- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07746375
Talking Circle for Native American Youth Living Well (AYoLi) (AYoLi)
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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San Antonio, Texas, 미국, 78207
- American Indians In Texas at the Spanish Colonial Missions
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Native Reliance Questionnaire
기간: 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
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Global Youth Commercial Tobacco-Survey
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pediatric Symptom Checklist-17 (PSC-17) is a pre-screening tool
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Jennifer N Baumgartner, PhD, National Center for Complementary and Integrative Health (NCCIH)
- 수석 연구원: John R Lowe, PhD, RN, University of Texas at Austin
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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