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 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 skyrocketing 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 address this serious problem and in accordance with International Patient Decision Aid Standards, we developed a digital, tailored, multicomponent Tool to Empower ParentaL TeLling and Talking (i.e., TELL Tool). 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 with 60 donor-recipient parents and 10 clinicians to determine intervention viability and inform a larger, efficacy trial. An eBook with content about good parenting principles serves as the attention control.

The feasibility trail will use a longitudinal, mixed-methods design that is guided by International Patient Decision Aid Standards and NIH Guidelines for pilot studies. The study design is necessary to achieve the objective of the study, which is to examine the feasibility and acceptability of the TELL Tool intervention in a pilot randomized-controlled feasibility trial to determine intervention viability and inform a larger, efficacy trial. There are three Specific Aims that are: Aim 1 determine feasibility of the study procedures (e.g., recruitment, retention) by pilot testing the TELL Tool using a 2-arm randomized-controlled trial (RCT) with 60 donor-recipient parents using pre- to post-test measures for disclosure intention, competence, and anxiety. (A pretesting of the measures will be implemented with 8 to 12 donor-recipient parents, who are not participants of the pilot RCT, prior to launching the RCT.); Aim 2 survey participating donor-recipient parents at 2 additional time points (4 and 12 weeks/months 1 and 3) post-intervention/attention control completion to obtain meaningful outcome data about actual parental disclosure to their donor-conceived children; and Aim 3 refine the study tools (e.g., TELL Tool, eBook) through post-intervention/attention control written evaluations with participating donor-recipient parents and cognitive interviews with 10 donor-recipient parents, who are a sub-sample of parents from our larger sample of parents, and 10 clinicians. The findings will inform the final protocol for a larger, efficacy trial.

Inclusion Criteria Parents:

• Reside in the United States or one of its recognized territories
• Conceived 1 or more children via gamete (egg/sperm) or embryo donation who are currently between the ages of 1 - 16 years of age
• Have not informed their child(ren) about their donor conception origins
• Are 21 years-of-age or older
• English speaking

Inclusion Criteria Clinicians:

• Active practice as a healthcare professional (e.g., nurse, physician, psychologist, social worker)
• Provide education and/or counseling to gamete (eggs, sperm) and/or embryo donation recipient parents about disclosure to their children in the United States or one of its recognized territories
• Able to provide feedback and insight about new tools to assist gamete (eggs, sperm) and/or embryo donation recipient parents with disclosure to their donor-conceived children
• Are 21 years-of-age or older
• English speaking

Exclusion Criteria Parents:

• Have already disclosed the donor conception to their donor-conceived child or children
• Reside outside of the United States or one of its recognized territories

Exclusion Criteria Clinicians:

• Not directly involved in providing education and/or counseling to gamete (eggs, sperm) and/or embryo donation recipient parents about disclosure to their children
• Are a member of the research team

When we publish our results, electronic copies of publications will be deposited in PubMed Central within four weeks of acceptance by a journal. We will also submit our results to ClinicalTrials.gov Protocol Registration and Results System as required.

Parents who participated in the pilot, RCT were assessed about adverse events at the 4-week and 12-week post-test data collection time points. The overall implementation of the pilot, RCT was from recruitment of our first parent participant into the pilot, RCT on July 26, 2021 through the 12-week post-test time point, which was September 30, 2022 when data collection for the pilot, RCT was completed.

At the conclusion of the 4-week and 12-week data collection time points, participants were asked via an open-ended survey question about their reaction to participating in the study to assess for adverse events. For parents that reported disclosure to their children at the 4-week or 12-week time points, parent participants were asked about their child(ren)'s reaction(s) to the disclosure.

Parents will be randomized into two groups (either the TELL Tool group or the attention control eBook group) using a permuted block approach that is stratified by the age categories of the parent's children and using an online (REDCap) randomization module.