Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)

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 American Indians in Texas at the Spanish Colonial Missions (AIT-SCM) in Central Texas.

Study Overview

• Status: Enrolling by invitation
• Conditions: Wait-List Control; Intervention Condition
• Intervention / Treatment: Behavioral: Talking Circle Intervention; Behavioral: Wait-List Control Group

Detailed Description

The UH3 will now continue with a new site in Central Texas the American Indian Texas-Spanish Colonial Mission Tribes (AIT-SCM). This study will test the effectiveness of the Talking Circle intervention primarily for increasing Native-Reliance, and reducing anxiety, stress, depression, and substance use (alcohol, drugs, commercial tobacco,), and secondarily for suicide ideation, among rural and urban Native American youth, ages 10-12 via a cluster randomized trial with a 2 (intervention v. wait-list control) x 2 (rural v. urban) factorial design across three timepoints (baseline, 3-months, 6-months). For youth assigned to the intervention group, Native Reliance will increase more, and anxiety, stress, substance use (alcohol, drugs, commercial tobacco) and suicide ideation will decrease significantly more across the 3 measurement occasions (baseline, 3 months post-intervention, 6 months post-intervention) than for youth assigned to the control group. This study will also examine whether primary and secondary outcomes differ by location (rural vs urban), and the extent to which the intervention's impact on outcomes is moderated by location.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78207
      • American Indians In Texas at the Spanish Colonial Missions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Participant criteria include Native American students in 5th or 6th grade (ages 10-12) and part of one of the Urban or Rural School After School Programs (5 Urban and 5 Rural).

Inclusion Criteria includes:

• Native American students enrolled in the 5th and 6th grades
• English-speaking
• Able to read and write English
• Willingness to provide Assent
• Not part of another Mental, Emotional or Behavioral Health Program

Exclusion Criteria includes

• Not Native American or in 5th or 6th grades,
• Non-English speakers,
• Unable to read and write English
• Unwillingness to provide Assent
• Part of another Mental, Emotional or Behavioral Health Program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talking Circle Intervention Group; The intervention group is receiving the talking circle intervention.	Behavioral: Talking Circle Intervention; The intervention group is receiving a 10-week manual-based guide delivered in a talking circle format. A talking circle is a sacred space for youth to share information with a group in a respectful way. This instructional guide includes cultural materials as well as healthy ways to cope with and manage stress.
Other: Wait-List Control Group; Mental Health	Behavioral: Wait-List Control Group; The wait-list control group will receive general education materials on mental, emotional, and behavioral wellness as well as healthy ways to cope and manage stress. The wait-list control group will receive the talking circle intervention at the completion of the 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Native Reliance Questionnaire	Native Reliance Questionnaire is a cultural derived self-report instrument measuring self-reliance (or cultural identity), using a five-point Likert scale (1-5) varying from strongly disagree to strongly agree with a minimum score of 24 and a maximum score of 120. A higher score indicates a better outcome or a strong connection to self-reliance cultural identity.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress Index	The Global Assessment of Individual Needs-Quick (GAIN-Q) sources of stress scale is a self-report and brief assessment designed for use in diverse settings. This assessment includes questions on general life problems such as sources of stress and health distress. The sources of stress index, is a 13-item scale used to measure stress and includes a score of 0 to 13 with a minimum score of 0 and a maximum score of 13. A higher score indicates higher sources or stress or a worse outcome.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder-7 (GAD-7) is a brief self-report instrument used to evaluate anxiety using a 3-point Likert scale of 0 to 3. All 7 items are added together to create a total score. This scale has a score of 0 to 30, with 0 being the minimum score and 30 being the maximum score. Further evaluation is recommended when the score is 10 or greater. A higher score indicates a worse outcome and higher anxiety. disorder	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)	The Center for Epidemiologic Studies Depression Scale-Revised-10 (CESD-R-10) is a 10-item self-reported instrument used to measure depression. Items are summed to create a total score of 30. The total score is calculated by finding the sum of 10 items. The scale has a score of 0 to 30 with a minimum score of 0 and a maximum score of 30. Any score equal to or above 10 is considered a worse outcome and defined as depressed.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Youth Commercial Tobacco-Survey	The Global Youth Commercial Tobacco Survey is a self-reported instrument measuring tobacco. In this survey we are utilizing 13-items with a score of 0 to 13 with a minimum score of 0 and a maximum score of 13. A higher score indicates a worse outcome and a higher use of commercial tobacco products.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Suicidal Ideation Questionnaire-Junior-15	Suicidal Ideation will be measured using the 15-item scale. Each item is rated on a 7-point scale to indicate the frequency of having suicidal thoughts.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Global Assessment of Needs Assessment-Q Substance Use Scale	The Global Assessment of Needs Assessment-Q Substance Use scale is a sub-scale used to measure substance use. For this study, we are utilizing 14 items with a score of 0 to 14, with a minimum score of 0 and a maximum score of 14. A higher score indicates a worse outcome and higher substance use.	Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool	The Pediatric Symptom Checklist is being used as a pre-screening tool. The Pediatric Symptom Checklist-17 is not meant to be used as a diagnostic tool. It includes a 17-item checklist. Each of the 17 items is rated as "NEVER" (0), "SOMETIMES" (1), or "OFTEN" (2). The total score is the sum of these ratings ranging from 0 to 34, with a minimum score of 0 and a maximum score of 34. A higher score is a worse outcome and may indicate impairment in psycho-social functioning, which may include cognitive, emotional, and behavioral problems. Higher scores suggest that individuals may be 'at risk' and require further assessment by a qualified health professional.	Baseline prior to start of the Intervention

Collaborators and Investigators

• Sponsor: Melessa Kelley
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Director: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH); Principal Investigator: John R Lowe, PhD, RN, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 5, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Emotional Health; Talking Circle intervention
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: STUDY00004266-02; UH3AT012547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No