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：
10252953
负责人：
Alison Elaine Parker
金额：
$ 48.28万
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 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10252953
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.

需要更多的儿科临床研究，以确保青年接受适当的药物，治疗和已通过青年而不是成人测试的设备。但是，招募障碍青年及其父母都存在：不了解临床试验的重要性，担心程序，对研究中未知的恐惧，缺乏有关知情的研究程序的知识同意和关注安慰剂，并想知道健康状况不佳。青少年也更多可能与父母一起参与决策过程。因此，两个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以及鼓励与参与研究有关的高质量联合决策。这个快速轨道应用提出基于早期版本的Digiknowit News（DKIN）成功的建议，这是一种基于Web的资源教育儿童（8-11岁）关于小儿临床研究。我们旨在填补可用资源的空白青少年通过创建Digiknowit新闻 - TEEN（DKIN：TEEN），这是一个适当的基于网络的新闻 12-17岁青年的资源，其中包括一个创新的部分，供父母和青年实践交流和联合决策。假设通过使用资源，青少年将报告他们的知识，积极的参与者/信念，自我有效和参与的意愿临床试验。第一阶段将包括为青少年创建开发适当的DKIN版本使用迭代开发过程以及青年和家长咨询面板的反馈以及专家顾问和对资源的可行性研究，包括青少年样本（n = 30），他们将完成自我报告有关其知识，参与者和自我效益的衡量标准以及消费者满意度问卷调查提供有关资源的反馈。如果Dkin-teen是可行的，那么第二阶段将包括创建小儿临床试验中特定于常见程序的其他内容（例如，镇静/麻醉）以及为研究人员使用DKIN资源进行研究创造其他自定义能力招聘。 DKIN：青少年将被优化用于计算机，移动设备和平板电脑，并经过测试第508节的合规性，从而增加了基于Web的资源的可访问性和可用性。最后， DKIN的有效性：将通过潜水员组（种族/种族/性别/健康状况）评估青少年成对的成对（n = 180），以影响青年的知识，参加/信念，自我效能和意愿以及加强与参与临床试验有关的父母沟通。当前的小儿临床试验招募方法是随意，耗时，沮丧，效率低下，通常导致统计分析所需的样本量不足。这个高度可扩展的，可自定义的产品将旨在增加愿意参加临床研究的青少年数量，需要改善小儿疾病和疾病的治疗方法。