Fertility IssuesNCT04841967
Feasibility Trial of the TELL Tool Intervention
A study testing TELL Tool Intervention in people with Fertility Issues and Disclosure, run by University of Illinois Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues, Disclosure, Parenting
- What is being tested?
- TELL Tool Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60605
About this study
Official title: Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents
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.
Read the 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.
- Conditions
- Fertility Issues, Disclosure, Parenting
- Being tested
- TELL Tool Intervention, eBook Attention Control
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELL Tool InterventionBehavioural
Also called TELL Tool
A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
eBook Attention ControlBehavioural
Also called eBook
A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: eBook Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)
Measured: Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3
Change in Disclosure Competence
Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)
Measured: Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3
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.
Measured: Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start26 Jul 2021
- Primary completion30 Sep 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Patricia Hershberger, PhD, RN, FNP-BC, FAAN, University of Illinois Chicago
- Investigators
- Patricia Hershberger, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841967
- Sponsor's protocol ID
- 2020-1086
- Other IDs
- R34NR019278
- Status last verified
- Jan 2024
- First submitted
- 8 Apr 2021
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When we publish our results, electronic copies of publications will be deposited in PubMed Central within four weeks of acceptance by a journal. We will also submit our results to ClinicalTrials.gov Protocol Registration and Results System as required.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Pilot Testing of the TELL Tool Among Gamete and Embryo Donation Recipient Parents
- ClinicalTrials.gov ID
- NCT04841967
- Acronym / sponsor ID
- 2020-1086
- Conditions
- Fertility Issues, Disclosure, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| TELL Tool Group | Experimental | Behavioral: TELL Tool InterventionParents 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. |
| eBook Attention-Control | Active comparator | Behavioral: eBook Attention ControlParents 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TELL Tool InterventionAlso: TELL ToolA 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location. | Behavioural | TELL Tool Group |
| eBook Attention ControlAlso: eBookA 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location. | Behavioural | eBook Attention-Control |
Primary outcome
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)
3 secondary outcomes
Change in Disclosure Intention
Time frame: Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3
Change in Disclosure Competence
Time frame: Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3
Change in Disclosure Anxiety
Time frame: Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. When we publish our results, electronic copies of publications will be deposited in PubMed Central within four weeks of acceptance by a journal. We will also submit our results to ClinicalTrials.gov Protocol Registration and Results System as required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Hershberger, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TELL Tool Intervention in people with Fertility Issues and Disclosure, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.