Talking Circle for Native American Youth (AYoLi)

January 16, 2025 updated by: University of Texas at Austin

Talking Circle for Native American Youth Living Well (AYoLi)

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".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specific aims for Phase 1 (UG3) include:

UG3 Aim 1. To inform adaptation of the school-based Talking Circle intervention, a Community Partnership Committee (CPC) of UKB members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for MEB health of UKB youth, paying special attention to the nuances of cultural difference between rural and urban UKB communities in Oklahoma.

UG3 Aim 2. To conduct a Talking Circle intervention Facilitator Training Program with rural and urban UKB tribal community members to catalyze capacity building and sustainability for future intervention.

UG3 Aim 3. To pilot the adapted evidenced-based Talking Circle intervention for the promotion of MEB health among (N=20) 10 to 12 year-olds UKB youth in Oklahoma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • United Keetoowah Band of Cherokee Indians in Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Mental Health Wellness 1
Talking Circle Intervention to promote the mental, emotional, and behavioral well-being
Behavioral: Talking Circle intervention
Talking Circle intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Native Reliance Questionnaire (NRQ)
Time Frame: Baseline and 3 month post-intervention
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)
Time Frame: Baseline and 3 month post-intervention
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
Time Frame: baseline and 3 month post-intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: baseline and 3 month post-intervention
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) a 10 item measure of depressed affect used in samples of NA youth with good reliability and validity (minimum score of 6; maximum score of 24) higher score is a worse outcome and lower score is a better outcome
baseline and 3 month post-intervention
Suicide Ideation
Time Frame: baseline and 3 month post-intervention
Suicidal Ideation Questionnaire-Junior (SIQ-JR-15),15-items is rated on a 7-point scale indicating the frequency of suicidal thoughts, showing excellent validity and reliability, and an effective predictor of suicide risks in the Native American adolescent population (minimum score of 15 maximum score 105); the higher score indicates the greater risk of suicidal Ideation and lower score indicates lower risk of suicidal ideation.
baseline and 3 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004266
  • 1UG3AT012547-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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