KEEP-P 试验,一种针对寄养学龄前儿童的预防性干预措施 (KEEP-P) (KEEP-P)
KEEP-P 的随机试验,一种针对寄养学龄前儿童的预防干预措施
研究概览
详细说明
KEEP-P 的随机试验,一种针对寄养学龄前儿童的预防性干预措施 (KEEP-P)。
学龄前寄养儿童和其他高危儿童面临许多负面后果的风险增加。 然而,对这些年幼的儿童使用基于证据的干预措施非常有限。 在这一领域取得进展的主要障碍包括缺乏针对学龄前高危儿童的可用循证计划,以及现有的少数循证干预措施在资金和工作人员专业水平方面往往是资源密集型的需要忠实地执行。 显然需要针对寄养和其他高风险学龄前儿童采取易于扩展、基于证据的干预措施,以减少普遍存在的差异。 拟议研究的目标是对学龄前儿童的看护者进行一项新的、低成本的、手动的、基于群体的干预的随机临床试验。 研究人员建议评估干预的两个版本:(a) 基本版本采用由 12 个每周心理教育看护者支持小组组成的课程,以及 (b) 增强版由看护者支持小组和扩展课程组成,包括添加关于早期大脑发育的最新发现和拍摄互动以培养发展 (FIND) 视频辅导计划的要素的信息。 在四波数据收集中(基线、干预后立即以及基线后 12 和 18 个月),研究人员将检查这两种干预条件在多大程度上显示了育儿改善、安置中断率降低以及儿童结果改善。 研究人员将进行多变量建模,以检查假设的即时和长期干预效果背后的中介机制。
最后,研究人员将进行全面的经济评估,以检查与实施干预相关的增量成本以及干预条件在增加儿童积极成果方面实现的收益。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Oregon
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Eugene、Oregon、美国、97403
- University of Oregon
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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:
- 学龄前寄养儿童
- 学龄前儿童转介早期干预/儿童特殊教育服务
排除标准:
- 如果儿童或他们的主要照顾者的英语不够流利,无法完成评估,或者如果确定儿童由于严重的发育、医学或身体障碍而无法完成评估程序,则儿童将被排除在招募之外.
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:平行线
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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ACTIVE_COMPARATOR:保持-P
护理人员被随机分配到两组中的一组。
KEEP-P 小组完成了课程的基础版本。
干预内容由 KEEP-P 小组协调员以每周 2 小时的小组形式提供。
该计划的持续时间为 12 周。
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KEEP-P 计划是一种针对学龄前儿童看护人的低成本、手动化、基于群体的干预措施。
该试验正在评估干预的 2 个版本。
KEEP-P 是一个基本版本,它采用每周 12 次心理教育护理人员支持小组的课程 在四波数据收集中(基线、干预后以及基线后 12 个月和 18 个月),我们将检查这种干预的程度情况表明,养育方式得到改善,安置中断率降低,儿童成果得到改善。
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实验性的:保持-P+
护理人员被随机分配到两组中的一组。
KEEP-P+ 小组通过课程完成了干预的增强版本,其中包括添加有关早期大脑发育的最新发现的信息,以及基于电影互动培养发展 (FIND) 计划的视频辅导部分。
干预内容由 KEEP-P 小组协调员以每周 2 小时的小组形式提供。
该计划的持续时间为 12 周。
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KEEP-P 计划是一种针对学龄前儿童看护人的低成本、手动化、基于群体的干预措施。
该试验正在评估干预的 2 个版本。
KEEP-P+ 是一个增强版本,由看护者支持小组组成,课程扩展,包括有关早期大脑发育的最新发现的信息以及拍摄互动以培养发展视频辅导计划的要素。
在四波数据收集(基线、干预后以及基线后 12 和 18 个月)中,我们将检查这种干预条件在多大程度上显示出改善育儿、降低安置中断率和改善儿童结果的程度。
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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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通过自我报告衡量的育儿压力 育儿压力指数 IV (PSI-IV) 简表
大体时间:从基线到终点的变化(基线后 3-4 个月)
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Parenting Stress Index IV (PSI-IV) Short Form 根据父母对孩子特征的认知、父母的个人特征以及亲子之间的互动来评估亲子关系中的压力大小。 这是一个从“非常同意”到“非常不同意”的 5 点李克特量表,共 36 个条目。 项目 32 是唯一反向编码的项目。 对于所有其他项目,较高的分数表示较高的压力水平。 育儿压力总分是通过将所有 36 个项目的分数相加计算得出的,范围从 36 到 180。 |
从基线到终点的变化(基线后 3-4 个月)
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看护人通过自我报告衡量父母能力感量表 (PSOC) 对育儿能力的感知
大体时间:从基线到终点的变化(基线后 3-4 个月)
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照顾者填写了根据 FOI 改编的育儿能力感 (PSOC) 问卷,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。 项目以从“强烈同意”到“强烈不同意”的 4 点李克特量表回答。 九个项目(#s 2、3、4、5、8、9、13、15 和 17)被反向编码,因此,对于所有项目,较高的分数表示较高的育儿自尊。 父母感知能力的总分是通过将所有 18 个项目的分数相加得出的,范围从 18 到 72。 |
从基线到终点的变化(基线后 3-4 个月)
