The Enhancing Connection Telephone Study: A cancer parenting education program

描述（由申请人提供）：2012年，估计有120万学龄儿童的父母将在美国新诊断出癌症。父母癌症会给被诊断的父母和孩子带来大量的行为和情绪困扰。据估计，22-33%的儿童在标准化的痛苦或行为情绪调整措施上超过了临床截止分数。父母，无论教育和社会经济水平如何，都知道如何告诉他们的孩子关于他们的癌症或如何在数月的医疗期间支持孩子。与治疗或疾病有关的症状和父母的抑郁情绪对儿童与父母的身体和情感接触以及养育质量产生负面影响。尽管问题的严重性和受影响的人数，只有一个癌症育儿教育计划，已被测试的有效性，增强连接计划。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，提高了养育质量，养育技能和信心，并增强了孩子的行为情绪调整。与对照组相比，儿童结局在1年随访时具有显著性。但是，该方案，加强联系方案（EC），是作为一个亲自交付的方案进行测试的，限制了其访问和提供给父母的成本和时间限制或旅行负担是禁止的。 拟议的研究的目的是测试的可行性，通过电话（EC-T）提供增强连接程序，并评估其对父母和孩子的结果的短期影响，使用前后测试（组内）设计和组间设计，比较当前的研究结果，从人交付EC。总共有60名最近被诊断为0-3期癌症的父母将从太平洋西北部5个州的提供者网站招募。符合条件的父母将有一个5- 12岁的孩子，可以使用电话，在他们的语言中可以读、写和说英语。在同意并获得基线测量后，研究参与者将接受5次完全脚本化的电话癌症教育咨询会议，间隔2周。将在退出时使用与用于检测EC有效性的相同标准化措施评估结局。该研究有足够的把握度检测中等效应量，把握度为0.80，p= 0.05。研究结果将为随机临床试验的开发提供信息。

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.