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N/A N=348 Randomized Quadruple-blind Treatment

Software Treatment for Actively Reducing Severity of ADHD

Attention Deficit Disorder With Hyperactivity

Enrolled (actual)
348
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment) — 0.93; 0.03 z-score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AKL-T01 (Device); AKL-T09 (Device)
Age
Pediatric · 8+ yrs
Sex
All
Sponsor
Akili Interactive Labs, Inc.
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)
0.93; 0.03
SECONDARY
ADHD-RS Total (Change From Baseline to Posttreatment)
-6.2; -5.7
SECONDARY
ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment)
-3.6; -3.2
SECONDARY
ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment)
-2.6; -2.5
SECONDARY
BRIEF Working Memory Percentile (Change From Baseline to Posttreatment)
-3.1; -3.3
SECONDARY
BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)
-2.8; -3.5
SECONDARY
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment)
-0.5; -0.4
SECONDARY
CGI-I (at Posttreatment)
3.4; 3.4

Summary

The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.

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 = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02674633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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