Virtual Reality to Improve Social Perspective Taking

NCT03927612 | Completed Results DMC FDA Device

• 1 other identifier: 1902596251
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  1 Day

• 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.

  1 Day

• 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.

  The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).

Study Arms (2)

Alternate Perspective

EXPERIMENTAL

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

Control Perspective

PLACEBO COMPARATOR

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

Device: Virtual reality control perspective

Interventions

Virtual reality perspective taking training DEVICE

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.

Alternate Perspective

Virtual reality control perspective DEVICE

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.

Control Perspective

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders; Child Behavior Disorders; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Indiana University School of Medicine

vrlab@iupui.edu

317-274-8670

Study Officials

• Tom A Hummer, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assignment will be sealed for the experimenter until immediately prior to Visit 3 (for visit preparation, experimenter must be unblinded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 25, 2019
• Study Start: January 7, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)