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Virtual Reality to Improve Social Perspective Taking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927612
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Tom Hummer, Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Conduct Disorder Child Adolescent Attention Deficit and Disruptive Behavior Disorders Child Behavior Disorders Virtual Reality Social Perception Magnetic Resonance Imaging Device: Virtual reality perspective taking training Device: Virtual reality control perspective Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This project will examine how levels of a virtual reality treatment that provides users with the alternate perspective of an interpersonal interaction impacts psychological and neurobiological markers of perspective taking. Following the initial screening visit, participants will be randomly assigned to different VR perspective conditions, stratified by sex, presence/absence of ADHD diagnosis, and ODD/CD diagnosis, via an a priori randomization chart. An equal number of youth will be randomly assigned to either the alternate perspective condition or control condition. Visits 1 and 2 will be identical for both groups. At Visit 3, the initial VR scenarios and assessments will be identical. The participant will then re-experience the VR scenarios depending on their assigned condition. Additional VR assessments and the MRI scan will be identical for both groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Assignment will be sealed for the experimenter until immediately prior to Visit 3 (for visit preparation, experimenter must be unblinded).
Primary Purpose: Treatment
Official Title: Virtual Reality to Improve Social Perspective Taking in Youth With Disruptive Behavior Disorders
Actual Study Start Date : January 7, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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.
Device: 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.

Placebo Comparator: Control Perspective
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Device: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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). ]
    Functional magnetic resonance imaging (fMRI) will measure the blood-oxygen level-dependent (BOLD) response in the dorsal anterior cingulate cortex and 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. A greater decrease in the BOLD response to Self vs. Other pain results from a stronger response to other's pain, reflecting improved perspective taking.



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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927612


Contacts
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Contact: Tom A Hummer, PhD 317-274-8670 thummer@iupui.edu

Locations
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United States, Indiana
IU Health Neuroscience Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jocelyn Brickman    317-274-8670    VRLab@iupui.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Tom A Hummer, PhD Indiana University School of Medicine
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Responsible Party: Tom Hummer, Assistant Research Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03927612    
Other Study ID Numbers: 1902596251
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tom Hummer, Indiana University:
virtual reality
perspective taking
conduct disorder
oppositional defiant disorder
functional magnetic resonance imaging
child
adolescent
Additional relevant MeSH terms:
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Disease
Mental Disorders
Problem Behavior
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Child Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Behavioral Symptoms