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Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD)

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ClinicalTrials.gov Identifier: NCT02674633
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Akili Interactive Labs, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Device: AKL-T01 Device: AKL-T09 Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Parallel-group, Intervention Study to Assess At-home, Game-based Digital Therapy for Treating Pediatric Participants Ages 8 to 12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : May 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AKL-T01 (EVO Multi)
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
Device: AKL-T01
Videogame-like digital therapy
Other Name: EVO Multi

Active Comparator: AKL-T09 (EVO Words)
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
Device: AKL-T09
Videogame-like digital therapy
Other Name: EVO Words




Primary Outcome Measures :
  1. Change in the Attention Performance Index (API), an overall composite score, from the Test of Variables of Attention (TOVA 8) [ Time Frame: Study Day 0 to Study Day 28 ]

Secondary Outcome Measures :
  1. Change in The Cambridge Neuropsychological Test Automated Battery (CANTAB) - Spatial Working Memory, subtest [ Time Frame: Study Day 0 to Study Day 28 ]
  2. Change in the ADHD symptoms as reported on the clinician-rated Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS), subscale and total scale [ Time Frame: Study Day 0 to Study Day 28 ]
  3. Change in the Executive function measurements on the parent-completed Behavior Rating Inventory of Executive Function (BRIEF-Parent), subscale [ Time Frame: Study Day 0 to Study Day 28 ]
  4. Change in non-composite scores on the Test or Variables of Attention (TOVA 8) [ Time Frame: Study Day 0 to Study Day 28 ]
  5. Change in the Impairment Rating Scale (IRS) [ Time Frame: Study Day 0 to Study Day 28 ]
  6. Clinical Global Impression - Improvement Score (CGI-I) [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. Exploratory Measure - Responder Analysis [ Time Frame: Study Day 0 to Study Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674633


Locations
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United States, Alabama
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, Arizona
Melmed Center
Scottsdale, Arizona, United States, 85254
United States, California
Avida, Inc.
Newport Beach, California, United States, 92660
University of California Davis MIND Institute
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
Florida Clinical Research Center
Maitland, Florida, United States, 32751
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Massachusetts
South Shore Psychiatric Services
Marshfield, Massachusetts, United States, 02050
United States, Missouri
Midwest Research Group
Saint Charles, Missouri, United States, 63304
United States, Nevada
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
The Neuropsychiatric Clinic at Carolina Partners
Raleigh, North Carolina, United States, 27606
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
FutureSearch Trials
Dallas, Texas, United States, 75231
Bayou City Research, Ltd
Houston, Texas, United States, 77007
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Seattle Children's
Seattle, Washington, United States, 98121
Sponsors and Collaborators
Akili Interactive Labs, Inc.
Investigators
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Principal Investigator: Scott Kollins, PhD Duke Clinical Research Institution

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Responsible Party: Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier: NCT02674633     History of Changes
Other Study ID Numbers: Akili-001R
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Akili Interactive Labs, Inc.:
ADHD

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms