Clinical trial NCT06301516: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD
Official title: Impact Virtual Reality: An Emotion Recognition and Regulation Training Program for Youth With Conduct Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Conduct Disorder
Conduct Disorders in Children
Conduct Disorders in Adolescence
Callous-Unemotional Traits
Keywords: Conduct Problems
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-03-08
Enrollment: 110
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits
timeFrame: Baseline, 1-month and 3-months post-randomization
measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder
timeFrame: Baseline, 1-month and 3-months post-randomization
measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems
timeFrame: Baseline, 1-month and 3-months post-randomization
measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation
timeFrame: Baseline, 1-month and 3-months post-randomization
measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition
timeFrame: Baseline, 1-month and 3-months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nicholas Thomson
role: PRINCIPAL_INVESTIGATOR
References: