Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)

10. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78207
        • American Indians In Texas at the Spanish Colonial Missions

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Talking Circle Intervention Group
The intervention group is receiving the talking circle intervention.
Verhalten: Talking Circle Intervention
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.
Sonstiges: Wait-List Control Group
Mental Health
Verhalten: Wait-List Control Group
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Native Reliance Questionnaire
Zeitfenster: 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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress Index
Zeitfenster: 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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Generalized Anxiety Disorder-7 (GAD-7)
Zeitfenster: 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
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)
Zeitfenster: 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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Global Youth Commercial Tobacco-Survey
Zeitfenster: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Suicidal Ideation Questionnaire-Junior-15
Zeitfenster: 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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
Global Assessment of Needs Assessment-Q Substance Use Scale
Zeitfenster: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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.
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool
Zeitfenster: Baseline prior to start of the Intervention
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.
Baseline prior to start of the Intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Melessa Kelley

Mitarbeiter

National Center for Complementary and Integrative Health (NCCIH)

Ermittler

  • Studienleiter: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH)
  • Hauptermittler: John R Lowe, PhD, RN, University of Texas at Austin

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. August 2029

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

5. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00004266-02
  • UH3AT012547 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren