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

A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents, Aged 13-17 Years Old, Diagnosed With Attention Deficit Hyperactive Disorder (ADHD)

NCT04897074•Akili Interactive Labs, Inc.

View on ClinicalTrials.gov

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

Detailed Description

This study is a multi-center, unblinded/non-controlled study to evaluate objective attention functioning and ADHD symptoms and impairments in adolescents aged 13 to 17 years old, with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 4-weeks of AKL-T01 treatment. Up to 165 total participants from up to 20 sites will be enrolled. During the Screening/baseline, participants will undergo screening to evaluate eligibility for the study. Eligible participants will continue onto baseline procedures in the same visit. Treatment phase (Day 2-27) will involve using the digital therapy at home for each participant. Compliance with treatment/use requirements will be monitored remotely during this phase. An In-Clinic assessment will be completed on Day 28 to assess key outcomes.

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adolescents between the ages of 13 and 17 years and 10 months at time of consent (must be under 18 years at study completion)
•2. 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.
•3. Stably on or off ADHD medication for ≥4 weeks prior to study enrollment and throughout the 4-week study
•4. Baseline visit score on the TOVA-ACS score ≤ -1.8
•5. Access to and self-report of ability to connect wireless devices to a functional wireless network
•6. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
•7. Able to comply with all testing and study requirements
•8. Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
•9. Patient assent and caregiver informed consent
•10. Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 4-week study

Exclusion Criteria

•1. Current controlled or uncontrolled, comorbid psychiatric diagnosis that in the opinion of the Investigator may confound study data/assessments.
•2. 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.
•3. Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
•4. Recent history (6 months prior to screening) of substance use disorder
•5. History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
•6. Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea or motion sickness.
•7. Participation in a clinical trial within 3 months prior to screening.
•8. Plans to initiate, or to make significant changes in frequency, of non-pharmacological behavioral therapy during the study
•9. Color blindness as detected by Ishihara Color Blindness Test
•10. Urine test positive for nicotine or marijuana
+3 more criteria

Locations (14)

Melmed Center

Scottsdale, Arizona, United States

Cortica, Inc.

San Diego, California, United States

Accel Research Sites

Maitland, Florida, United States

MTP Psychiatry

Baltimore, Maryland, United States

Midwest Research Group

Saint Charles, Missouri, United States

Lincoln Pediatric Group

Lincoln, Nebraska, United States

Alivation Research

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, United States

MindPath Care Centers

Raleigh, North Carolina, United States

Key Dates

Start Date

June 29, 2021

Primary Completion Date

September 1, 2022

Completion Date

September 1, 2022

Last Updated

August 14, 2023

Enrollment

165

ACTUAL participants

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

AKL-T01

DEVICE

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

NCT07189442

Attention Deficit Hyperactivity Disorder (ADHD)Autism Spectrum Disorder (ASD)

View study

RECRUITINGNA

Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

NCT06123741

Attention Deficit Hyperactivity Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

Effects of Probiotics on the Gut-brain Axis in Children

Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery