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NCT04481061 · ClinicalTrials.gov registry record · NA
Engaging Adolescents in Decisions About Return of Genomic Research Results
A NA study of Adolescent and Knowledge, Attitudes, Practice, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- NA
- Development phase
- 787
- Enrollment target
- 2
- Study locations
NCT04481061: Active NA study of Adolescent and Knowledge, Attitudes, Practice, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04481061 is a NA study of Adolescent and Knowledge, Attitudes, Practice that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 787 participants, above the 211-participant average among 15 other Adolescent trials with a reported enrollment target (273% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04481061, a NA study of Adolescent and Knowledge, Attitudes, Practice, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 787 participants
- Enrollment target
- 2
- Study locations
Study Summary
Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenting (\<age 18) and consenting (\>age 18) to return of genomic research results. There is an urgent need to understand adolescents' informational preferences and to create ethically informed, scalable processes that empower adolescents from diverse backgrounds to participate in the decision-making process about learning genomic results. This research will provide important insights into adolescents' choices, as well as the ethical, legal and societal implications of engaging adolescents in making choices about learning genomic results in genomic research and community-based research settings.
Primary Outcome
Choices will be operationalized as the decisions to receive all results, some results, or no results. We will be measuring the changes in these choices at various time points, including from baseline to immediately after the intervention (about one hour after baseline), and again four weeks after the intervention.
Conditions Studied
Interventions
- GENETIC Electronic Decision Tool
Study Locations (2)
Minnesota
- Michelle McGowan - Rochester
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What the registry record for NCT04481061 still lists
NCT04481061 is an interventional study that assigns participants to a tested intervention. The registered 787 participants enrollment target is mid-sized for trials with a published cap, above the 211-participant average among 15 other Adolescent trials with a reported enrollment target (273% higher).
The record links to 6 conditions, with Adolescent appearing as the primary indexed condition, and to 1 intervention - of which Electronic Decision Tool is the first listed.
NCT04481061 reports a single indexed study location in Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT04481061 about?
NCT04481061 is a clinical study titled "Engaging Adolescents in Decisions About Return of Genomic Research Results". Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenti...
What is the current status of trial NCT04481061?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 787 participants. The study started on 2020-03-10. Estimated completion is 2026-11-30.
What conditions does trial NCT04481061 study?
This clinical trial studies the following conditions: Adolescent, Knowledge, Attitudes, Practice, Shared Decision Making, Genetic Testing, Genetic Screening.
What interventions are being tested in trial NCT04481061?
The interventions under investigation include: Electronic Decision Tool (GENETIC).
Who is sponsoring clinical trial NCT04481061?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04481061 being conducted?
This trial has 2 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04481061's enrollment target sits among peer trials
787 2nd of 15 the highest of 15 other Adolescent trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adolescent trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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