Feasibility Trial of the TELL Tool Intervention

Parenting Clinical Trial

Official title:

Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841967
• Other study ID #: 2020-1086
• Secondary ID: R34NR019278
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disclosure
• Fertility Issues
• Infertility
• Parenting

Intervention

Behavioral:
• TELL Tool Intervention
A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
• eBook Attention Control
A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the TELL Tool and eBook	Participant's reports to the Acceptability Survey. No score range (19 items)	Immediate posttest
Other	Acceptability of the TELL Tool, eBook and Study Protocol	Participant's responses to the Cognitive Interviews. No score range (Cognitive Interview Guide for Acceptability)	Month 15
Other	Pretesting of the Measures	Participant's (8 to 12 participants who are not part of the pilot randomized controlled trial) responses to Cognitive Interviews. No score range. (Cognitive Interview Guide for Measures)	Before baseline
Primary	Number of Participants Who Disclosed the Donor Conception to Their Children	Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)	Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.
Secondary	Change in Disclosure Intention	Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)	Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3
Secondary	Change in Disclosure Competence	Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)	Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3
Secondary	Change in Disclosure Anxiety	Parent's report on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Computer Adapted Test (CAT). Total scores for CAT will be comparable across participants.	Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3