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Attention Deficit Hyperactivity DisorderNCT04897074

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

A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
AKL-T01
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
14 sitesUnited States
Study dates
29 Jun 2021to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • MTP Psychiatry

    Baltimore, Maryland, 21229

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45206

  • Dayton Clinical Research

    Dayton, Ohio, 45409

  • Southeast Houston Research, Inc.

    Houston, Texas, 77089

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • Lincoln Pediatric Group

    Lincoln, Nebraska, 68516

  • Alivation Research

    Lincoln, Nebraska, 68526

  • Accel Research Sites

    Maitland, Florida, 32751

  • IPS Research

    Oklahoma City, Oklahoma, 73106

  • MindPath Care Centers

    Raleigh, North Carolina, 27606

  • Midwest Research Group

    Saint Charles, Missouri, 63304

  • Cortica, Inc.

    San Diego, California, 92121

  • Melmed Center

    Scottsdale, Arizona, 85254

Other trials in United States

About this study

Official title: 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)

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

Read the 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.

Being tested
AKL-T01
Keywords
ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AKL-T01Device

    AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.

Study groups in NCT04897074
Study groupRoleWhat they receive
AKL-T01ExperimentalDigital Treatment
Receives: Device: AKL-T01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: After 4 weeks of treatment with AKL-T01

Secondary outcomes (1)

  1. Secondary objective of this study is to evaluate the change in ADHD symptoms

    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.

    Measured: After 4 weeks of treatment with AKL-T01

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start29 Jun 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04897074
Sponsor's protocol ID
Akili-051
Status last verified
Aug 2023
First submitted
18 May 2021
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Stamatis CA, Heusser AC, Simon TJ, Ala'ilima T, Kollins SH. Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01. Transl Psychiatry. 2024 Aug 11;14(1):328. doi: 10.1038/s41398-024-03045-0.

    PubMed 39128918

  • Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD. BMC Public Health. 2024 Apr 29;24(1):1195. doi: 10.1186/s12889-024-18597-5.

    PubMed 38685016

Questions about this trial

What is this clinical trial studying?

A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: After 4 weeks of treatment with AKL-T01). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04897074, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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