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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)

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

Study 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

Select...

I am between 18 and 21 years old and agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention.

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiOTHER

428 Previous Clinical Trials

633,538 Total Patients Enrolled

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,530,735 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has been approved to take part in this clinical experiment?

"Patients must demonstrate knowledge, practice and mental aptitude to be applicable for this trial. All participants need to fall within the ages of 13-99 years old and about 856 patients are being taken in."

Answered by AI

Do individuals who are younger than fifty qualify for the trial?

"The minimum age for inclusion in this trial is 13 years old, with a cap of 99 when considering patients' eligibility."

Answered by AI

To what extent are participants involved in this experiment?

"Affirmative. Clinicaltrials.gov has information which suggests that this clinical trial, initially posted on March 10th 2020, is currently accepting participants. The study necessitates 856 individuals from a single medical site."

Answered by AI

Is enrollment being opened for this experiment at the moment?

"According to information hosted on clinicaltrials.gov, this research endeavour is currently looking for participants; it was first made public on March 10th 2020 and the most recent edit occurred on February 24th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Engaging Adolescents in Decisions About Return of Genomic Research Results

2020. "Engaging Adolescents in Decisions About Return of Genomic Research Results". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04481061.