A Phase 1 interventional study of Virtual Reality and Comparative Control in Conduct Disorder, Conduct Disorders in Children and Conduct Disorders in Adolescence, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Virginia Commonwealth University · Phase 1, Interventional, and Prevention
Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.
Within the CD diagnosis, a subset of youth (12-46%) display callous-unemotional (CU) traits (termed "limited prosocial emotions"). CU traits denote additional symptoms including a lack of remorse/guilt, a callous lack of empathy, shallow affect, and/or lack of concern about performance. Although both CD and CU traits are inextricably linked to poor outcomes for youth, there remains a scarcity of targeted interventions for CD and CU traits. One of the most significant challenges for treatment is that youth with CD are often perceived by providers as treatment-resistant and treatment disrupters. This leads to poor treatment retention and further isolation from treatment opportunities. Further, existing interventions that target antisocial behaviors more generally are costly because they require 24/7 behavioral management therapies. Impact VR is a psychoeducational intervention for improving emotion recognition and regulation, using immersive gameplay and storylines that are relevant to youth. Impact VR uses evidence-based cognitive and dialectical behavioral approaches to improve emotion regulation. At the center of Impact VR is an individualized training program that teaches youth to effectively identify emotional expressions in others.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's enrollment of 220 is above the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school or a mutual private meeting place
Behavioral: Virtual Reality
Participants enrolled into the comparative control group will complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others
Other: Comparative Control
VR: The goal of the VR intervention is to provide youth an immersive, engaging, and therapeutic environment to reduce CD and CU traits
Complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others.
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits)
Participants enrolled in Impact VR will complete the first of four sessions. The Inventory of Callous-Unemotional Traits (ICU) is a 24-item questionnaire used to assess traits like lack of empathy, uncaring behavior, and restricted emotions in youth. Rated on a 4-point Likert scale (0=not at all true to 3=definitely true), it is scored by summing all items, with higher scores indicating greater CU traits. Sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school, or a mutual private meeting place. A reduction in the score indicates improvement. Both youth and caregiver subjects were assessed.
Time frame: Baseline, 1-month and 3-months post-randomization
Assess Conduct Problems Subscale From the BASC-3 Caregiver Rating Scales for Caregiver Only
The Conduct Problems subscale from the BASC-3 Caregiver Rating Scales was used to assess caregiver-reported externalizing behavior. This includes items rated on a 4-point Likert scale from 0 (Never) to 3 (Almost Always). The scale measures disruptive behaviors commonly associated with conduct problems, including defiance, rule-breaking, and aggression (e.g., "Breaks the rules," "Lies or cheats"). Improvement is indicated in a reduction in the overall score. A "good" or healthy score generally falls in the average range, indicating that behavioral, emotional, and adaptive functioning are within normal limits. Only caregiver subjects were assessed. T-scores (Mean = 50 , SD = 10) are generated, usually via Q-global® Web-based Administration.
Time frame: Baseline, 1-month and 3-months post-randomization
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Emotion Recognition/ Youth Arm Only
Emotion recognition will be measured using the Penn Emotion Recognition Test, which is a computer-based task completed by the youth only. The Penn Emotion Recognition Test (specifically the ER-40) is a computerized neuropsychological tool used to measure an individual's ability to identify and differentiate facial expressions. Participants are shown 40 color photographs of actors (balanced for gender, age, and ethnicity) portraying various emotions. Scoring for the Penn Emotion Recognition Test (ER-40) focuses on two primary metrics: Accuracy and Speed. Results are often further broken down by emotion type and intensity to pinpoint specific social-cognitive deficits. A higher score would indicate improvement. Only youth subjects were assessed.
Time frame: Baseline, 1-month and 3-months post-randomization
Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each arm enrolled 55 caregivers. Overall, 110 youth and 110 caregivers, evenly divided by arm.
| Milestone | Experimental Youth | Experimental Caregiver | Comparative Control Youth | Comparative Caregiver |
|---|---|---|---|---|
| Started | 55 | 55 | 55 | 55 |
| Completed | 55 | 55 | 55 | 55 |
| Not completed | 0 | 0 | 0 | 0 |
Participants enrolled in Impact VR will complete the first of four sessions. The Inventory of Callous-Unemotional Traits (ICU) is a 24-item questionnaire used to assess traits like lack of empathy, uncaring behavior, and restricted emotions in youth. Rated on a 4-point Likert scale (0=not at all true to 3=definitely true), it is scored by summing all items, with higher scores indicating greater CU traits. Sessions will be completed over 4 weeks (one session per week) either in the lab, at the participant's home, school, or a mutual private meeting place. A reduction in the score indicates improvement. Both youth and caregiver subjects were assessed.
