- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06781736
Talking Circle for Native American Youth (AYoLi)
Talking Circle for Native American Youth Living Well (AYoLi)
Study Overview
Status
Intervention / Treatment
Detailed Description
Specific aims for Phase 1 (UG3) include:
UG3 Aim 1. To inform adaptation of the school-based Talking Circle intervention, a Community Partnership Committee (CPC) of UKB members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for MEB health of UKB youth, paying special attention to the nuances of cultural difference between rural and urban UKB communities in Oklahoma.
UG3 Aim 2. To conduct a Talking Circle intervention Facilitator Training Program with rural and urban UKB tribal community members to catalyze capacity building and sustainability for future intervention.
UG3 Aim 3. To pilot the adapted evidenced-based Talking Circle intervention for the promotion of MEB health among (N=20) 10 to 12 year-olds UKB youth in Oklahoma.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Tahlequah, Oklahoma, United States, 74464
- United Keetoowah Band of Cherokee Indians in Oklahoma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Native American students
- English speakers
- Read and write English
- At risk for mental health and behavioral health issues
Exclusion Criteria:
- Not Native American
- Non-English speakers
- Not able to read and write English
- Not at risk for mental health or behavioral health issues
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Mental Health Wellness 1
Talking Circle Intervention to promote the mental, emotional, and behavioral well-being
|
Talking Circle intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Native Reliance Questionnaire (NRQ)
Time Frame: Baseline and 3 month post-intervention
|
24-items rated on a 5-point Likert scale to evaluate the presence of Native Reliance cultural identity; (minimum score of 24; maximum score of 120); higher score indicates a better outcome
|
Baseline and 3 month post-intervention
|
|
Global Assessment of Individual Needs-Quick (GAIN-Q)
Time Frame: Baseline and 3 month post-intervention
|
Subscales: Anxiety (7-items), ( minimum score of 0; maximum score of 7; lower score indicates better outcome) Stress (20-items; minimum score of 0; maximum score of 20; lower score indiciates better outcome) and Substance Use (16-items; minimum score of 0; maximum score of 16; lower score indicates better outcome)
|
Baseline and 3 month post-intervention
|
|
Commercial Tobacco Use
Time Frame: baseline and 3 month post-intervention
|
Global Youth Tobacco Survey (GYTS) a 43 item measure to assess key tobacco-control indicators, minimum score of 0; maximum score of 43 including use, cessation, and availability; lower score indicates better outcome
|
baseline and 3 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: baseline and 3 month post-intervention
|
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) a 10 item measure of depressed affect used in samples of NA youth with good reliability and validity (minimum score of 6; maximum score of 24) higher score is a worse outcome and lower score is a better outcome
|
baseline and 3 month post-intervention
|
|
Suicide Ideation
Time Frame: baseline and 3 month post-intervention
|
Suicidal Ideation Questionnaire-Junior (SIQ-JR-15),15-items is rated on a 7-point scale indicating the frequency of suicidal thoughts, showing excellent validity and reliability, and an effective predictor of suicide risks in the Native American adolescent population (minimum score of 15 maximum score 105); the higher score indicates the greater risk of suicidal Ideation and lower score indicates lower risk of suicidal ideation.
|
baseline and 3 month post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004266
- 1UG3AT012547-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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