Mental Health Wellness 1AYoLiNCT06781736
Talking Circle for Native American Youth
A study testing Talking Circle intervention in people with Mental Health Wellness 1 and Behavior, Health, run by University of Texas at Austin at 1 site in United States.
Trial summary
Native American youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Behavior, Health, Emotional Stress
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- English speakers
- Read and write English
- At risk for mental health and behavioral health issues
Who cannot join
- Not Native American
- Non-English speakers
- Not able to read and write English
- Not at risk for mental health or behavioral health issues
Trial locations and contacts
1 site in 1 country.
United States1 site
United Keetoowah Band of Cherokee Indians in Oklahoma
Tahlequah, Oklahoma, 74464
About this study
Official title: Talking Circle for Native American Youth Living Well (AYoLi)
Native American youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. The COVID19 pandemic only compounded this suffering--anxiety, stress, depression, substance use, and suicide related mental health disorders skyrocketed in many Native American communities, especially among youth. Though many are desperate for help, treatment options are scarce to non-existent. To meet this urgent need, our overarching objective is to leverage the empirically proven, highly effective, school based, Talking Circle intervention to promote the mental, emotional, and behavioral (MEB) health of geographically diverse (rural, urban) Native American youth. 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 United Keetoowah Band (UKB) of Cherokee Indians Tribe in Oklahoma, with members living in two geographically diverse areas, Adair County (rural), and Tulsa City (urban). "A Yo Li" in the UKB tribal language means "youth".
Read the detailed description
Specific aims for Phase 1 (UG3) include:
UG3 Aim 1. To inform adaptation of the school-based Talking Circle intervention, a Community Partnership Committee (CPC) of UKB members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for MEB health of UKB youth, paying special attention to the nuances of cultural difference between rural and urban UKB communities in Oklahoma.
UG3 Aim 2. To conduct a Talking Circle intervention Facilitator Training Program with rural and urban UKB tribal community members to catalyze capacity building and sustainability for future intervention.
UG3 Aim 3. To pilot the adapted evidenced-based Talking Circle intervention for the promotion of MEB health among (N=20) 10 to 12 year-olds UKB youth in Oklahoma.
- Conditions
- Mental Health Wellness 1, Behavior, Health, Emotional Stress
- Being tested
- Talking Circle intervention
- Keywords
- mental well-being, emotional well-being, behavioral well-being
- Medical subject headings
- Health Behavior, Stress, Psychological, 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
Talking Circle intervention
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Wellness 1 | Other | Talking Circle Intervention to promote the mental, emotional, and behavioral well-being Receives: Behavioral: Talking Circle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native Reliance Questionnaire (NRQ)
24-items rated on a 5-point Likert scale to evaluate the presence of Native Reliance cultural identity; (minimum score of 24; maximum score of 120); higher score indicates a better outcome
Measured: Baseline and 3 month post-intervention
Global Assessment of Individual Needs-Quick (GAIN-Q)
Subscales: Anxiety (7-items), ( minimum score of 0; maximum score of 7; lower score indicates better outcome) Stress (20-items; minimum score of 0; maximum score of 20; lower score indiciates better outcome) and Substance Use (16-items; minimum score of 0; maximum score of 16; lower score indicates better outcome)
Measured: Baseline and 3 month post-intervention
Commercial Tobacco Use
Global Youth Tobacco Survey (GYTS) a 43 item measure to assess key tobacco-control indicators, minimum score of 0; maximum score of 43 including use, cessation, and availability; lower score indicates better outcome
Measured: baseline and 3 month post-intervention
Secondary outcomes (2)
Depression
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) a 10 item measure of depressed affect used in samples of NA youth with good reliability and validity (minimum score of 6; maximum score of 24) higher score is a worse outcome and lower score is a better outcome
Measured: baseline and 3 month post-intervention
Suicide Ideation
Suicidal Ideation Questionnaire-Junior (SIQ-JR-15),15-items is rated on a 7-point scale indicating the frequency of suicidal thoughts, showing excellent validity and reliability, and an effective predictor of suicide risks in the Native American adolescent population (minimum score of 15 maximum score 105); the higher score indicates the greater risk of suicidal Ideation and lower score indicates lower risk of suicidal ideation.
