Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Other: Digital Treatment
- Registration Number
- NCT05183919
- Lead Sponsor
- Akili Interactive Labs, Inc.
- Brief Summary
The purpose of this study is to evaluate the effects of the videogame-like digital therapy on attentional functioning and symptoms in Adults diagnosed with ADHD.
- Detailed Description
This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment.
A maximum of 325 total participants from 12-30 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 2-42) 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 42 to assess key outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 223
- Adults 18 years and older
- Diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by Mini International Neuropsychiatric Interview (MINI) for Attention - Deficit / Hyperactivity Disorders Studies (Adult) 7.0.2
- Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
- Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
- Baseline visit score on the ADHD-RS-IV of ≥ 24
- Baseline visit score on the TOVA-ACS score ≤ -1.8
- Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
- 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
- Completion of informed consent form
- Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments.
- Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
- History of moderate or severe substance use disorder within the last 12 months prior to informed consent
- 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.
- Color blindness as detected by Ishihara Color Blindness Test
- Positive urine drug screen
- Current or recent (3 months prior to screening) history of heavy smoking defined as the equivalent of greater than or equal to a pack of cigarettes a day
- Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
- Participation in a clinical trial within 3 months prior to screening.
- Previous exposure to Akili products within the 6 months prior to study enrollment
- Plans to initiate new concomitant medications during the primary study, except for common over the counter (OTC) (e.g., ibuprofen, acetaminophen) and prescription medications (e.g., antibiotics) for minor transient ailments.
- Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
- Planned initiation of, or significant changes in frequency of, non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the primary study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AKL-T01 Digital Treatment Digital treatment
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure, Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS), of sustained and selective attention, after 6 weeks of treatment with AKL-T01 Study Day 1 to Study Day 42 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 42
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: TOVA 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. 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.
- Secondary Outcome Measures
Name Time Method To evaluate the change in ADHD symptoms, as determined by change in the ADHD Rating Scale-IV with adult prompts inattention sub-scale and total scale scores, after 6 weeks of treatment with AKL-T01 Study Day 1 to Study Day 42 Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).
ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.
Trial Locations
- Locations (14)
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Behavioral Clinical Research, Inc.
🇺🇸Miami Lakes, Florida, United States
Melmed Center
🇺🇸Scottsdale, Arizona, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
CNS Clinical Research Trials
🇺🇸Garden Grove, California, United States
Accel Research Sites
🇺🇸Maitland, Florida, United States
Midwest Research Group
🇺🇸Saint Charles, Missouri, 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
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Trials
🇺🇸Dallas, Texas, United States
Southeast Houston Research, Inc.
🇺🇸Houston, Texas, United States