Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2020-01-07
2022-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)
NCT05391698
Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy
NCT07201090
How Virtual Reality Can Help Neurodivergent Children Improve Their Attention
NCT07341204
Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems
NCT06559813
Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder
NCT05778526
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alternate Perspective
After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system.
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.
Control Perspective
After experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
9 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tom Hummer
Assistant Research Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tom A Hummer, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IU Health Neuroscience Center
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1902596251
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.