Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents
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- End Date
- Funding Source
- National Institute of Nursing Research
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.