Phase 2 ADHD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The child must agree to take part (assent), and a parent or guardian must also give their written agreement (consent).
• Children of any sex, race, or ethnicity are welcome.
• The child must be between 8 and 16 years old (up to but not yet 17).
• The child must have a diagnosis of ADHD — either the inattentive or combined type — or have significant attention difficulties that cause problems in two or more settings, even if a full ADHD diagnosis has not been given.
• The child and family must be willing and available to follow all study procedures for the full duration of the trial.
• For the pilot phase only: If the child takes stimulant medication for ADHD, the family must be willing to stop that medication three days before the initial assessments and keep it paused until after the follow-up assessment; the child must also not have taken any other psychiatric medication for at least 30 days before the initial assessments.

Who may not be able to join:

• Children who are not able to complete the study tasks due to a significant intellectual disability — for example, those with a known IQ under 70 or a history suggesting global intellectual difficulties.
• Children with a history of severe migraines, vertigo, epilepsy (except febrile seizures, which are fever-related), or serious balance problems.
• Children with uncorrected vision problems that would make using a virtual reality (VR) headset difficult or impossible.
• Children who are known to be pregnant.
• Children with a psychotic disorder (such as schizophrenia) or a current substance dependence problem.
• Children identified as being at risk of suicide during the initial clinical interview.
• Children with any other medical or psychiatric condition that, in the lead researcher's opinion, could affect study results — for example, physical limitations that would make wearing a VR headset impossible.
• Children who have used another computer-based brain training program (such as Cogmed) for ADHD within the past three months.
• Children for whom the VR headset causes significant discomfort — for example, those whose eye spacing means the headset produces blurry images, or who show signs of notable neck or upper body strain when trying the headset.
• For the main trial only: Children currently taking certain psychiatric medications, including antipsychotics or certain mood stabilisers (lithium, valproate, lamotrigine, or gabapentin). Medications commonly used for ADHD, as well as antidepressants and anti-anxiety medications (if they are not expected to interfere with the study), are not considered exclusionary (confirm with trial site).
• For the main trial only: Children who have previously used any Floreo products, including their ADHD cognitive training application.

Important: Always verify eligibility with the trial site directly before applying.