Trial Outcomes & Findings for Virtual Reality to Improve Social Perspective Taking (NCT NCT03927612)
NCT ID: NCT03927612
Last Updated: 2023-06-28
Results Overview
This scale provides a 0-100 score that indicates the degree to which participants understand the perspective of their virtual counterpart, derived from the Perspective Taking subscale of the Interpersonal Reactivity Index. A higher change score indicate greater improvement in perspective taking in the virtual environment. The scale will be completed twice on the same day, before and after the intervention.
COMPLETED
NA
90 participants
1 Day
2023-06-28
Participant Flow
Families underwent clinical interview to establish child's psychiatric diagnoses (required disruptive behavior disorder without autism spectrum disorder or current depression for assignment to group). Participants also underwent baseline surveys, practice VR (also used to assess presence of VR sickness for exclusion criteria), and baseline MRI scan. Enrolled participants were not randomized if they did not meet inclusion criteria or discontinued participation prior to the intervention visit.
Participant milestones
| Measure |
Alternate Perspective
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Virtual reality perspective taking training: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
|
Control Perspective
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Virtual reality control perspective: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
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|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality to Improve Social Perspective Taking
Baseline characteristics by cohort
| Measure |
Alternate Perspective
n=23 Participants
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Virtual reality perspective taking training: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
|
Control Perspective
n=22 Participants
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Virtual reality control perspective: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.87 years
STANDARD_DEVIATION 1.00 • n=5 Participants
|
11.16 years
STANDARD_DEVIATION 1.03 • n=7 Participants
|
11.01 years
STANDARD_DEVIATION 1.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Children aged 9-12 with a disruptive behavior disorder
This scale provides a 0-100 score that indicates the degree to which participants understand the perspective of their virtual counterpart, derived from the Perspective Taking subscale of the Interpersonal Reactivity Index. A higher change score indicate greater improvement in perspective taking in the virtual environment. The scale will be completed twice on the same day, before and after the intervention.
Outcome measures
| Measure |
Alternate Perspective
n=23 Participants
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Virtual reality perspective taking training: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
|
Control Perspective
n=22 Participants
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Virtual reality control perspective: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
|
|---|---|---|
|
Change From Pre-intervention on the Virtual Reality Perspective Taking Scale
|
16.3 Score on a scale
Standard Deviation 27.9
|
-10.4 Score on a scale
Standard Deviation 26.3
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Children aged 9-12 with a disruptive behavior disorder
This scale allows participants to rate the relative importance of the virtual counterpart's perspective, on a 0-100 scale, with a scenario-specific question. A higher change score indicates greater improvement in acknowledging the virtual counterpart's perspective. The scale will be completed twice on the same day, before and after the intervention.
Outcome measures
| Measure |
Alternate Perspective
n=23 Participants
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Virtual reality perspective taking training: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
|
Control Perspective
n=22 Participants
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Virtual reality control perspective: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
|
|---|---|---|
|
Change From Pre-intervention on the Acknowledgement of Other Perspective Scale
|
2.0 score on a scale
Standard Deviation 27.1
|
-1.4 score on a scale
Standard Deviation 18.5
|
PRIMARY outcome
Timeframe: The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).Population: Children aged 9-12 with a disruptive behavior disorder
Functional magnetic resonance imaging (fMRI) will measure the blood-oxygen level-dependent (BOLD) response in the dorsal anterior cingulate cortex, left anterior insula, and right anterior insula while imagining pain happening to oneself or the virtual counterpart. Perspective taking and empathy are reflected by a similar BOLD response to self and other pain. This score reflects the change from baseline in the Self Pain - Other Pain contrast in each region. A lower score to Self vs. Other pain results from a stronger response to other's pain, reflecting improved perspective taking. Therefore, lower values reflect a stronger neural response to other's pain, compared to the baseline visit.
Outcome measures
| Measure |
Alternate Perspective
n=20 Participants
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Virtual reality perspective taking training: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
|
Control Perspective
n=18 Participants
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Virtual reality control perspective: Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
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|---|---|---|
|
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
Left Anterior Insula Change
|
0.089 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.19
|
-0.070 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.25
|
|
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
Right Anterior Insula Change
|
0.078 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.22
|
-0.128 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.30
|
|
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
Dorsal Anterior Cingulate Cortex Change
|
0.10 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.27
|
-0.080 BOLD signal change (Self vs. Other Pain)
Standard Deviation 0.34
|
Adverse Events
Alternate Perspective
Control Perspective
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Specialist
Indiana University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place