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

Phase 1

Completed

• Conditions: Conduct Disorders in Children; Conduct Disorder; Callous-Unemotional Traits; Conduct Disorders in Adolescence
• Interventions: Other: Comparative Control; Behavioral: Virtual Reality

• Registration Number: NCT06301516
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2024-02-16
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-03-03
• Study First Posted: 2024-03-08
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparative Control	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
Experimental: Impact VR	Virtual Reality	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

Primary Outcome Measures

Name	Time	Method
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits	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.
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation	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).
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems	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)
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition	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
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States