Web-based Resource for Children and Adolescents about Clinical Research

项目摘要- 这篇摘要的大部分内容都已修改 需要进行更多的儿科临床研究，以确保青少年接受适当的药物治疗， 治疗，以及已经在年轻人而不是成年人身上测试过的设备。然而，招聘障碍 青少年和他们的父母都存在的问题包括：不理解临床试验的重要性，害怕 程序，害怕研究中的未知，缺乏对研究程序的了解，喜欢知情 同意和对安慰剂的担忧，以及对不良健康结果的担忧。青少年也更多 他们可能会和父母一起参与决策过程。因此，青少年和 父母需要资源来帮助他们了解儿科临床研究和程序， 鼓励与参与研究有关的高质量联合决策。快速通道申请 建议建立在DigiKnowIt News（DKIN）早期版本的成功基础上，这是一种基于网络的资源， 教育儿童（8 - 11岁）了解儿科临床研究。我们的目标是填补现有资源的差距， 青少年通过创建DigiKnowIt新闻-青少年（DKIN：青少年），一个发展适当的基于网络的 为12 - 17岁的青少年提供的资源，其中将包括一个供父母和青少年实践的创新部分 沟通和共同决策。据推测，通过使用资源，青少年将 报告他们的知识，积极的态度/信念，自我效能感和参与意愿有所增加 临床试验第一阶段将包括为青少年创建适合发育的DKIN版本 采用迭代开发过程，并听取青年和家长咨询小组以及专家的反馈， 顾问和可行性研究的资源与样本的青少年（N = 30），谁将完成自我- 报告他们的知识，态度和自我效能感，以及消费者满意度的措施 问卷调查，以提供对资源的反馈。如果DKIN-Teen可行，第二阶段将包括创建 儿科临床试验中常见程序特有的附加内容（例如，镇静/麻醉）， 并为研究人员创建额外的定制功能，以使用DKIN资源进行研究 招聘DKIN：Teen将针对计算机、移动的设备和平板电脑进行优化，并针对 遵守508条款，从而提高基于Web的资源的可访问性和可用性。最后 DKIN的有效性：青少年将与以下不同群体（种族/民族/性别/健康状况）一起进行评价： 父母-青少年对（N = 180）影响青少年的知识，态度/信念，自我效能， 参与临床试验的意愿以及加强父母与青少年的沟通。 目前的儿科临床试验招募方法是随意的，耗时的，令人沮丧的，效率低下的， 并且经常导致统计分析所需的样本量小于理想的样本量。这种高度可扩展、可定制的 产品的设计将增加愿意参与临床研究的青少年人数， 这是改善儿科疾病和病症的治疗所需要的。

Project Abstract – Much of this abstract has been revised There is a need for more pediatric clinical research to ensure that youth are receiving appropriate medications, treatments, and devices that have been tested with youth rather than adults. However, recruitment barriers exist for both youth and their parents including: not understanding the importance of clinical trials, fear of procedures, fear of the unknown in research, lack of knowledge about research procedures like informed consent and concerns around placebos, and worries about poor health outcomes. Adolescents are also more likely to be involved in the decision-making process along with their parents. Therefore, both adolescents and parents need resources to help them understand pediatric clinical research and procedures as well as to encourage high quality joint decision-making related to participation in research. This Fast Track application proposes to build upon the success of an earlier version of DigiKnowIt News (DKIN), a web-based resource to educate children (ages 8-11) about pediatric clinical research. We aim to fill the gap in available resources for adolescents by creating DigiKnowIt News – Teen (DKIN: Teen), a developmentally appropriate web-based resource for youth ages 12-17, which will include an innovative section for parents and youth to practice communicating and joint decision-making. It is hypothesized that by using the resource, adolescents will report an increase in their knowledge, positive attitudes/beliefs, self-efficacy, and willingness to participate in clinical trials. Phase I will include creating a developmentally appropriate version of DKIN for adolescents using an iterative development process with feedback from youth and parent advisory panels as well as expert consultants and a feasibility study of the resource with a sample of adolescents (N=30), who will complete self- report measures about their knowledge, attitudes, and self-efficacy, as well as consumer satisfaction questionnaire to provide feedback on the resource. If DKIN-Teen is feasible, Phase II will include the creation of additional content specific to common procedures in pediatric clinical trials (e.g., sedation/anesthesia) as well as to create additional customization abilities for researchers to use the DKIN resources for study recruitment. DKIN: Teen will be optimized for use on computers, mobile devices, and tablets, and tested for Section 508 compliance, thus increasing the accessibility and usability of the web-based resource. Finally, the effectiveness of DKIN: Teen will be evaluated with a diverse group (race/ethnicity/gender/health status) of parent-adolescent pairs (N=180) for impacting youths’ knowledge, attitudes/beliefs, self-efficacy, and willingness as well as enhancing parent-adolescent communication related to participating in clinical trials. Current methods of pediatric clinical trials recruitment are haphazard, time-consuming, frustrating, inefficient, and often result in less than ideal sample size needed for statistical analysis. This highly scalable, customizable product will be designed to increase the number of adolescents who are willing to participate in clinical studies, which is needed to improve the treatments for pediatric illnesses and disorders.