Measured: baseline and 3 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 posted17 Jan 2025
- Study start1 Mar 2024
- Primary completion1 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Mental Health Wellness (mental, emotional and behavioral health issues)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781736
- Sponsor's protocol ID
- STUDY00004266
- Other IDs
- 1UG3AT012547-01
- Acronym
- AYoLi
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. 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
- NCT06781736
- Acronym / sponsor ID
- AYoLi / STUDY00004266
- Conditions
- Mental Health Wellness 1, Behavior, Health, Emotional Stress
- Keywords
- mental well-being, emotional well-being, behavioral well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Jan 2025 (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.
Native American youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. The COVID19 pandemic only compounded this suffering--anxiety, stress, depression, substance use, and suicide related mental health disorders skyrocketed in many Native American communities, especially among youth. Though many are desperate for help, treatment options are scarce to non-existent. To meet this urgent need, our overarching objective is to leverage the empirically proven, highly effective, school based, Talking Circle intervention to promote the mental, emotional, and behavioral (MEB) health of geographically diverse (rural, urban) Native American youth. 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 United Keetoowah Band (UKB) of Cherokee Indians Tribe in Oklahoma, with members living in two geographically diverse areas, Adair County (rural), and Tulsa City (urban). "A Yo Li" in the UKB tribal language means "youth".
Detailed description
Specific aims for Phase 1 (UG3) include:
UG3 Aim 1. To inform adaptation of the school-based Talking Circle intervention, a Community Partnership Committee (CPC) of UKB members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for MEB health of UKB youth, paying special attention to the nuances of cultural difference between rural and urban UKB communities in Oklahoma.
UG3 Aim 2. To conduct a Talking Circle intervention Facilitator Training Program with rural and urban UKB tribal community members to catalyze capacity building and sustainability for future intervention.
UG3 Aim 3. To pilot the adapted evidenced-based Talking Circle intervention for the promotion of MEB health among (N=20) 10 to 12 year-olds UKB youth in Oklahoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mental Health Wellness (mental, emotional and behavioral health issues)
| Arm | Type | Receives |
|---|---|---|
| Mental Health Wellness 1 | Other | Behavioral: Talking Circle interventionTalking Circle Intervention to promote the mental, emotional, and behavioral well-being |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Native American students
- English speakers
- Read and write English
- At risk for mental health and behavioral health issues
Key exclusion criteria (4 listed)
- Not Native American
- Non-English speakers
- Not able to read and write English
- Not at risk for mental health or behavioral health issues
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 interventionTalking Circle intervention | Behavioural | Mental Health Wellness 1 |
Primary outcome
Native Reliance Questionnaire (NRQ)
Time frame: Baseline and 3 month post-intervention
24-items rated on a 5-point Likert scale to evaluate the presence of Native Reliance cultural identity; (minimum score of 24; maximum score of 120); higher score indicates a better outcome
Global Assessment of Individual Needs-Quick (GAIN-Q)
Time frame: Baseline and 3 month post-intervention
Subscales: Anxiety (7-items), ( minimum score of 0; maximum score of 7; lower score indicates better outcome) Stress (20-items; minimum score of 0; maximum score of 20; lower score indiciates better outcome) and Substance Use (16-items; minimum score of 0; maximum score of 16; lower score indicates better outcome)
Commercial Tobacco Use
Time frame: baseline and 3 month post-intervention
Global Youth Tobacco Survey (GYTS) a 43 item measure to assess key tobacco-control indicators, minimum score of 0; maximum score of 43 including use, cessation, and availability; lower score indicates better outcome
2 secondary outcomes
Depression
Time frame: baseline and 3 month post-intervention
Suicide Ideation
Time frame: baseline and 3 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mental Health Wellness 1 and Behavior, Health, run by University of Texas at Austin 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (NRQ) (time frame: Baseline and 3 month post-intervention). The study lists 3 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 20 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.