Feasibility Trial of the TELL Tool Intervention

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.

Conditions

• Fertility Issues
• Disclosure
• Parenting

Interventions

BEHAVIORAL

TELL Tool Intervention

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

BEHAVIORAL

eBook Attention Control

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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Patricia Hershberger, PhD · University of Illinois Chicago

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-26

Primary Completion

2022-09-30

Completion

2023-07-31

Countries

• United States

Study Locations