Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)
10. august 2026 opdateret af: Melessa Kelley
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.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Texas
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San Antonio, Texas, Forenede Stater, 78207
- American Indians In Texas at the Spanish Colonial Missions
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Talking Circle Intervention Group
The intervention group is receiving the talking circle intervention.
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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.
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Andet: Wait-List Control Group
Mental Health
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Native Reliance Questionnaire
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress Index
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Generalized Anxiety Disorder-7 (GAD-7)
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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 |
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Global Youth Commercial Tobacco-Survey
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Suicidal Ideation Questionnaire-Junior-15
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Global Assessment of Needs Assessment-Q Substance Use Scale
Tidsramme: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool
Tidsramme: Baseline prior to start of the Intervention
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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.
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Baseline prior to start of the Intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH)
- Ledende efterforsker: John R Lowe, PhD, RN, University of Texas at Austin
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. juni 2026
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
31. august 2029
Datoer for studieregistrering
Først indsendt
29. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
5. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00004266-02
- UH3AT012547 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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