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

NCT05371665 | Completed Results DMC

• 2 other identifiers: bscott5P20GM104417
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention

  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 symptoms at post-intervention, 8 weeks post-baseline.

  Post-Intervention

• Post-Intervention Youth-reported Depressive Disorder Symptoms

  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' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.

  Post-Intervention

• Post-Intervention Teacher-reported Anxiety Disorder Symptoms

  The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth 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 symptoms at post-intervention, 8 weeks post-baseline.

  Post-Intervention

• Post-Intervention Teacher-reported Depressive Disorder Symptoms

  The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth 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' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.

  Post-Intervention

Secondary Outcomes (11)

• Post-Intervention Youth-reported Anxiety Control Beliefs

  Post-Intervention

• Post-Intervention Youth-reported Rumination

  Post-Intervention

• Post-Intervention Youth-reported Personal Skills Resilience

  Post-Intervention

• Post-Intervention Youth-reported Peer Support Resilience

  Post-Intervention

• Post-Intervention Youth-reported Social Skills Resilience

  Post-Intervention

Other Outcomes (2)

• Mean Likability of the Prevention and Early Intervention Modules

  Assessed at Completion of Each 30-minute Module

• Mean Enjoyability of Compass for Courage Modules

  Assessed at Completion of Each 30-minute Module

Study Arms (1)

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

EXPERIMENTAL

All youth received the culturally adapted prevention and early intervention program from trained providers in the school setting.

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

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.

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

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Montana State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Brandon Scott
• Organization: Montana State University

brandon.scott2@montana.edu

(406) 994-5218

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 12, 2022
• Study Start: March 28, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)