Adolescent Responses to Varying Environments in Virtual Reality Simulations

May 10, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel A Hackman, PhD
  • Phone Number: (213) 821-3112
  • Email: dhackman@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California / USC Suzanne Dworak-Peck School of Social Work

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Virtual reality
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.
Other: Virtual reality
Participants are immersed in a neighborhood environment in virtual reality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Emotional Response
Time Frame: Immediately after the virtual reality task (average of 28 minutes post baseline)

Multiple measures were used for emotion felt in the VR neighborhood:

  1. Participants rate how strongly they felt 9 specific emotions (0-8 scale; 0 indicates none, 8 is the strongest possible feeling).
  2. Two composite scores based on averaging responses for specific emotions: Positive emotion (enthusiasm, contentment, amusement) and Negative emotion (fear, sadness, disgust, anger). Averages were based on the standard score representing standard deviations above/below the mean. The mean score was 0. Positive emotion ranged from -1.9, the lowest positive emotion, to 2.0, the highest. Negative emotion ranged from -0.7, the lowest negative emotion, to 3.5, the highest. A positive score reflects greater than average for that type of emotion, and negative score reflects less than average for that type of emotion.
  3. Self-Assessment Manikin (SAM) scale: two dimensional scales for how they felt, from (a) happy to unhappy (1 to 9), and (b) excited to calm (1 to 9) (Bradley & Lang, 1994)
Immediately after the virtual reality task (average of 28 minutes post baseline)
Salivary Cortisol
Time Frame: Measured 5 times: (1) end of baseline, (2) after virtual reality (VR) neighborhood (VR: 11 minutes, average), (3) after questionnaires (26 minutes after VR end, average), (4) video (recovery), after first 15 minutes, (5) after final 15 minutes of video
Concentration of the stress hormone cortisol in saliva samples, measured in (µg/dL), that participants provide over the course of the study session to assess cortisol response
Measured 5 times: (1) end of baseline, (2) after virtual reality (VR) neighborhood (VR: 11 minutes, average), (3) after questionnaires (26 minutes after VR end, average), (4) video (recovery), after first 15 minutes, (5) after final 15 minutes of video
Blood Pressure
Time Frame: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Systolic (SBP) and diastolic (DBP) blood pressure, in mmHG, measured and summarized across epochs in the study session.
Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Respiratory Sinus Arrhythmia (RSA)
Time Frame: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Respiratory Sinus Arrhythmia (RSA) reflects parasympathetic nervous systemt activity and is used as an index of emotion regulation, with higher scores indicating greater parasympathetic activation. It is derived from the natural log of the power of high frequency heart rate variability (heart rate variability is the variability in the amount of time in between heart beats, and high frequency heart rate variability is the power of activity in the 0.15-0.4 Hz range). Based on electrocardiograph signals measured and summarized across epochs in the study session.
Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Cardiac Output (CO)
Time Frame: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Cardiac Output (CO) represents the volume of blood pumped by the heart (L/min). Increasing values indicate greater volume of blood pumped per unit time. Derived from impedance cardiography signals measured and and then summarized across epochs in the study session.
Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Total Peripheral Resistance (TPR)
Time Frame: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Total peripheral resistance (TPR) is an index of an index of vasoconstriction (mean arterial pressure divided by cardiac output). Increasing values indicate greater vasoconstriction. Derived from impedance cardiography signals measured and and then summarized across epochs in the study session.
Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Pre-ejection Period (PEP)
Time Frame: Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes
Pre-ejection period (PEP) is a measure of sympathetic nervous system activation. Higher values indicate greater sympathetic activation. Derived from impedance cardiography (Q-point in ECG to B-point in impedance cardiography), signals are measured and and then summarized across epochs in the study session.
Measured in 5 epochs, typical 60-90 minutes total: (1) Baseline before virtual reality (VR), (2) VR neighborhood (11 minutes, average), (3) Questionnaires (begins 6 minutes after VR end, average), (4) Video: first 15 minutes, (5) Video, final 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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