Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents

TELL 工具在配子和胚胎捐赠接受者父母中的可行性和试点测试

• 批准号: 10261460
• 负责人: Agatha M. Gallo
• 金额: $ 15.68万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-11 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10261460
• 关键词: Address; Adult; Age; Anxiety; Area; Calendar; Cessation of life; Child; Child Rearing; Clinical Trials; Collection; Competence; Conceptions; Counseling; DNA; Data; Data Analyses; Decision Aid; Decision Making; Disclosure; Embryo; Embryology; Evaluation; Explosion; Family; Family member; Feasibility Studies; Fertilization; Future; Genealogy; Genetic; Germ Cells; Health; Health Promotion; History of Medicine; Human; Intention; International; Intervention; Intervention Studies; Knowledge; Learning; Life; Longitudinal Studies; Measures; Medical; Methods; Modeling; Modernization; Online Systems; Outcome; Parent-Child Relations; Parents; Patients; Persons; Pregnancy; Procedures; Process; Prospective Studies; Protocols documentation; Randomized; Randomized Controlled Trials; Reporting; Research; School-Age Population; Scientist; Secrecy; Self Administration; Site; Surface; Surveys; Technology; Testing; Time; Trauma; United Kingdom; Woman; arm; attentional control; authority; base; cognitive interview; design; digital; efficacy clinical trial; efficacy testing; efficacy trial; egg; electronic book; evidence base; feasibility trial; follow-up; genetic testing; implementation protocol; interest; junior high school; malignant breast neoplasm; maltreatment; post intervention; precision medicine; preempt; prevent; recruit; reproductive; response; sperm cell; support tools; tool; web-based intervention

A radical paradigm shift is taking place where technology, notably the explosion in easy accessible direct-to- consumer genetic testing (e.g., 23andMe) and a high consumer interest in genealogy (e.g., Ancestry.com), has hijacked gamete (eggs, sperm) and embryo donation recipient (DR) parents' control over whether to inform their children about their donor conception. Historically, the practice of gamete donation has been shrouded in secrecy, however, the burgeoning use of direct-to-consumer genetic testing means that at any point in an adult life, an uninformed donor-conceived person can learn their DNA does not match their presumed ancestry of their parents and family members, putting into question their genetic relatedness to their parents and launching a spiraling sequence of negative health consequences and trauma. Furthermore, the lack of one's knowledge about actual genetic heritage in the age of precision medicine can be enormously detrimental to health and can result in medical maltreatment, including death. To understand the phenomenon of DR parents' disclosure in the U.S., we recently completed a 12-year longitudinal study that found 86% of DR parents did not disclose to their donor-conceived children by age 11, which is supported by other research that has estimated DR parents' non-disclosure as high as 91%. To address this serious problem and in accordance with International Patient Decision Aid Standards, we developed a digital, tailored, multicomponent Tool to Empower ParentaL DiscLosure (i.e., TELL Tool). The TELL Tool aligns with our Decision-Making Process Model and the lessons learned from implementing CHOICES, a web-based, educational reproductive intervention. The objective of this R34 study is to examine the feasibility, acceptability, and preliminary effects of the TELL Tool intervention in a pilot randomized-controlled feasibility trial to determine intervention viability and inform a larger, efficacy trial. An eBook with content about good parenting principles serves as the attention control. Our Specific Aims in this mixed-methods study are: Aim 1 determine feasibility of the study procedures (e.g., preliminary effects) by pilot testing the TELL Tool using a 2-arm randomized-controlled trial with 60 DR parents using pre- to post-test measures for disclosure intention, competence, and anxiety; Aim 2 survey participating DR parents at 2 additional time points (4 and 12 weeks) post-intervention completion to obtain meaningful outcome data about actual parental disclosure to their donor-concevied children; and Aim 3 refine the study tools through post-intervention/attention control written evaluations with participating DR parents, input from our Parent Advisory Board, and cognitive interviews with 10 DR parents and 10 clinicians. Integrating data from the three Aims will accomplish our objective and will 1) determine whether the TELL Tool is viable and, if so, 2) inform the final implementation protocol. The value of our study lies in obtaining critical data about the promise and protocol of the TELL Tool, which may be able to promote health by preempting trauma to modern families and knowledge of actual genetic heritage, an NINR high scientific priority area.

一个激进的范式转变正在发生，技术，特别是爆炸性的容易获得的直接到- 消费者基因测试（例如，23andMe）和消费者对家谱的高度兴趣（例如，Ancestry.com）， 劫持配子（卵子，精子）和胚胎捐赠接受者（DR）父母对是否 告诉他们的孩子关于捐赠者的想法。从历史上看，配子捐赠的做法一直是 然而，在保密的情况下，直接面向消费者的基因检测的迅速发展意味着， 在成年生活中，一个不知情的捐赠者怀孕的人可以了解他们的DNA与他们的DNA不匹配。 假定他们的父母和家庭成员的祖先，质疑他们的遗传关系， 父母和启动一个螺旋式的负面健康后果和创伤序列。而且 在精准医疗时代，缺乏对实际遗传遗产的了解可能会极大地 有害健康，并可能导致医疗虐待，包括死亡。为了理解这个现象 DR父母在美国的披露，我们最近完成了一项为期12年的纵向研究， 父母在11岁之前没有向他们的捐赠者怀孕的孩子透露，这得到了其他研究的支持， 据估计，DR父母的保密率高达91%。为了解决这一严重问题， 根据国际患者决策辅助标准，我们开发了一种数字化、定制化、多组件工具， 授权家长披露（即，TELL Tool）。TELL工具与我们的决策过程保持一致 从执行“选择”方案中获得的经验教训， 干预本R34研究的目的是检查可行性、可接受性和初步效果 TELL工具干预的随机对照可行性试验，以确定干预的可行性 并为更大规模的疗效试验提供信息一本关于良好育儿原则的电子书可以作为 注意力控制我们在这项混合方法研究中的具体目标是：目标1确定研究的可行性 程序（例如，初步效果），使用双臂随机对照试验对TELL工具进行初步测试 60名DR父母使用前测后测的披露意图，能力和焦虑的措施;目标2 在干预完成后的2个额外时间点（4周和12周）对参与DR的父母进行调查， 获得关于父母向其捐赠者接受捐赠的子女实际披露的有意义的结果数据;以及目标3 通过参与DR的干预后/注意力控制书面评估来完善研究工具 父母，我们的父母咨询委员会的意见，以及与10名DR父母和10名临床医生的认知访谈。 整合来自三个目标的数据将实现我们的目标，并将1）确定TELL工具是否 是否可行，如果可行，2）告知最终实施方案。我们研究的价值在于获得批判性的 关于TELL工具的承诺和协议的数据，该工具可能能够通过抢占来促进健康。 对现代家庭的创伤和对实际遗传遗产的了解，这是国家核研究所高度优先的科学领域。