The Enhancing Connection Telephone Study: A cancer parenting education program

描述（由申请人提供）：2012年美国估计有120万学龄儿童的父母将被新诊断为癌症。父母患癌症会给父母和孩子造成严重的行为和情绪困扰。据估计，22-33%的儿童在痛苦或行为-情绪调整的标准化测量中超过了临床临界值。众所周知，无论受教育程度和社会经济水平如何，父母们都在为如何以及如何告诉孩子自己患了癌症，以及如何在长达数月的治疗期间支持孩子而挣扎。治疗或与疾病相关的症状和父母的抑郁情绪会对孩子的身体和情感与父母的接触以及父母养育的质量产生负面影响。尽管这个问题很严重，受影响的人数也很多，但只有一个癌症父母教育项目经过了有效性测试，那就是加强联系项目。在6个州的随机对照试验中，该项目减少了父母的抑郁情绪和焦虑，提高了育儿质量、育儿技巧和信心，增强了孩子的行为-情绪调节。与对照组相比，1年随访的儿童结局显著。但是，这个名为“加强联系项目”（enhanced Connections program， EC）的项目是作为一种面对面授课的项目进行测试的，对于那些因成本和时间的限制或旅行负担而难以接受的家长来说，它的可及性和可用性受到限制。拟议研究的目的是测试通过电话提供增强联系计划（EC- t）的可行性，并评估其对父母和儿童结果的短期影响，使用测试前-后（组内）设计和组间设计，将当前研究结果与亲自交付EC获得的结果进行比较。共有60名最近诊断出患有0-3期癌症的父母将从服务于太平洋西北地区5个州的医疗机构中入选。符合条件的父母将有一个5- 12岁的孩子，可以使用电话，在他们的语言中阅读，写作和说英语。在同意并获得基线测量后，研究参与者将接受5个完整的脚本，电话传递的癌症教育咨询会议，间隔2周。在退出时，将使用与测试EC有效性相同的标准化措施评估结果。该研究有足够的能力来检测中等效应大小。80次幂，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.