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

Part of paid clinical trials in Bozeman, Montana.

Sponsor
Montana State University
Study ID
NCT05371665
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 28, 2022
Status verified
Aug 2025
Primary completion
May 14, 2024
Completion
May 14, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program
    All youth received the culturally adapted prevention and early intervention program from trained providers in the school setting.

Primary Outcome Measure

Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention [ Time Frame: Post-Intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montana State UniversityBozemanMontana59717-

Find similar trials in Bozeman, MT

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Montana State University· Bozeman, MT

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