User-centered approach to the development of a parent toolkit to improve willingness to participate in pediatric clinical research

以用户为中心的方法开发家长工具包，以提高参与儿科临床研究的意愿

• 批准号: 10663456
• 负责人: Alison Elaine Parker
• 金额: $ 26.1万
• 依托单位: INNOVATION RESEARCH AND TRAINING, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663456
• 关键词: Address; Adolescent; Adult; Age; Attitude; Awareness; Behavior Therapy; Child; Childhood; Clinical Research; Clinical Trials; Collaborations; Communication; Communities; Computers; Consumer Satisfaction; Dangerousness; Decision Making; Development; Devices; Disease; Enrollment; Ethnic Origin; Evaluation; Evaluation Studies; Familiarity; Family Practice; Feasibility Studies; Feedback; Feeling; Foundations; Fright; Gender; Goals; Happiness; Health; Health Promotion; Human; Institution; Internet; Joints; Knowledge; Language; Latina; Latino; Latinx; Literature; Logistics; Measures; Medical; Medicine; Methods; Minority Groups; Modeling; Multimedia; Online Systems; Outcome; Parents; Patient Self-Report; Pharmaceutical Preparations; Play; Procedures; Process; Questionnaires; Race; Randomized; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Research Personnel; Resources; Risk; Role; Sample Size; Sampling; Self Efficacy; Solid; Tablets; Testing; Thinking; Time; Travel; Trust; Uncertainty; Voice; Youth; active control group; aged; design; effectiveness evaluation; evidence base; experience; feasibility testing; group intervention; handheld mobile device; human centered design; improved; information gathering; innovation; member; news; online resource; optimism; parental influence; programs; recruit; shared decision making; side effect; skills; social influence; theories; usability; web page; web site; willingness

Abstract Pediatric clinical trials are needed to improve the medicines and treatments available for children and adolescents that are actually tested with youth rather than adults. However, recruitment barriers exist including: not understanding the importance of clinical trials, fear of procedures and unknown in research, mistrust in the research process, lack of knowledge about procedures, and worries about risks. Parents play an important role in the decision about whether their child can participate in a pediatric clinical trial. Parents need to be educated about clinical trials so that they can make an informed decision about participation and effectively communicate with their child about the research opportunity. Although there exists websites and YouTube videos that provide information on pediatric clinical trials, none of these resources provide parents with skills or strategies to use when communicating with others and participating in shared decision-making. Existing multimedia programs appear to only impact knowledge; however, changing attitudes and self-efficacy to make decisions about clinical trials are also important factors that can influence parents’ willingness to allow their child to participate in a clinical trial. With this R21, we aim to fill the gap in available resources for parents by creating an (English/Spanish language) web-based parent toolkit for parents of children (ages 7-17), which will provide information about clinical trials as well as provide opportunities for parents to practice and build communication, information-gathering, and shared decision-making skills. It is hypothesized that by using the web-based parent toolkit, parents will report an increase in their knowledge, positive attitudes, self-efficacy, and willingness to participate in clinical trials, as well as decrease in mistrust and fear. In Year 1, we develop the parent toolkit using a user/human-centered approach with feedback from multiple Advisory Panels of parents (diverse in terms of ethnicity, race, gender, child age, and trust in research) and Latino/a/x community group members , as well as toolkit review by expert consultants. The toolkit 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 toolkit. In Year 2, we will conduct a feasibility study with a sample of parents (N = 150), who will complete self-report measures about their knowledge, attitudes, fears, self-efficacy, and willingness to allow their child to participate in a clinical trial, as well as a consumer satisfaction questionnaire to provide feedback on the toolkit. The results of the R21 will lay the foundation for the development of web- based toolkit for parents that takes into account the perspectives of parents who are low in trust and familiarity with clinical trials as well as parents that are diverse in ethnicity, race, gender, and age of their child. The ultimate goal of this toolkit will be to increase the number of children and adolescents who are permitted to participate in clinical studies, which is needed to improve treatments for pediatric illnesses and diseases.

抽象的 需要进行儿科临床试验来改善儿童和儿童可用的药物和治疗方法 然而，招募障碍仍然存在。 包括：不了解临床试验的重要性、对程序的恐惧和研究中的未知， 对研究过程的不信任、对程序缺乏了解以及对风险的担忧都是造成这种情况的原因。 父母在决定孩子是否可以参加儿科临床试验时发挥着重要作用。 需要接受有关临床试验的教育，以便他们能够就参与和参与做出明智的决定 尽管存在网站和研究机会，但仍与孩子进行有效沟通。 提供儿科临床试验信息的 YouTube 视频，这些资源均不提供给家长 拥有与他人沟通和参与共同决策时使用的技能或策略。 现有的多媒体程序似乎只会影响知识；然而，会改变态度和自我效能。 做出有关临床试验的决定也是影响父母允许意愿的重要因素 通过 R21，我们的目标是填补父母可用资源的空白。 通过创建一个 （英语/西班牙语） 面向儿童（7-17 岁）家长的基于网络的家长工具包，其中 将提供有关临床试验的信息，并为家长提供实践和构建的机会 沟通、信息收集和共同决策的技能。 基于网络的家长工具包，家长将报告他们的知识、积极态度、自我效能、 在第一年，我们发展了参与临床试验的意愿，以及减少了不信任和恐惧。 父级工具包采用以用户/人为中心的方法，并结合来自多个咨询小组的反馈 父母（在民族、种族、性别、儿童年龄和对研究的信任方面存在差异）和 拉丁裔/a/x 社区 小组成员 ，以及专家顾问的工具包审查，该工具包将针对使用进行优化。 计算机、移动设备和平板电脑，并进行了第 508 条合规性测试，从而提高了可访问性 以及基于网络的工具包的可用性 在第二年，我们将针对家长样本（N）进行可行性研究。 = 150），谁将完成有关其知识、态度、恐惧、自我效能和 愿意让孩子参加临床试验，以及消费者满意度调查问卷 提供有关该工具包的反馈，R21 的结果将为 Web 的开发奠定基础。 基于家长的工具包，考虑到信任度和熟悉度较低的家长的观点 临床试验以及孩子的不同种族、性别和年龄的父母。 该工具包的最终目标是增加允许的儿童和青少年数量 参与临床研究，这对于改善儿科疾病的治疗是必要的。