Virtual Reality Treatment for Emerging Adults With ADHD

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70802
      • Louisiana State University
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Rutgers University - New Brunswick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VR Passthrough; 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; 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.
Experimental: Virtual Reality; 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; 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.
Experimental: Virtual Reality + Feedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Mental Health (NIMH); Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Joshua M Langberg, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ADHD; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Pro2023001005; R61MH131632-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Analyzed/experimental data related to the primary aims of the study will be submitted when a publication on the data is accepted, or the project period ends, and shared when published or one year after the project period ends, whichever comes first in both cases.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No