Feasibility Trial of the TELL Tool Intervention

NCT04841967 | Completed Results DMC

• 2 other identifiers: 2020-1086R34NR019278
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Issues; Disclosure; Parenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Disclosure Intention

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

• Change in Disclosure Competence

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

• Change in Disclosure Anxiety

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

Other Outcomes (3)

• Acceptability of the TELL Tool and eBook

  Immediate posttest

• Acceptability of the TELL Tool, eBook and Study Protocol

  Month 15

• Pretesting of the Measures

  Before baseline

Study Arms (2)

TELL Tool Group

EXPERIMENTAL

Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.

Behavioral: TELL Tool Intervention

eBook Attention-Control

ACTIVE COMPARATOR

Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.

Behavioral: eBook Attention Control

Interventions

TELL Tool Intervention BEHAVIORAL

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

Also known as: TELL Tool

TELL Tool Group

eBook Attention Control BEHAVIORAL

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

Also known as: eBook

eBook Attention-Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60605, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Patricia Hershberger
• Organization: University of Illinois Chicago

phersh@uic.edu

3129961305

Study Officials

• Patricia Hershberger, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Parents will be randomized into two groups (either the TELL Tool group or the attention control eBook group) using a permuted block approach that is stratified by the age categories of the parent's children and using an online (REDCap) randomization module.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: July 26, 2021
• Primary Completion: September 30, 2022
• Study Completion: July 31, 2023
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)