父亲和婴儿 (FAB) 的发展、可行性和可接受性：试点研究
2022年7月8日 更新者：Darius Tandon、Northwestern University
将短信整合到母婴课程中以解决低收入女性及其伴侣的抑郁问题
在这个项目中，研究人员将开发并试点测试针对父亲的伴随干预（Fathers and Babies-FAB），以补充为家访客户提供压力和情绪管理工具的母亲和婴儿课程 (MB)。
与之前的研究参与者、他们的男性伴侣和家访人员的焦点小组将用于开发 FAB 课程和协议。
FAB 短信旨在改善男性伴侣的心理健康，帮助他支持伴侣的心理健康。
可行性、可接受性和结果测量将得到父亲心理健康和伴侣关系评估的补充。
在这项不受控制的试点研究中，参与者评估将在基线、3 个月和 6 个月时进行。
该项目的公共卫生意义和创新意义重大。
如果研究人员能够将 MB-TXT 和 MB-DAD 整合到家访计划中并为家访客户及其伴侣带来更好的心理健康结果，研究人员将准备在全国范围内在家访计划中复制这种干预措施通过联邦资助，家访作为一种为有婴幼儿的家庭提供服务的模式正在迅速普及。
研究概览
详细说明
通过家访服务交付模式，许多风险最高的家庭在孩子的婴儿期和幼儿期建立了提供者-客户关系，因此有必要加强母婴服务以解决父母双方的心理健康问题。
以前的产后抑郁症预防干预措施（包括 MB）都忽略了对孕妇伴侣的干预，尽管人们越来越认识到父亲抑郁症也会对儿童的社交情感发展产生影响，并且发生在相似的时间范围内。 因此，在其他方面成功的干预中，这些局限性——在改善假设的干预机制方面的成功和父亲的有限参与——可能会降低干预效果。 假设父亲抑郁症可以调节 MB 模块与母亲心理健康结果之间的关系。
本研究解决了这一局限性。 研究人员将与 10-12 个主要服务于低收入家庭的家访 (HV) 项目合作。 调查人员将招募 24 对父母进行不受控制的试点，其中母亲将接受 MB-TXT，父亲将接受 FAB，这是一项试点课程，使用现有材料和通过家访客户、他们的合作伙伴和家庭的定性研究收集的数据开发来访的工作人员。
目标 1。 制定和确定 a) 执行 MB-DAD 干预协议和 b) 评估两个家访计划中父亲和二元结果的可行性和可接受性。 与之前的试验参与者、他们的男性伴侣和家访人员组成的焦点小组将生成以下信息：a) 干预内容，b) 联系频率，以及 c) 与其伴侣收到的 MB 材料的关系。
研究类型
介入性
注册 (实际的)
60
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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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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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
14年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
在第一个或第二个或第三个三个月参加家访计划的 18 岁以上讲英语的女性将有资格参加
年龄大于 18 岁并参加家访计划且处于第一、第二或第三个三个月的说英语女性的男性伴侣将有资格参加
注意：父母/伴侣都必须参加这项研究，而不仅仅是其中之一。
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：FAB 试点研究（父亲/男性参与者）
父亲（男性伴侣）收到父亲和婴儿（FAB）。 FAB 是一项为期 12 节的干预，其内容与 MB 中的内容相似，但以父亲为中心。 最初的 FAB 会议由与母亲一起工作的家访员亲自或通过电话进行，平均持续 30 分钟。 随后的会议是通过带有在线内容嵌入式链接的文本消息面对面进行的，或者是面对面和文本消息的混合，具体取决于父亲的偏好和可用性。 父亲们在每次 FAB 会议上收到三到六条短信。 |
最初的 FAB 会议由与母亲一起工作的家访员亲自或通过电话进行，平均持续 30 分钟。
随后的会议是通过带有在线内容嵌入式链接的文本消息面对面进行的，或者是面对面和文本消息的混合，具体取决于父亲的偏好和可用性。
父亲们在每次 FAB 会议上收到三到六条短信。
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实验性的：MB 1对1加文本（母亲/女性参与者）
家访客户在定期家访（即 MB 1 对 1 加 MB-TXT）期间亲自收到母亲和婴儿的短信干预，而她的伴侣同时收到父亲和婴儿。
MB 一对一是 12 个疗程，是一种产后抑郁症预防干预措施。
MB 包括一个介绍模块，然后是三个认知行为治疗模块：(1) 愉快的活动，(2) 思想，以及 (3) 与他人接触。
在每次面对面的家庭访问后，客户都会收到三条消息，以加强技能练习并提醒他们有关他们的个人项目。
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家访客户在定期家访（即 MB 1 对 1 加 MB-TXT）期间亲自收到带有文本消息干预的母亲和婴儿。
在每次面对面的家庭访问后，客户都会收到三条消息，以加强技能练习并提醒他们有关他们的个人项目。
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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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抑郁症状的变化
大体时间：3 个月和 6 个月时的基线和干预后
