ADHD is the most common childhood psychiatric disorder, and the symptoms are usually most evident at home and in academic or classroom settings. Children with ADHD often have academic and behavioral problems that affect their relationships with friends, family, and teachers.
The good news is that more and more families are willing to seek out evaluations and treatment when their children are struggling. A variety of treatment options are now available and important new research is being conducted which provides even more data to help determine how effective new potential ADHD drugs are. These studies are called Laboratory Classroom Studies and take place in simulated classroom environments.
Below is a conversation with Dr. Andrea Marraffino, Principal Investigator (PI) at Meridien Research’s Maitland and Orlando sites, as she shares her thoughts about Laboratory Classroom Studies.
How do ADHD “Classroom” studies differ from “traditional” child ADHD studies which are conducted solely in a clinic setting?
Dr. Marraffino: “For both types of studies, participants visit us regularly at the clinic for medical checkups and assessments with a doctor. The classroom studies have an additional element that make them unique, where the participant attends 2-3 simulated classroom sessions. These are done in a rigorously controlled environment at a local school. The classroom sessions take place on Saturdays and are really fun for everyone!”
What is the purpose of conducting a Classroom study?
Dr. Marraffino: “The FDA now requires all new ADHD medications go through testing in a simulated classroom environment. The classroom sessions are used to collect data on the participants’ ADHD symptoms in a realistic environment, to see how their symptoms get better or worse throughout the day. The classroom setting provides a simulation of a real academic environment, including the potential for interaction and distraction among the children. This allows the pharmaceutical company to see if their medication works in the real world, and if so, how long does the improvement last.”
What is the design of a Classroom study?
Dr. Marraffino: “On classroom days, all the participants in the study (up to 18 kids) come to the school early in the morning. The regular clinic staff (doctors, nurses, study coordinators) are there, along with teachers and counselors. We spend all day together – the clinic staff collect data in a nearly invisible way, where the kids don’t even notice. The kids stay busy all day, participating in classes with two teachers and doing activities with the counselors. They play on the playground, make crafts, watch movies, and play games. The participants go home tired, and the clinic staff have a lot of data for the study!”
Are classroom studies safe? It seems like studies conducted in a clinic setting might be more controlled, and therefore have better safety for the children.
Dr. Marraffino: “We make every possible effort to ensure participants’ safety, no matter the type of study. Safety is our priority under any circumstance, and all studies are very structured and controlled. For the classroom-style studies, that means having a nearly 1-to-1 ratio of kids to professional adults on classroom session days. The children are with multiple adults at all times, the school is child-proofed and access to the building is secure, we keep a structured schedule, and we have nurses and/or doctors on site for any medical concerns.”
What do you feel is the most important thing for parents/people to know about Pediatric ADHD Classroom studies?
Dr. Marraffino: “Classroom studies are a great way to learn more about your child’s ADHD symptoms while working closely with leading medical experts in the field.”
Meridien Research strives to provide children and parents with the right tools to have healthy and functional lives, while living with an ADHD diagnosis. Each of our facilities is staffed by a professional team of board certified physicians, psychologists, nurses, masters-level clinicians, research coordinators, and medical assistants, to ensure that every study participant is well cared for. If a child in your life has ADHD, feel free to reach out for a confidential consultation at 888-777-8839 or submit in inquiry to Info@MeridienResearch.net.
Dr. Andrea Marraffino, is a Principal Investigator at Meridien Research in Maitland, Florida. She is a psychologist and has conducted dozens of pediatric ADHD studies.