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Clinical Trials/NCT07746375
NCT07746375Enrolling By InvitationNot Applicable

Talking Circle for Native American Youth Living Well (AYoLi)

Melessa Kelley1 site in 1 country200 target enrollmentStarted: June 23, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Native Reliance Questionnaire

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
10 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

  • •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

Arms & Interventions

Talking Circle Intervention Group

Experimental

The intervention group is receiving the talking circle intervention.

Intervention: Talking Circle Intervention (Behavioral)

Wait-List Control Group

Other

Mental Health

Intervention: Wait-List Control Group (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Global Youth Commercial Tobacco-Survey(Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention)
  • Suicidal Ideation Questionnaire-Junior-15(Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention)
  • Global Assessment of Needs Assessment-Q Substance Use Scale(Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention)

Investigators

Sponsor
Melessa Kelley
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Melessa Kelley

Co-Investigator

University of Texas at Austin

Study Sites (1)

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