Before any teen or young adult participates in Limbix’s virtual clinical trial for Spark, a digital therapeutic mobile app designed for teens ages 13–21 experiencing symptoms of depression, they speak with one of the members of the Limbix clinical trials team. This team — consisting of the clinical trial investigators and research coordinators — acts as Limbix’s dedicated liaison to the teens and parents who participate in the clinical trial. The concept of virtual clinical trials can sound daunting, especially to teens and their parents who are navigating a pandemic on top of seeking options for depression treatment. But the clinical trials team works tirelessly to ensure that the entire virtual trial process feels simple and seamless for participants.
After reviewing the information on the webpage, teens and their parents are able to indicate if they’d like to connect directly with a member of the Limbix clinical trials team and start the enrollment process. This initial connection is vital — the Limbix team is able to directly answer any questions potential participants may have about the trial and ensure they are comfortable throughout the process.
Once questions are answered, teens (and their parents, if the teens are minors) are able to set up a consent/enrollment video call with a Limbix clinical trial team member. In this call, teens are informed of the trial procedures, including what the onboarding and follow up processes entail. They are also informed about, and the time commitment for trial participation, and their rights and responsibilities as a research participant, and. They are also told that the information they share in the app will be reviewed by a team member and a clinician if there’s a safety concern, as the trial includes safety monitoring. This helps ensure that participants have the resources they need throughout their participation in the trial, and often reassures parents about their teen’s safety. As trial procedures are explained to participants, they are able to ask as many questions as they want about the research process. The clinical trials team ensures that participants (and parents) understand that participation is entirely voluntary and they can withdraw at any time. In the final step of the consent process, participants provide signed informed consent and then begin enrollment.
The team is trained to receive participant consent and facilitate the enrollment process with sensitivity and empathy, always ensuring that everyone is on the same page regarding participation — particularly as they combat stigma related to depression and balance sensitive parent-child dynamics. “Depression can be a touchy subject in a lot of families… [especially] when teens haven’t had open conversations about their mental health with their parents,” Smith says.
The intentionality of the consent and onboarding process sets participants up for a smooth and user-friendly experience. The clinical trials team is able to see firsthand the successes of the process and product when they conduct interviews with participants and parents at the end of the study period. Post-study interviews provide participants with an opportunity to share more about their mental health and their experiences using Spark, while providing the Limbix team with valuable, non-clinical insights about product usage. Teens can then move on to the next phase of their mental health journey, inspired and empowered by the knowledge that their feedback will help make Spark better for future participants.
The concept of participating in clinical trials can be intimidating, but as teenagers have recently become eligible to receive COVID vaccinations, clinical trials have risen to the forefront of peoples’ minds . People are more aware than ever that those who volunteer for trials can help propel innovation and make new treatments accessible to the public.
While teens had no agency in coming of age during a pandemic and a ballooning mental health crisis, they do have the choice to be a part of the solution.
“I’ve been hearing excitement in teenagers’ voices when they realize that they’re part of a trial that can then help adolescents in the future with the symptoms that they’re experiencing themselves,” says Smith.
To learn more about the research we’re conducting at Limbix, please visit https://www.limbix.com/research.