An interventional study of DEEP VR in Emotional Regulation and Adolescent Behavior, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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
AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions
AIM 3: Identify potential changes in symptom severity across treatment sessions
Exclusion Criteria:
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.
Device: DEEP VR
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.
Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey
Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".
Time frame: up to 8 weeks
Mean Change in Difficulty in Emotion Regulation Scale (DERS)
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.
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.
Physiological Arousal Measured by Change in Heart Rate
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.
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
Physiological Arousal Measured by Change in Galvanic Skin Response
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.
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
Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale
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).
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.
Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale
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).
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.
Mean Change in Child PTSD Symptom Scale (CPSS)
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.
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.
| Milestone | DEEP VR Experiment Group |
|---|---|
| Started | 74 |
| 1 vr session completed | 74 |
| 2 vr sessions completed | 49 |
| 3 vr sessions completed | 34 |
| 4 vr sessions completed | 17 |
| 5 vr sessions completed | 11 |
| 6 vr sessions completed | 10 |
| Completed | 10 |
| Not completed | 64 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Youth left detention facilities prior to completing 6 sessions | 63 |
Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".
| Participants | DEEP VR Experiment Group |
|---|---|
| Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey | 47 |
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.
| score on a scale | DEEP VR Experiment Group |
|---|---|
| Baseline to session 2 | -3.03 ± 12.5 |
| Baseline to session 3 | -9.22 ± 12.6 |
| Baseline to session 4 | -5.91 ± 22.9 |
| Baseline to session 5 | 3 ± 13.1 |
| Baseline to session 6 | 3.75 ± 17.6 |
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.
| beats per millisecond | DEEP VR Experiment Group |
|---|---|
| Session 1 | 41 ± 225 |
| Session 2 | 35.3 ± 257 |
| Session 3 | 143 ± 734 |
| Session 4 | -5.85 ± 42.8 |
| Session 5 | -6.03 ± 12.6 |
| Session 6 | -2.45 ± 15.5 |
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.
| microsiemens (µS) | DEEP VR Experiment Group |
|---|---|
| Session 1 | 0.255 ± 1.95 |
| Session 2 | 0.834 ± 1.73 |
| Session 3 | 0.631 ± 1.09 |
| Session 4 | 1.500 ± 1.21 |
| Session 5 | 0.837 ± 0.526 |
| Session 6 | 0.987 ± 0.921 |
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).
| score on a scale | DEEP VR Experiment Group |
|---|---|
| Baseline to Session 2 | -1.15 ± 3.78 |
| Baseline to Session 3 | 0.968 ± 4.86 |
| Baseline to Session 4 | -1.11 ± 5.26 |
| Baseline to Session 5 | 0.636 ± 5.26 |
| Baseline to Session 6 | 1.6 ± 6.28 |
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).
| score on a scale | DEEP VR Experiment Group |
|---|---|
| Baseline to Session 2 | -0.404 ± 2.12 |
| Baseline to Session 3 | 0.812 ± 4.04 |
| Baseline to Session 4 | 0.526 ± 2.37 |
| Baseline to Session 5 | 0.636 ± 2.98 |
| Baseline to Session 6 | 1.2 ± 4.52 |
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.
| score on a scale | DEEP VR Experiment Group |
|---|---|
| Baseline to Session 2 | 0.585 ± 7.75 |
| Baseline to Session 3 | -3.26 ± 8.89 |
| Baseline to Session 4 | -4.33 ± 4.94 |
| Baseline to Session 5 | -5.71 ± 3.49 |
| Baseline to Session 6 | -2.71 ± 4.31 |
Mean number of sessions each participant completed
| sessions completed | DEEP VR Experiment Group |
|---|---|
| Number of Sessions Completed | 2.65 ± 1.68 |
| minutes | DEEP VR Experiment Group |
|---|---|
| Average Length of Session | 12.83 ± 3.06 |
| minutes | DEEP VR Experiment Group |
|---|---|
| Average Total Minutes in Game | 38.30 ± 23.82 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DEEP VR Experiment Group | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
Baseline demographics were not collected from the participant who withdrew.
| Age, Continuous(years) | DEEP VR Experiment Group |
|---|---|
| Mean | 15.42 ± 1.26 |
| Sex: Female, Male(Participants) | DEEP VR Experiment Group |
|---|---|
| Female | 16 |
| Male | 51 |
| Ethnicity (NIH/OMB)(Participants) | DEEP VR Experiment Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 70 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | DEEP VR Experiment Group |
|---|---|
| American Indian or Alaska Native | 4 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 47 |
| White | 11 |
| More than one race | 8 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | DEEP VR Experiment Group |
|---|---|
| United States | 73 |
| Historical and current delinquency offenses(Participants) | DEEP VR Experiment Group |
|---|---|
| Property offense | 17 |
| Sex offense | 2 |
| Weapons offense | 3 |
| Violent offense | 4 |
| Multiple offenses | 21 |
| Unknown | 26 |
| Youth Self-Report (YSR) Total Score(score on a scale) | DEEP VR Experiment Group |
|---|---|
| Mean | 47.36 ± 27.37 |
| Youth Self-Report (YSR) Sub-Scores(score on a scale) | DEEP VR Experiment Group |
|---|---|
| Internalizing Sub-Score | 14.36 ± 10.39 |
| Externalizing Sub-Score | 17.94 ± 11.6 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Information to be shared may include questionnaire responses, physiological recordings, or game play data. These data will be coded with the unique subject ID, and will not include any linking protected health information or other identifiable information. Data will be shared via encrypted, password protected cloud storage (Box.com).
Supporting information: Study protocol, Sap, Analytic code
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University of Wisconsin, Madison