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

February 10, 2025 updated by: Virginia Commonwealth University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Impact VR
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
VR: The goal of the VR intervention is to provide youth an immersive, engaging, and therapeutic environment to reduce CD and CU traits
Other: Comparative Control
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
Complete a one-time PowerPoint presentation that provides an overview of emotion expressions and instructions on how to recognize emotions in others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits
Time Frame: Baseline, 1-month and 3-months post-randomization
Participants enrolled into Impact VR will be complete the first of four sessions. The four 20-minute Callous-unemotional traits will be measured using the 24-item Inventory of Callous-Unemotional Traits. Both the parent and youth reports will be completed. 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.
Baseline, 1-month and 3-months post-randomization
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder
Time Frame: Baseline, 1-month and 3-months post-randomization
Conduct disorder symptoms will be measured using the Kiddie Schedule for Affective Disorders and Schizophrenia, which is a semi-structured interview administered to the caregiver and child.
Baseline, 1-month and 3-months post-randomization
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems
Time Frame: Baseline, 1-month and 3-months post-randomization
Conduct problems will be assessed using parent and child reports on the Behavior Assessment System for Children, 3rd edition (BASC-3)
Baseline, 1-month and 3-months post-randomization
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation
Time Frame: Baseline, 1-month and 3-months post-randomization
Emotion Regulation will be assessed using parent and child reports on the Behavior Assessment System for Children, 3rd edition (BASC-3).
Baseline, 1-month and 3-months post-randomization
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition
Time Frame: Baseline, 1-month and 3-months post-randomization
Emotion recognition will be measured using the Penn Emotion Recognition Test, which is a computer-based task completed by the youth
Baseline, 1-month and 3-months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Nicholas Thomson, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Actual)

September 26, 2024

Study Completion (Actual)

September 26, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20027823
  • R41MH133540 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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