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 通知 和 好处， 父母 （DS）， 差异， 同意/同意 将要 人类主题研究的同意旨在拥护个人自治的道德原则 尊重人和S旨在提供有关学习目的，程序，风险/的信息 并以全面的格式自愿。在青年同意中被认为是一个需要的过程 随着儿童的发展而成熟。在智力残疾人（例如唐氏综合症）中 参与同意/同意程序可能会通过疾病，沟通来复杂化 和神经认知能力下降。不幸的是，有限的数据t告知优化 过程，决策的参与尚未考虑。这项患者信息的研究 杠杆1）在我们目前的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 DS的儿童和成人2）我们的团队在决策参与和沟通方面的专业知识 潜水员国家队列的能力。我们的长期目标是解决人类受试者的方法论差距 研究，即智力残疾人的同意/同意，以提高决策 参与，倡导自我效能，并参与研究。为此，这项研究提出了： 与DS，西班牙翻译人员和我们的创意服务设计团队的家庭合作，以修改现有 多媒体材料并为研究团队开发了最初的交互式移动友好的Web应用程序 评估基本研究元素的理解，并将视频和问卷转化为西班牙语。 与看护人进行半结构化的面对面和虚拟访谈，并在可能的情况下（如果可能） 和来自潜水员的DS的年轻成年人国家队列，以获取有关研究的反馈 参与，电子教育材料和社会故事以及决策参与问题。 使用访谈中的初步反馈来“优化材料”。 试行交互式移动友好的Web应用程序 从全国各地的调查团队获得有关可行性和可接受性的反馈 将多媒体材料纳入现实世界/同意实施中。 为了实现这些目标，将在AIM 1中建立半结构化访谈的基础设施。 来自全国各地的针对性地区的DS（14-30岁）二元组（14-30岁）的护理人孩子，来自粗糙和城市 具有良好代表性的种族/民族和子集的环境将参与 半结构化访谈，讨论研究参与和审查视频，交互式数字应用程序， 和问卷。完成学习后，下一步将是评估已建立的申请 研究方案或在比较其影响与标准方法对患者报告结果的试验中， 理解，入学，学习程序完成和决策参与。