R61/33 - VR Study Phase 4

Last updated: January 26, 2026
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

4

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Autism Spectrum Disorder (Asd)

Williams Syndrome

Treatment

Meta Quest 3 VR Headset with noise cancelling headphones

Clinical Study ID

NCT07169760
Pro2023001005.phase 4
R61MH131632-01
  • Ages 18-25
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 whomeet criteria for ODD, anxiety or depressive disorders on the diagnostic intervieware not excluded

  • Participants must have an item mean score of >2.0 (often or very often) on thehomework task specific version of the Adult Concentration Index (ACI), ensuring thepresence 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 ADHDinattention domain as currently present and impairing and at least 6 symptoms in theADHD inattention domain as present and impairing during childhood

  • To rule out exclusionary conditions and/or to assess for the presence of comorbidconditions, psychological functioning will be assessed using the DSM-5 version ofthe Structured Clinical Interview for DSM Disorders (SCID-5-RV)

Exclusion

Exclusion Criteria:

  • Whether primary or not, the comorbid presence of several other conditions will beexclusionary.This includes autism spectrum disorders, bipolar disorder,obsessive-compulsive disorder, active substance abuse, and other psychiatricconditions 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 ofVR

Study Design

Total Participants: 252
Treatment Group(s): 1
Primary Treatment: Meta Quest 3 VR Headset with noise cancelling headphones
Phase: 4
Study Start date:
September 09, 2025
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Louisiana State University

    Baton Rouge 4315588, Louisiana 4331987 70802
    United States

    Active - Recruiting

  • Rutgers University - New Brunswick

    New Brunswick 5101717, New Jersey 5101760 08854
    United States

    Active - Recruiting

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