家庭倾听计划：多部落实施和评估
2025年1月28日 更新者：University of New Mexico
这是一项为期五年的 R01 有效性试验，部落合作伙伴致力于评估家庭倾听/圈子计划的有效性，并在印第安国家传播该方法和干预措施，作为减少药物滥用健康差异的最佳实践。赠款的三个具体目标是1）严格测试FLCP的有效性；在部落内部和部落之间采用比较纵向设计，让四年级学生防止物质开始/使用并巩固家庭； 2) 通过 CBPR，支持 TRT 将其研究能力转化为地方预防研究基础设施和合作； 3) 评估其他计划对部落内其他健康/教育计划和领导力的影响。
总之，这种多部落/学术伙伴关系建立在成就的基础上，以测试创新干预的有效性。
这笔赠款提供了一个无与伦比的机会，可以减少三个部落社区的药物滥用，加强部落研究能力，并通过说明 CBPR 流程如何整合以证据为基础和以文化为中心的实践来创建有效的项目，从而在全国范围内影响药物滥用预防研究设计。社区所有权和可持续性。
研究概览
详细说明
由于药物滥用问题困扰着部落社区，美洲印第安人 (AI) 儿童的健康预防方法需要紧急关注。
主流项目未能按照自己的方式与 AI 儿童对话。
家庭倾听/圈子计划 (FL/CP) 并非如此，它整合了以证据为基础的家庭强化核心，以及针对四年级学生、他们的父母和长辈的文化价值观和实践。
通过以前的美洲原住民健康研究中心资助（印第安人健康服务和国立卫生研究院合作伙伴关系），FL/CP 是由新墨西哥大学参与研究中心和三个基于社区的参与研究 (CBPR) 合作伙伴关系创建和试点的部落社区：Jemez 的 Pueblo、Navajo 的 Ramah Band 和 Mescalero Apache Nation。
FL/CP 通过重拾文化传播的历史传统，填补药物滥用预防方面的空白，例如家庭晚餐讲故事，老人与孩子联系，支持通过传统对话、土著语言和赋权加强儿童与家庭的沟通和社会心理应对儿童和家庭创建解决社区药物滥用问题的社区行动项目。
随着最初的 FL/CP 试点和可行性研究的完成，来自 Jemez 普韦布洛、Navajo 的 Ramah Band 和 Mescalero Apache Nation 的部落研究团队 (TRT) 现已到位，通过纵向准实验设计进行全面的计划实施和有效性测试，涉及长期的、多部落/学术研究伙伴关系。
根据这项为期五年的 R01 有效性试验，部落合作伙伴致力于评估该计划的有效性，并在印第安国家传播该方法和干预措施，作为减少药物滥用健康差异的最佳实践，TRT 将在所有研究活动、实施、解释/分析和传播计划。
三个具体目标是 1) 严格测试 FLCP 的有效性；在部落内部和部落之间采用比较纵向设计，让四年级学生防止物质开始/使用并巩固家庭； 2) 通过 CBPR，支持 TRT 将其研究能力转化为地方预防研究基础设施和合作； 3) 评估其他计划对部落内其他健康/教育计划和领导力的影响。
总之，这种多部落/学术伙伴关系建立在成就的基础上，以测试创新干预的有效性。
这笔赠款提供了一个无与伦比的机会，可以减少三个部落社区的药物滥用，加强部落研究能力，并通过说明 CBPR 流程如何整合以证据为基础和以文化为中心的实践来创建有效的项目，从而在全国范围内影响药物滥用预防研究设计。社区所有权和可持续性。
研究类型
介入性
注册 (实际的)
266
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Mexico
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Jemez Pueblo、New Mexico、美国、87024
- Pueblo of Jemez Department of Education
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Mescalero、New Mexico、美国、88340
- Mescalero Prevention Program
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Pinehill、New Mexico、美国、87357
- Ramah Navajo School Board
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 11年 (孩子)
接受健康志愿者
是的
描述
纳入标准：纳入标准包括来自 Mescalero Apache、Jemez Pueblo 和 Ramah Navajo 的任何有四年级和五年级儿童的家庭及其父母或监护人，以及自愿参加的祖父母。
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排除标准：不符合本研究资格的人是：不同意和/或不同意参加的人；那些不属于 Mescalero Apache、Jemez Pueblo 和 Ramah Navajo 的部落成员，或者不属于 Mescalero Apache、Jemez Pueblo 和 Ramah Navajo 的人的家庭成员；不在四五年级目标范围内的儿童。
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：节目组
部落研究小组成员通过给四年级和五年级的孩子寄信来招募参与者。
这封信提供了 FL/CP 的概述，并邀请感兴趣的家长和孩子了解更多信息。
TRT 和 UNM 团队成员分别与感兴趣的家长进行跟进。
如果家庭承诺成为 FL/CP 的一部分，将召开会议进行知情同意程序并完成预测试。
然后，计划组中的家庭将参加涵盖代际文化适应课程的 FL/CP 课程。
计划家庭还参与计划的各个方面，包括完成社区行动项目。
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每节课都以家庭聚餐开始。
然后练习他们的印第安和氏族名字。
会议由主持人以他们自己的语言或双语主持。
然后，主持人将家庭分为儿童组和成人组，以讨论会议的主题，然后他们在会议结束时一起回来分享他们的经验教训。
课程总是以儿童和成人在他们的日记中写作而结束，这些日记是单独的页面，然后他们将它们放入课程活页夹中。
然后给家庭进行“家庭练习”，这是家庭在接下来的一周内一起完成的任务。
辅导员会在每次课程结束后收集课程活页夹，并在下周带回给家庭。
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无干预：对照组
收到信件后，选择不参加或拒绝参加的家庭将被邀请作为比较参与者参加研究。
比较参与者不参加 FL/CP 课程，只完成前、后和 1 年后的测试。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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孩子的幸福
大体时间：测试后（干预后2-4个月）
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自我报告的焦虑量度，焦虑恐慌/GAD子尺度，基线的平均变化（预编程参与）。
编码的焦虑项目为1-4。
将量表计算为项目的算术平均值，最小值为1，最大值为4。得分较低。
恐慌/GAD子尺度是三个物品的平均值，其最小/最大最大为全尺度。
在测试前，测试后（干预后2-4个月）和一年干预后进行调查的儿童。
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测试后（干预后2-4个月）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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孩子的幸福
大体时间：秘密调查：干预后一年
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自我报告的抑郁量度量，从基线在一年中，抑郁量表项目的变化为1至3，使用26个项目的算术平均值来计算量表。
该量表的最小值为1.0，最大值为3.0，值较高，即抑郁症的水平较低。
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秘密调查：干预后一年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Lorenda Belone, PhD、University of New Mexico
- 首席研究员：Nina Wallerstein, DrPH、University of New Mexico
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年4月1日
初级完成 (实际的)
2019年3月31日
研究完成 (实际的)
2019年3月31日
研究注册日期
首次提交
2017年5月3日
首先提交符合 QC 标准的
2017年5月3日
首次发布 (实际的)
2017年5月5日
研究记录更新
最后更新发布 (实际的)
2025年3月25日
上次提交的符合 QC 标准的更新
2025年1月28日
最后验证
2025年1月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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