Skip to main content
OpenTrials
Completed

NCT Number: NCT04841967

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fertility Issues Disclosure Genital Diseases Infertility Parenting Urogenital Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TELL Tool Intervention

Behavioral

A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.

Other names: TELL Tool

eBook Attention Control

Behavioral

A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.

Other names: eBook

Primary outcomes

  1. Number of Participants Who Disclosed the Donor Conception to Their Children

    Time frame: Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.

    Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)

Secondary outcomes

  1. Change in Disclosure Intention

    Time frame: Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3

    Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)

  2. Change in Disclosure Competence

    Time frame: Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3

    Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)

  3. Change in Disclosure Anxiety

    Time frame: Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3

    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.

Other outcomes

  1. Acceptability of the TELL Tool and eBook

    Time frame: Immediate posttest

    Participant's reports to the Acceptability Survey. No score range (19 items)

  2. Acceptability of the TELL Tool, eBook and Study Protocol

    Time frame: Month 15

    Participant's responses to the Cognitive Interviews. No score range (Cognitive Interview Guide for Acceptability)

  3. Pretesting of the Measures

    Time frame: Before baseline

    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)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 12, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.