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

NCT06301516 | Completed Phase 1

• 2 other identifiers: HM20027823R41MH133540
• Study Type: interventional
• Target: 110
• 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 (5)

• 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

• 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

• 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

• 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

• 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

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

Study Officials

• Nicholas Thomson

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

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: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)