Clinical trial NCT04841967: Feasibility Trial of the TELL Tool Intervention
Official title: Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Issues
Disclosure
Parenting
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-04-12
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parent participants will be randomized to one of two groups: (1) TELL Tool group, or (2) eBook attention control group. Data will be collected at baseline, immediate posttest (post-TELL tool/post-eBook attention control) and at 2 additional time points (months 1 and 3)
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Disclosed the Donor Conception to Their Children
timeFrame: Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.
Secondary outcomes:
measure: Change in Disclosure Intention
timeFrame: Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3
measure: Change in Disclosure Competence
timeFrame: Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3
measure: Change in Disclosure Anxiety
timeFrame: Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3
Other outcomes:
measure: Acceptability of the TELL Tool and eBook
timeFrame: Immediate posttest
measure: Acceptability of the TELL Tool, eBook and Study Protocol
timeFrame: Month 15
measure: Pretesting of the Measures
timeFrame: Before baseline
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Patricia Hershberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: