Trial Outcomes & Findings for Software Treatment for Actively Reducing Severity of ADHD (NCT NCT02674633)
NCT ID: NCT02674633
Last Updated: 2020-08-14
Results Overview
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.
COMPLETED
NA
348 participants
Day 0 to Day 28
2020-08-14
Participant Flow
Participants who met full criteria for ADHD at Screening and who the PI believed were not optimally treated with current medication were eligible to washout their medication regimen. For those electing to washout, treatment was discontinued between 7 and 3 days prior to their scheduled Baseline Visit.
Participant milestones
| Measure |
AKL-T01 (EVO Multi)
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
168
|
|
Overall Study
COMPLETED
|
175
|
164
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
AKL-T01 (EVO Multi)
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
1
|
2
|
Baseline Characteristics
Software Treatment for Actively Reducing Severity of ADHD
Baseline characteristics by cohort
| Measure |
AKL-T01 (EVO Multi)
n=180 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=168 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.711 years
STANDARD_DEVIATION 1.322 • n=5 Participants
|
9.601 years
STANDARD_DEVIATION 1.341 • n=7 Participants
|
9.658 years
STANDARD_DEVIATION 1.331 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=5 Participants
|
168 participants
n=7 Participants
|
348 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: Intent to Treat Population - all randomized participants
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.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=180 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=168 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)
|
0.93 z-score
Standard Deviation 3.2
|
0.03 z-score
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all randomized participants) from whom both Day 0 and Day 28 data was able to be collected in full. For the ADHD-RS, this population included all participants for whom all 18 items of the rating scale were completed. In the AKL-T01 arm, two participants were missing a response for at least one item of the ADHD-RS.
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. A negative change in total score indicates improvement from Day 0 to Day 28.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=173 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=164 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
ADHD-RS Total (Change From Baseline to Posttreatment)
|
-6.2 score on a scale
Standard Deviation 7.6
|
-5.7 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all randomized participants) from whom both Day 0 and Day 28 data was able to be collected in full. For the ADHD-RS, this population included all participants for whom all 9 items of the sub-scale were completed. In the AKL-T01 arm, two participants were missing a response for at least one item of the sub-scale.
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. The 18 items are grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Each subscale produces a sub-scale score ranging from 0-27. A higher subscale score indicates more severe ADHD symptoms and behaviors. A negative change indicated improvement on the subscale from Day 0 to Day 28.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=173 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=164 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment)
|
-3.6 score on a scale
Standard Deviation 4.8
|
-3.2 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Study Day 0 to Study Day 28Population: Intent to Treat Population - all randomized participants
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. The 18 items are grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Each subscale produces a sub-scale score ranging from 0-27. A higher subscale score indicates more severe ADHD symptoms and behaviors. A negative change indicated improvement on the subscale from Day 0 to Day 28.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=175 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=164 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment)
|
-2.6 score on a scale
Standard Deviation 4.2
|
-2.5 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT from whom both Day 0 and Day 28 data was able to be collected in full. For the BRIEF WM, this includes all participants for whom all items of the sub-scale were completed. In both the AKL-T01 and AKL-T09 arms 9 participants were missing a response for at least one item (18 total participants were missing responses to items).
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF working memory metacognition subscale measures the participants ability to hold information when completing a task in a sequential manner. A negative change in percentile indicated an improvement on the subscale.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=166 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=155 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
BRIEF Working Memory Percentile (Change From Baseline to Posttreatment)
|
-3.1 percentile
Standard Deviation 8.0
|
-3.3 percentile
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT from whom both Day 0 and Day 28 data was able to be collected in full. For BRIEF Inhibit this includes all participants for whom all items of the sub-scale were completed. In both the AKL-T01 and AKL-T09 arms 9 participants were missing a response for at least one item (18 total participants were missing responses to items).
The Behavior Rating Inventory of Executive Function (BRIEF) is a parent-rated form that assesses everyday behavior associated with specific domains of the executive functions of their child. The BRIEF Inhibit subscale measures the participant's ability to control impulses and to stop engaging in a behavior. A negative change in percentile indicated an improvement on the subscale.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=166 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=155 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)
|
-2.8 percentile
Standard Deviation 13.3
|
-3.5 percentile
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT from whom both Day 0 and Day 28 data was able to be collected in full. For the IRS, this includes all participants for whom item #8 (overall impairmant) was completed. In the AKL-T01 arm, item #8 was not answered by 4 participants. In the AKL-T09 arm, item #8 was not answered by 3 participants.
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=171 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=161 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment)
|
-0.5 score on a scale
Standard Deviation 1.4
|
-0.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Day 28Population: Intent to Treat Population - all randomized participants
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Outcome measures
| Measure |
AKL-T01 (EVO Multi)
n=175 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=164 Participants
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
CGI-I (at Posttreatment)
|
3.4 score on a scale
Standard Deviation 0.9
|
3.4 score on a scale
Standard Deviation 0.9
|
Adverse Events
AKL-T01 (EVO Multi)
AKL-T09 (EVO Words)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AKL-T01 (EVO Multi)
n=180 participants at risk
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
|
AKL-T09 (EVO Words)
n=168 participants at risk
AKL-T09, or EVO Words, is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.
AKL-T09: Videogame-like digital therapy
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.56%
1/180 • 28 Days
|
0.00%
0/168 • 28 Days
|
|
Nervous system disorders
Headache
|
1.7%
3/180 • 28 Days
|
1.2%
2/168 • 28 Days
|
|
Nervous system disorders
Dizziness
|
0.56%
1/180 • 28 Days
|
0.00%
0/168 • 28 Days
|
|
Psychiatric disorders
Frustration tolerance decreased
|
2.8%
5/180 • 28 Days
|
0.00%
0/168 • 28 Days
|
|
Psychiatric disorders
Emotional disorder
|
1.1%
2/180 • 28 Days
|
0.60%
1/168 • 28 Days
|
|
Psychiatric disorders
Aggression
|
0.56%
1/180 • 28 Days
|
0.00%
0/168 • 28 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place