NCT04465240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

June 11, 2020

Results QC Date

April 5, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

NeighborhoodsPoverty AreasAdolescent Development

Outcome Measures

Primary Outcomes (7)

  • Emotional Response

    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

    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

    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)

    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)

    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)

    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)

    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

Study Arms (2)

Virtual reality simulation of neighborhood disadvantage

EXPERIMENTAL

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

Virtual reality simulation of neighborhood affluence

ACTIVE COMPARATOR

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

Interventions

Participants are immersed in a neighborhood environment in virtual reality

Virtual reality simulation of neighborhood affluenceVirtual reality simulation of neighborhood disadvantage

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • English speaking
  • Are able to use a dominant hand for joystick manipulation and a non- dominant hand for physiological measurements,
  • Have hair at least 1cm in length based on self-report to be able to provide a hair sample.

You may not qualify if:

  • Pregnant, by self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Daniel A. Hackman, Ph.D.
Organization
University of Southern California

Study Officials

  • Daniel A Hackman, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

July 10, 2020

Study Start

October 6, 2021

Primary Completion

April 22, 2023

Study Completion

April 22, 2023

Last Updated

June 7, 2024

Results First Posted

June 7, 2024

Record last verified: 2024-05

Locations