Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R41MH133540 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Impact VR | Experimental | 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 |
|
| Comparative Control | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Behavioral | VR: The goal of the VR intervention is to provide youth an immersive, engaging, and therapeutic environment to reduce CD and CU traits |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Thomson | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Youth | 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. 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. |
| FG001 | Experimental Caregiver | 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. 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. |
| FG002 | Comparative Control Youth | 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. 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. |
| FG003 | Comparative Caregiver | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Youth | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only the minor participant demographic data was collected and will be reported. 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. Overall 110 youth: 55 experimental youth, and 55 comparative control youth. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver. | Posted | Mean | Standard Deviation | score on a scale (ICU questionnaire) | Baseline, 1-month and 3-months post-randomization |
Baseline to 3 months post-randomization
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Youth | 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. Both the Experimental and comparative control arms will be reported as an aggregate for the demographic sections. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Nicholas Thomson | Virginia Commonwealth University | (804) 828-6386 | nicholas.thomson@vcuhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2023 | Dec 12, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2025 | Oct 29, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D019955 | Conduct Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Randomized clinical trial of psychological intervention. Once all assessments are completed, the treatment group allocation will be disclosed to the administrating researcher, youth, and caregiver. This blinded approach to block randomization prevents any bias from occurring during the assessment phase by the researcher.
Not provided
Not provided
Not provided
Not provided
| Comparative Control | Other | Complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others. |
|
| Baseline, 1-month and 3-months post-randomization |
| BG001 | Comparative Control Youth | 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. 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. |
| BG002 | Caregivers Aggregate Demographic (Experimental and Control Caregivers) | Caregiver baseline data was not collected. The focus was on the youth arms. |
| BG003 | Total | Total of all reporting groups |
Overall 110 youth: 55 experimental youth, and 55 comparative control youth |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver. | Only the minor participant demographic data was collected and will be reported. For the outcome sessions, each youth arm enrolled 55 subjects, and each caregiver arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers: 55 experimental youth, 55 comparative control youth, 55 experimental caregivers, and 55 comparative control caregiver. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Experimental Youth | 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. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm. |
| OG001 | Experimental Caregiver | 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. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm. |
| OG002 | Comparative Control Youth | 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. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm. |
| OG003 | Comparative Control Caregiver | 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. For the sessions each youth arm enrolled 55 subjects and each arm enrolled 55 caregivers. Overall 110 youth and 110 caregivers, evenly divided by arm. |
|
|
| Primary | 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. | Each of the two caregiver arms enrolled 55 caregivers. Overall 110 caregivers: 55 experimental caregivers, and 55 comparative control caregiver. | Posted | Mean | Standard Deviation | score on a questionnaire (BASC-3) | Baseline, 1-month and 3-months post-randomization |
|
|
|
| Primary | 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. | For the outcome sessions, each youth arm enrolled 55 subjects. Overall 110 youth: 55 experimental youth, 55 comparative control youth. | Posted | Mean | Standard Deviation | percentage of correct responses (ER-40) | Baseline, 1-month and 3-months post-randomization |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Experimental Caregiver | 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. Both the Experimental and comparative control arms will be reported as an aggregate for the demographic sections. 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG002 | Comparative Control Youth | 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. Both the Experimental and comparative control arms will be reported as an aggregate for the demographic sections. 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG003 | Comparative Control Caregiver | 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. Both the Experimental and comparative control arms will be reported as an aggregate for the demographic sections. 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. | 0 | 55 | 0 | 55 | 0 | 55 |
Not provided
Not provided
Not provided
| 3 month post-randomization |
|
| 3 months post-randomization |
|