Skip to main content
OpenTrials
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.

Enrolling by Invitation

Interested in participating?

Request Info

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.

Inclusion criteria

Participant inclusion criteria include: (a) Native American students enrolled in the 5th and 6th grades from (10 schools in 2 districts, (5 rural) and (5 urban) after-school programs

Exclusion criteria

Not Native American, not 5th or 6th graders, non-English speakers, not able to read and write English or provide assent.

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.

Primary outcomes

  1. GAIN-Q Global Assessment of Individual Needs-Quick

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

    this a brief assessment designed for use in diverse settings. GAIN-Q includes sub-scales for general life problems (general risk factors, sources of stress, health distress), internal behavior (depression, suicide risk, anxiety), and substance-related difficulties (substance use and abuse, substance dependence). In this study, we will use the 20-item "sources of stress index" (SOSI-20) to measure stress, the 7-item sub-scale "anxiety-trauma scale" (ATS-7) to measure anxiety, and the 16-item sub-scale "substance-related issues" (SRS-16) to assess substance use

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

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

    omprised of 10 items that ask how many days in the last week (Less than 1 day, 1-2 days, 3-4 days, or 5-7 days, scored 0 to 3, respectively). Students felt, for example, that they could not 'get going' , felt lonely, or had restless sleep. Items are summed to create a total score.

  3. Suicidal Ideation Questionnaire-Junior (SIQ-JR-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.

  4. Native Reliance Questionnaire (NRQ)

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

    Native Reliance is a 24-item Likert scale, will be used to evaluate the presence of Native-Reliance. It is expected that increased presence of Native-Reliance will predict better mental health outcomes

Secondary outcomes

  1. Global Youth Tobacco-Survey

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

    This is 43-item measure to assess key tobacco-control indicators within 7 domains (1) tobacco use, 2) cessation, 3) second-hand smoke exposure, 4) exposure to media/advertising, 5) commercial tobacco product availability, 6) commercial tobacco product access, 7) knowledge and attitudes regarding commercial tobacco use).

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 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.