Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)
10. august 2026 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Texas
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San Antonio, Texas, Forente stater, 78207
- American Indians In Texas at the Spanish Colonial Missions
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH)
- Hovedetterforsker: John R Lowe, PhD, RN, University of Texas at Austin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. juni 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. august 2029
Datoer for studieregistrering
Først innsendt
29. juli 2026
Først innsendt som oppfylte QC-kriteriene
29. juli 2026
Først lagt ut (Faktiske)
5. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00004266-02
- UH3AT012547 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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