| score on a scale (ICU questionnaire) | Experimental Youth | Experimental Caregiver | Comparative Control Youth | Comparative Control Caregiver |
|---|---|---|---|---|
| Baseline | 25.96 ± 9.28 | 28.06 ± 11.73 | 25.01 ± 9.36 | 27.22 ± 12.62 |
| 1 Month post-randomization | 24.23 ± 8.62 | 20.30 ± 9.72 | 24.85 ± 9.59 | 26.90 ± 12.22 |
| 3 month post-randomization | 18.52 ± 8.52 | 20.98 ± 11.11 | 25.07 ± 10.33 | 28.28 ± 12.87 |
The Conduct Problems subscale from the BASC-3 Caregiver Rating Scales was used to assess caregiver-reported externalizing behavior. This includes items rated on a 4-point Likert scale from 0 (Never) to 3 (Almost Always). The scale measures disruptive behaviors commonly associated with conduct problems, including defiance, rule-breaking, and aggression (e.g., "Breaks the rules," "Lies or cheats"). Improvement is indicated in a reduction in the overall score. A "good" or healthy score generally falls in the average range, indicating that behavioral, emotional, and adaptive functioning are within normal limits. Only caregiver subjects were assessed. T-scores (Mean = 50 , SD = 10) are generated, usually via Q-global® Web-based Administration.
| score on a questionnaire (BASC-3) | Experimental Caregiver | Comparative Control Caregiver |
|---|---|---|
| Baseline | 58.89 ± 15.71 | 54.85 ± 14.52 |
| 1 month post-randomization | 58.93 ± 8.00 | 55.67 ± 13.67 |
| 3 month post-randomization | 47.93 ± 7.25 | 55.66 ± 13.06 |
Emotion recognition will be measured using the Penn Emotion Recognition Test, which is a computer-based task completed by the youth only. The Penn Emotion Recognition Test (specifically the ER-40) is a computerized neuropsychological tool used to measure an individual's ability to identify and differentiate facial expressions. Participants are shown 40 color photographs of actors (balanced for gender, age, and ethnicity) portraying various emotions. Scoring for the Penn Emotion Recognition Test (ER-40) focuses on two primary metrics: Accuracy and Speed. Results are often further broken down by emotion type and intensity to pinpoint specific social-cognitive deficits. A higher score would indicate improvement. Only youth subjects were assessed.
| percentage of correct responses (ER-40) | Experimental Youth | Comparative Control Youth |
|---|---|---|
| Baseline | 29.74 ± 7.52 | 29.75 ± 6.66 |
| 1 month post-randomization | 34.06 ± 5.46 | 29.41 ± 10.48 |
| 3 months post-randomization | 34.81 ± 4.66 | 28.57 ± 9.87 |
Collected over Baseline to 3 months post-randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Youth | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Experimental Caregiver | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Comparative Control Youth | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Comparative Control Caregiver | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
Only the youth participant demographic data was collected and will be reported as an aggregate. The youth participant cohort was 110 total (55 in the Experimental youth arm and 55 in the control youth arm). The caregiver arms are not included in the demographic data.
| Age, Continuous(years) | Experimental Youth | Comparative Control Youth | Caregivers Aggregate Demographic (Experimental and Control Caregivers) | Total |
|---|---|---|---|---|
| Age, Continous | 13.91 ± 2.27 | 13.69 ± 2.43 | — | 13.8 ± 2.35 |
| Sex: Female, Male(Participants) | Experimental Youth | Comparative Control Youth | Caregivers Aggregate Demographic (Experimental and Control Caregivers) | Total |
|---|---|---|---|---|
| Sex: Female, Male — Female | 22 | 24 | — | 46 |
| Sex: Female, Male — Male | 33 | 31 | — | 64 |
| Race (NIH/OMB)(Participants) | Experimental Youth | Comparative Control Youth | Caregivers Aggregate Demographic (Experimental and Control Caregivers) | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | — | 0 |
| Race — Asian | 0 | 0 | — | 0 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Race — Black or African American | 33 | 31 | — | 64 |
| Race — White | 18 | 19 | — | 37 |
| Race — More than one race | 0 | 0 | — | 0 |
| Race — Unknown or Not Reported | 4 | 5 | — | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2024 to primary completion in Sep 2024, 7 months.
Results were first posted in Jun 2026, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Commonwealth University →