Traumatic Brain Injury Positive Strategies (TIPS)
Brain Injury Support and Strategies for Families Impacted by Childhood TBI
研究概览
详细说明
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes.
The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).
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
- Center on Brain Injury Research and Training / 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
Inclusion Criteria:
- Adult 18 years old or older
- Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
- Involved in the care and support of the child with the TBI.
- Live in the same household as child with a TBI.
- The child with the TBI is able to follow simple instructions such as "please eat your toast."
Exclusion Criteria:
- Does not speak and read English.
- Does not have high speed Internet access.
- Not US resident
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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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实验性的：TIPS Intervention
The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families.
The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
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Web-based training for family member.
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有源比较器：Control
An existing website related to traumatic brain injury.
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Traumatic Brain Injury website for family members.
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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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TIPS Change in Knowledge Survey
大体时间：Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
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Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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PedsQL Family Impact
大体时间：Baseline and for a 3 month follow up after completed intervention.
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Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
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Baseline and for a 3 month follow up after completed intervention.
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Caregiver Self-Efficacy Scale
大体时间：Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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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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The Pediatric Quality of Life Inventory (PedsQL)
大体时间：Baseline
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23 items measuring physical, emotional, social, and school function.
Caregiver report forms have been developed for children 2-18 years.
The PedsQL has been used in pediatric TBI as a quality of life outcome.
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Baseline
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PedsQL Cognitive Function
大体时间：Baseline
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Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
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Baseline
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Health Behavior Inventory (HBI)
大体时间：Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional).
It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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合作者和调查者
调查人员
- 首席研究员：Ann Glang, PhD、University of Oregon
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 (实际的)
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
更多信息
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.
TIPS Intervention的临床试验
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Medical College of WisconsinSiemens Medical Solutions完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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University Hospital, Strasbourg, France招聘中