Software Treatment for Actively Reducing Severity of ADHD

The study will be a randomized, parallel group, controlled trial of two videogame-like
(iPad-based) digital therapies. The study will consist of 3 primary phases: Screening,
Washout/Baseline, and Treatment. During the Screening Phase (Day -28 to Day -7), participants
will undergo screening to evaluate eligibility for the study. Screening may take place up to
28 days before the Baseline Visit (Day 0). For those children currently on medication for
ADHD the Washout period will begin 7 days prior to Baseline where treatment will be
discontinued. On Day 0, the Baseline visit will occur wherein additional eligibility criteria
will be established. The Treatment Phase (Day 1 to Day 27) will involve using the digital
therapy at home for each participant followed by an In-Clinic assessment on Day 28 to assess
key outcomes. Compliance with treatment/use requirements will be monitored remotely during
this phase.

Inclusion Criteria:

Confirmed ADHD diagnosis, any presentation, at Screening based on the Diagnostic and
Statistical Manual of Mental Health-Fifth Edition criteria and established via the
MINI-International Neuropsychiatric Interview for Children and Adolescents administered by
a trained clinician

Screening/Baseline score on the clinician-rated ADHD-RS-IV score >= 28

Screening/Baseline score on the TOVA 8 API <= -1.8

Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products
at time of Screening; or, if undergoing pharmacological treatment, must be willing and
appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of
current regimen

Ability to follow written and verbal instructions (English), as assessed by the PI

Estimated Intelligence Quotient score >= 80 as assessed by the Kaufmann Brief Intelligence
Test, Second Edition (KBIT-II)

Ability to comply with all the testing and requirements.

Exclusion Criteria:

Current, controlled (requiring a restricted medication) or uncontrolled, comorbid
psychiatric diagnosis, based on MINI-KID and subsequent clinical interviewing, with
significant symptoms including but not limited to post-traumatic stress disorder,
psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive
disorder, severe depressive or severe anxiety disorder, conduct disorder, or other
symptomatic manifestations that in the opinion of the Investigator that may confound study
data/assessments. Participants with clinical history of learning disorders will be allowed
to participate, provided the disorder does not impact their ability to participate in the
trial based on PI judgment

Participants who are currently treated with a non-stimulant medication for ADHD (i.e.,
atomoxetine, clonidine clonidine, guanfacine)

Initiation within the last 4 weeks of behavioral therapy. Participants who have been in
behavior therapy consistently for more than 4 weeks may participate provided their routine
is unchanged during the course of the study. Participants planning on changing or
initiating behavior therapy during the course of the study will be excluded

Participant is currently considered a suicide risk in the opinion of the Investigator, has
previously made a suicide attempt, or has a prior history of, or is currently demonstrating
active suicidal ideation or self-injurious behavior as measured by Columbia Suicide
Severity Rating Scale at screening

Motor condition (e.g., physical deformity of the hands/arms; prostheses) that prevents game
playing as reported by the parent or observed by the investigator

Recent history (within the past 6 months) of suspected substance abuse or dependence

History of seizures (exclusive of febrile seizures), or significant motor or vocal tics,
including but not limited to Tourette's Disorder

Has participated in a clinical trial within 90 days prior to screening

Diagnosis of or parent-reported color blindness (Confirmed in-clinic via ICBT)

Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the
intervention)

Regular use of psychoactive drugs (other than stimulant) that in the opinion of the
Investigator may confound study data/assessments

Any other medical condition that in the opinion of the investigator may confound study
data/assessments

Has a sibling also enrolled/currently participating in the same study

Has previously participated in a study of Akili's EVO videogame-like digital therapy