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

正在发生一场根本性的范式转变，技术，特别是易于访问的直接到 消费者基因检测(例如23andMe)和消费者对家谱(例如Ancestry.com)的高度兴趣 被劫持的配子(卵子、精子)和胚胎捐赠接受者(DR)父母对是否 告诉他们的孩子他们的捐献者受孕。从历史上看，配子捐赠的做法一直是 然而，在秘密的笼罩下，直接面向消费者的基因检测的蓬勃发展意味着 在成年生活中，一个不知情的捐赠者受孕的人可能会发现他们的DNA与他们的 推测他们的父母和家庭成员的祖先，质疑他们与他们的 并引发了一系列负面的健康后果和创伤。此外， 在精确医学时代，缺乏对实际遗传基因的了解可能是巨大的 对健康有害，并可能导致医疗虐待，包括死亡。要理解这一现象 在美国，我们最近完成了一项为期12年的纵向研究，发现86%的DR 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 Parents的保密比例高达91%。解决这一严重问题，并根据 根据国际患者决策辅助标准，我们开发了一个数字化的、量身定制的多组件工具 授权父母披露(即，Tell工具)。Tell工具与我们的决策过程保持一致 模型和从实施选择中学到的教训，一个基于网络的教育生殖 干预。本R34研究的目标是检查可行性、可接受性和初步效果 Tell工具干预在先导性随机对照可行性试验中的应用以确定干预可行性 并通知一项更大规模的疗效试验。一本包含良好育儿原则内容的电子书可以作为 注意控制。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 通过使用双臂随机对照试验对Tell工具进行试点测试的程序(例如，初步效果) 对60名DR家长进行前后测试，以了解他们的信息披露意向、能力和焦虑；目标2 在干预完成后的另外两个时间点(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设想的子女披露实际情况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 家长，来自家长咨询委员会的意见，以及对10名DR家长和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)决定Tell工具 是可行的，如果可行，2)通知最终实施协议。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 对现代家庭的创伤和对实际遗传遗产的了解，这是NINR的一个高度科学优先领域。

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.