

A Native Path to Courage: Feasibility Study of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 larger sample and randomized, two-group design.

Study identification

NCT ID
NCT05371665
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Montana State University
Other
Enrollment
28 participants

Conditions and interventions

Eligibility (public fields only)

Age range
8 Years to 12 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 27, 2022
Primary completion
May 13, 2024
Completion
May 13, 2024
Last update posted
Sep 3, 2025

2022 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Montana State University Bozeman Montana 59717

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05371665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2025 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05371665 live on ClinicalTrials.gov.

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