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临床试验/NCT07746375
NCT07746375Enrolling By Invitation不适用

Talking Circle for Native American Youth Living Well (AYoLi)

Melessa Kelley1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
GAIN-Q Global Assessment of Individual Needs-Quick

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Talking Circle Intervention Group

Experimental

The intervention group is receiving the talking circle intervention.

干预措施: Talking Circle Intervention (Behavioral)

Wait-List Control Group

Other

Mental Health

干预措施: Wait-List Control Group (Behavioral)

结局指标

主要结局

GAIN-Q Global Assessment of Individual Needs-Quick

时间窗: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

this a brief assessment designed for use in diverse settings. GAIN-Q includes sub-scales for general life problems (general risk factors, sources of stress, health distress), internal behavior (depression, suicide risk, anxiety), and substance-related difficulties (substance use and abuse, substance dependence). In this study, we will use the 20-item "sources of stress index" (SOSI-20) to measure stress, the 7-item sub-scale "anxiety-trauma scale" (ATS-7) to measure anxiety, and the 16-item sub-scale "substance-related issues" (SRS-16) to assess substance use

Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10)

时间窗: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

omprised of 10 items that ask how many days in the last week (Less than 1 day, 1-2 days, 3-4 days, or 5-7 days, scored 0 to 3, respectively). Students felt, for example, that they could not 'get going' , felt lonely, or had restless sleep. Items are summed to create a total score.

Suicidal Ideation Questionnaire-Junior (SIQ-JR-15)

时间窗: 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.

Native Reliance Questionnaire (NRQ)

时间窗: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention

Native Reliance is a 24-item Likert scale, will be used to evaluate the presence of Native-Reliance. It is expected that increased presence of Native-Reliance will predict better mental health outcomes

Native Reliance Questionnaire

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Global Youth Tobacco-Survey(Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention)
  • 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)

研究者

发起方
Melessa Kelley
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melessa Kelley

Co-Investigator

University of Texas at Austin

研究点 (1)

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