Back to resultsSoftware Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AKL-T01
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Melmed Center
- Cortica, Inc.
- Accel Research Sites
- MTP Psychiatry
- Midwest Research Group
- Lincoln Pediatric Group
- Alivation Research
- Center for Psychiatry and Behavioral Medicine, Inc.
- Albuquerque Neuroscience, Inc.
- MindPath Care Centers
- Cincinnati Children's Hospital
- Dayton Clinical Research
- IPS Research
- Southeast Houston Research, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AKL-T01
Arm Description
Digital Treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04897074
First Posted
May 18, 2021
Last Updated
August 4, 2023
Sponsor
Akili Interactive Labs, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04897074
Brief Title
Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akili Interactive Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AKL-T01
Arm Type
Experimental
Arm Description
Digital Treatment
Intervention Type
Device
Intervention Name(s)
AKL-T01
Intervention Description
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
After 4 weeks of treatment with AKL-T01
Secondary Outcome Measure Information:
Title
Secondary objective of this study is to evaluate the change in ADHD symptoms
Description
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.
Time Frame
After 4 weeks of treatment with AKL-T01
Other Pre-specified Outcome Measures:
Title
To evaluate the change in patient and caregiver perceived cognitive deficits
Description
The change will be determined in selected items from the PROMIS® Parent Proxy Item Bank v1.1 - Cognitive Function and the PROMIS® Pediatric Item Bank v1.0-Cognitive Function
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in functional impairment
Description
The change will be determined in ADHD-Rating Scale 5 Home Version relationship with significant others, peer relationships, academic functioning, behavioral functioning, homework functioning and self-esteem domains.
ADHD Rating Scale-5 is a clinician-administered questionnaire completed by the child's parent. The scale asses six domains of impairment that are common among children with ADHD with one question item per domain. The scale is administered twice, once after each set of symptom subscale items (Inattention and Hyperactivity-Impulsivity). Each item is rated on a 4-point scale; No Problem (0), Minor Problem (1), Moderate Problem (2), Severe Problem (3). A higher score indicates more severe impairment due to ADHD symptoms and behaviors.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - Ex-Gaussian Tau Total
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Ex-Gaussian Tau.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
Ex-Gaussian Tau: The exponential decay (or "right hand tail") of the correct response times, modeled using the Ex-Gaussian distribution. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - Commission Errors Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Commission Errors Standard.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
-- Commission Errors Standard Score H2: Commission errors are the number of times the patient clicked the microswitch at the incorrect time. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - Response Time Variability Standard Score Total
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Variability Standard Score Total.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
- - Response Time Variability Standard Score Total: The standard score for the first standard deviation of the correct response times. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - Response Time Mean Standard Score H1
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Mean Standard Score H1.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
- Response Time Mean Standard Score H1:The standard score for the mean response time of the correct responses. H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - D-Prime Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - D-Prime Standard Score H2.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
-- D-Prime Standard Score H2: D-Prime score is a response discriminability score reflecting the ratio of hits to false alarms. The measure is derived from Signal Detection Theory and has been shown to help distinguish non-impaired individuals from those diagnosed with attention disorders. The score reflects the accuracy of target (signal) and nontarget (noise) discrimination and can be interpreted as a measure of perceptual sensitivity. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate changes in TOVA metrics other than ACS - Omission Errors Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Omission Errors Standard Score H2.
TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.
TOVA metric evaluated for change is:
- - Omission Errors Standard Score H2: Omission Errors are the number of times the patient failed to click the microswitch when the target was presented. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate response rates for TOVA-ACS
Description
The change will be determined in responder analyses for Test of Variables of Attention, Attention Comparison Score (TOVA-ACS).
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 a standardized formula.
Responder rates will be 1.0-point improvement and TOVA-ACS greater then or equal to 1.0 at exit visit.
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
Title
To evaluate response rates for ADHD Rating Scale-5
Description
The change will be determined in responder analyses for ADHD Rating Scale 5.
ADHD Rating Scale-5 is a clinician-administered questionnaire completed by the child's parent. The scale asses six domains of impairment that are common among children with ADHD with one question item per domain.
Greater than or equal to 30% improvement in ADHD RS-5 total score from baseline after 4 weeks of AKL-T01 treatment.
Measures at Day 1 and Exit/Post-Treatment Visit Day 28.
Time Frame
After 4 weeks of treatment with AKL-T01
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Melmed Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Cortica, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Accel Research Sites
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
MTP Psychiatry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Lincoln Pediatric Group
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Alivation Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
MindPath Care Centers
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Southeast Houston Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
We'll reach out to this number within 24 hrs