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Virtual Reality to Improve Social Perspective Taking

Primary Purpose

Conduct Disorder, Child, Adolescent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality perspective taking training
Virtual reality control perspective
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring virtual reality, perspective taking, conduct disorder, oppositional defiant disorder, functional magnetic resonance imaging, child, adolescent

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IU Health Neuroscience Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alternate Perspective

Control Perspective

Arm Description

After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.

After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.

Outcomes

Primary Outcome Measures

Change From Pre-intervention on the Virtual Reality Perspective Taking Scale
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.
Change From Pre-intervention on the Acknowledgement of Other Perspective Scale
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.
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2019
Last Updated
June 27, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03927612
Brief Title
Virtual Reality to Improve Social Perspective Taking
Official Title
Virtual Reality to Improve Social Perspective Taking in Youth With Disruptive Behavior Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Child, Adolescent, Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Virtual Reality, Social Perception, Magnetic Resonance Imaging
Keywords
virtual reality, perspective taking, conduct disorder, oppositional defiant disorder, functional magnetic resonance imaging, child, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Assignment will be sealed for the experimenter until immediately prior to Visit 3 (for visit preparation, experimenter must be unblinded).
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternate Perspective
Arm Type
Experimental
Arm Description
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
Arm Title
Control Perspective
Arm Type
Placebo Comparator
Arm Description
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
Intervention Type
Device
Intervention Name(s)
Virtual reality perspective taking training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality control perspective
Intervention Description
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 Measure Information:
Title
Change From Pre-intervention on the Virtual Reality Perspective Taking Scale
Description
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.
Time Frame
1 Day
Title
Change From Pre-intervention on the Acknowledgement of Other Perspective Scale
Description
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.
Time Frame
1 Day
Title
Change From Pre-intervention in Brain Activity in Response to Self Pain vs. Other Pain
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom A Hummer, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality to Improve Social Perspective Taking

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