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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Device: AKL-T01

• Registration Number: NCT04897074
• Lead Sponsor: Akili Interactive Labs, Inc.

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 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.

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2021-06-29
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-08
• Disposition First Submitted: 2023-08-04
• Last Update Submitted: 2023-08-04
• Disposition First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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
11. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
12. Previous exposure to Akili Products within the 6 months prior to study enrollment
13. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AKL-T01	AKL-T01	Digital Treatment

Primary Outcome Measures

Name	Time	Method
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	After 4 weeks of treatment with AKL-T01	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.

Secondary Outcome Measures

Name	Time	Method
Secondary objective of this study is to evaluate the change in ADHD symptoms	After 4 weeks of treatment with AKL-T01	Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-5 inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 28).; ADHD Rating Scale-5 is a clinician-administered questionnaire completed by the child's parent. The scale consists of two symptom subscales: Inattention and Hyperactivity-Impulsivity. The Inattention subscale raw score is computed by summing the item scores for 9 items. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; Never or Rarely (0), Sometimes (1), Often (2), Very Often (3) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors.

Trial Locations

Locations (14)

Southeast Houston Research, Inc.; 🇺🇸 Houston, Texas, United States

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

IPS Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Midwest Research Group; 🇺🇸 Saint Charles, Missouri, United States

Lincoln Pediatric Group; 🇺🇸 Lincoln, Nebraska, United States

MindPath Care Centers; 🇺🇸 Raleigh, North Carolina, United States

Alivation Research; 🇺🇸 Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine, Inc.; 🇺🇸 Las Vegas, Nevada, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Albuquerque Neuroscience, Inc.; 🇺🇸 Albuquerque, New Mexico, United States

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States