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Enrolling by invitation NCT07746375

Talking Circle for Native American Youth Living Well (AYoLi)

No phase Interventional Intervention Condition Wait-List Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Talking Circle Intervention, Wait-List Control Group.
Who it may be relevant to
Registry conditions: Intervention Condition, Wait-List Control. Basic parameters: 10 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • GAIN-Q Global Assessment of Individual Needs-Quick [Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention]
  • Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) [Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention]
  • Suicidal Ideation Questionnaire-Junior (SIQ-JR-15) [Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention]
  • Native Reliance Questionnaire (NRQ) [Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention]
Secondary outcome measures (1)
  • Global Youth Tobacco-Survey [Time frame: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention]

Eligibility criteria

Inclusion Criteria: Participant inclusion criteria include: (a) Native American students enrolled in the 5th and 6th grades from (10 schools in 2 districts, (5 rural) and (5 urban) after-school programs

Exclusion Criteria: Not Native American, not 5th or 6th graders, non-English speakers, not able to read and write English or provide assent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • American Indians in Texas at the Spanish Colonial Missions — San Antonio

Identifiers

NCT: NCT07746375 · STUDY00004266-02 · UH3AT012547

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