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

Completed · Not applicable

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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

Key facts

Study ID

NCT04897074

Run by

Akili Interactive Labs, Inc.

People needed

165

Starts

2021-06-29

Expected to finish

2022-09-01

Last updated by the study team

2023-08-14

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• Southeast Houston Research, Inc. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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