A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer
2015年7月30日 更新者：Case Comprehensive Cancer Center
A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.
研究概览
详细说明
Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.
- Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms.
- Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms.
Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.
- Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
- Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
- Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention.
Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").
研究类型
介入性
注册 (实际的)
5
阶段
- 第一阶段早期
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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Ohio
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Cleveland、Ohio、美国、44106
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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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
4年 至 10年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Families who have had children diagnosed with any type of cancer in the past year.
- At least one sibling between the ages of 4 and 10 years old
- Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.
Exclusion Criteria:
-
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：Active Control Group
Children in the active control group will play with puzzles, a building toy, or color.
The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult.
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其他名称：
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实验性的：Play Intervention
children in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts).
The play facilitator will play with the child, modeling and praising use of positive coping skills.
In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session.
The child will be allowed to make up a story about whatever they want before ending each session.
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其他名称：
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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Number of children with increase in coping skills after intervention
大体时间：4 weeks
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Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
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4 weeks
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Number of children with better psychological adjustment following intervention
大体时间：4 weeks
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Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
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4 weeks
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Number of parents with decreased parenting stress following intervention
大体时间：4 weeks
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Parents of children in the play intervention group will report decreased parenting stress following the intervention.
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4 weeks
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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：Karla Fehr, M.A.、Case Western Reserve University
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
2011年9月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2012年10月9日
首先提交符合 QC 标准的
2012年10月9日
首次发布 (估计)
2012年10月12日
研究记录更新
最后更新发布 (估计)
2015年8月3日
上次提交的符合 QC 标准的更新
2015年7月30日
最后验证
2015年7月1日
更多信息
与本研究相关的术语
其他研究编号
- CASE4Z11
- CC00130 (其他标识符：University Hospitals Cancer IRB)
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.