Attention Deficit Hyperactivity DisorderPhase 4NCT07169760
R61/33 - VR Study Phase 4
A Phase 4 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.
Trial summary
The goal of this larger parallel group randomized 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2025to Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Participants must meet DSM-5 criteria for ADHD
- 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
- 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 are not eligible
- Students 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. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Louisiana State University
Baton Rouge, Louisiana, 70802
David C Shepherd, PhD, 225-578-3202, dshepherd@lsu.edu
- Recruiting
Rutgers University - New Brunswick
New Brunswick, New Jersey, 08854
Joshua M Langberg, PhD, 803-429-1838, jl3079@gsapp.rutgers.edu
Sophia R Frontale, MPS, 3155062647, sf924@gsapp.rutgers.edu
About this study
Official title: Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD
The goal of this larger parallel group randomized 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 parallel randomized control trial (RCT) to assess the feasibility/usability and preliminary effects of a virtual reality (VR) environment alone compared to VR environment + feedback about focus and to a VR passthrough control. Phase 4 will follow the same procedures as Phase 3 except instead of n=45, we will randomize n=252 (note, number who consent is higher, to account for those found not eligible after consenting). 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, 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 4 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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 group | Role | What they receive |
|---|---|---|
| VR Passthrough | Active comparator | 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. Receives: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones |
| Virtual Reality | Experimental | 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. Receives: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones |
| Virtual Reality + Feedback | Experimental | 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. 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.
Concentration
Participants rate how concentrated they were to complete work and study
Measured: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
On-task Behavior
% of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data
Measured: Measured throughout the 60-minute duration of each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Secondary outcomes (2)
Motivation
Participants rate how motivated they were to complete work and study
Measured: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Effort
Participants rate how much effort they put into completing their work and studying
Measured: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start9 Sep 2025
- Primary completionSep 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized trial
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Joshua M. Langberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Joshua M Langberg, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169760
- Sponsor's protocol ID
- Pro2023001005.phase 4
- Other IDs
- R61MH131632-01
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD
- ClinicalTrials.gov ID
- NCT07169760
- Acronym / sponsor ID
- Pro2023001005.phase 4
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Virtual reality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Louisiana State University Health Sciences Center in New Orleans
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this larger parallel group randomized 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.
Detailed description
This study involves a parallel randomized control trial (RCT) to assess the feasibility/usability and preliminary effects of a virtual reality (VR) environment alone compared to VR environment + feedback about focus and to a VR passthrough control. Phase 4 will follow the same procedures as Phase 3 except instead of n=45, we will randomize n=252 (note, number who consent is higher, to account for those found not eligible after consenting). 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, 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 4 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel group randomized trial
| Arm | Type | Receives |
|---|---|---|
| VR Passthrough | Active comparator | Behavioral: Meta Quest 3 VR Headset with noise cancelling headphonesParticipants 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. |
| Virtual Reality | Experimental | Behavioral: Meta Quest 3 VR Headset with noise cancelling headphonesParticipants 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. |
| Virtual Reality + Feedback | Experimental | Behavioral: Meta Quest 3 VR Headset with noise cancelling headphonesParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must meet DSM-5 criteria for ADHD
- 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
- 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
Key exclusion criteria (4 listed)
- 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 are not eligible
- Students 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Quest 3 VR Headset with noise cancelling headphonesWearing 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. | Behavioural | VR Passthrough, Virtual Reality, Virtual Reality + Feedback |
Primary outcome
Concentration
Time frame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Participants rate how concentrated they were to complete work and study
On-task Behavior
Time frame: Measured throughout the 60-minute duration of each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
% of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data
2 secondary outcomes
Motivation
Time frame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Effort
Time frame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua M Langberg, PhD principal investigator
Rutgers University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua M Langberg, PhD ((848) 445-2000, jl3079@gsapp.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration (time frame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)). 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 28 Jan 2026.