Clinical trial NCT05022550: Virtual-reality and Emotion Regulation in Violence-Exposed Youth
Official title: Virtual-reality and Emotion Regulation in Violence-Exposed Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Adolescent Behavior
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Radboud University Medical Center
name: Explore DEEP Inc
First posted: 2021-08-26
Enrollment: 74
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* AIM 1: Evaluate the feasibility of a virtual reality treatment for youth

  * 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.
* AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions

  * 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).
* AIM 3: Identify potential changes in symptom severity across treatment sessions

  * Hypothesis 3: Youth receiving virtual reality biofeedback (VRB) treatment will show greater improvements in youth emotion regulation and reduced severity of PTSD mental health symptoms.

Eligibility criteria: Inclusion Criteria:

1. 13 to 17 years of age at enrollment
2. Availability of a caregiver to provide oral consent
3. Able to provide assent/consent in English
4. Visual acuity adequate to read text on a computer monitor

Exclusion Criteria:

1. Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media
2. Active psychosis or comparably impairing psychiatric condition

Primary outcomes:
measure: Feasibility: Number of Participants who Enjoyed VR simulation experience: Determined via Qualitative Survey
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Mean Change in Difficulty in Emotion Regulation Scale (DERS)
timeFrame: Baseline and after each session completed for up to 6 study visits, up to 4 weeks
measure: Physiological Arousal Measured by Change in Heart Rate
timeFrame: 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)
measure: Physiological Arousal Measured by Change in Galvanic Skin Response
timeFrame: 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)
measure: Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B)
timeFrame: Baseline and up to 4 weeks
measure: Mean Change in Child PTSD Symptom Scale (CPSS)
timeFrame: Baseline and after each session completed for up to 6 study visits, up to 4 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan J Herringa, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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