Clinical trial NCT06454604: Virtual Reality Treatment for Emerging Adults With ADHD
Official title: Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Virtual reality
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2024-06-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomized trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration
timeFrame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over 2 weeks-1 month)
measure: Productivity Rate
timeFrame: Measured throughout the 40-minute duration of each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
measure: System usability and satisfaction
timeFrame: Measured immediately after the 6th and 11th VR intervention sessions and in the post-intervention surveys (taking place over a total of 1-1.5 months)
Secondary outcomes:
measure: Motivation
timeFrame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
measure: Effort
timeFrame: Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Louisiana State University
state: Louisiana
city: New Brunswick
country: United States
facility: Rutgers University - New Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Joshua M Langberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: