Intervention ConditionAYoLiNCT07746375
Talking Circle for Native American Youth Living Well (AYoLi)
A study testing Talking Circle Intervention in people with Intervention Condition and Wait-List Control, run by Melessa Kelley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention Condition, Wait-List Control
- What is being tested?
- Talking Circle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
American Indians in Texas at the Spanish Colonial Missions
San Antonio, Texas, 78207
About this study
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.
Read the 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.
- Conditions
- Intervention Condition, Wait-List Control
- Being tested
- Talking Circle Intervention, Wait-List Control Group
- Keywords
- Talking Circle intervention, Mental Health, Emotional Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking Circle InterventionBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Talking Circle Intervention Group | Experimental | The intervention group is receiving the talking circle intervention. Receives: Behavioral: Talking Circle Intervention |
| Wait-List Control Group | Other | Mental Health Receives: Behavioral: Wait-List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start23 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melessa Kelley
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Melessa Kelley, University of Texas at Austin
- Investigators
- Jennifer N Baumgartner, PhD, Study director, National Center for Complementary and Integrative Health (NCCIH)John R Lowe, PhD, RN, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746375
- Sponsor's protocol ID
- STUDY00004266-02
- Other IDs
- UH3AT012547
- Acronym
- AYoLi
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking Circle for Native American Youth Living Well (AYoLi)
- ClinicalTrials.gov ID
- NCT07746375
- Acronym / sponsor ID
- AYoLi / STUDY00004266-02
- Conditions
- Intervention Condition, Wait-List Control
- Keywords
- Talking Circle intervention, Mental Health, Emotional Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Melessa KelleyUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Talking Circle Intervention Group | Experimental | Behavioral: Talking Circle InterventionThe intervention group is receiving the talking circle intervention. |
| Wait-List Control Group | Other | Behavioral: Wait-List Control GroupMental Health |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking Circle InterventionThe 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. | Behavioural | Talking Circle Intervention Group |
| Wait-List Control GroupThe 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. | Behavioural | Wait-List Control Group |
Primary outcome
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.
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.
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
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.
3 secondary outcomes
Global Youth Commercial Tobacco-Survey
Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Suicidal Ideation Questionnaire-Junior-15
Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Global Assessment of Needs Assessment-Q Substance Use Scale
Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer N Baumgartner, PhD study director
National Center for Complementary and Integrative Health (NCCIH)
John R Lowe, PhD, RN principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Circle Intervention in people with Intervention Condition and Wait-List Control, run by Melessa Kelley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Native Reliance Questionnaire (time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.