Software Treatment for Actively Reducing Severity of ADHD

NCT02674633 | Completed Results

• 1 other identifier: Akili-001R
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 20

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)

  TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study.

  Day 0 to Day 28

Secondary Outcomes (7)

• ADHD-RS Total (Change From Baseline to Posttreatment)

  Day 0 to Day 28

• ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment)

  Day 0 to Day 28

• ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment)

  Study Day 0 to Study Day 28

• BRIEF Working Memory Percentile (Change From Baseline to Posttreatment)

  Day 0 to Day 28

• BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)

  Day 0 to Day 28

Study Arms (2)

AKL-T01 (EVO Multi)

ACTIVE COMPARATOR

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

AKL-T09 (EVO Words)

ACTIVE COMPARATOR

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

Interventions

AKL-T01 DEVICE

Videogame-like digital therapy

Also known as: EVO Multi

AKL-T01 (EVO Multi)

AKL-T09 DEVICE

Videogame-like digital therapy

Also known as: EVO Words

AKL-T09 (EVO Words)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (20)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

Avida, Inc.

Newport Beach, California, 92660, United States

Location

University of California Davis MIND Institute

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

South Shore Psychiatric Services

Marshfield, Massachusetts, 02050, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

The Neuropsychiatric Clinic at Carolina Partners

Raleigh, North Carolina, 27606, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

Bayou City Research, Ltd

Houston, Texas, 77007, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Seattle Children's

Seattle, Washington, 98121, United States

Location

Related Publications (2)

• Stamatis CA, Heusser AC, Simon TJ, Ala'ilima T, Kollins SH. Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01. Transl Psychiatry. 2024 Aug 11;14(1):328. doi: 10.1038/s41398-024-03045-0.

  PMID: 39128918 DERIVED

• 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.

  PMID: 33334505 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Kathryn Jenkins
• Organization: Akili Interactive Labs

kjenkins@akiliinteractive.com

8572543399

Study Officials

• Scott Kollins, PhD

  Duke Clinical Research Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 4, 2016
• Study Start: May 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: August 14, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-08

Locations

US (20)