Leveraging E-education to Advance Assent and Decision-Making Involvement in Down Syndrome

利用电子教育促进唐氏综合症的同意和决策参与

• 批准号: 10727155
• 负责人: ANDREA Bridget KELLY
• 金额: $ 26.7万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10727155
• 关键词: Address; Adolescent and Young Adult; Adult; Advocate; Age; Area; Benefits and Risks; Caregivers; Child; Child Development; Chronic; Clinical; Clinical Research; Collaborations; Communication; Communication Barriers; Complement; Comprehension; Consent; Country; Creativeness; Data; Decision Making; Development; Disparity; Down Syndrome; Education; Educational Materials; Elements; Enrollment; Ethnic Origin; Exclusion; Faculty; Family; Family Research; Feedback; Fostering; Friends; Geographic Locations; Health; Home; Human Subject Research; Individual; Informed Consent; Infrastructure; Intellectual functioning disability; Intervention; Interview; Investigation; Learning; Limited English Proficiency; Longevity; Medical; Methodology; Modeling; Morals; Multimedia; Neurocognitive Deficit; Paper; Parents; Participant; Patient Outcomes Assessments; Patients; Pediatric Hospitals; Performance; Persons; Philadelphia; Population Heterogeneity; Procedures; Process; Protocols documentation; Provider; Questionnaires; Race; Regulation; Research; Research Institute; Research Methodology; Research Personnel; Risk; Role; Rural; Sampling; Self Efficacy; Services; Sleep; Sleep Apnea Syndromes; Structure; Techniques; Testing; Text; Training; Translating; Translations; Update; Visual; Voice; Vulnerable Populations; Work; Writing; Youth; acceptability and feasibility; clinical trial readiness; cognitive ability; cohort; decision research; demographics; design; digital; disability; experience; human subject protection; interest; multidisciplinary; patient oriented; process optimization; programs; recruit; rural environment; social; tool; trial comparing; urban setting; verbal; virtual; web app; young adult

PROJECT SUMMARY/ABSTRACT Informed and benefits, parent (DS), differences, consent/assent will consent in human subject research is designed to espouse the moral principles of individual autonomy respect for persons and s intended to provide information regarding study purpose, procedures, risks/ and voluntariness in a comprehensible format. In youth assent is recognized as a process that requires input and matures with child development. In people with intellectual disabilities such as Down syndrome participation in the consent/assent process can be complicated by earning disabilities, communication and neurocognitive decline. Unfortunately, limited data are available t inform an optimized process, an decision-making involvement has not bee considered. This patient-informed study leverage 1) educational materials and multi-media platforms in use in our current studies of i , l o d n sleep apnea in children and adults with DS and 2) our team expertise in decision-making involvement and communication abilities in a diverse, national cohort. Our long-term objective is to address a methodologic gap in human subjects research, namely consent/assent in people with intellectual disabilities, to advance their decision-making involvement, advocate for self-efficacy, and engage them in research. To this end, this study proposes to :  partner with families with DS, Spanish translators, and our Creative Services Design team to revise existing multi-media materials and develop an initial interactive mobile-friendly web application for the study team to assess comprehension of essential study elements and translate videos and questionnaires into Spanish.  conduct semi-structured in-person and virtual interviews with caregivers and (when possible) their adolescent and young adult adults with DS from a diverse, national cohort to obtain feedback regarding research engagement, e-education materials and social story, and decision-making involvement questions.  use initial feedback from interviews to “optimize material”.  pilot the interactive mobile-friendly web application  obtain feedback from investigative teams from across the country on the feasibility and acceptability of incorporating multi-media materials in real-world assent/consent implementation. To accomplish these aims, the infrastructure for semi-structured interviews will be established in Aim 1. Then “caregiver-child with DS (age 14-30y) dyads” from targeted regions across the country, from both rural and urban environments, with well-represented race/ethnicity and subset with limited English proficiency will participate in semi-structured interviews to discuss research engagement and review video, interactive digital applications, and questionnaires. Upon study completion, the next steps will be to evaluate the applications in established research protocols or in a trial comparing their impact vs standard approach upon patient reported outcomes, understanding, enrollment, study procedure completion, and decision-making involvement.

项目总结/摘要 知情 和 好处， 母 (DS), 差异， 同意/同意 将 人类受试者研究中的同意旨在支持个人自主的道德原则 尊重拟提供研究目的、程序、风险/ 和非自愿性。在年轻人中，同意被认为是一个过程， 随着孩子的成长而成熟。在患有智力残疾的人中，如唐氏综合症 参与同意/同意过程可能会因收入障碍、沟通 和神经认知能力下降不幸的是，有限的数据可用于通知优化的 在这个过程中，没有考虑到决策参与。这项患者知情的研究 利用1）我们目前研究中使用的教育材料和多媒体平台， 我 , L O D n 睡眠呼吸暂停 儿童和成人与DS和2）我们的团队在决策参与和沟通的专业知识 在一个多样化的国家群体中的能力。我们的长期目标是解决人类受试者的方法学差距 研究，即智障人士的同意/同意，以推进他们的决策 参与，倡导自我效能，并让他们参与研究。为此，本研究报告建议： 与DS、西班牙语翻译和我们的创意服务设计团队合作， 多媒体材料，并为研究小组开发一个互动的移动友好的网络应用程序， 评估对基本学习要素的理解，并将视频和问卷翻译成西班牙语。 * 与照顾者及其青少年（如可能）进行半结构化的面对面和虚拟访谈 和来自不同国家队列的年轻成年DS患者，以获得有关研究的反馈 参与、电子教育材料和社会故事以及决策参与问题。 充分利用面试中的初步反馈来“优化材料”。 试用交互式移动友好Web应用程序 * 从全国各地的调查小组获得关于下列问题的可行性和可接受性的反馈意见： 将多媒体材料纳入真实世界的同意/同意实施。 为了实现这些目标，将在目标1中建立半结构化面试的基础设施。然后 来自全国农村和城市目标地区的“患有DS（14- 30岁）的二对儿” 环境，具有良好代表性的种族/民族和英语水平有限的子集将参加 半结构化面试，讨论研究参与并审查视频、交互式数字应用程序， 和问卷调查。研究完成后，下一步将是评估已建立的 研究方案或在比较其与标准方法对患者报告结果的影响的试验中， 理解、入组、研究程序完成和决策参与。