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Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD

Impact Virtual Reality: An Emotion Recognition and Regulation Training Program for Youth With Conduct Disorder

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06301516
Enrollment
220
Registered
2024-03-08
Start date
2024-02-16
Completion date
2024-09-26
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Callous-Unemotional Traits, Conduct Disorder, Conduct Disorders in Adolescence, Conduct Disorders in Children

Keywords

Conduct Problems

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVirtual Reality

VR: The goal of the VR intervention is to provide youth an immersive, engaging, and therapeutic environment to reduce CD and CU traits

OTHERComparative Control

Complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Aged 10-17 years old * Identified through the TriNetX database as having a conduct disorder diagnosis * English speaking

Exclusion criteria

* Youth aged \<10 years and \>18 years old * Non-English speaking * Youth of caregivers younger than 18 years old.

Design outcomes

Primary

MeasureTime frameDescription
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Callous-Unemotional Traits in Both Subjects and Caregivers (Callous-Unemotional Traits)Baseline, 1-month and 3-months post-randomizationParticipants 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.
Assess Conduct Problems Subscale From the BASC-3 Caregiver Rating Scales for Caregiver OnlyBaseline, 1-month and 3-months post-randomizationThe 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.
Assess the Preliminary Efficacy of Impact Virtual Reality (VR) in Reducing Emotion Recognition/ Youth Arm OnlyBaseline, 1-month and 3-months post-randomizationEmotion 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNicholas Thomson

Virginia Commonwealth University

Participant flow

Recruitment details

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.

Baseline characteristics

Characteristic
Age, Continuous
Age, Continous
13.91 years
STANDARD_DEVIATION 2.27
Race (NIH/OMB)
Race
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Race
Asian
0 Participants
Race (NIH/OMB)
Race
Black or African American
33 Participants
Race (NIH/OMB)
Race
More than one race
0 Participants
Race (NIH/OMB)
Race
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Race
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
Race
White
37 Participants
Sex: Female, Male
Sex: Female, Male
Female
22 Participants
Sex: Female, Male
Sex: Female, Male
Male
31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 550 / 550 / 55
other
Total, other adverse events
0 / 550 / 550 / 550 / 55
serious
Total, serious adverse events
0 / 550 / 550 / 550 / 55

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026