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临床试验/NCT06301516
NCT06301516已完成1 期

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

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年2月16日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
220
试验地点
2
主要终点
Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 10-17 years old
  • Identified through the TriNetX database as having a conduct disorder diagnosis
  • English speaking

排除标准

  • Youth aged <10 years and >18 years old
  • Non-English speaking
  • Youth of caregivers younger than 18 years old.

研究组 & 干预措施

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

干预措施: Virtual Reality (Behavioral)

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

干预措施: Comparative Control (Other)

结局指标

主要结局

Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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