- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465240
Adolescent Responses to Varying Environments in Virtual Reality Simulations
November 9, 2023 updated by: Daniel Hackman, University of Southern California
Adolescent Responses to Varying Environments in Virtual Reality Simulations (THRIVE: The Research In Virtual Environments Study)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel A Hackman, PhD
- Phone Number: (213) 821-3112
- Email: dhackman@usc.edu
Study Locations
-
-
California
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Los Angeles, California, United States, 90089
- University of Southern California / USC Suzanne Dworak-Peck School of Social Work
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual reality simulation of neighborhood disadvantage
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 are immersed in a neighborhood environment in virtual reality
|
Active Comparator: Virtual reality simulation of neighborhood affluence
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.
|
Participants are immersed in a neighborhood environment in virtual reality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional response
Time Frame: Immediately after the virtual reality task
|
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).
|
Immediately after the virtual reality task
|
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
|
Participants will give saliva samples to assess cortisol response, with statistical models assessing change over time during the study session
|
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
|
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
|
Systolic and diastolic blood pressure will be measured, with statistical models assessing change over time during the study session.
|
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
|
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
|
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
|
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
|
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
|
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.
|
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
|
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
|
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
|
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
|
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
|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel A Hackman, PhD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2021
Primary Completion (Actual)
April 22, 2023
Study Completion (Actual)
April 22, 2023
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262625
- 1R21HD099596-01 (U.S. NIH Grant/Contract)
- UP-19-00205 (Other Identifier: University of Southern California)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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