Software Treatment for Actively Reducing Severity of ADHD

Launched by AKILI INTERACTIVE LABS, INC. · Feb 2, 2016

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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