NCT04481061

Engaging Adolescents in Decisions About Return of Genomic Research Results

Active, enrolled NA Last updated 23 July 2025

What this trial tests

NA trial testing Electronic Decision Tool in Genetic Screening in 787 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 March 2020

Primary endpoint
30 November 2026

30 November 2026

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	787
Start date	10 March 2020
Primary completion	30 November 2026
Estimated completion	30 November 2026
Sites	2 locations across United States

Drugs / interventions tested

• Electronic Decision Tool

Conditions studied

• Genetic Screening — all drugs for Genetic Screening →
• Adolescent — all drugs for Adolescent →
• Genetic Change — all drugs for Genetic Change →
• Shared Decision Making — all drugs for Shared Decision Making →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 13 to 99, any sex, with Genetic Screening or Adolescent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engaging adolescents and young adults in decisions about return of genomic research results: study protocol for a mixed-methods longitudinal clinical trial protocol.
   Blumling AA, McGowan ML, Prows CA, Childers-Buschle K, et al · · 2024 · cited 6× · PMID 39696322 · DOI 10.1186/s12911-024-02784-w
2. Representation is power: traditional, hybrid, and digital recruitment results from a non-randomized clinical trial engaging adolescents.
   Harrison TB, Sinclair JA, Martin LJ, Childers-Buschle K, et al · · 2025 · cited 2× · PMID 41057631 · DOI 10.1038/s41746-025-01947-x
3. Adolescents' and young adults' reactions to and perceived utility of carrier screening results in the context of a genomic research study.
   Grimes HN, McGowan ML, Sinclair JA, Prows CA, et al · · 2025 · cited 1× · PMID 40305233 · DOI 10.1002/jgc4.70027
4. Participant Choice of Centralized or Remote Trial Engagement: Secondary Analysis of a Nonrandomized Clinical Trial.
   Harrison TB, Sinclair JA, Martin LJ, Brinkman WB, et al · · 2026 · PMID 42113517 · DOI 10.1001/jamanetworkopen.2026.12029
5. Engaging Adolescents and Young Adults in Decisions About Return of Genomic Research Results: a mixed-methods longitudinal clinical trial protocol
   Blumling A, McGowan M, Prows C, Childers-Buschle K, et al · · 2023 · DOI 10.21203/rs.3.rs-2819191/v1