A Phase 3 interventional study of Meta Quest 3 VR Headset with noise cancelling headphones in Attention Deficit Hyperactivity Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 2 sites in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Rutgers, The State University of New Jersey · Phase 3, Interventional, and Treatment
The goal of this pilot randomized clinical trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.
This study involves a pilot randomized control trial (RCT) to assess the feasibility/usability and preliminary effects of a virtual reality (VR) environment alone (n=15) compared to VR environment + feedback about focus (n=15) and to a VR passthrough control (n=15). Proposed mechanisms of action will be measured every session, including data on keyboard and mouse clicks plus self-ratings of concentration, homework effort, and homework motivation. After completing the initial diagnostic evaluation and confirming eligibility, 45 emerging adults with ADHD (ages 18-25) will be randomized to 1 of 3 groups and then provided with a VR headset and computer to use in their dorm/home. Randomization will be performed (1:1:1) to the three conditions. Randomization will be blocked on ADHD medication status to ensure an equal number of participants taking and not taking ADHD medication in each group. Phase 3 includes a 2-session baseline where all participants complete homework and study without using the VR headset.
Group 1, VR passthrough: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. The participant will wear the headset, but it will not be used as usual. The headset will be in "VR passthrough" mode, meaning the participant will see through to the normal environment and laptop (i.e., they can see the real world around them, just wearing a headset).
Group 2, VR environment only: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment.
Group 2, VR environment + feedback: After completing the two session baseline, participants will use the VR headset in their room/home or the 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment while receiving real time visual feedback on performance and focus.
Participants concentration, effort/efficiency, and motivation is assessed each baseline and VR session, and participants answer questions about VR feasibility, useability, and acceptability.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this condition wear the same VR headset as participants in the in the other arms. However, they see directly through to their laptop and are not emersed in the virtual world.
Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones
Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world.
Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones
Participants in this condition wear the virtual reality headset. They are emersed in a virtual world that looks like a cabin room with windows. They are sitting at a desk and can see their laptop screen as part of the virtual world. The program tracks their keyboard and mouse click data to assess how consistently they are working. A stoplight in the virtual environment is green when they are working consistently and turns red when the not.
Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones
Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.
Objective On-Task Assessment Algorithm
Percentage of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data. There are no subscales in this measure. Percentages below are for sessions 1-2 (T1) and 3-12 (T2). Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation/motivational purposes (payment after sessions 1-7 and after 8-12) and were not outcome measurement time points. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions, which we considered 'baseline,' giving us a base focus score before participants put on a headset. Participants wore the headsets for sessions 3-12. Percentages below were averaged for each time point. T1 is an average of session 1+2's percentages. T2 is an average of sessions 3-12's percentages.
Time frame: Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions, equaling 12 sessions within 3 weeks.
Homework Concentration Index
This measure looks at how concentrated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = worse concentration. The total score is summed. Numbers below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 (Sessions 1+2) and T2 (Sessions 3-12).
Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks.The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.
Homework Effort Index
The Homework Effort Index looks at how much effort participants were able to put in while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of effort. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below are averaged for T1 and T2.
Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.
Homework Motivation Index
The Homework Motivation Index measures how motivated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True.There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of motivation. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 and T2.
Time frame: Participants had 2 weeks to complete sessions 1-7, a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation purposes and were not outcome measure points.
| Milestone | VR Passthrough | Virtual Reality | Virtual Reality + Feedback |
|---|---|---|---|
| Started | 22 | 18 | 20 |
| Completed | 16 | 16 | 17 |
| Not completed | 6 | 2 | 3 |
Percentage of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data. There are no subscales in this measure. Percentages below are for sessions 1-2 (T1) and 3-12 (T2). Participants had 2 weeks to complete sessions 1-7 and a 3rd week to complete the last 5 sessions (sessions 8-12), equaling 12 sessions within 3 weeks. The 1-7 and 8-12 time points were only for compensation/motivational purposes (payment after sessions 1-7 and after 8-12) and were not outcome measurement time points. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions, which we considered 'baseline,' giving us a base focus score before participants put on a headset. Participants wore the headsets for sessions 3-12. Percentages below were averaged for each time point. T1 is an average of session 1+2's percentages. T2 is an average of sessions 3-12's percentages.
| percentage of time focused | VR Passthrough | Virtual Reality | Virtual Reality + Feedback |
|---|---|---|---|
| Sessions 1+2 (T1)(Baseline) | .86 ± .21 | .62 ± .35 | .83 ± .27 |
| Sessions 3-12 (T2) | .83 ± .04 | .85 ± .06 | .95 ± .01 |
This measure looks at how concentrated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = worse concentration. The total score is summed. Numbers below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 (Sessions 1+2) and T2 (Sessions 3-12).
| units on a scale | VR Passthrough | Virtual Reality | Virtual Reality + Feedback |
|---|---|---|---|
| Sessions 1+2 (T1)(Baseline) | 15.93 ± 4.69 | 16.17 ± 6.03 | 17.93 ± 5.57 |
| Sessions 3-12 (T2) | 11.82 ± 5.19 | 12.75 ± 3.88 | 12.96 ± 4.37 |
The Homework Effort Index looks at how much effort participants were able to put in while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True. There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of effort. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below are averaged for T1 and T2.
