Overview

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 10 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.

Eligibility

• 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 gender identity, sex assigned at birth or race/ethnicity.
          3. Aged between 10 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. 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).