Status:
NOT_YET_RECRUITING
R61/33 - VR Study Phase 4
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Louisiana State University Health Sciences Center in New Orleans
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-25 years
Phase:
PHASE4
Brief 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...
Detailed 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 + feedb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT07169760
Start Date
September 20 2025
End Date
December 1 2030
Last Update
September 12 2025
Active Locations (2)
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1
Louisiana State University
Baton Rouge, Louisiana, United States, 70802
2
Rutgers University - New Brunswick
New Brunswick, New Jersey, United States, 08854