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通过观察措施观察到的发展支持育儿水平与儿童的育儿互动:与结果相关的观察清单(PICCOLO)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“与孩子的育儿互动:与结果相关的观察清单 (PICCOLO) 是一项观察措施,它对四个领域的发展支持育儿进行评级:情感、反应、鼓励和教学。 这是一份包含 29 个项目的清单,反映了积极的亲子互动行为。 每个行为根据它们的频率被评为 0(不存在,没有观察到行为),1(几乎没有,轻微或新出现的行为)和 2(明确,明确,强烈和频繁的行为)。 分数越高表明积极教养水平越高。 PICCOLO 总分是将所有 29 个项目的分数相加得出的,范围从 0 到 58。” |
从基线到终点的变化(基线后 3-4 个月)
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通过自我报告测量家庭惯例问卷(FRQ)的家庭惯例频率
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“家庭惯例问卷 (FRQ) 是一个包含 28 个项目的衡量标准,用于衡量家庭惯例的频率和重要性。 分数是根据家庭日常活动的频率和日常活动对他们的重要性计算的。 结果报告了家庭惯例结构的频率。 为了根据家庭执行的频率对每个认可的例行程序进行评分,每日执行的权重为 3,每周 3-5 次频率稍低的执行分配为 2 的权重;每周 l-2 次的频率更低的性能分配的权重为 1。 “几乎从不”类别被认为是指该家庭不参与特定的例程,因此在计算总清单得分时,它被指定为 0 值。 通过将所有 28 个项目的频率得分相加,总频率得分范围为 0 到 84。 分数越高表明家庭惯例的频率越高。” |
从基线到终点的变化(基线后 3-4 个月)
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通过自我报告衡量育儿中的人际关系正念(IEMP)的正念育儿
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“育儿中的人际关系正念 (IEMP) 量表是一个包含 10 个项目的衡量标准,用于调查育儿过程中人际关系正念的质量。 项目以 5 点李克特量表回答,范围从““从不正确”到“总是正确”。 四个项目(#s 1、5、9 和 10)被反向编码。 总分是所有项目得分的总和,范围从 10 到 50。 分数越高表明正念育儿的质量越高。” |
从基线到终点的变化(基线后 3-4 个月)
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通过看护者报告衡量依恋日记 (ADRY) 的儿童依恋行为
大体时间:从基线到终点的变化(基线后 3-4 个月)
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依恋日记 (ADRY) 是一项包含 47 项的措施,照顾者通过在行为列表上打勾来报告孩子在受伤、害怕或与照顾者分离时的反应。 所有被检查的行为都被编码为三类,接近寻求/接触维持、回避和抵抗,以评估儿童依恋行为的个体差异。 因此,ADRY 没有总分,只有三个类别的子量表分数。 结果包括接近寻求/联系维持的分数(范围从 0 到 14)、回避分数(范围从 0 到 18)和抵抗分数(范围从 0 到 6),这些分数是通过计算检查行为的数量生成的在相应的分量表中。 较高的分数相应地表示较高水平的行为。 |
从基线到终点的变化(基线后 3-4 个月)
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儿童内化/外化症状和总行为评分通过看护者报告测量儿童行为检查表 (CBCL)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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儿童行为检查表 (CBCL) 是一份包含 100 个项目的问卷,用于评估儿童的情绪和行为问题。 看护者被要求使用 3 分李克特量表(0 = 不正确,1 = 有点/有时正确,2 = 非常正确/经常正确)对他们的孩子在过去两个月中表现出某些行为的频率进行评分。 分量表包括:内化症状 - 情绪反应:21、46、82、83、92、97、99;焦虑/抑郁:10、33、37、43、47、68、87、90;躯体主诉:1、7、39、45、78、86、93;孤僻:2、4、12、19、23、62、67、70、71、98 外化症状-注意力问题:5、6、24、48、51、56、59、64、95;攻击性行为:8、14、15、16、17、18、20、22、27、28、29、35、40、42、44、53、58、66、69、74、81、84、85、88 , 每个子量表的 96 个原始分数是通过相应地总结项目分数然后归一化为 T 分数来计算的。 均值固定为 50,标准差为 10 个点。 T 值越高表示行为问题越多。 |
从基线到终点的变化(基线后 3-4 个月)
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学龄前和幼儿园行为量表 (PKBS)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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看护人通过学前班和幼儿园行为量表 (PKBS) 对孩子行为的看法。 项目采用从“从不”到“经常”的 4 点量表。 分数越高表示行为问题越多。 PKBS总分(76项)总分介于0-228之间。 |
从基线到终点的变化(基线后 3-4 个月)
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通过看护者报告衡量的父母压力 父母每日报告 (PDR)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“家长每日报告 (PDR) 是一项照顾者报告措施,用于评估过去 24 小时内发生的儿童行为问题和相关的父母压力。 该措施有多个版本。 本研究中使用的版本是俄勒冈社会学习中心社区计划 PDR,它有 39 个问题,只有消极的儿童行为,针对 3 至 6 岁的儿童。 看护人将每个孩子的行为评分为 0 = 未发生,1 = 发生但压力不大,2 = 发生且压力大。 PDR 每波 3 次。 对于每个响应,压力行为的总分是通过计算被评为 2 = 发生和压力的行为的数量来计算的。 然后将三个总分取平均值,得到压力行为的平均值(范围从 0 到 39)作为父母压力的指标。 分数越高表明父母压力水平越高。” |
