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

NCT04897074 | Completed FDA Device

• 1 other identifier: Akili-051
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the effects of videogame-like digital therapy on attentional functioning and symptoms in adolescents ages 13-17 diagnosed with ADHD

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Primary objective of this study is to evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure after 4 weeks of treatment

  Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) of sustained and selective attention. Measures at Day 1 and Exit/Post-Treatment Visit Day 28 TOVA ACS is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated using the following formula: ACS = 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. ACS 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.

  After 4 weeks of treatment with AKL-T01

Secondary Outcomes (1)

• Secondary objective of this study is to evaluate the change in ADHD symptoms

  After 4 weeks of treatment with AKL-T01

Other Outcomes (10)

• To evaluate the change in patient and caregiver perceived cognitive deficits

  After 4 weeks of treatment with AKL-T01

• To evaluate changes in functional impairment

  After 4 weeks of treatment with AKL-T01

• To evaluate changes in TOVA metrics other than ACS - Ex-Gaussian Tau Total

  After 4 weeks of treatment with AKL-T01

Study Arms (1)

AKL-T01

EXPERIMENTAL

Digital Treatment

Device: AKL-T01

Interventions

AKL-T01 DEVICE

AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.

AKL-T01

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents between the ages of 13 and 17 years and 10 months at time of consent (must be under 18 years at study completion)
• Confirmed diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by MINI-Kid Version 7.0.2.
• Stably on or off ADHD medication for ≥4 weeks prior to study enrollment and throughout the 4-week study
• Baseline visit score on the TOVA-ACS score ≤ -1.8
• Access to and self-report of ability to connect wireless devices to a functional wireless network
• Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
• Able to comply with all testing and study requirements
• Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
• Patient assent and caregiver informed consent
• Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 4-week study

You may not qualify if:

• Current controlled or uncontrolled, comorbid psychiatric diagnosis that in the opinion of the Investigator may confound study data/assessments.
• Participant is currently considered at risk for attempting suicide, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior, in the opinion of the Investigator based on the MINI-kid clinical interview.
• Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
• Recent history (6 months prior to screening) of substance use disorder
• History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
• Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea or motion sickness.
• Participation in a clinical trial within 3 months prior to screening.
• Plans to initiate, or to make significant changes in frequency, of non-pharmacological behavioral therapy during the study
• Color blindness as detected by Ishihara Color Blindness Test
• Urine test positive for nicotine or marijuana
• Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
• Previous exposure to Akili Products within the 6 months prior to study enrollment
• Plans to initiate or make significant changes to frequency or duration of non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the study

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (14)

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

Cortica, Inc.

San Diego, California, 92121, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

MTP Psychiatry

Baltimore, Maryland, 21229, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Lincoln Pediatric Group

Lincoln, Nebraska, 68516, United States

Location

Alivation Research

Lincoln, Nebraska, 68526, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

MindPath Care Centers

Raleigh, North Carolina, 27606, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45206, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73106, United States

Location

Southeast Houston Research, Inc.

Houston, Texas, 77089, 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

• Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD. BMC Public Health. 2024 Apr 29;24(1):1195. doi: 10.1186/s12889-024-18597-5.

  PMID: 38685016 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: June 29, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (14)