The Enhancing Connection Telephone Study: A cancer parenting education program

描述(由申请人提供)：据估计，2012年美国将有120万学龄儿童的父母被新诊断为癌症。父母的癌症会给确诊的父母和孩子带来巨大的行为和情感上的痛苦。据估计，有22%-33%的儿童在痛苦或行为-情绪调整的标准化衡量标准上超过了临床临界值。众所周知，无论受教育程度和社会经济水平如何，父母都在为如何以及如何告诉孩子他们的癌症，或者在长达数月的医疗期间如何支持孩子而苦苦挣扎。治疗或与疾病相关的症状和父母抑郁情绪对儿童与父母的身体和情感接触以及育儿质量产生负面影响。尽管问题的严重性和受影响的人数很多，但只有一项癌症育儿教育计划的有效性得到了测试，那就是增强联系计划。在一项6个州的随机对照试验中，该计划减少了父母的抑郁情绪和焦虑，改善了父母的养育质量、父母的养育技能和信心，并增强了孩子的行为-情绪适应。与对照组相比，儿童在一年的随访期内的结果显著。但这项名为增强联系计划(EC)的计划是作为面对面交付计划进行测试的，限制了成本和时间限制或旅行负担令人望而却步的父母访问和获得它的机会。本研究的目的是测试电话增强联系计划(EC-T)的可行性，并评估其对父母和孩子结果的短期影响，采用测试前(组内)设计和组间设计，比较当前的研究结果和通过面对面提供的EC获得的结果。总共60名最近被诊断患有0-3期癌症的父母将从服务于太平洋西北部5个州的提供者网站登记。符合条件的父母将有一个5-12岁的孩子，可以使用电话，并能在他们的语言中读、写和说英语。在同意并获得基线测量后，研究参与者将每隔2周接受5次完全按脚本进行的电话癌症教育咨询会议。在退出时，将使用与用于测试欧共体效力的相同标准化措施来评估结果。这项研究有足够的能量来检测中等效应大小，功率为.80，p=0.05。研究结果将为随机临床试验的发展提供信息。

DESCRIPTION (provided by applicant): An estimated 1.2 million parents of school age children will be newly diagnosed with cancer in the U.S. in 2012. Parental cancer causes substantial behavioral and emotional distress in both the diagnosed parent and child. An estimated 22-33% of the children exceed clinical cut off scores on standardized measures of distress or behavioral-emotional adjustment. Parents, regardless of education and socioeconomic level, are known to struggle with how and what to tell their child about their cancer or how to support the child during the many months of medical treatment. Treatment or disease-related symptoms and parental depressed mood negatively affect the child's physical and emotional access to the parent and the quality of parenting. Despite the magnitude of the problem and numbers affected, there is only 1 cancer parenting education program that has been tested for efficacy, the Enhancing Connections Program. In a 6-state randomized control trial, the program decreased parental depressed mood and anxiety, improved parenting quality, parenting skills and confidence, and enhanced the child's behavioral-emotional adjustment. Child outcomes were significant at 1- year follow up compared to controls. But that program, the Enhancing Connections Program (EC), was tested as an in-person delivered program, constraining its access and availability for parents for whom cost and time constraints or the burden of travel are prohibitive. The purpose of the proposed study is to test the feasibility of delivering the Enhancing Connections Program by telephone (EC-T) and to assess its short-term impact on parent and child outcomes, using both a pre-post-test (within group) design and a between group design, comparing current study outcomes with those obtained from the in-person delivered EC. A total of 60 recently diagnosed parents with Stage 0-3 cancer will be enrolled from provider sites that serve 5 states in the Pacific Northwest. Eligible parents will have a child 5- 12 years, have access to a telephone, and read, write and speak English among their languages. After consenting and obtaining baseline measures, study participants will receive 5 fully scripted, telephone delivered cancer education counseling sessions at 2- week intervals. Outcomes will be assessed at exit using the same standardized measures as those used to test efficacy of the EC. The study is adequately powered to detect a moderate effect size with .80 power, p=.05. Study results will inform the development of a randomized clinical trial.