针对使用阿片类药物的母亲的可扩展视频辅导干预
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Alexander S Wagnon, B.S.
- 电话号码:541-346-8064
- 邮箱:awagnon@uoregon.edu
研究联系人备份
- 姓名:Elizabeth Backus, B.A.
- 电话号码:541-346-3442
- 邮箱:ebackus@uoregon.edu
学习地点
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Oregon
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Eugene、Oregon、美国、97403
- 招聘中
- University of Oregon
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接触:
- Alexander S Wagnon, B.S.
- 电话号码:541-346-8064
- 邮箱:awagnon@uoregon.edu
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首席研究员:
- Philip A Fisher, Ph.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 必须是成年人(18-50岁)
- 必须是 0-48 个月大的孩子的亲生父母
- 必须接受过或目前正在接受任何 DSM-5 类物质使用障碍的物质使用障碍治疗,咖啡因或烟草除外。 这包括酒精、大麻、致幻剂、吸入剂、阿片类药物、镇静剂、催眠药/抗焦虑药和兴奋剂。
- 必须每周至少让孩子有两天在入学时
排除标准:
- 金属植入物、金属碎片、心脏起搏器或其他电子医疗植入物
- 幽闭恐惧症
- 重量 > 550 磅
- 怀孕或认为可能怀孕的女性
- 神经系统疾病史
- 左撇子
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:拍摄互动以培育发展 (FIND)
FIND 是一种简短的视频辅导干预,涉及教练使用从看护者与儿童互动视频中提取的简短电影片段向看护者提供反馈。
辅导的重点是向看护者展示他们在辅导课程中参与发展支持互动的实例。
FIND 每周提供 10 节课,持续 30-45 分钟。
该过程从初始课程开始,教练提供概述,记录 10-15 分钟的看护者与孩子的互动,然后介绍发球和返回的概念。
该视频经过编辑以显示简短的片段,其中看护者参与了五个特定的基于看护者的服务和返回组件中的第一个。
下周,FIND 教练会与看护人详细审查编辑后的片段。
课程继续进行,在拍摄和辅导课程之间交替进行,直到依次涵盖所有五个组成部分。
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FIND 是一种简短的视频指导干预,涉及教练使用从家中收集的看护者与儿童互动视频中提取的简短电影片段向看护者提供反馈。
其他名称:
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有源比较器:健康幼儿计划 (HTP)
HTP 是主动控制干预,包括每周一次的会议,交替进行 (a) 涵盖儿童发展五个领域之一(运动、认知、语言、游戏和社交情感)的辅导会议和 (b) 将包括回顾的观察会议之前的辅导课程以及对照顾者与儿童互动的观察和讨论。
该干预将包括 10 节课,每节课持续 25-30 分钟。
教练不会进行任何拍摄或视频指导,但可以讨论护理问题。
HTP 材料改编自佛罗里达州立大学预防和早期干预政策中心开发的 Partners for a Healthy Baby 课程。
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HTP 是主动控制干预,包括每周一次的会议,交替进行 (a) 涵盖儿童发展五个领域之一(运动、认知、语言、游戏和社交情感)的辅导会议和 (b) 将包括回顾的观察会议之前的辅导课程以及对照顾者与儿童互动的观察和讨论。
其他名称:
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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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通过父母压力指数-IV 的育儿压力发生率
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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项目采用 5 分制,从“非常同意”到“非常不同意”。 分数越高表明育儿压力越大。 这些措施包括三个分量表和一个总分:
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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看护人通过父母能力感量表 (PSOC) 感知的育儿能力感
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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育儿能力感(PSOC)问卷由看护者填写,以评估父母的能力感和育儿乐趣。 这是 PSOC 的改编版本(原始 PSOC 有 17 个项目,Johnston & Mash,1989),有 18 个项目和简化的语言,适用于较低的阅读水平。 这些项目以从“非常同意”到“非常不同意”的 4 分制回答。 某些项目的评分是相反的,因此对于所有项目,较高的分数表示较高的育儿自尊。 PSOC 上的九 (9) 个项目(#s 2、3、4、5、8、9、13、15 和 17)采用反向编码。 分量表包括: 满意度:平均得分 2、3、4、5、9、13、15、17 和 18(范围 = 1-4) 功效:平均得分 1、6、7、8、10、11、14 和16(范围 = 1-4)总分:18 - 72,总分 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过测量行为抑制系统和行为激活系统 (BIS/BAS) 量表评估看护者的动机
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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BIS/BAS 量表是一个包含 24 个项目的自我报告问卷,旨在衡量两个动机系统:行为抑制系统 (BIS) 和行为激活系统 (BAS)。 参与者使用 4 点李克特量表回答每个项目。 该量表有四个子量表。 一个分量表对应于 BIS。 七个项目有助于这个分数。 其余三个分量表对应于 BAS 的三个组成部分。 BAS Drive 衡量追随个人目标的动机。 四个项目有助于这个分数。 BAS Reward Responsiveness 衡量对环境中愉快增强物的敏感性。 四个项目有助于这个分数。 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过 SDQ-Infant 问卷评估儿童的情绪或行为问题
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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优势和困难问卷 (SDQ) 是一份简短的行为筛查问卷。
共 25 个项目,从不真实到肯定真实,采用 3 分制。
接下来是 5 个项目,评估情绪、注意力、行为或与人相处的困难。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过阿片类药物渴望量表测量阿片类药物渴望
