Systematically Adapted Delivery of the Family Check-Up
2019年3月31日 更新者：Christina Studts
Systematically Adapted Delivery of the Family Check-Up in Underserved Communities
Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions.
To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must be ensured.
This pilot project will systematically adapt and pilot-test the delivery model of an existing effective parent training intervention for implementation in rural Appalachia, a region with many documented health disparities, high levels of poverty, and shortages of mental health providers.
Community health workers in 5 rural Appalachian counties will be trained to deliver a behavioral parent training intervention.
Each worker will deliver the intervention to 4 parent-child dyads.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
51
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
-
-
Kentucky
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Lexington、Kentucky、美国、40506
- University of Kentuckyi
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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
3年 及以上 (孩子、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
Inclusion Criteria:
- Parents: aged 18+ years, custodial guardian of child, can speak/read/understand English
- Children: ages 3-5 years, lives full time in custodial guardian's home
- Community health workers: aged 18+ years, currently employed at a partnering health department, able to speak/read/understand English
Exclusion Criteria:
- Parents: has already accessed behavioral health services for the child, reports suicidal ideation or intent to harm self or others, participated in formative research for this study
- Children: diagnosed with a severe developmental condition (i.e., significant developmental delay, autism, debilitating neurological condition)
- Community health workers: none
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：卫生服务研究
- 分配：非随机化
- 介入模型：单组作业
- 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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其他：Community Health Workers
Community health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention.
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Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community
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其他：Parent-Child Dyads
Parents and children will receive a behavioral parent training intervention delivered by community health workers.
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Parents receive up to 6 sessions of the Family Check-Up program
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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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Feasibility: Enrollment
大体时间：2 weeks after final parent-child dyad completes the study
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Percentage of invited parents who enroll in the study (obtained from process records)
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2 weeks after final parent-child dyad completes the study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility: Number of sessions completed
大体时间：2 weeks after final parent-child dyad completes the study
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Number of sessions completed by each parent-child dyad (obtained from process records)
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2 weeks after final parent-child dyad completes the study
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Feasibility: Interventionist-reported fidelity
大体时间：following each behavioral parent training intervention session
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Fidelity Checklist (completed by community health workers)
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following each behavioral parent training intervention session
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Feasibility: Parent satisfaction
大体时间：10 weeks after parent baseline
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European Parent Satisfaction Scale about Early Intervention (EPASSEI) (completed by parents)
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10 weeks after parent baseline
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Interventionist satisfaction
大体时间：2 weeks after final parent-child dyad completes study
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Therapist Satisfaction Index (completed by community health workers)
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2 weeks after final parent-child dyad completes study
|
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Interventionist evidence-based practice attitudes
大体时间：2 weeks after final parent-child dyad completes study
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Evidence-Based Practice Attitude Scale-50 (completed by community health workers)
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2 weeks after final parent-child dyad completes study
|
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Interventionist self-efficacy
大体时间：2 weeks after final parent-child dyad completes study
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Counselor Activity Self-Efficacy Scale (completed by community health workers)
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2 weeks after final parent-child dyad completes study
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility: Observer-rated fidelity
大体时间：Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
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Family Check-Up COACH fidelity rating system (observer-rated videos of 10% of intervention sessions)
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Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
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Costs: Training
大体时间：2 weeks after final parent-child dyad completes study
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Total costs of training (obtained from process records maintained by investigators)
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2 weeks after final parent-child dyad completes study
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Costs: Per-family interventionist time
大体时间：2 weeks after final parent-child dyad completes study
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Obtained from process records maintained by community health workers
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2 weeks after final parent-child dyad completes study
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Costs: Per-family interventionist travel
大体时间：2 weeks after final parent-child dyad completes study
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Obtained from process records maintained by community health workers
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2 weeks after final parent-child dyad completes study
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Costs: Supervision time
大体时间：2 weeks after final parent-child dyad completes study
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Obtained from process records maintained by community health workers
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2 weeks after final parent-child dyad completes study
|
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Costs: Number of contacts outside of intervention sessions
大体时间：2 weeks after final parent-child dyad completes study
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Obtained from process records maintained by community health workers
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2 weeks after final parent-child dyad completes study
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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：Christina R Studts, PhD、University of Kentucky
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)
2017年2月20日
初级完成 (实际的)
2018年5月16日
研究完成 (实际的)
2018年6月26日
研究注册日期
首次提交
2016年3月8日
首先提交符合 QC 标准的
2016年3月10日
首次发布 (估计)
2016年3月16日
研究记录更新
最后更新发布 (实际的)
2019年4月2日
上次提交的符合 QC 标准的更新
2019年3月31日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
其他研究编号
- R34MH106661 (美国 NIH 拨款/合同)
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
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.