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

Conduct Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301516
• Other study ID #: HM20027823
• Secondary ID: R41MH133540
• Status: Recruiting
• Phase: Phase 1
• Start date: February 16, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: Nicholas Thomson
• Phone: (804) 297-5740
• Email: nicholas.thomson[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conduct Disorder
• Conduct Disorders in Adolescence
• Conduct Disorders in Children

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits	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
Primary	Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder	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
Primary	Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems	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
Primary	Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation	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
Primary	Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition	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