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Enrolling by Invitation

NCT Number: NCT07746375

Talking Circle for Native American Youth Living Well (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.

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Key information

Conditions

Intervention Condition Behavior Personal Satisfaction Psychological Well-Being Wait-List Control

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Indians in Texas at the Spanish Colonial Missions

San Antonio, Texas, 78207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Native Reliance Questionnaire

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

  2. Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress Index

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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

  4. Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

Secondary outcomes

  1. Global Youth Commercial Tobacco-Survey

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

  2. Suicidal Ideation Questionnaire-Junior-15

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

  3. Global Assessment of Needs Assessment-Q Substance Use Scale

    Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

    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.

Other outcomes

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

    Time frame: Baseline prior to start of the Intervention

    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.

Sponsors and collaborators

Lead sponsor

Melessa Kelley

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: AYoLi

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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