Conduct DisorderNCT03927612
Virtual Reality to Improve Social Perspective Taking
A study testing Virtual reality perspective taking training in people with Conduct Disorder and Child, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Conduct Disorder, Child, Adolescent
- What is being tested?
- Virtual reality perspective taking training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
About this study
Official title: Virtual Reality to Improve Social Perspective Taking in Youth With Disruptive Behavior Disorders
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.
Read the 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.
- Conditions
- Conduct Disorder, Child, Adolescent, Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Virtual Reality
- Being tested
- Virtual reality perspective taking training, Virtual reality control perspective
- Keywords
- virtual reality, perspective taking, conduct disorder, oppositional defiant disorder, functional magnetic resonance imaging, child, adolescent
- Medical subject headings
- Conduct Disorder, Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality perspective taking trainingDevice
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 perspectiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Alternate Perspective | Experimental | After experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system. Receives: 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. Receives: Device: Virtual reality control perspective |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The fMRI scans will be administered 0-2 weeks prior to the intervention and the day of the intervention (upon completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start7 Jan 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Hummer, Indiana University
- Investigators
- Tom A Hummer, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927612
- Sponsor's protocol ID
- 1902596251
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2019
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Improve Social Perspective Taking in Youth With Disruptive Behavior Disorders
- ClinicalTrials.gov ID
- NCT03927612
- Acronym / sponsor ID
- 1902596251
- Conditions
- Conduct Disorder, Child, Adolescent, Attention Deficit and Disruptive Behavior Disorders, Child Behavior Disorders, Virtual Reality
- Keywords
- virtual reality, perspective taking, conduct disorder, oppositional defiant disorder, functional magnetic resonance imaging, child, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alternate Perspective | Experimental | Device: Virtual reality perspective taking trainingAfter experiencing VR scenarios, participants will experience the interactions again from the virtual counterpart's perspective within the VR system. |
| Control Perspective | Placebo comparator | Device: Virtual reality control perspectiveAfter experiencing VR scenarios, participants will experience the interactions again from the same perspective in the VR system. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality perspective taking trainingVirtual 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. | Device | Alternate Perspective |
| Virtual reality control perspectiveVirtual 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. | Device | Control Perspective |
Primary outcome
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.
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.
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, 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom A Hummer, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality perspective taking training in people with Conduct Disorder and Child, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-intervention on the Virtual Reality Perspective Taking Scale (time frame: 1 Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.