<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481061</url>
  </required_header>
  <id_info>
    <org_study_id>5R01HG010166-02</org_study_id>
    <nct_id>NCT04481061</nct_id>
  </id_info>
  <brief_title>Engaging Adolescents in Decisions About Return of Genomic Research Results</brief_title>
  <official_title>Engaging Adolescents in Decisions About Return of Genomic Research Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent recommendations to return children's results for adult-onset conditions to parents&#xD;
      anytime whole exome or genome sequencing is performed, as well as growing expectations to&#xD;
      return research results to participants on a large-scale basis, mean adolescents will&#xD;
      increasingly be engaged in assenting (&lt;age 18) and consenting (&gt;age 18) to return of genomic&#xD;
      research results. There is an urgent need to understand adolescents' informational&#xD;
      preferences and to create ethically informed, scalable processes that empower adolescents&#xD;
      from diverse backgrounds to participate in the decision-making process about learning genomic&#xD;
      results. This research will provide important insights into adolescents' choices, as well as&#xD;
      the ethical, legal and societal implications of engaging adolescents in making choices about&#xD;
      learning genomic results in genomic research and community-based research settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess assenting and consenting adolescents' choices about&#xD;
      learning genomic research results. The investigator will refine existing decision tools and&#xD;
      processes to promote informed genomic decision-making through the use of focus groups with&#xD;
      adolescents and parents recruited from an existing genomic research study and a diverse,&#xD;
      medically-underserved community to assess whether and how recruitment pathways impact&#xD;
      perceived value, risks, and benefits of participation in genomic research and return of&#xD;
      personal genomic information. Once these materials have been refined, consenting adolescents&#xD;
      between the ages of 18-21, assenting adolescents between the ages of 13-17, and their parents&#xD;
      (optional for consenting adolescents) will be invited to make choices using an electronic&#xD;
      decision tool for an actual return of results study using two different genome sequencing&#xD;
      panels. A joint decision-making process involving adolescents, a parent (if applicable), and&#xD;
      a study team member will facilitate confirmation of choices. A subset of adolescents will&#xD;
      also be asked to reflect upon the genetic results they chose to learn, factors that impacted&#xD;
      their choices, and decision-stability during in-depth interviews. Genomic research results&#xD;
      will be returned that reflect the participants' choices. Surveys and interviews will be&#xD;
      conducted following return of results to assess participants' understanding, perceived risks&#xD;
      and benefits, psychosocial and behavioral impact, and whether decisional regret is associated&#xD;
      with decisional stability. Throughout the study legal, ethical, and social issues pertaining&#xD;
      to adolescents' preferences and responses to return of genomic research results will be&#xD;
      explored, including normative assessments of empirical findings as well as the&#xD;
      population-level utility and impact of involving adolescents in the decision-making process.&#xD;
      Findings from this study will contribute to filling a critical gap in the literature&#xD;
      regarding engaging adolescents' in the decision to learn genomic research results, and will&#xD;
      help inform best practices with adolescent populations. This information is critical given&#xD;
      recent recommendations by the American College of Medical Genetics to return children's&#xD;
      results for adult onset conditions to parents' anytime whole exome or genome sequencing is&#xD;
      performed. Findings from this study will also help inform a growing expectation to return&#xD;
      research results on a large-scale basis, necessitating examination of ethical return of&#xD;
      research results with a range of populations recruited from a variety of settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>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</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Participant Choices Throughout the Study</measure>
    <time_frame>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).</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Participant's &quot;Decisional Conflict Scale&quot; Score Throughout the Study</measure>
    <time_frame>Decisional Conflict will be measured at baseline, immediately after the intervention (about one hour after baseline), and four weeks after the intervention.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Participant Decisional Stability Throughout the Study</measure>
    <time_frame>Measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention.</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of Participant's Post Return of Results Decision Regret Score</measure>
    <time_frame>Measurement taken within one week after returning results. This is an average of 1 year of the intervention.</time_frame>
    <description>The &quot;Decision Regret Scale&quot; 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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">856</enrollment>
  <condition>Genetic Screening</condition>
  <condition>Adolescent</condition>
  <condition>Genetic Change</condition>
  <condition>Shared Decision Making</condition>
  <condition>Knowledge, Attitudes, Practice</condition>
  <condition>Genetic Testing</condition>
  <arm_group>
    <arm_group_label>Decision Making About Genetic Results</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Electronic Decision Tool</intervention_name>
    <description>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.</description>
