Talking Circle for Native American Youth Living Well (AYoLi)

NCT07746375 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY00004266-02UH3AT012547
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intervention Condition; Wait-List Control

Keywords

Talking Circle intervention; Mental Health; Emotional Health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Global Youth Commercial Tobacco-Survey

  Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

• Suicidal Ideation Questionnaire-Junior-15

  Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

• Global Assessment of Needs Assessment-Q Substance Use Scale

  Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Other Outcomes (1)

• Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool

  Baseline prior to start of the Intervention

Study Arms (2)

Talking Circle Intervention Group

EXPERIMENTAL

The intervention group is receiving the talking circle intervention.

Behavioral: Talking Circle Intervention

Wait-List Control Group

OTHER

Mental Health

Behavioral: Wait-List Control Group

Interventions

Talking Circle Intervention BEHAVIORAL

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.

Talking Circle Intervention Group

Wait-List Control Group BEHAVIORAL

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.

Wait-List Control Group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melessa Kelley: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

American Indians in Texas at the Spanish Colonial Missions

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Jennifer N Baumgartner, PhD

  National Center for Complementary and Integrative Health (NCCIH)

  STUDY DIRECTOR

• John R Lowe, PhD, RN

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Model Details: The team is employing a two (intervention vs. wait-list control) by two (rural vs. urban) factorial design to examine the effectiveness of the Talking Circle Intervention among 10 to 12 year-old Native American youth living in Central Texas. This design allows the team to examine the main effect of the intervention while also providing the flexibility to examine the interaction between location and intervention and the main effect of rural vs. urban location on outcomes.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 5, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)