Adults 9 to 12, any sex, with Conduct Disorder or Child. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Pre-intervention on the Virtual Reality Perspective Taking ScalePrimary· 1 Day
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.
Group
Value
95% CI
Alternate Perspective
16.3
± 27.9
Control Perspective
-10.4
± 26.3
Change From Pre-intervention on the Acknowledgement of Other Perspective ScalePrimary· 1 Day
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.
Group
Value
95% CI
Alternate Perspective
2.0
± 27.1
Control Perspective
-1.4
± 18.5
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other PainPrimary· The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).
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,
Left Anterior Insula Change
Group
Value
95% CI
Alternate Perspective
0.089
± 0.19
Control Perspective
-0.070
± 0.25
Right Anterior Insula Change
Group
Value
95% CI
Alternate Perspective
0.078
± 0.22
Control Perspective
-0.128
± 0.30
Dorsal Anterior Cingulate Cortex Change
Group
Value
95% CI
Alternate Perspective
0.10
± 0.27
Control Perspective
-0.080
± 0.34
Sponsor's own description
This project will examine how virtual reality treatment that provides users with the alternate perspective of a virtual interpersonal interaction impacts psychological and neurobiological markers of social perspective taking in children with a disruptive behavior disorder. The investigators anticipate that experiencing a virtual encounter from a counterpart's point-of-view improves a child's perspective taking and alters brain function related to imagining another person's pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 28 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03927612.