Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)
10 de agosto de 2026 atualizado por: Melessa Kelley
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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Texas
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San Antonio, Texas, Estados Unidos, 78207
- American Indians In Texas at the Spanish Colonial Missions
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
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 includes
- 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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Talking Circle Intervention Group
The intervention group is receiving the talking circle intervention.
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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.
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Outro: Wait-List Control Group
Mental Health
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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 at the completion of the 10 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Native Reliance Questionnaire
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Global Assessment of Individual Needs-Quick (GAIN-Q)- Sources of Stress Index
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Generalized Anxiety Disorder-7 (GAD-7)
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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 |
Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Global Youth Commercial Tobacco-Survey
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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The Global Youth Commercial Tobacco Survey is a self-reported instrument measuring tobacco.
In this survey we are utilizing 13-items with a score of 0 to 13 with a minimum score of 0 and a maximum score of 13.
A higher score indicates a worse outcome and a higher use of commercial tobacco products.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Suicidal Ideation Questionnaire-Junior-15
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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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.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Global Assessment of Needs Assessment-Q Substance Use Scale
Prazo: Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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The Global Assessment of Needs Assessment-Q Substance Use scale is a sub-scale used to measure substance use.
For this study, we are utilizing 14 items with a score of 0 to 14, with a minimum score of 0 and a maximum score of 14.
A higher score indicates a worse outcome and higher substance use.
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Baseline, 3-Month Post-Intervention and 6-Month-Post-Intervention
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool
Prazo: Baseline prior to start of the Intervention
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The Pediatric Symptom Checklist is being used as a pre-screening tool.
The Pediatric Symptom Checklist-17 is not meant to be used as a diagnostic tool.
It includes a 17-item checklist.
Each of the 17 items is rated as "NEVER" (0), "SOMETIMES" (1), or "OFTEN" (2).
The total score is the sum of these ratings ranging from 0 to 34, with a minimum score of 0 and a maximum score of 34.
A higher score is a worse outcome and may indicate impairment in psycho-social functioning, which may include cognitive, emotional, and behavioral problems.
Higher scores suggest that individuals may be 'at risk' and require further assessment by a qualified health professional.
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Baseline prior to start of the Intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH)
- Investigador principal: John R Lowe, PhD, RN, University of Texas at Austin
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de junho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de agosto de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
29 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2026
Primeira postagem (Real)
5 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00004266-02
- UH3AT012547 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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