Web-based Resource for Children and Adolescents about Clinical Research

有必要进行更多的儿科临床研究，以确保年轻人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的设备。然而，招聘障碍 对于年轻人和他们的父母来说都存在：不了解临床试验的重要性，害怕 程序，对研究中的未知的恐惧，缺乏对研究程序的了解，如知情的 对安慰剂的同意和担忧，以及对不良健康结果的担忧。青少年也更多地 可能和他们的父母一起参与决策过程。因此，无论是青少年还是 父母需要资源来帮助他们了解儿科临床研究和程序，以及 鼓励与参与研究相关的高质量联合决策。此Fast Track应用程序 建议在早期版本的DigiKnowit News(DKIN)的成功基础上再接再厉，DKIN是一个基于网络的资源，用于 教育儿童(8-11岁)了解儿科临床研究。我们的目标是填补可用资源的缺口，用于 青少年通过创建DigiKnowit News-Teen(DKIN：Teen)，一个适合发展的基于网络的 为12-17岁的青少年提供资源，其中将包括一个供父母和青少年练习的创新部分 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、自我效能感和参与的意愿增加 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 使用迭代开发流程，从青年和家长咨询小组以及专家那里获得反馈 顾问和对该资源的可行性研究，抽样为青少年(N=30)，他们将完成自我 报告关于他们的知识、态度、自我效能感以及消费者满意度的测量 调查问卷，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(例如镇静/麻醉)特有的额外内容 以及为研究人员创建额外的定制能力，以便使用DKIN资源进行研究 招聘。DKIN：Ten将针对计算机、移动设备和平板电脑的使用进行优化，并进行测试 第508条得到遵守，从而提高了基于网络的资源的可及性和可用性。最后， DKIN的有效性：青少年将与不同的群体(种族/民族/性别/健康状况)进行评估 父母-青少年配对(N=180)影响青少年的知识、态度/信念、自我效能和 与参与临床试验相关的意愿以及加强亲子沟通。 目前的儿科临床试验招募方法随意、耗时、令人沮丧、效率低下， 而且往往导致统计分析所需的样本大小不够理想。这种高度可扩展、可定制的 该产品的设计将增加愿意参与临床研究的青少年数量， 这是改善儿科疾病和障碍治疗所需的。

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.