OpenMindXR is developing virtual reality software designed to assess and support children’s mental and behavioral health. By bringing together expertise in psychiatry, neuroscience, game design, and technology, the team is exploring new ways to help children build behavioral skills, social skills, and empathy through immersive experiences.
The company’s current research focuses on a novel VR program for children with ADHD, designed to help strengthen behavioral and social skills while giving families a tool that can be used from home.
For OpenMindXR, the ability to conduct research remotely is fundamental to both its study and the technology being evaluated.
Participants do not need to visit a clinic. Instead, children use OpenMindXR’s VR program at home, while the research team collects feedback and outcomes remotely from both children and their parents.
This creates a unique data collection challenge. OpenMindXR needs to capture information from multiple sources at different time points, including how children respond to the program, whether parents observe behavioral changes, and whether those changes continue outside of the VR experience.
At the same time, as a small research team, OpenMindXR needed a system that could support this remote model without sacrificing the data integrity and auditability expected of clinical research.
“We knew paper wasn’t going to be an option because everything we do is remote. Our interviews, consents, and data collection are all remote with our participants,” said Tom, Co-founder and Chief Science Officer at OpenMindXR.
The team also wanted to ensure its data could support future regulatory needs. That meant maintaining secure records, tracking corrections and changes, and establishing an audit trail rather than relying on tools such as spreadsheets where values could simply be overwritten.
“We needed to hold two things together: Part 11 compliance and a fully remote study. An EDC with a PRO option gave us a solution to both.”
In other words, collecting outcomes data needed to be practical for patients and manageable for research teams.
OpenMindXR found Captivate® through its search for an EDC that could provide the capabilities of a full scale Electronic Data Capture System, with resources allowing access to smaller organizations with lesser budgets than huge companies.
Items required to run study:
Ease of use was particularly important. The team wanted a platform that researchers could configure without extensive programming knowledge while also making participation straightforward for children and families completing surveys, consent forms, and other study activities remotely.
Captivate® VDC® ePRO and eConsent became important components of that approach. OpenMindXR configured its study to handle both processes remotely, allowing participants to complete study activities from home while supporting the Part 11 compliance requirements of the research.
“If we can continue to provide something easy to access for families who are looking for help for their kids so that they can lead productive, healthy lives, interact with their peers, and continue to succeed in school, then I think we’re doing okay.”
At the time of the interview, OpenMindXR was recruiting participants and preparing to begin data collection. Initial testing of the remote study workflow had already been completed, including taking a test participant through the system.
Captivate® also allows OpenMindXR to configure its study online and use ePRO extensively for the participant-reported data at the center of its research.
“The PRO tool is something that we’re using a lot. We were able to set up the rules, get it functioning, and it’s working for us,” Luke said.
For a small organization pursuing an ambitious new approach to pediatric mental health, access to those capabilities was especially important.
“Affordability was a big factor for us, and we’re able to get the same tools that the big guys have,” Luke said. “We’re just little guys trying to get ADHD treatment accessible to kids.”
“Affordability was a big factor for us, and we’re able to get the same tools that the big guys have,” Luke said. “We’re just little guys trying to get ADHD treatment accessible to kids.”
Captivate® also allows OpenMindXR to configure its study online and use ePRO extensively for the participant-reported data at the center of its research.
“The PRO tool is something that we’re using a lot. We were able to set up the rules, get it functioning, and it’s working for us,” Luke said.
For a small organization pursuing an ambitious new approach to pediatric mental health, access to those capabilities was especially important.
“Affordability was a big factor for us, and we’re able to get the same tools that the big guys have,” Luke said. “We’re just little guys trying to get ADHD treatment accessible to kids.”
Like many growing medical device companies, OpenMind XR had to balance ambition with budget.
Traditional EDC pricing models can make large-scale deployment difficult, particularly when planning multiple concurrent studies. The expansion of ClinCapture’s Weidley’s Wish program allowed OpenMind XR to implement a fully featured EDC system aligned with their financial planning.
That flexibility made it possible to move forward with structured data collection now, rather than postponing until budgets allowed.
OpenMindXR’s immediate goal is to determine whether its VR program is engaging and enjoyable for children and families, while systematically measuring whether it can produce meaningful improvements in behavior and social skills.
“We want something that works, so we want to be able to quantify through our data collection improvements in behavior, improvements in social skills, and improvements in behaviors that occur outside just their use of our VR program,” Tom said.
Longer term, the team sees an opportunity to expand beyond the specific skills and population being studied today. OpenMindXR hopes VR can provide families with an accessible tool that complements existing approaches to mental healthcare and can be used by children at home, on their own time.
For Tom, the ultimate measure of success goes beyond the technology itself.
“If we can continue to provide something easy to access for families who are looking for help for their kids so that they can lead productive, healthy lives, interact with their peers, and continue to succeed in school, then I think we’re doing okay.”
