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Electronic Decision Tool for Genetic Testing Decisions in Adolescents

N/A
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consenting adolescents (18-21 years)
Must not have
Individuals with developmental disabilities that interfere with their ability to make independent decisions
Those who do not communicate in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

Summary

This trial will help researchers understand how well adolescents can make decisions about their genomic results and whether they should be included in the decision-making process for genomic research.

Who is the study for?
This trial is for parents or guardians of teens (13-17) who can assent, and young adults (18-21) who can consent to participate. They must be able to take part in remote study visits if needed. It's not open to non-English speakers or individuals with developmental disabilities affecting decision-making.Check my eligibility
What is being tested?
The trial is testing an electronic tool designed to help adolescents make informed decisions about receiving their genomic research results. The focus is on understanding their preferences and creating ethical processes for decision-making.See study design
What are the potential side effects?
Since this trial involves the use of an electronic decision tool rather than a medical intervention, traditional physical side effects are not applicable. However, there may be psychological impacts from learning about personal genetic information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 21 years old and agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a developmental disability that affects my decision-making.
Select...
I cannot communicate in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Participant Choices Throughout the Study
Change in Participant Decisional Stability Throughout the Study
Change in Participant's "Decisional Conflict Scale" Score Throughout the Study
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Decision Making About Genetic ResultsExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of CincinnatiOTHER
431 Previous Clinical Trials
633,690 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiLead Sponsor
816 Previous Clinical Trials
6,574,312 Total Patients Enrolled

Media Library

Decision Making About Genetic Results Clinical Trial Eligibility Overview. Trial Name: NCT04481061 — N/A
Shared Decision Making Research Study Groups: Decision Making About Genetic Results
Shared Decision Making Clinical Trial 2023: Decision Making About Genetic Results Highlights & Side Effects. Trial Name: NCT04481061 — N/A
Decision Making About Genetic Results 2023 Treatment Timeline for Medical Study. Trial Name: NCT04481061 — N/A
~160 spots leftby Jul 2025
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