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Набор по приглашению NCT07746375

Talking Circle for Native American Youth Living Well (AYoLi)

Без фазы С лечением Intervention Condition Wait-List Control

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Talking Circle Intervention, Wait-List Control Group.
Кому может быть актуально
Состояния в реестре: Intervention Condition, Wait-List Control. Базовые параметры: 10 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

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

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • American Indians in Texas at the Spanish Colonial Missions — San Antonio

Идентификаторы

NCT: NCT07746375 · STUDY00004266-02 · UH3AT012547

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