Engaging Adolescents in Decisions About Return of Genomic Research Results

NCT04481061 | Active Not Recruiting

• 1 other identifier: 5R01HG010166-02
• Study Type: interventional
• Target: 787
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Genetic Screening; Adolescent; Genetic Change; Shared Decision Making; Knowledge, Attitudes, Practice; Genetic Testing

Outcome Measures

Primary Outcomes (4)

• Change in Participant Choices Throughout the Study

  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.

  Pre-intervention baseline choices made at enrollment; choices made during the intervention (about one hour after baseline); post-intervention choices (4 weeks after intervention); post return of results choices (an average of 1 year after intervention).

• Change in Participant's "Decisional Conflict Scale" Score Throughout the Study

  Decisional conflict is a continuous variable measured using a validated scale called the Decisional Conflict Scale. Decisional conflict will vary depending on the difficulty of the decision being made and is greater if an individual feels uninformed about benefits and risks of a decision, is unclear about their values, or feels unsupported or pressured to make a decision. The scale will range from 0-100. The more conflicted someone is the higher the score.

  Decisional Conflict will be measured at baseline, immediately after the intervention (about one hour after baseline), and four weeks after the intervention.

• Change in Participant Decisional Stability Throughout the Study

  Decisional stability will be measured by the proportion of assenting and consenting adolescents whose choices stay consistent or change at the three time points (baseline, immediately after the intervention, four weeks after the intervention)

  Measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention.

• Measurement of Participant's Post Return of Results Decision Regret Score

  The "Decision Regret Scale" is a validated scale that measures distress or remorse after a healthcare decision. The scale ranges from 0- 100. The higher the score, the more the person regrets their choices.

  Measurement taken within one week after returning results. This is an average of 1 year of the intervention.

Study Arms (1)

Decision Making About Genetic Results

OTHER

Adolescents between 13-21 and parent (if applicable) will make decisions about learning results using an electronic decision tool. Results that match their choices will be returned.

Genetic: Electronic Decision Tool

Interventions

Electronic Decision Tool GENETIC

Adolescents and a parent, if applicable, will use an electronic decision tool to make categorical choices of types of diseases (treatable, preventable, adult-onset, and carrier status) they want to learn about the adolescent. Granular choices can be made within each category.

Decision Making About Genetic Results

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Assenting adolescents (13-17 years)
• Consenting adolescents (18-21 years)
• Parent / legal guardian of assenting or consenting adolescent
• Ability to participate in remote study visits, if applicable

You may not qualify if:

• Those who do not communicate in English
• Individuals with developmental disabilities that interfere with their ability to make independent decisions

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Cincinnati: collaborator

Study Sites (2)

Michelle McGowan

Rochester, Minnesota, 55902, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Blumling AA, McGowan ML, Prows CA, Childers-Buschle K, Martin LJ, Lynch JA, Dufendach KR, Lipstein EA, Kovacic MB, Brinkman WB, Myers MF. Engaging adolescents and young adults in decisions about return of genomic research results: study protocol for a mixed-methods longitudinal clinical trial protocol. BMC Med Inform Decis Mak. 2024 Dec 18;24(1):391. doi: 10.1186/s12911-024-02784-w.

  PMID: 39696322 DERIVED

MeSH Terms

Conditions

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adolescents between 13-21 years of age will be given the option to learn categories of genomic results. Results will be returned based on their choices

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 22, 2020
• Study Start: March 10, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (2)