将儿童读物与家访计划中的安全睡眠教育小册子进行比较
一项随机对照试验,将儿童读物与小册子进行比较,以在参加家访计划的高危人群中进行安全睡眠教育
研究概览
详细说明
安全睡眠和健康素养是国家、州和地方各级的优先事项。 自 1990 年代发起“重返睡眠”运动以来,虽然情况有了很大改善,但与睡眠有关的婴儿死亡率,尤其是婴儿猝死综合症 (SIDS) 的死亡率,在十多年来一直停滞不前。 虽然为小岛屿发展中国家教育广泛分发了印刷材料,但迄今为止,没有一种材料被证明有效,总体满意度也很低。 原因包括被动传递、没有吸引力的内容和阅读水平过高,尤其是对于社会经济地位低的人群。 有证据表明,理想的策略是将印刷材料结合简单、情感吸引力、文化敏感性和低阅读水平,由医疗保健从业者传达并多次审查。 儿童读物可能是实现这一目标的理想媒介,它结合了图片和文字来唤起情感并激发有价值和重复的亲子共享体验。
这是一项随机对照试验,涉及参加早期干预家访计划 Every Child Succeeds (ECS) 的高危人群、社会经济地位低的初为人母的人。 来自 9 个机构的 ECS 家庭访问者将被随机分配使用专门设计的儿童读物(干预)或标准手册(对照)进行安全睡眠教育。 我们的目标招生人数是 230 名母亲。 经过培训的 ECS 家庭访问者将获得同意,分发书籍或小册子,并在妊娠晚期产前家访期间对健康素养(通过 REALM-R 屏幕)、安全睡眠知识和家庭素养方向进行基线评估。 结果数据将由同一位访问者在随后的家访中收集,时间为 1 周大时婴儿睡眠常规建立,以及 2 个月大时 SIDS 风险高峰期。 每次访问时,都会对书籍或小册子进行审查。
将在以下类别中比较干预组和对照组之间的结果:1) 产妇安全睡眠知识,2) 产妇对安全睡眠指南的遵守情况(观察),3) 产妇和提供者对用于传达安全睡眠指南的材料的满意度,以及 4 ) 利用儿童读物进行健康教育对家庭识字方向的影响程度(即 对阅读的态度)。
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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Ohio
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Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center
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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:
- 参加“每个孩子都成功”家访计划的产前登记,
- 说英语(没有西班牙语版本的干预书),以及
- 至少15岁。
排除标准:
- 不会说英语,
- 15岁以下,
- 延迟出院,以至于不可能在 3 周大之前进行首次产后家访。
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:小册子
这只手臂中的母亲将使用通常用于此家访计划的标准手册(包括 1 页的讲义和小册子)从家访中接受安全睡眠教育。
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家访员在规定的家访期间提供的各种标准安全睡眠教育手册,涵盖安全睡眠的各种建议。
其他名称:
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实验性的:儿童图书
这只手臂中的母亲将使用一本特别设计的儿童读物接受家庭访问者的安全睡眠教育,其中包含美国儿科学会安全睡眠指南。
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一本专门设计的、插图(全彩)的一年级儿童读物,通过故事传达美国儿科学会的安全睡眠指南。
扩展指南列在封底,适合 4 年级阅读水平。
本书将专门用于 3 次研究家访的安全睡眠教育:产前 32 周至足月、产后 1 周和产后 2 个月。
鼓励妈妈与宝宝分享这本书。
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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产妇安全睡眠知识的变化
大体时间:产前基线至产后 1 周和 2 个月
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从产前收集的基线到产后大约 1 周和 2 个月时测量的结果,产妇对安全睡眠建议(根据美国儿科学会)的了解发生了变化。
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产前基线至产后 1 周和 2 个月
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婴幼儿睡眠环境评估
大体时间:产后 1 周和 2 个月的研究家访期间
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在家中直接评估婴儿睡眠环境和母亲对美国儿科学会安全睡眠建议的依从性,通过家庭访问者在出生后大约 1 周和 2 个月时进行
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产后 1 周和 2 个月的研究家访期间
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提供的安全睡眠材料的产妇印象
大体时间:产后 1 周和 2 个月的研究家访
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用于安全睡眠教学、内容和用途的印刷材料(书籍或小册子)的母亲印象。
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产后 1 周和 2 个月的研究家访
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家庭访客对提供的安全睡眠材料的印象
大体时间:每次研究家访时:产前、产后 1 周和 2 个月
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家庭访客对用于安全睡眠教学、交付时间和有用性的印刷材料(书籍或小册子)的印象。
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每次研究家访时:产前、产后 1 周和 2 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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孕产妇健康素养筛查
大体时间:有一次产前
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使用经过验证的 REALM-R 测量(识别和发音医学词汇)的孕产妇健康素养筛查
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有一次产前
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家庭素养方向的变化
大体时间:产前和产后 2 个月的基线
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通过六个问题评估变化,这些问题涉及计划或当前的共享阅读频率、家庭中的儿童书籍、对共享阅读的态度,以及对电视使用的态度和频率。
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产前和产后 2 个月的基线
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合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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