从基线到终点的变化(基线后 3-4 个月)
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通过照顾者报告测量年龄和阶段问卷的儿童社会情感发展:社会情感 (ASQ:SE)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“年龄和阶段问卷:社会情感发展筛查工具 (ASQ:SE) 是一份关于儿童社会情感发展的看护人报告问卷。 ASQ:SE共有29道题,其中26道题的评分范围为0-15分,其余为开放式。 因此,总分(26 个项目分数的总和)介于 0 到 390 之间。 较低的分数表示更积极的结果,即更好的社交情感发展。” |
从基线到终点的变化(基线后 3-4 个月)
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通过延迟选择范式观察到的儿童抑制控制水平
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“在延迟选择范例中,孩子们被要求在“现在得到一分钱/贴纸/治疗”或“四(或更多)带回家”之间做出选择,共九次。 总分是孩子选择“带回家”选项的总次数(范围从0到9)。 分数越高表明孩子延迟满足的能力越强,即抑制控制能力越强。” |
从基线到终点的变化(基线后 3-4 个月)
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维度变化卡片分类法 (DCCS)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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DCCS 中通过的阶段总数。
如果 4/6 次试验正确,则通过一个阶段。
孩子们只有通过了前一个阶段才能进入下一阶段。
共5个阶段。
较高的分数表示更好的执行功能。
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从基线到终点的变化(基线后 3-4 个月)
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通过熊/龙任务观察到的儿童抑制控制水平
大体时间:从基线到终点的变化(基线后 3-4 个月)
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在熊/龙任务中,孩子们看到了一只“好熊”和一条“卑鄙的龙”,并被指示按照熊说的去做(例如,“摸你的鼻子”),但不要按照龙说的去做。 在 5 次熊试验(0 = 不能移动;1 = 错误动作;2 = 部分动作;3 = 完全正确的动作)和 5 次龙试验(0 = 完全命令运动;1 = 部分命令运动;2 = 畏缩或错误运动;3 = 无运动)。 将每个试验的分数相加以产生从 0 到 30 的总分。 分数越高表示抑制控制越好。 |
从基线到终点的变化(基线后 3-4 个月)
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通过旋转锅任务观察到的儿童工作记忆水平
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 Spin the Pots 任务中,几个视觉上不同的盒子被排列在一个旋转的托盘上(2.5 岁:8 个盒子;3 岁:9 个盒子;3.5 岁:10 个盒子;4 岁;4 岁:10 个;4 岁:10 个;4 岁:10 个。 11 盒)。 孩子们看着实验者把五颜六色的贴纸藏在除了两个盒子之外的所有盒子里,用一块布盖住盒子,然后旋转托盘几秒钟以标记搜索试验的开始。 布被移除,孩子们被指示选择一个盒子来找到贴纸。 如果找到贴纸,孩子们可以保留它。 每次搜索尝试后,托盘被盖上并再次旋转以标记下一次搜索试验的开始。 一旦孩子们找到所有隐藏的贴纸或完成分配的试验次数(2.5 岁:12 次试验;3 岁:14 次试验;3.5 岁:16 次试验;4 岁;18 次)试验)。 找到的贴纸与试验次数的比率在 0 到 1 之间。 更高的分数表示更好的工作记忆。” |
从基线到终点的变化(基线后 3-4 个月)
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愚蠢的动物类别
大体时间:从基线到终点的变化(基线后 3-4 个月)
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规则切换后正确分类的动物比例。
较高的分数表示更好的执行功能。
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从基线到终点的变化(基线后 3-4 个月)
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儿童执行功能通过堪萨斯学龄前儿童反射冲动量表 (KRISP)
大体时间:从基线到终点的变化(基线后 3-4 个月)
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“堪萨斯学龄前儿童反思冲动量表 (KRISP) 向儿童展示了一张目标图片和 4-6 张相似图片。 要求儿童识别与目标图片完全匹配的图片。 在一次练习试验之后进行了 15 次测试试验。 根据不正确回答的数量对每个项目进行评分,最多 3 个错误。 最终分数计算为从可能的总错误数 (45) 中减去的错误数,范围从 0 到 45。分数越高表示执行功能越好。 |
从基线到终点的变化(基线后 3-4 个月)
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合作者和调查者
出版物和有用的链接
一般刊物
- Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9. doi: 10.1542/peds.2004-0962.
- Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000 Apr 29;320(7243):1197-200. doi: 10.1136/bmj.320.7243.1197. No abstract available.
- Muthén, L. K., & Muthén, B. O. (2002). How to use a Monte Carlo study to decide on sample size and determine power. Structural Equation Modeling, 9, 599-620.
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