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Adolescent Responses to Varying Environments in Virtual Reality Simulations

Primary Purpose

Residential Characteristics, Emotions, Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Residential Characteristics focused on measuring Neighborhoods, Poverty Areas, Adolescent Development

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking
  • Are able to use a dominant hand for joystick manipulation and a non- dominant hand for physiological measurements,
  • Are in good physical and mental health, with no self-reported history of hypertension, cardiovascular disease (CVD) or CVD treatment (with associated medication list indicative of treatments that result in exclusion),
  • Have hair at least 1cm in length based on self-report to be able to provide a hair sample.

Exclusion Criteria:

  • Pregnant, by self-report

Sites / Locations

  • University of Southern California / USC Suzanne Dworak-Peck School of Social WorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality simulation of neighborhood disadvantage

Virtual reality simulation of neighborhood affluence

Arm 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.

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.

Outcomes

Primary Outcome Measures

Emotional response
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).
Change in salivary cortisol
Participants will give saliva samples to assess cortisol response, with statistical models assessing change over time during the study session
Change in blood pressure
Systolic and diastolic blood pressure will be measured, with statistical models assessing change over time during the study session.
Change in high frequency heart rate variability
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
Change in cardiac output
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.
Change in total peripheral resistance
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
Change in pre-ejection period / left ventricular contractility
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.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
April 21, 2023
Sponsor
University of Southern California
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04465240
Brief Title
Adolescent Responses to Varying Environments in Virtual Reality Simulations
Official Title
Adolescent Responses to Varying Environments in Virtual Reality Simulations (THRIVE: The Research In Virtual Environments Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residential Characteristics, Emotions, Stress, Psychological, Stress, Physiological
Keywords
Neighborhoods, Poverty Areas, Adolescent Development

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality simulation of neighborhood disadvantage
Arm Type
Experimental
Arm 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 Title
Virtual reality simulation of neighborhood affluence
Arm Type
Active Comparator
Arm 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(s)
Virtual reality
Intervention Description
Participants are immersed in a neighborhood environment in virtual reality
Primary Outcome Measure Information:
Title
Emotional response
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).
Time Frame
Immediately after the virtual reality task
Title
Change in salivary cortisol
Description
Participants will give saliva samples to assess cortisol response, with statistical models assessing change over time during the study session
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
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure will be measured, with statistical models assessing change over time during the study session.
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
Title
Change in high frequency heart rate variability
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
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
Title
Change in cardiac output
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.
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
Title
Change in total peripheral resistance
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
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
Title
Change in pre-ejection period / left ventricular contractility
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking Are able to use a dominant hand for joystick manipulation and a non- dominant hand for physiological measurements, Are in good physical and mental health, with no self-reported history of hypertension, cardiovascular disease (CVD) or CVD treatment (with associated medication list indicative of treatments that result in exclusion), Have hair at least 1cm in length based on self-report to be able to provide a hair sample. Exclusion Criteria: Pregnant, by self-report
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel A Hackman, PhD
Phone
(213) 821-3112
Email
dhackman@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Hackman, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California / USC Suzanne Dworak-Peck School of Social Work
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel A Hackman, PhD
Phone
213-821-9501
Email
thrive.study@usc.edu
First Name & Middle Initial & Last Name & Degree
Daniel A Hackman, PhD

12. IPD Sharing Statement

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Adolescent Responses to Varying Environments in Virtual Reality Simulations

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