An interventional study of Virtual reality perspective taking training and Virtual reality control perspective in Conduct Disorder, Child and Adolescent, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
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.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's enrollment of 90 is below the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
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.
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.
Time frame: 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.
Time frame: 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.
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).
| Milestone | Alternate Perspective | Control Perspective |
|---|---|---|
| Started | 24 | 24 |
| Completed | 24 | 24 |
| Not completed | 0 | 0 |
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.
| Score on a scale | Alternate Perspective | Control Perspective |
|---|---|---|
| Change From Pre-intervention on the Virtual Reality Perspective Taking Scale | 16.3 ± 27.9 | -10.4 ± 26.3 |
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.
| score on a scale | Alternate Perspective | Control Perspective |
|---|---|---|
| Change From Pre-intervention on the Acknowledgement of Other Perspective Scale | 2.0 ± 27.1 | -1.4 ± 18.5 |
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.
| BOLD signal change (Self vs. Other Pain) | Alternate Perspective | Control Perspective |
|---|---|---|
| Left Anterior Insula Change | 0.089 ± 0.19 | -0.070 ± 0.25 |
| Right Anterior Insula Change | 0.078 ± 0.22 | -0.128 ± 0.30 |
| Dorsal Anterior Cingulate Cortex Change | 0.10 ± 0.27 | -0.080 ± 0.34 |
Collected over 1 Day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alternate Perspective | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Control Perspective | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
While all participants completed the study, data from one participant in the Alternate Perspective arm was not included in analysis due to inability to follow instructions and two participants in the Control Perspective were not included (one failure to follow instructions; one equipment malfunction).
| Age, Categorical(Participants) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| <=18 years | 23 | 22 | 45 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| Mean | 10.87 ± 1.00 | 11.16 ± 1.03 | 11.01 ± 1.01 |
| Sex: Female, Male(Participants) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| Female | 8 | 10 | 18 |
| Male | 15 | 12 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 20 | 20 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 18 | 16 | 34 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Alternate Perspective | Control Perspective | Total |
|---|---|---|---|
| United States | 23 | 22 | 45 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2020 to primary completion in Mar 2022, 26 months.
Results were first posted in Jun 2023, 1 year 2 months after primary completion.
Of 29 interventional studies with no phase under Conduct Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 26 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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