Virtual Reality Treatment for Emerging Adults With ADHD

NCT06454604 | Completed Phase 3 Results

• 2 other identifiers: Pro2023001005R61MH131632-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Virtual reality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Homework Effort Index

  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

  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.

Study Arms (3)

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.

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.

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.

Behavioral: Meta Quest 3 VR Headset with noise cancelling headphones

Interventions

Meta Quest 3 VR Headset with noise cancelling headphones BEHAVIORAL

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.

VR Passthrough; Virtual Reality; Virtual Reality + Feedback

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (2)

Louisiana State University

Baton Rouge, Louisiana, 70802, United States

Location

Rutgers University - New Brunswick

New Brunswick, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Joshua Langberg
• Organization: Center for Youth Social Emotional Wellness - Graduate School of Applied and Professional Psychology

jl3079@gsapp.rutgers.edu

(848) 445-2000

Study Officials

• Joshua M Langberg, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Parallel group randomized trial

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 12, 2024
• Study Start: September 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (2)