RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

About This Trial

Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions. Objective: To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD. Eligibility: Children aged 8 to 16 years with ADHD. Design: We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain. Participants will receive a set of virtual reality games. The set includes 4 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks. The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, temporal information processing, and working memory. Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played. Blood or saliva tests and the MRI may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.

Who May Be Eligible (Plain English)

* Who May Qualify: In order to be eligible to participate, an individual must meet all of the following criteria: 1. Children must provide informed assent and parents must provide willing to sign a consent form to participate in the study. 2. Any sex assigned at birth, or race/ethnicity. 3. Aged between 8 and 16 years of age, including all months leading up to age 17. 4. Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation). 5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study. 6. For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment. Who Should NOT Join This Trial: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.) 2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders. 3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training. 4. Known to be pregnant. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

* INCLUSION CRITERIA: In order to be eligible to participate, an individual must meet all of the following criteria: 1. Children must provide informed assent and parents must provide informed consent to participate in the study. 2. Any sex assigned at birth, or race/ethnicity. 3. Aged between 8 and 16 years of age, including all months leading up to age 17. 4. Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation). 5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study. 6. For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.) 2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders. 3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training. 4. Known to be pregnant. 5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is considered to be one of the dominant sources of impairment for the child. 6. Considered a suicide risk as determined during the clinical interview at baseline. 7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable). 8. Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD. 9. The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or children showing signs of undue neck and upper body strain or fatigue while trying the headset). 10. For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). Medications for ADHD will not be considered as exclusionary. This includes psychostimulants, atomoxetine, alpha 2 adrenergic agonists. Antidepressant and anxiolytic medication will also not be exclusionary if they are deemed not to not interfere with study procedures 11. For the main trial only: Prior use of Floreo s products including but not limited to their ADHD cognitive training application.

Treatments Being Tested

BEHAVIORAL

Floreo Virtual Reality application

Floreo VR is a novel VR-based cognitive training therapy for ADHD. It incorporates multiple learning modules, each of which targets a neuropsychological domain relevant to ADHD (inhibitory control, working memory, temporal processing, processing speed). The demands of the training intervention adapt to the subject s practice-driven improvements in performance. Specifically, when the subject is deemed to perform adequately well at a given level of difficulty, the training adapts by presenting a more challenging difficulty. This adaptation to the subject s performance is designed to allow for continued incremental improvements in the trained domains. The VR games take place in a spaceship themed environment. The VR training is designed to be used at home, under the supervision of a parent.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States