- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927612
Virtual Reality to Improve Social Perspective Taking
Virtual Reality to Improve Social Perspective Taking in Youth With Disruptive Behavior Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Oppositional defiant disorder (ODD) and conduct disorder (CD), collectively known as disruptive behavior disorders (DBDs), involve persistent physical or verbal confrontations, antisocial behavior, and emotional outbursts. Despite a range of biological and environmental risk factors for DBD, social-cognitive impairments are a common link, and improving these deficits should be beneficial for all patients with DBD.
Children and adolescents with DBD have deficits in social perspective taking that contribute significantly to these behavior problems. Perspective taking is the ability to perceive the world from another person's point of view, including making inferences about the capabilities, feelings, and expectations of others. Perspective taking requires substantial motivation and cognitive resources and can be difficult to achieve, particularly for children. A failure to understand or value another person's perspective inhibits helping behavior without clear direct benefits. Perspective taking skills are related to empathic concern, which encompasses feelings of sympathy and concern for unfortunate others, and theory of mind, the ability to accurately infer others' mental states, such as intentions. Negative attribution biases are more likely in individuals with poor theory of mind. Thus, improving children's perspective-taking skills should allow them to better understand a counterpart's thinking and intentions, increasing empathic concern, and reducing hostile attribution biases-and therefore improving the likelihood that prosocial behavior occurs.
In the brain, perspective taking engages circuitry underlying empathic concern and theory of mind. In fMRI studies, imagining pain to the self or other, often in conjunction with images depicting painful scenarios, engages the brain's salience network. Dorsal ACC and bilateral anterior insula, the regions most commonly activated in response to other's pain, also show strong responses to self-perspective pain. However, in youth with DBD, there is a decreased response to other-perspective pain in dACC and anterior insula, despite no change or a heightened response to self-perspective pain.
Software interventions have shown some promise to improve perspective taking. In particular, VR has exciting therapeutic potential to address perspective-taking deficits because it provides naturalistic yet controlled environments in which users can experience interactions from multiple viewpoints. VR interventions typically provide better generalization to real-world behavioral changes compared to traditional methods. VR has an advantage over traditional interventions because it provides an embodied experience that is a middle ground between therapy room settings and the real world (e.g., school, home) where problematic behaviors occur.
In this investigation, the investigators will build upon a current VR design using an Oculus Quest virtual reality headset. After experiencing virtual interpersonal conflicts in a school cafeteria setting, participants will re-experience scenarios in one of two manners: an enriched perspective from the virtual counterpart's point-of-view, with internal dialogue and background information; or a control perspective, which replays the original point-of-view. During this proof-of-concept phase, the primary target is social perspective taking. The investigators will assess functional engagement of this target by quantifying (1) the ability to recognize and understand the virtual counterpart's perspective; and (2) the neural response (in pain circuitry) to pain experienced by the virtual counterpart, a common marker for perspective taking that is abnormal in DBD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health Neuroscience Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 9-12
- English-speaking
- Meet DSM-5 criteria for oppositional defiant disorder (ODD), conduct disorder (CD), or Other Specified or Unspecified Disruptive, Impulse-Control, and Conduct Disorder
- Right-handed
- Estimated full-scale IQ greater than 70
Exclusion Criteria:
- Bipolar disorder, any disorder involving psychosis, pervasive developmental disorders, current or past substance use disorder, or current major depressive disorder
- History of neurological problems (e.g., epilepsy, traumatic brain injury)
- Contraindications for MRI
- Sibling who has participated in this study
- Experience negative side effects during use of virtual reality (e.g., VR sickness)
- In opinion of investigator, cannot complete study procedures or is inappropriate for study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alternate Perspective
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
|
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.
|
Placebo Comparator: Control Perspective
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Pre-intervention on the Virtual Reality Perspective Taking Scale
Time Frame: 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.
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1 Day
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Change From Pre-intervention on the Acknowledgement of Other Perspective Scale
Time Frame: 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.
|
1 Day
|
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
Time Frame: The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).
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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.
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The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tom A Hummer, PhD, Indiana University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1902596251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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