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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阿片类药物渴望量表是可卡因渴望量表(Weiss 等人,1995、1997、2003)的改进版,用于测量阿片类药物的渴望。
该量表由 0-10 的视觉模拟量表评分的三个项目组成
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过 ECHO 措施自我报告收入、职业和财务压力(收入、职业、财务压力)
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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该措施是一份包含收入、职业和财务压力的 9 项自我报告。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过社会支持问卷测量社会支持
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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衡量社会支持,得出以下方面的分数:
根据列出的支持人员的数量对每个项目进行评分,满意度等级按 1 到 6 的等级评分(1 = 非常满意,6 = 非常不满意)。 将总体数量和满意度得分相加并除以 27。 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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根据家庭环境量表的凝聚力子量表评估的家庭成员承诺和支持的自我报告
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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Family Environment Scale (FES) 是一个自评量表,包含 90 个项目,用于评估家庭的社会氛围,侧重于测量和描述家庭成员之间的人际关系,个人成长方向和家庭的基本组织结构. Cohesion 子量表是一个 9 项量表,旨在衡量家庭成员相互提供的承诺和支持程度。 受访者按照从大部分真实到大部分虚假的等级对陈述进行评分。 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过麦克阿瑟交际发展清单 (MCDI) 评估的交际技能
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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MacArthur 交际发展量表 (MCDI) 是评估婴幼儿交际技能的家长报告工具。 婴儿表格(一级)专为 8 至 18 个月的儿童设计,包含一个 89 个单词的词汇表,其中包含单独的理解栏和生产栏。 有两种等效形式的幼儿形式(II 级,形式 A 和 B),均专为 16 至 30 个月的儿童设计。 每个表格包含 100 个词汇项目。 使用适合女孩和男孩的规范表,为从第 5 到第 99 等级的每个第 5 个百分位水平提供原始分值。 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过停止信号任务观察到的抑制控制水平
大体时间:从基线到终点的变化(基线后 3-4 个月)
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在 MRI 扫描期间,将通过停止信号任务 (SST) 评估抑制控制。
任务速度根据表现进行调整,并且将为每个参与者输出单个响应时间分数。
关键的神经测量是停止试验期间血液氧合水平依赖性 (BOLD) 信号的程度,相对于去试验(即整个试验期间的“停止 > 去”对比)。
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从基线到终点的变化(基线后 3-4 个月)
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观察父母的自我概念
大体时间:从基线到终点的变化(基线后 3-4 个月)
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PSET 涉及在两种不同的教学条件下看到的育儿领域中单个单词或短语的视觉呈现(例如,善良、支持、强制规则)。
身份条件将要求参与者通过按下按钮来表明该单词或短语是否将他们描述为父母(左手食指 = 是,右手食指 = 否)。
控制条件将要求参与者通过按下按钮来指示单词或短语是否是可以为父母改变的质量(是/否)。
分数是在每种情况下对发展支持 (DS) 和发展不支持 (DU) 项目的认可百分比。
关键的神经对比是在呈现 (a) 身份 > 控制试验和 (b) 身份-是 > 身份-无试验期间的神经激活。
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从基线到终点的变化(基线后 3-4 个月)
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通过对话轮流进行响应式护理的编码率
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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Conversational turns 是一种简单的编码方案,旨在记录看护者和儿童话语的时间、数量和长度。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过使用爱荷华家庭互动评定量表评估父母对孩子的热情和敌意
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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爱荷华家庭互动评定量表用于评估父母对伴侣的热情和敌意,他们从伴侣那里感受到的温暖和敌意,以及对孩子的热情和敌意。 问卷分为3个部分;前 10 个问题询问您如何对待您的伴侣,接下来的 10 个问题询问您的伴侣如何对待您,最后 10 个问题询问您如何对待您的孩子。 问卷的每个部分有 2 个量表,温暖(6 个条目)和敌意(4 个条目)。 对于两个量表,每个项目都有可能的 7 个响应。 每个量表反向评分,然后通过添加每个项目分数来求和,为温暖量表提供 0-42 的可能范围,为敌意量表提供 0-28 的可能范围。 较高的分数分别表示较高程度的热情/敌意。 |
从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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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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响应式护理的移动消息传递 (MMRC)
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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看护者自我报告的儿童与看护者之间的响应性看护互动率。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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人口统计信息
大体时间:基线
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人口统计信息,包括社会经济地位、照顾者和儿童的年龄和性别、教育水平、种族/族裔
