Virtual Reality Games to Improve Thinking Skills in Children with ADHD A Pilot and Randomized Controlled Trial for Ages 8 to 16

What this Trial Is About

Children with attention deficit hyperactivity disorder ADHD often face challenges with behavior control, concentration, and decision-making, impacting their education, friendships, and daily life. Researchers are evaluating whether virtual reality-based games can help improve cognitive skills and brain function in children with ADHD aged 8 to 16 years. This study includes a pilot phase and a randomized controlled trial to assess the effectiveness of a VR cognitive training intervention. Participants will use the Floreo Virtual Reality application, which consists of four adaptive games designed to improve specific cognitive skills such as inhibitory control, processing speed, temporal information processing, and working memory. The games are played using a VR headset for 20 minutes, five days a week, over four weeks. Caregivers will assist in starting each game via an iPad. The pilot study involves all participants receiving the games, while the randomized trial will assign participants to either the full or a limited version of the games. Throughout the study, participants will be evaluated for mood, memory, attention, thinking, and behavior through various tests and interviews. Researchers may collect blood or saliva samples and perform MRI brain scans before and after the intervention. Weekly interviews will monitor side effects like motion sickness or eye strain and track game session completion. The primary outcome measures include changes in inattention symptoms and neuropsychological performance, with follow-up assessments occurring up to one month after the training ends.

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial