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NCT04841967 · ClinicalTrials.gov registry record · NA
Feasibility Trial of the TELL Tool Intervention
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT04841967 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 75 participants.
The verdict
NCT04841967, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL TELL Tool Intervention
- BEHAVIORAL eBook Attention Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04841967
The ClinicalTrials.gov registry entry for NCT04841967 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TELL Tool Intervention is the first listed.
NCT04841967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04841967 about?
NCT04841967 is a clinical study titled "Feasibility Trial of the TELL Tool 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 parents' control over...
What is the current status of trial NCT04841967?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2021-07-26. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT04841967?
The interventions under investigation include: TELL Tool Intervention (BEHAVIORAL), eBook Attention Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04841967?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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