Virtual-reality and Emotion Regulation in Violence-Exposed Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Feasibility: Number of Participants who Enjoyed VR simulation experience: Determined via Qualitative Survey
研究概览
简要总结
The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.
详细描述
The goal of this proposal is to determine the feasibility of a novel virtual-reality-based biofeedback (VR-B) treatment among youth highly vulnerable to difficulties in emotional regulation. Biofeedback, which involves the provision of real-time information about physiology, is a well-studied approach to enhancing self-regulatory ability, with potential promise for alleviating mental health problems. In children (as well as adults), biofeedback may be ideally facilitated through video game environments, which offer engaging, immersive, yet dynamic environments that can be changed in real-time. Video games are enormously popular with youth, and may represent an important avenue for treatment in adolescent populations. The current proposal aims to evaluate a novel virtual-reality-based video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. Exposure to risk factors known to promote impaired self-regulation, such as child mal-treatment, is nearly endemic in this population. Indeed, 'delinquent' youth (i.e., youth in contact with the justice system) are considerably more likely to meet diagnostic criteria for a range of disorders centrally involving dysregulation of affect or arousal, such as post-traumatic stress disorder, anxiety, depression, oppositional defiant disorder, and many others.
Specific Aims:
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AIM 1: Evaluate the feasibility of a virtual reality treatment for youth
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Hypothesis 1: Study youth receiving treatment with the virtual reality-based paradigm will qualitatively report the experience to be tolerable and positive with minimal discomfort.
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AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions
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Hypothesis 2: Youth receiving virtual reality biofeedback (VRB) treatment will exhibit physiological changes across sessions (e.g., increased heart rate variability or changes in skin conductance responses).
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AIM 3: Identify potential changes in symptom severity across treatment sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 to 17 years of age at enrollment
- •Availability of a caregiver to provide oral consent
- •Able to provide assent/consent in English
- •Visual acuity adequate to read text on a computer monitor
排除标准
- •Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media
- •Active psychosis or comparably impairing psychiatric condition
研究组 & 干预措施
DEEP VR Experiment Group
Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires.
干预措施: DEEP VR (Device)
结局指标
主要结局
Feasibility: Number of Participants who Enjoyed VR simulation experience: Determined via Qualitative Survey
时间窗: up to 8 weeks
Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey
时间窗: up to 8 weeks
Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".
次要结局
- Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B)(Baseline and up to 4 weeks)
- Mean Change in Difficulty in Emotion Regulation Scale (DERS)(Baseline and after each session completed for up to 6 study visits, up to 4 weeks)
- Physiological Arousal Measured by Change in Heart Rate(Change measured throughout the 15 minute VR session at baseline and before and after each task condition, for up to 6 sessions (up to 6 weeks on study))
- Physiological Arousal Measured by Change in Galvanic Skin Response(Change measured throughout the 15 minute VR session at baseline and before and after each task condition, for up to 6 sessions (up to 6 weeks on study))
- Mean Change in Child PTSD Symptom Scale (CPSS)(Baseline and after each session completed for up to 6 study visits, up to 4 weeks)
- Mean Change in Difficulty in Emotion Regulation Scale (DERS)(Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.)
- Physiological Arousal Measured by Change in Heart Rate(Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period)
- Physiological Arousal Measured by Change in Galvanic Skin Response(Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period)
- Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale(Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.)
- Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale(Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.)
- Mean Change in Child PTSD Symptom Scale (CPSS)(Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.)