NCT06781736

Brief Summary

Native American youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. The COVID19 pandemic only compounded this suffering--anxiety, stress, depression, substance use, and suicide related mental health disorders skyrocketed in many Native American communities, especially among youth. Though many are desperate for help, treatment options are scarce to non-existent. To meet this urgent need, our overarching objective is to leverage the empirically proven, highly effective, school based, Talking Circle intervention to promote the mental, emotional, and behavioral (MEB) health of geographically diverse (rural, urban) Native American youth. This study, "Talking Circle for Native American Youth Living Well (A Yo Li)" uses a Community Based Participatory Research (CBPR) approach to evaluate Talking Circle effectiveness, partnering with the United Keetoowah Band (UKB) of Cherokee Indians Tribe in Oklahoma, with members living in two geographically diverse areas, Adair County (rural), and Tulsa City (urban). "A Yo Li" in the UKB tribal language means "youth".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 3, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

mental well-beingemotional well-beingbehavioral well-being

Outcome Measures

Primary Outcomes (3)

  • Native Reliance Questionnaire (NRQ)

    24-items rated on a 5-point Likert scale to evaluate the presence of Native Reliance cultural identity; (minimum score of 24; maximum score of 120); higher score indicates a better outcome

    Baseline and 3 month post-intervention

  • Global Assessment of Individual Needs-Quick (GAIN-Q)

    Subscales: Anxiety (7-items), ( minimum score of 0; maximum score of 7; lower score indicates better outcome) Stress (20-items; minimum score of 0; maximum score of 20; lower score indiciates better outcome) and Substance Use (16-items; minimum score of 0; maximum score of 16; lower score indicates better outcome)

    Baseline and 3 month post-intervention

  • Commercial Tobacco Use

    Global Youth Tobacco Survey (GYTS) a 43 item measure to assess key tobacco-control indicators, minimum score of 0; maximum score of 43 including use, cessation, and availability; lower score indicates better outcome

    baseline and 3 month post-intervention

Secondary Outcomes (2)

  • Depression

    baseline and 3 month post-intervention

  • Suicide Ideation

    baseline and 3 month post-intervention

Study Arms (1)

Mental Health Wellness 1

OTHER

Talking Circle Intervention to promote the mental, emotional, and behavioral well-being

Behavioral: Talking Circle intervention

Interventions

Talking Circle intervention

Mental Health Wellness 1

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Native American students
  • English speakers
  • Read and write English
  • At risk for mental health and behavioral health issues

You may not qualify if:

  • Not Native American
  • Non-English speakers
  • Not able to read and write English
  • Not at risk for mental health or behavioral health issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Keetoowah Band of Cherokee Indians in Oklahoma

Tahlequah, Oklahoma, 74464, United States

Location

MeSH Terms

Conditions

Health BehaviorStress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Mental Health Wellness (mental, emotional and behavioral health issues)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 17, 2025

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

August 31, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Locations