Status:
COMPLETED
Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
Lead Sponsor:
Akili Interactive Labs, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
13-17 years
Phase:
NA
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
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 A...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04897074
Start Date
June 29 2021
End Date
September 1 2022
Last Update
August 14 2023
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Melmed Center
Scottsdale, Arizona, United States, 85254
2
Cortica, Inc.
San Diego, California, United States, 92121
3
Accel Research Sites
Maitland, Florida, United States, 32751
4
MTP Psychiatry
Baltimore, Maryland, United States, 21229