Software Treatment for Actively Reducing Severity of ADHD

NCT ID: NCT02674633

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-08-31

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.

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

AKL-T01

Intervention Type: DEVICE

Videogame-like digital therapy

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.

Group Type: ACTIVE_COMPARATOR

AKL-T09

Intervention Type: DEVICE

Videogame-like digital therapy

Interventions

AKL-T01

Videogame-like digital therapy

Intervention Type: DEVICE

AKL-T09

Videogame-like digital therapy

Intervention Type: DEVICE

Other Intervention Names

EVO Multi; EVO Words

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akili Interactive Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kollins, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institution

Locations

Harmonex Neuroscience Research

Dothan, Alabama, United States

Melmed Center

Scottsdale, Arizona, United States

Avida, Inc.

Newport Beach, California, United States

University of California Davis MIND Institute

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

Meridien Research

Bradenton, Florida, United States

Florida Clinical Research Center

Maitland, Florida, United States

Capstone Clinical Research

Libertyville, Illinois, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

South Shore Psychiatric Services

Marshfield, Massachusetts, United States

Midwest Research Group

Saint Charles, Missouri, United States

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

Duke Child and Family Study Center

Durham, North Carolina, United States

The Neuropsychiatric Clinic at Carolina Partners

Raleigh, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

FutureSearch Trials

Dallas, Texas, United States

Bayou City Research, Ltd

Houston, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Seattle Children's

Seattle, Washington, United States

Countries

United States

References

Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.

Reference Type: DERIVED

PMID: 33334505 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Akili-001R

Identifier Type: -

Identifier Source: org_study_id