Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-31
Brief Title:
Virtual Reality Treatment for Emerging Adults With ADHD
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 feasibilityusability and preliminary effects of a virtual reality VR environment alone n15 compared to VR environment feedback about focus n15 and to a VR passthrough control n15 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 dormhome Randomization will be performed 111 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 roomhome 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 ie 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 roomhome 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 roomhome 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 effortefficiency and motivation is assessed each baseline and VR session and participants answer questions about VR feasibility useability and acceptability
Group 1 VR passthrough After completing the two session baseline participants will use the VR headset in their roomhome 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 ie 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 roomhome 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 roomhome 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 effortefficiency and motivation is assessed each baseline and VR session and participants answer questions about VR feasibility useability and acceptability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61MH131632-01 | NIH | None | httpsreporternihgovquickSearchR61MH131632-01 |