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.

项目摘要/摘要 知情者 和 福利， 亲本 (Ds)， 差异， 同意/同意 将要 人类受试者研究中的同意旨在支持个人自主的道德原则 尊重人和S打算提供关于研究目的、程序、风险/的信息 以及可理解格式的自愿性。在年轻人中，同意是一个需要 投入并随着儿童的发展而成熟。有智力障碍的人，如唐氏综合症 参与同意/同意过程可能会因为获得残疾、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 在这一过程中，尚未考虑决策参与。这项患者知情的研究 利用1)在我们当前的研究中使用的教材和多媒体平台 我 ， L O D n 睡眠呼吸暂停 患有DS的儿童和成人；2)我们团队在决策、参与和沟通方面的专业知识 在一个多样化的国家队列中的能力。我们的长期目标是解决人类受试者的方法论差距。 研究，即对智障人士的同意/同意，以促进他们的决策 参与，倡导自我效能感，并让他们参与研究。为此，本研究建议： 与DS家庭、西班牙语翻译人员和我们的创意服务设计团队合作，以修订现有的 多媒体材料，并为研究团队开发一个最初的交互式移动友好网络应用程序，以 评估对基本学习要素的理解，并将视频和调查问卷翻译成西班牙语。 对照顾者和他们的青少年(如果可能)进行半结构化的面对面和虚拟访谈 以及来自不同国家队列的患有DS的年轻成年人，以获得关于研究的反馈 参与、电子教育材料和社会故事，以及决策参与问题。 利用从采访中得到的初步反馈来“优化材料”。 试行交互式移动友好型Web应用 从全国各地的调查小组那里获得关于以下项目的可行性和可接受性的反馈 在现实世界的同意/同意实施中纳入多媒体材料。 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 来自全国不同地区的“照顾者--患有DS(14-30岁)的儿童”，来自农村和城市 具有良好代表性的种族/民族和英语水平有限的子集的环境将参加 半结构化访谈，讨论研究活动并回顾视频、交互式数字应用、 和调查问卷。研究完成后，下一步将是对已建立的申请进行评估 研究方案或在试验中比较它们与标准方法对患者报告结果的影响， 了解、招生、完成学习程序和参与决策。