<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/NCT04465240</url>
  </required_header>
  <id_info>
    <org_study_id>262625</org_study_id>
    <secondary_id>1R21HD099596-01</secondary_id>
    <secondary_id>UP-19-00205</secondary_id>
    <nct_id>NCT04465240</nct_id>
  </id_info>
  <brief_title>Adolescent Responses to Varying Environments in Virtual Reality Simulations</brief_title>
  <official_title>Adolescent Responses to Varying Environments in Virtual Reality Simulations (THRIVE: The Research In Virtual Environments Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study, named THRIVE (The Research In Virtual Environments Study), is to&#xD;
      test hypotheses for how neighborhood environments influence stress and emotion, as a&#xD;
      mechanism by which they may influence health. Neighborhood environments may have both acute&#xD;
      influences on stress-related processes, but also may have lifespan effects due to the&#xD;
      chronic, cumulative effects of repeated exposures and the long-term toll of adapting to&#xD;
      adverse neighborhood environments. However, assessing neighborhood influences on stress and&#xD;
      emotion is methodologically challenging. This study develops such a novel, alternative&#xD;
      approach to address these questions by deploying a virtual reality (VR) based model of&#xD;
      neighborhood disadvantage and affluence that creates an immersive experience approximating&#xD;
      the experience of being in different neighborhoods. In this study, this model will be applied&#xD;
      to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range&#xD;
      of disadvantaged and affluent neighborhoods. The proposed study will employ a randomized&#xD;
      experiment (n = 65 per condition), with online questionnaires and a single study session, to&#xD;
      determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion&#xD;
      and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in&#xD;
      habituation or sensitization to different neighborhood characteristics; and (3) if chronic&#xD;
      stress results in habituation or sensitization to different neighborhood characteristics.&#xD;
      This research will develop an innovative methodology that will help establish the role that&#xD;
      neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic&#xD;
      stress and chronic neighborhood exposures. In addition, it will help establish a method that&#xD;
      can be utilized more broadly to study contextual and social environmental influences on&#xD;
      psychological and biological risk in adolescence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional response</measure>
    <time_frame>Immediately after the virtual reality task</time_frame>
    <description>Participants will rate how strongly they felt 9 specific emotions while in the virtual neighborhood (each emotion rated 0-8 scale, with 8 being the highest) (e.g. Haase, Seider, Shiota, &amp; Levenson, 2012; Mauss &amp; Robinson, 2009). Participants will also complete the Self-Assessment Manikin, which assesses on two dimensional scales how they felt, from (a) happy to unhappy, and (b) excited to calm (Bradley &amp; Lang, 1994).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in salivary cortisol</measure>
    <time_frame>From baseline before the virtual reality task to immediately after the virtual reality task, and to immediately and 15 and 30 minutes following completion of all post-task questionnaires</time_frame>
    <description>Participants will give saliva samples to assess cortisol response, with statistical models assessing change over time during the study session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Assessed at regular intervals from the baseline period before the task through 30 minutes following the completion of the virtual reality task and post-task questionnaires</time_frame>
    <description>Systolic and diastolic blood pressure will be measured, with statistical models assessing change over time during the study session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in high frequency heart rate variability</measure>
    <time_frame>Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires</time_frame>
    <description>Electrocardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session) to measure high frequency heart rate variability, with statistical models assessing change over time during the study session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cardiac output</measure>
    <time_frame>Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires</time_frame>
    <description>Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of cardiac output, with statistical models assessing change over time during the study session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total peripheral resistance</measure>
    <time_frame>Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires</time_frame>
    <description>Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of total peripheral resistance, with statistical models assessing change over time during the study session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pre-ejection period / left ventricular contractility</measure>
    <time_frame>Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires</time_frame>
    <description>Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of pre-ejection period / left ventricular contractility, with statistical models assessing change over time during the study session.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Residential Characteristics</condition>
  <condition>Emotions</condition>
  <condition>Stress, Psychological</condition>
  <condition>Stress, Physiological</condition>
  <arm_group>
    <arm_group_label>Virtual reality simulation of neighborhood disadvantage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will watch a video again during a recovery period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality simulation of neighborhood affluence</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will watch a video again during a recovery period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality</intervention_name>
    <description>Participants are immersed in a neighborhood environment in virtual reality</description>
    <arm_group_label>Virtual reality simulation of neighborhood affluence</arm_group_label>
    <arm_group_label>Virtual reality simulation of neighborhood disadvantage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Are able to use a dominant hand for joystick manipulation and a non- dominant hand for&#xD;
             physiological measurements,&#xD;
&#xD;
          -  Are in good physical and mental health, with no self-reported history of hypertension,&#xD;
             cardiovascular disease (CVD) or CVD treatment (with associated medication list&#xD;
             indicative of treatments that result in exclusion),&#xD;
&#xD;
          -  Have hair at least 1cm in length based on self-report to be able to provide a hair&#xD;
             sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, by self-report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel A Hackman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel A Hackman, PhD</last_name>
    <phone>(213) 821-3112</phone>
    <email>dhackman@usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Southern California / USC Suzanne Dworak-Peck School of Social Work</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel A Hackman, PhD</last_name>
      <phone>213-821-9501</phone>
      <email>thrive.study@usc.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel A Hackman, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Daniel Hackman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Neighborhoods</keyword>
  <keyword>Poverty Areas</keyword>
  <keyword>Adolescent Development</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- 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/NCT04465240
org study id: 262625
secondary id: 1R21HD099596-01
secondary id: UP-19-00205
nct id: NCT04465240
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study, named THRIVE (The Research In Virtual Environments Study), is to
      test hypotheses for how neighborhood environments influence stress and emotion, as a
      mechanism by which they may influence health. Neighborhood environments may have both acute
      influences on stress-related processes, but also may have lifespan effects due to the
      chronic, cumulative effects of repeated exposures and the long-term toll of adapting to
      adverse neighborhood environments. However, assessing neighborhood influences on stress and
      emotion is methodologically challenging. This study develops such a novel, alternative
      approach to address these questions by deploying a virtual reality (VR) based model of
      neighborhood disadvantage and affluence that creates an immersive experience approximating
      the experience of being in different neighborhoods. In this study, this model will be applied
      to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range
      of disadvantaged and affluent neighborhoods. The proposed study will employ a randomized
      experiment (n = 65 per condition), with online questionnaires and a single study session, to
      determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion
      and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in
      habituation or sensitization to different neighborhood characteristics; and (3) if chronic
      stress results in habituation or sensitization to different neighborhood characteristics.
      This research will develop an innovative methodology that will help establish the role that
      neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic
      stress and chronic neighborhood exposures. In addition, it will help establish a method that
      can be utilized more broadly to study contextual and social environmental influences on
      psychological and biological risk in adolescence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Emotional response
time frame: Immediately after the virtual reality task
description: Participants will rate how strongly they felt 9 specific emotions while in the virtual neighborhood (each emotion rated 0-8 scale, with 8 being the highest) (e.g. Haase, Seider, Shiota, & Levenson, 2012; Mauss & Robinson, 2009). Participants will also complete the Self-Assessment Manikin, which assesses on two dimensional scales how they felt, from (a) happy to unhappy, and (b) excited to calm (Bradley & Lang, 1994).
measure: Change in salivary cortisol
time frame: From baseline before the virtual reality task to immediately after the virtual reality task, and to immediately and 15 and 30 minutes following completion of all post-task questionnaires
description: Participants will give saliva samples to assess cortisol response, with statistical models assessing change over time during the study session
measure: Change in blood pressure
time frame: Assessed at regular intervals from the baseline period before the task through 30 minutes following the completion of the virtual reality task and post-task questionnaires
description: Systolic and diastolic blood pressure will be measured, with statistical models assessing change over time during the study session.
measure: Change in high frequency heart rate variability
time frame: Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires
description: Electrocardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session) to measure high frequency heart rate variability, with statistical models assessing change over time during the study session
measure: Change in cardiac output
time frame: Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires
description: Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of cardiac output, with statistical models assessing change over time during the study session.
measure: Change in total peripheral resistance
time frame: Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires
description: Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of total peripheral resistance, with statistical models assessing change over time during the study session
measure: Change in pre-ejection period / left ventricular contractility
time frame: Continuously assessed from the baseline period before the task through 30 minutes following the completion of both the virtual reality task and post-task questionnaires
description: Impedance cardiograph signals will be recorded continuously at baseline, during the virtual reality task, and after the task (during the session), to generate measures of pre-ejection period / left ventricular contractility, with statistical models assessing change over time during the study session.
arm group label: Virtual reality simulation of neighborhood disadvantage
arm group type: Experimental
description: Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood representative of disadvantage they were assigned to. Then they will watch a video again during a recovery period.
arm group label: Virtual reality simulation of neighborhood affluence
arm group type: Active Comparator
description: Participants will attend one study session. They will watch a video during a baseline rest period. Participants will be assigned to navigate and explore the virtual neighborhood, representative of affluence they were assigned to. Then they will watch a video again during a recovery period.
intervention type: Other
intervention name: Virtual reality
description: Participants are immersed in a neighborhood environment in virtual reality
arm group label: Virtual reality simulation of neighborhood affluence
arm group label: Virtual reality simulation of neighborhood disadvantage
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel A Hackman, PhD
role: Principal Investigator
affiliation: University of Southern California
last name: Daniel A Hackman, PhD
phone: (213) 821-3112
email: dhackman@usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Daniel Hackman
investigator title: Assistant Professor
mesh term: Stress, Psychological