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

NCT06301516 | Completed Phase 1 Results

• 2 other identifiers: HM20027823R41MH133540
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Conduct Problems

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, 1-month and 3-months post-randomization

Study Arms (2)

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

Behavioral: Virtual Reality

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

Other: Comparative Control

Interventions

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

Experimental: Impact VR

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.

Comparative Control

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr, Nicholas Thomson
• Organization: Virginia Commonwealth University

nicholas.thomson@vcuhealth.org

(804) 828-6386

Study Officials

• Nicholas Thomson

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 8, 2024
• Study Start: February 16, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)