Web-based Resource for Children and Adolescents about Clinical Research

面向儿童和青少年的临床研究网络资源

基本信息

批准号：
10226693
负责人：
Alison Elaine Parker
金额：
$ 50.08万
依托单位：
INNOVATION RESEARCH AND TRAINING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-19 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10226693
关键词：
Address Adolescent Adult Age Anesthesia procedures Anxiety Area Attitude Awareness Behavior Therapy Belief Books Child Childhood Clinical Research Clinical Trials Communication Complex Computers Consumer Satisfaction Consumption Contracts Custom Dangerousness Decision Making Development Devices Disease Disease Management Education Effectiveness Ensure Ethics Ethnic Origin Feasibility Studies Feedback Fright Funding Gender Goals Happiness Health Health Status Health behavior Informed Consent Institution Joints Knowledge Learning Learning Module Life Experience Literature Lung Measures Medical Methods Motivation National Heart, Lung, and Blood Institute Outcome Parents Patient Recruitments Patient Self-Report Pediatric Research Pediatrics Personal Satisfaction Pharmaceutical Preparations Pharmacotherapy Phase Placebos Play Procedures Process Protocols documentation Questionnaires Race Randomized Controlled Trials Readiness Reporting Research Research Personnel Resources Risk Role Sample Size Sampling Sedation procedure Self Efficacy Small Business Innovation Research Grant Statistical Data Interpretation Tablets Teenagers Testing Time Trust Uncertainty Update Youth base cognitive development dashboard design early adolescence effectiveness evaluation experience handheld mobile device hands-on learning improved innovation news online resource parent-adolescent communication participant retention recruit research study shared decision making success usability user-friendly web site willingness

项目摘要

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.

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，治疗方法和设备已在青少年而非成人中进行过测试。然而，招募障碍。青少年及其父母都存在以下问题：不了解临床试验的重要性、害怕程序、对研究中未知的恐惧、缺乏有关研究程序的知识，例如知情对安慰剂的同意和担忧以及对青少年不良健康结果的担忧也更多。因此，青少年和父母都可能与父母一起参与决策过程。家长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。提议以 DigiKnowIt News (DKIN) 早期版本的成功为基础，DKIN 是一种基于网络的资源，旨在帮助对儿童（8-11 岁）进行儿科临床研究教育我们的目标是填补可用资源的空白。通过创建 DigiKnowIt News – Teen (DKIN: Teen) 来帮助青少年，这是一个适合发展的基于网络的网站为 12-17 岁青少年提供的资源，其中包括供家长和青少年练习的创新部分据了解，通过使用该资源，青少年将能够进行沟通和共同决策。报告他们的知识、积极态度/信念、自我效能和参与意愿有所增加第一阶段临床试验将包括为青少年开发适合发育的 DKIN 版本。使用迭代开发流程，并结合青少年和家长咨询小组以及专家的反馈顾问和对青少年样本（N = 30）的资源进行可行性研究，他们将完成自我报告有关他们的知识、态度、自我效能以及消费者满意度的衡量标准调查问卷以提供有关资源的反馈如果 DKIN-Teen 可行，第二阶段将包括创建。针对儿科临床试验中常见程序（例如镇静/麻醉）的附加内容以及为研究人员创建额外的定制能力，以使用 DKIN 资源进行研究 DKIN：Teen 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。遵守第 508 条，从而提高基于网络的资源的可访问性和可用性。 DKIN 的有效性：青少年将接受不同群体（种族/民族/性别/健康状况）的评估父母-青少年对（N = 180）影响青少年的知识、态度/信念、自我效能和意愿以及加强与参与临床试验相关的父母与青少年的沟通。目前儿科临床试验的招募方法是随意的、耗时的、令人沮丧的、低效的、这种高度可扩展、可定制的方法通常会导致统计分析所需的样本量不够理想。产品将旨在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失调的治疗所需要的。