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Feasibility Trial of the TELL Tool Intervention
NA trial testing TELL Tool Intervention in Fertility Issues in 75 participants. Completed in 31 July 2023.
| Lead sponsor | University of Illinois at Chicago |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 75 |
| Start date | 26 July 2021 |
| Primary completion | 30 September 2022 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across United States |
University of Illinois at Chicago
21 and older, any sex, with Fertility Issues or Disclosure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)
| Group | Value | 95% CI |
|---|---|---|
| TELL Tool Group | 23 | |
| eBook Attention-Control | 16 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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