    <arm_group_label>Decision Making About Genetic Results</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Assenting adolescents (13-17 years)&#xD;
&#xD;
          -  Consenting adolescents (18-21 years)&#xD;
&#xD;
          -  Parent / legal guardian of assenting or consenting adolescent&#xD;
&#xD;
          -  Ability to participate in remote study visits, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who do not meet inclusion criteria&#xD;
&#xD;
          -  Those who do not communicate in English&#xD;
&#xD;
          -  Individuals with developmental disabilities that interfere with their ability to make&#xD;
             independent decisions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Melanie F Myers, PhD</last_name>
    <phone>513-636-8195</phone>
    <email>Melanie.Myers@cchmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michelle L McGowan, PhD</last_name>
    <phone>513-636-3656</phone>
    <email>Michelle.McGowan@cchmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Corsmo, MPH</last_name>
      <phone>513-636-5449</phone>
      <email>Jeremy.Corsmo@CCHMC.org</email>
    </contact>
    <contact_backup>
      <last_name>Kacey Appel, PhD</last_name>
      <phone>(513) 636-3564</phone>
      <email>Kacey.Appel@cchmc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Melanie F Myers, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michelle L McGowan, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481061
org study id: 5R01HG010166-02
nct id: NCT04481061
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
The purpose of this study is to assess assenting and consenting adolescents' choices about
      learning genomic research results. The investigator will refine existing decision tools and
      processes to promote informed genomic decision-making through the use of focus groups with
      adolescents and parents recruited from an existing genomic research study and a diverse,
      medically-underserved community to assess whether and how recruitment pathways impact
      perceived value, risks, and benefits of participation in genomic research and return of
      personal genomic information. Once these materials have been refined, consenting adolescents
      between the ages of 18-21, assenting adolescents between the ages of 13-17, and their parents
      (optional for consenting adolescents) will be invited to make choices using an electronic
      decision tool for an actual return of results study using two different genome sequencing
      panels. A joint decision-making process involving adolescents, a parent (if applicable), and
      a study team member will facilitate confirmation of choices. A subset of adolescents will
      also be asked to reflect upon the genetic results they chose to learn, factors that impacted
      their choices, and decision-stability during in-depth interviews. Genomic research results
      will be returned that reflect the participants' choices. Surveys and interviews will be
      conducted following return of results to assess participants' understanding, perceived risks
      and benefits, psychosocial and behavioral impact, and whether decisional regret is associated
      with decisional stability. Throughout the study legal, ethical, and social issues pertaining
      to adolescents' preferences and responses to return of genomic research results will be
      explored, including normative assessments of empirical findings as well as the
      population-level utility and impact of involving adolescents in the decision-making process.
      Findings from this study will contribute to filling a critical gap in the literature
      regarding engaging adolescents' in the decision to learn genomic research results, and will
      help inform best practices with adolescent populations. This information is critical given
      recent recommendations by the American College of Medical Genetics to return children's
      results for adult onset conditions to parents' anytime whole exome or genome sequencing is
      performed. Findings from this study will also help inform a growing expectation to return
      research results on a large-scale basis, necessitating examination of ethical return of
      research results with a range of populations recruited from a variety of settings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 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
primary purpose: Screening
masking: None (Open Label)
measure: Change in Participant Choices Throughout the Study
time frame: 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).
description: 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.
measure: Change in Participant's "Decisional Conflict Scale" Score Throughout the Study
time frame: Decisional Conflict will be measured at baseline, immediately after the intervention (about one hour after baseline), and four weeks after the intervention.
description: 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.
measure: Change in Participant Decisional Stability Throughout the Study
time frame: Measured at baseline, immediately after the intervention, (within an hour of baseline), and four weeks after the intervention.
description: 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)
measure: Measurement of Participant's Post Return of Results Decision Regret Score
time frame: Measurement taken within one week after returning results. This is an average of 1 year of the intervention.
description: 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.
arm group label: Decision Making About Genetic Results
arm group type: Other
description: 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.
intervention type: Genetic
intervention name: Electronic Decision Tool
description: 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.
arm group label: Decision Making About Genetic Results
criteria: 
gender: All
minimum age: 13 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melanie F Myers, PhD
phone: 513-636-8195
email: Melanie.Myers@cchmc.org
last name: Michelle L McGowan, PhD
phone: 513-636-3656
email: Michelle.McGowan@cchmc.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor