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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: Completed NA study, sponsored by Montana State University.

NCT05371665 is a NA study that has completed, run by Montana State University. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The Revised Child Anxiety and Depression Scale - Short Version Child Report (RCADS-25-S) is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Youth rated how often each anxiety and depressive disorder symptom is true of them on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' anxiety disorder sy

Interventions

  • BEHAVIORAL Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2022-03-28
Est. Completion 2024-05-14
Phase NA
Montana State University

36 total trials

What the finished NCT05371665 record still lists

NCT05371665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05371665's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05371665, the US trial registry maintained by the National Library of Medicine. NCT05371665 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.