Adolescent Responses to Varying Environments in Virtual Reality Simulations

Stress, Psychological Clinical Trial

Official title:

Adolescent Responses to Varying Environments in Virtual Reality Simulations (THRIVE: The Research In Virtual Environments Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465240
• Other study ID #: 262625
• Secondary ID: 1R21HD099596-01U
• Status: Completed
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: April 22, 2023

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 22, 2023
• Est. primary completion date: April 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotions
• Residential Characteristics
• Stress, Physiological
• Stress, Psychological

Intervention

Other:
• Virtual reality
Participants are immersed in a neighborhood environment in virtual reality

Locations

Country	Name	City	State
United States	University of Southern California / USC Suzanne Dworak-Peck School of Social Work	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional Response	Multiple measures were used for emotion felt in the VR neighborhood: Participants rate how strongly they felt 9 specific emotions (0-8 scale; 0 indicates none, 8 is the strongest possible feeling).; 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.; 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)
Primary	Salivary Cortisol	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
Primary	Blood Pressure	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
Primary	Respiratory Sinus Arrhythmia (RSA)	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
Primary	Cardiac Output (CO)	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
Primary	Total Peripheral Resistance (TPR)	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
Primary	Pre-ejection Period (PEP)	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