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Attention Deficit Hyperactivity DisorderPhase 3NCT06454604

Virtual Reality Treatment for Emerging Adults With ADHD

A Phase 3 study testing Meta Quest 3 VR Headset with noise cancelling headphones in people with Attention Deficit Hyperactivity Disorder, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Meta Quest 3 VR Headset with noise cancelling headphones
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
20 Sep 2024to 30 Jul 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • To be included, participants must meet DSM-5 criteria for ADHD and be between the ages of 18 and 25. Given high rates of comorbidities in college students with ADHD, participants who meet criteria for ODD, anxiety or depressive disorders on the diagnostic interview are not excluded. In addition, participants must have an item mean score of >2.0 (often or very often) on the homework task specific version of the Adult Concentration Index (ACI), ensuring the presence of a problem in the mechanism being targeted in this study. The participant has to endorse a total of at least 5 symptoms in the ADHD inattention domain as currently present and impairing and at least 6 symptoms in the ADHD inattention domain as present and impairing during childhood. To rule out exclusionary conditions and/or to assess for the presence of comorbid conditions, psychological functioning will be assessed using the DSM-5 version of the Structured Clinical Interview for DSM Disorders (SCID-5-RV)

Who cannot join

  • Whether primary or not, the comorbid presence of several other conditions will be exclusionary. This includes autism spectrum disorders, bipolar disorder, obsessive-compulsive disorder, active substance abuse, and other psychiatric conditions whose treatment precludes participation in the study. Students who do not meet criteria for ADHD or who are not in the specified age range are also not eligible to participate. Students with a history of seizures are not eligible to participate given the use of VR.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Louisiana State University

    Baton Rouge, Louisiana, 70802

  • Rutgers University - New Brunswick

    New Brunswick, New Jersey, 08854

Other trials in United States

About this study

Official title: Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD

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.

Read the detailed description

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.

Being tested
Meta Quest 3 VR Headset with noise cancelling headphones
Keywords
ADHD, Virtual reality
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meta Quest 3 VR Headset with noise cancelling headphonesBehavioural

    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.

Study groups in NCT06454604
Study groupRoleWhat they receive
VR PassthroughActive comparatorParticipants 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.
Receives: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones
Virtual RealityExperimentalParticipants 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.
Receives: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones
Virtual Reality + FeedbackExperimentalParticipants 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.
Receives: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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).

    Measured: 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.

Secondary outcomes (2)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start20 Sep 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group randomized trial
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454604
Sponsor's protocol ID
Pro2023001005
Other IDs
R61MH131632-01
Status last verified
Nov 2025
First submitted
31 May 2024
Last updated
2 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meta Quest 3 VR Headset with noise cancelling headphones in people with Attention Deficit Hyperactivity Disorder, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective On-Task Assessment Algorithm (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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