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Completed

NCT Number: NCT05022550

Virtual-reality and Emotion Regulation in Violence-Exposed Youth

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.

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Key information

Conditions

Emotional Regulation Adolescent Behavior Behavior Self-Control Social Behavior

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

DEEP VR

Device

DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt.

Primary outcomes

  1. Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey

    Time frame: up to 8 weeks

    Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".

Secondary outcomes

  1. Mean Change in Difficulty in Emotion Regulation Scale (DERS)

    Time frame: 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.

    The DERS is a 36-item child-report survey measuring difficulties with emotion regulation. Respondents report the degree to which the given statement applied to them on a five point Likert scale: 1 = Almost Never to 5 = Always, with a possible total score range of 36 - 180. Higher scores indicate greater difficulties with emotion regulation.

  2. Physiological Arousal Measured by Change in Heart Rate

    Time frame: 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

    Participants will have electrodes affixed to their abdomen to measure heart rate. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions.

  3. Physiological Arousal Measured by Change in Galvanic Skin Response

    Time frame: 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

    Participants will have electrodes affixed to their fingers to measure skin response. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions.

  4. Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale

    Time frame: 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.

    The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Positive sub-scale is the sum of positive items in the VR-B engagement survey (total range of scores from 4-28). Positive change scores indicate that the VR experience got more positive over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline).

  5. Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale

    Time frame: 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.

    The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Negative sub-scale is the sum of negative items in the VR-B engagement survey (total possible range of scores from 4-28). Positive change scores indicate that the VR experience got less negative over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline).

  6. Mean Change in Child PTSD Symptom Scale (CPSS)

    Time frame: 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.

    Assesses lifetime trauma experiences and severity of PTSD symptom severity in a 20-item survey scored on a 5-point likert scale from 0 'not at all' to 4 'almost always' for a total range of scores between 0 - 80, where higher scores indicate increased PTSD symptoms.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Explore DEEP Inc
  • Radboud University Medical Center
  • University of Toronto

Registry information

Acronym: VERVE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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