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N/A N=28 Prevention

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

Anxiety Disorder · Depressive Disorder

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention — .94 mean score on scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program (Behavioral)
Age
Pediatric · 8+ yrs
Sex
All
Sponsor
Montana State University
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention
.94
PRIMARY
Post-Intervention Youth-reported Depressive Disorder Symptoms
1.03
PRIMARY
Post-Intervention Teacher-reported Anxiety Disorder Symptoms
.25
PRIMARY
Post-Intervention Teacher-reported Depressive Disorder Symptoms
.31
SECONDARY
Post-Intervention Youth-reported Anxiety Control Beliefs
2.42
SECONDARY
Post-Intervention Youth-reported Rumination
1.22
SECONDARY
Post-Intervention Youth-reported Personal Skills Resilience
1.35
SECONDARY
Post-Intervention Youth-reported Peer Support Resilience
1.50
SECONDARY
Post-Intervention Youth-reported Social Skills Resilience
1.52
SECONDARY
Post-Intervention Youth-reported Physical Caregiving Resilience
1.44
SECONDARY
Post-Intervention Youth-reported Psychological Caregiving Resilience
1.58
SECONDARY
Post-Intervention Youth-reported Spiritual Resilience
1.46
SECONDARY
Post-Intervention Youth-reported Educational Resilience
1.58
SECONDARY
Post-Intervention Youth-reported Cultural Resilience
1.38
SECONDARY
Post-Intervention Youth-reported Tribal Specific Resilience
1.23

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.

Eligibility Criteria

Inclusion Criteria

  • 8-12 year-old youth who attends either tribe-serving school and resides on the reservation with their parent/legal guardian.

Exclusion Criteria

  • Does not meet inclusion criteria.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05371665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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