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Talking Circle for Native American Youth Living Well (AYoLi)

Talking Circle for Native American Youth Living Well (AYoLi)

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07746375
Acronym
AYoLi
Enrollment
200
Registered
2026-08-05
Start date
2026-06-23
Completion date
2029-08-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention Condition, Wait-List Control

Keywords

Talking Circle intervention, Mental Health, Emotional Health

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.

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.

Interventions

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.

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.

Sponsors

Melessa Kelley
Lead SponsorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Native Reliance QuestionnaireBaseline, 3-Month Post-Intervention and 6-Month-Post-InterventionNative 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.
Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress IndexBaseline, 3-Month Post-Intervention and 6-Month-Post-InterventionThe 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.
Generalized Anxiety Disorder-7 (GAD-7)Baseline, 3-Month Post-Intervention and 6-Month-Post-InterventionThe 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
Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)Baseline, 3-Month Post-Intervention and 6-Month-Post-InterventionThe 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.

Secondary

MeasureTime frameDescription
Global Youth Commercial Tobacco-SurveyBaseline, 3-Month Post-Intervention and 6-Month-Post-InterventionThe 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.
Suicidal Ideation Questionnaire-Junior-15Baseline, 3-Month Post-Intervention and 6-Month-Post-InterventionSuicidal 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.
Global Assessment of Needs Assessment-Q Substance Use ScaleBaseline, 3-Month Post-Intervention and 6-Month-Post-InterventionThe 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.

Countries

United States

Contacts

STUDY_DIRECTORJennifer N Baumgartner, PhD

National Center for Complementary and Integrative Health (NCCIH)

PRINCIPAL_INVESTIGATORJohn R Lowe, PhD, RN

University of Texas at Austin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026