R61/33 - VR Study Phase 4
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-25
SponsorRutgers, The State University of New Jersey
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Meta Quest 3 VR Headset with noise cancelling headphones
BehavioralWearing 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.
Treatment groups
252 Participants
are divided into 3 treatment groupsGroup A: VR PassthroughActive comparator 1 intervention
Group B: Virtual RealityExperimental treatment 1 intervention
Group C: Virtual Reality + FeedbackExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Concentration
Participants rate how concentrated they were to complete work and study
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)2
On-task Behavior
% of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data
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)Secondary outcomes
1
Motivation
Participants rate how motivated they were to complete work and study
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)2
Effort
Participants rate how much effort they put into completing their work and studying
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Source ClinicalTrials.gov