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Beck 抑郁量表-II (BDI-II)（Beck 等人，1988 年）。 BDI-II 用于评估符合 DSM-IV 症状标准的抑郁症状的严重程度。 BDI-II 是一项包含 21 个项目的调查，每个项目要求受访者以 0 到 3 的量表表示他们在过去两周内对不同抑郁症状的认可程度，分数越高表示抑郁程度越严重，其中最高分63分。 0-10-认为正常 11-16 轻度情绪障碍 17-20 临界临床抑郁症 21-30 中度抑郁症 31-40 重度抑郁症 超过 40 极度抑郁症。 |
3 个月和 6 个月时的基线和干预后
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焦虑的变化
大体时间：3 个月和 6 个月时的基线和干预后
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广泛性焦虑症 7 项量表 (GAD-7)（Spitzer 等人，2006 年）。 GAD-7 是一个 7 项调查，每个项目要求受访者以 4 分制表示他们在过去两周内对不同焦虑症状的认可程度，分数越高表示焦虑症状越严重。 最高分是21。 0-4 分：极度焦虑 5-9 分：轻度焦虑 10-14 分：中度焦虑 大于 15 分：重度焦虑 |
3 个月和 6 个月时的基线和干预后
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感知压力的变化
大体时间：3 个月和 6 个月时的基线和干预后
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感知压力量表 10 项量表 (PSS-10)（Cohen & Williamson，1988）。 PSS-10 是一项包含 10 项的调查，要求受访者以 5 分制表示他们在过去一个月中将某些情况评估为压力的程度，分数越高表示感知到的压力越大。 PSS 的个人分数范围为 0 到 40，分数越高表示感知到的压力越大。 0-13 被认为是低压力 14-26 的分数被认为是中等压力 27-40 的分数被认为是高感知压力 |
3 个月和 6 个月时的基线和干预后
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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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社会支持有效性的变化
大体时间：3 个月和 6 个月时的基线和干预后
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社会支持有效性问卷 (SSE-Q)（Rini 等人，2011 年）。
SSE-Q 是一项包含 25 个项目的调查，要求受访者说明他们的合作伙伴在过去三个月中提供不同类型支持的程度。
SSE-Q 由任务支持、信息支持、情感支持和支持的负面影响等分量表组成。
对于这项研究，我们计算了总社会支持分数，将这四个分量表（范围 0-80）相加。
高分表示更有效的支持。
满分的范围是 0 到 80，每个分量表的范围是 0 到 20。
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3 个月和 6 个月时的基线和干预后
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工具性社会支持支持调查（Cyranowski 等人，2013 年）。
大体时间：3 个月和 6 个月时的基线和干预后
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该衡量标准由 8 个问题组成，要求受访者以 5 分制表示他们在上个月接受不同类型工具支持的程度。
分数越高表示支持度越高。
我们报告每个时间点具有高工具支持的个人的数量和百分比。
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3 个月和 6 个月时的基线和干预后
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情感支持支持（Cyranowski 等人，2013 年）
大体时间：3 个月和 6 个月时的基线和干预后
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NIH 工具箱情感支持支持调查。
该调查包括 8 个问题，并要求受访者以 5 分制表示他们在上个月获得不同类型情感支持的程度。
分数越高表示支持度越高。
我们报告每个时间点具有高情感支持的个体的数量和百分比。
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3 个月和 6 个月时的基线和干预后
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2018年2月15日
初级完成 (实际的)
2020年9月4日
研究完成 (实际的)
2020年9月4日
研究注册日期
首次提交
2018年1月29日
首先提交符合 QC 标准的
2018年2月7日
首次发布 (实际的)
2018年2月9日
研究记录更新
最后更新发布 (实际的)
2022年7月18日
上次提交的符合 QC 标准的更新
2022年7月8日
最后验证
2022年7月1日
更多信息
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