Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD
Brief summary
This is an exploratory study to assess potential maintenance of clinical benefit (cognition and symptoms) following 4 weeks of at-home digital therapy in ADHD children.
Detailed description
The study will be a blinded (investigators and outcome assessors), randomized (from parent study Akili-001R), parallel group, follow-up study of the sustained effects of 4-weeks of treatment with either AKL-T01 (EVO Multi) game-based digital therapy or AKL-T09 (EVO Words) game-based digital therapy. The trial will consist of 4 visits: Screening (to be conducted at the same time as the end-of-study visit for the parent study Akili-001R), FU-Day 28 visit (conducted in clinic), and FU-Day 56 and FU-Day 84 visits (conducted remotely via electronically captured parent reported outcomes).
Interventions
DEVICEEVO
videogame-like digital therapy
Sponsors
Akili Interactive Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Completed Akili Study Akili-001R including all clinical assessments at DAY28 per the study protocol * Ability to comply with all the testing and requirements per this protocol
Exclusion criteria
* Participant is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by C-SSRS at screening * Participant has demonstrated clinically significant deterioration in functioning as assessed by PI and other study staff that would contraindicate continued participation in the follow-up study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy | Day 0 to Day 28 | TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = 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. API 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. The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy | Day 0 to Day 28 | TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = 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. API 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. The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AKL-T01 (EVO Multi) AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633) | 88 |
| AKL-T09 (EVO Words) AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633) | 87 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 22 |
Baseline characteristics
| Characteristic | AKL-T09 (EVO Words) | Total | AKL-T01 (EVO Multi) |
|---|---|---|---|
| Age, Categorical <=18 years | 87 Participants | 175 Participants | 88 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 87 Participants | 175 Participants | 88 Participants |
| Sex: Female, Male Female | 21 Participants | 51 Participants | 30 Participants |
| Sex: Female, Male Male | 66 Participants | 124 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 87 |
| other Total, other adverse events | 0 / 88 | 0 / 87 |
| serious Total, serious adverse events | 0 / 88 | 0 / 87 |
Outcome results
Primary
Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy
TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = 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. API 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. The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study.
Time frame: Day 0 to Day 28
Population: All subjects who were randomized to the AKL-T01 arm in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AKL-T01 (EVO Multi) | Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy | -0.407 z-score | Standard Deviation 2.823 |
Secondary
Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy
TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = 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. API 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. The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study.
Time frame: Day 0 to Day 28
Population: All subjects who were enrolled in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AKL-T01 (EVO Multi) | Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy | -0.407 z-score | Standard Deviation 2.823 |
| AKL-T09 (EVO Words) | Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy | -0.615 z-score | Standard Deviation 3.338 |