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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD099596-01 | U.S. NIH Grant/Contract | View source | |
| UP-19-00205 | Other Identifier | University of Southern California |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Other | Participants are immersed in a neighborhood environment in virtual reality |
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| Measure | Description | Time Frame |
|---|---|---|
| Emotional Response | Multiple measures were used for emotion felt in the VR neighborhood:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Hackman, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California / USC Suzanne Dworak-Peck School of Social Work | Los Angeles | California | 90089 | United States |
While 107 participants were enrolled, eight withdrew after enrollment but prior to randomization to condition, without attending the single study session. Thus while enrollment was 107 the total started in the protocol flow was 99.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality |
| FG001 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Emotional Response | Multiple measures were used for emotion felt in the VR neighborhood:
| Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality presentation that lead to invalid data. One participant did not complete the measure of happy/unhappy | Posted | Mean | Standard Deviation | units on a scale | Immediately after the virtual reality task (average of 28 minutes post baseline) |
Adverse event data were collected during the single study session included in the study (up to 4-5 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel A. Hackman, Ph.D. | University of Southern California | (213) 821-3112 | dhackman@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2024 | Apr 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2024 | Apr 5, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2024 | Apr 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
| BG001 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Parental Education | Highest level of education attained by a parent/caregiver | Count of Participants | Participants |
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| Neighborhood Poverty Rate | For each participant, this represents the percentage of families with incomes below the poverty line in the U.S. census tract (neighborhood) that the participant resides within. Based on American Communities Survey five- year estimates from 2015-2019. | One address could not be accurately geocoded and assigned a U.S. census tract, leading to one fewer participant for this baseline measure | Mean | Standard Deviation | % below poverty in neighborhood |
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| 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 | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. Sixteen participants (7 in virtual affluent condition, 9 in virtual disadvantaged condition) were removed due potential contamination between saliva samples across time in the study session. | Posted | Mean | Standard Deviation | µg/dL | 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 |
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| Primary | Blood Pressure | Systolic (SBP) and diastolic (DBP) blood pressure, in mmHG, measured and summarized across epochs in the study session. | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant did not have blood pressure recordings and for one technical problems led to data not being recorded. | Posted | Mean | Standard Deviation | mmHG | 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 |
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| 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. | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and another had minimal signal recorded across data collection. | Posted | Mean | Standard Deviation | ms-squared | 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 |
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| 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. | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection. | Posted | Mean | Standard Deviation | L/min | 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 |
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| 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. | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection. | Posted | Mean | Standard Deviation | mmHg*min/L | 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 |
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| 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. | Two participants (one from each arm) were excluded from analyses due to major technical problems / glitches in virtual reality that lead to invalid data. One participant had technical problems led to data not being recorded, and four had minimal or low quality signal recorded across data collection. | Posted | Mean | Standard Deviation | ms | 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 |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 complete questionnaires and watch a video again during a recovery period. Virtual reality: Participants are immersed in a neighborhood environment in virtual reality | 0 | 49 | 0 | 49 | 0 | 49 |
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| Bachelor's Degree |
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| Master's Degree |
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| Doctoral Degree or Equivalent |
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| Questionnaire completion |
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| Video, After 15 minutes |
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| Video, After 30 minutes |
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| SBP, Questionnaires (mean, in mmHg) |
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| SBP, Video, First 15 Minutes (mean, in mmHg) |
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| SBP, Video, Second, 15 Minutes (mean, in mmHg) |
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| DBP, Baseline (mean, in mmHg) |
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| DBP, VR neighborhood (mean, in mmHg) |
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| DBP, Questionnaires (mean, in mmHg) |
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| DBP, Video, First 15 Minutes (mean, in mmHg) |
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| DBP, Video, Second 15 Minutes (mean, in mmHg) |
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| RSA, Questionnaires (Mean) |
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| RSA, Video, First 15 Minutes (Mean) |
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| RSA, Video, Second 15 Minutes (Mean) |
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| CO, Questionnaires (mean) |
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| CO, Video, First 15 Minutes (mean) |
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| CO, Video, Second 15 Minutes (mean) |
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| TPR, Questionnaires (mean) |
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| TPR, Video, First 15 Minutes (mean) |
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| TPR, Video, Second 15 Minutes (mean) |
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| PEP, Questionnaires (mean) |
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| PEP, Video, First 15 Minutes (mean) |
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| PEP, Video, Second 15 Minutes (mean) |
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