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基线
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通过不良童年经历 (ACE) 评估的早期逆境发生率
大体时间:基线
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ACE 是衡量童年逆境的 10 项指标,通常用作预测以后生活中较差结果的指标。 总分 10 分越高,结果越差的可能性越大。 总 ACE 分数的所有响应 1-10 的分数相加。 反向编码情感忽视问题,问题 10,如果其中一个子问题的回答为“否”,则该问题算作 ACE。 开发人员建议不要将补充问题包括在总 ACE 分数中。 他们建议忠于最初的 ACE 10 类别,以便我们可以跨站点比较数据。 如果需要,您可以将补充问题的分数相加,并创建一个补充总计以单独检查。 TotalACES=ACE 总分 TotalSupp=补充题总分 TotalAll=ACE 分和补充题总分 |
基线
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通过使用 PhenX Broad Psychopathology 问卷评估跨精神疾病的心理健康领域
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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该测量包括 23 个问题,评估 13 个精神领域,包括抑郁、愤怒、躁狂、焦虑、躯体症状、自杀意念、精神病、睡眠问题、记忆、重复的思想和行为、分离、人格功能和物质使用。
每个项目询问个人在过去 2 周内被特定症状困扰的程度(或频率)。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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通过使用保真度标准评估的干预保真度
大体时间:在干预结束时评估,直接在终点之前(基线后 3-4 个月)
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干预保真度是通过从给定干预所需行动的清单中完成的所需项目的数量来评估的。
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在干预结束时评估,直接在终点之前(基线后 3-4 个月)
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根据完成的疗程数评估的干预剂量
大体时间:在干预结束时评估,直接在终点之前(基线后 3-4 个月)
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干预剂量根据每次干预完成的疗程数来评估。 Total FIND Sessions Complete = 完成的会话数 (0-10) Total HTP Sessions Complete = 完成的会话数 (0-10) |
在干预结束时评估,直接在终点之前(基线后 3-4 个月)
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通过使用童年不可预测性问卷 (QUIC) 评估婴儿和儿童早期生活环境的不可预测性和碎片化
大体时间:在基线
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QUIC 是一种可靠且有效的自我报告评估,用于评估早期生活中社交、情感和身体领域的不可预测性,是预测精神疾病风险的简短、全面和有前途的工具。
QUIC 由总分和五个单独的分量表分数组成。
分数越高表明在童年时期更多地暴露于不可预测性。
求总分或子量表分,反向分选项目(项目编号后用R表示),然后计算各量表项目总和:家长监督与参与=1R+3R+4R+5R+6R+ 7R + 9R + 10R + 14R 父母可预测性 = 2 + 8R + 11 + 12 + 15R + 16 + 17R + 31 + 32 + 33 + 34 + 35 父母环境 = 18 + 19 + 21 + 22 + 28R + 29 + 30 物理环境 = 13 + 20 + 26 + 27 + 36R + 37 + 38 安全和安保 = 23 + 24 + 25 总体 = 所有子量表的总和。
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在基线
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通过 PhenX 和 iOpen 修改的问卷评估的自我报告的物质使用和治疗史
大体时间:从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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从 PhenX 和 iOpen 开发的问卷调查,用于评估物质使用和治疗史。
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从基线到终点(基线后 3-4 个月)和终点后 6 个月的变化
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合作者和调查者
调查人员
- 首席研究员:Philip A Fisher, Ph.D.、University of Oregon
出版物和有用的链接
一般刊物
- National Institutes of Health. Improve Treatments for Opioid Misuse and Addiction: NIH Heal Intitiative. 2018; https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/improve-treatments-opioid-misuse-addiction. Accessed September 17, 2018.
- Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015 Aug;35(8):650-5. doi: 10.1038/jp.2015.36. Epub 2015 Apr 30. Erratum In: J Perinatol. 2015 Aug;35(8):667. Lehman, C U [corrected to Lehmann, C U].
- National Institutes of Health. HEAL Initiative Research Plan. 2018; https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/heal-initiative-research-plan. Accessed September 17, 2018.
- National Institute on Drug Abuse. Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome. 2015; https://www.drugabuse.gov/related-topics/trends-statistics/infographics/dramatic-increases-in-maternal-opioid-use-neonatal-abstinence-syndrome. Accessed September 17, 2018.
- Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
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