| units on a scale | VR Passthrough | Virtual Reality | Virtual Reality + Feedback |
|---|---|---|---|
| Sessions 1+2 (T1)(Baseline) | 19.34 ± 3.93 | 17.69 ± 3.06 | 17.43 ± 3.05 |
| Sessions 3-12 (T2) | 19.95 ± 5.31 | 19.63 ± 4.42 | 19.92 ± 5.08 |
The Homework Motivation Index measures how motivated participants were while completing their homework.The rating options are Not True, Somewhat True, Pretty Much True, and Definitely True.There are no subscales in this measure, just a total score. The range is 7-28. Higher #s = greater levels of motivation. The total score is summed. Scores below are averages of units from sessions 1-2 (T1) and 3-12 (T2).The units were collected during each session's post survey. Sessions 1+2 are combined for a time point because participants did not wear headsets for those two sessions. Participants wore the headsets for sessions 3-12. Sessions 1+2 are considered baseline as they gave us a baseline score before participants put on a headset. Scores below were averaged for T1 and T2.
| units on a scale | VR Passthrough | Virtual Reality | Virtual Reality + Feedback |
|---|---|---|---|
| Sessions 1+2 (T1)(Baseline) | 20.73 ± 4.20 | 19.94 ± 3.40 | 19.35 ± 3.21 |
| Sessions 3-12 (T2) | 21.08 ± 6.89 | 20.53 ± 5.30 | 20.89 ± 5.07 |
Collected over AE data was monitored over 1-2 months, including the baseline assessment and active phase of the study with the VR sessions. Whether it was 1 or 2 months depended on how long participants took to schedule their baseline assessment, to pick up their VR technology, to complete the 12 sessions.We were in regular contact with participants over the time frame to ask how they were adjusting to the VR and to see if they had any problems.No participants met the criteria for adverse events in our study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VR Passthrough | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Virtual Reality | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Virtual Reality + Feedback | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 18 | 20 | 60 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| Female | 15 | 14 | 11 | 40 |
| Male | 7 | 4 | 9 | 20 |
| Ethnicity (NIH/OMB)(Participants) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 6 | 10 |
| Not Hispanic or Latino | 20 | 16 | 14 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 4 | 3 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 6 | 13 |
| White | 15 | 11 | 12 | 38 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| United States | 22 | 18 | 20 | 60 |
| The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV Self-Report(units on a scale) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| Current Inattention Symptom Count (A) | 7.27 ± 1.12 | 7.50 ± 1.58 | 7.15 ± 1.42 | 7.30 ± 1.36 |
| Current Inattention Total Rating Score (B) | 19.59 ± 3.72 | 20.44 ± 3.67 | 19.80 ± 3.81 | 19.91 ± 3.69 |
| Current Hyperactive Symptom Count (C) | 5.05 ± 1.96 | 4.94 ± 2.73 | 5.75 ± 1.55 | 5.25 ± 2.10 |
| Current Hyperactive Total Rating Score (D) | 15.36 ± 4.28 | 15.89 ± 6.06 | 16.85 ± 3.51 | 16.02 ± 4.63 |
| Current Total ADHD Symptom Count (E) | 18.32 ± 2.77 | 18.44 ± 5.14 | 18.35 ± 3.50 | 18.37 ± 3.78 |
| Current Total ADHD Rating Score (F) | 52.09 ± 7.98 | 53.72 ± 11.90 | 52.60 ± 8.67 | 52.75 ± 9.39 |
| Past Inattention Symptom Count (G) | 7.32 ± 2.19 | 7.33 ± 1.94 | 7.05 ± 1.64 | 7.23 ± 1.92 |
| Past inattention Total Rating Score (H) | 19.91 ± 5.77 | 20.28 ± 4.55 | 19.95 ± 4.62 | 20.03 ± 4.97 |
| Past hyperactive/impulsive Symptom Count (I) | 6.14 ± 2.29 | 5.17 ± 3.00 | 6.55 ± 1.82 | 5.98 ± 2.42 |
| Past Hyper/Impulsive Total Rating Score (J) | 17.50 ± 5.69 | 15.78 ± 7.11 | 19.30 ± 4.40 | 17.58 ± 5.86 |
| Past Total Adhd Symptom Count (K) | 13.45 ± 3.49 | 12.50 ± 4.44 | 13.60 ± 3.14 | 13.22 ± 3.66 |
| Past Total ADHD Rating Score (L) | 37.41 ± 10.00 | 36.06 ± 10.71 | 39.25 ± 7.89 | 37.62 ± 9.50 |
| Adult Concentration Index (ACI)(units on a scale) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| ACI Symptom Count | 5.91 ± 1.06 | 5.94 ± 1.30 | 6.35 ± .81 | 6.07 ± 1.07 |
| ACI Total Score | 16.05 ± 3.09 | 16.61 ± 3.76 | 17.65 ± 2.74 | 16.75 ± 3.22 |
| General Anxiety Disorder-7 (GAD-7)(units on a scale) | VR Passthrough | Virtual Reality | Virtual Reality + Feedback | Total |
|---|---|---|---|---|
| Mean | 12.55 ± 3.31 | 10.11 ± 5.57 | 11.25 ± 4.89 | 11.38 ± 4.64 |
6 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 — De-identified data can be used for many secondary analyses. Individual subject-level data and item-level data will be shared. Prior to sharing, all data will be de-identified so that it is HIPAA-compliant. Once deposited into an open database, data will be open to the greater scientific community according to the terms of the individual database. Data will then be fully available for secondary analyses, data mining, and to facilitate discovery by combining our data with that of other centers/investigators for large-scale analyses. As we will be using the NDA, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations. The NIMH Data Archive (NDA) will serve as the primary data repository for the current proposal.
Supporting information: Study protocol, Sap
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity→
Rutgers, The State University of New Jersey