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

NCT05371665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-04

Study results available
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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 larger sample and randomized, two-group design.

Conditions

  • Anxiety Disorder
  • Depressive Disorder

Interventions

BEHAVIORAL

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

The prevention and early intervention is originally an indicated cognitive-behavioral program for 8-13-year-old youth with higher anxiety. Our CAB adapted it as a universal prevention and early intervention for all American Indian youth in the tribal community. It was delivered across six weeks with 20-30 min weekly sessions. Youth engaged in games and role-play reducing anxiety and stress in mildly challenging situations to provide in-vivo exposure. Session 1 involved introductions, relaxation training, and discussing emotions. Session 2 taught youth about worries and how to handle them. Session 3 focused on having conversations with others. Session 4 taught youth how to be assertive (CAB identified this as an area of adaption in initial meetings). Session 5 taught youth how to face their fears. Session 6 was a review session. Parents and teachers were sent notes of what youth learned in each session and asked to encourage youth to practice their learned skills.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • Montana State University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2024-05-14
Completion
2024-05-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371665 on ClinicalTrials.gov