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R61/33 - VR Study Phase 4

RecruitingPhase 4Ages 18 Years - 25 YearsAllRutgers, The State University of New Jersey
NCT07169760 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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 * 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 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
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What it tests

  • Meta Quest 3 VR Headset with noise cancelling headphones
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Where

2 sites
Louisiana State University
Baton Rouge, United States
Rutgers University - New Brunswick
New Brunswick, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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