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: November 2023
• 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	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
Primary	Change in salivary cortisol	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
Primary	Change in blood pressure	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
Primary	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	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
Primary	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.	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
Primary	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	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
Primary	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.	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