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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674633
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : July 24, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Akili Interactive Labs, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Disorder With Hyperactivity
Interventions Device: AKL-T01
Device: AKL-T09
Enrollment 348
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description

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, 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

Period Title: Overall Study
Started 180 168
Completed 175 164
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             3             2
Physician Decision             1             0
Withdrawal by Parent/Guardian             1             2
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words) Total
Hide Arm/Group Description

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, 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 of all reporting groups
Overall Number of Baseline Participants 180 168 348
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 168 participants 348 participants
9.711  (1.322) 9.601  (1.341) 9.658  (1.331)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 168 participants 348 participants
Female
55
  30.6%
45
  26.8%
100
  28.7%
Male
125
  69.4%
123
  73.2%
248
  71.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 168 participants 348 participants
White
133
  73.9%
119
  70.8%
252
  72.4%
Black or African American
25
  13.9%
26
  15.5%
51
  14.7%
Other
22
  12.2%
23
  13.7%
45
  12.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 180 participants 168 participants 348 participants
180 168 348
1.Primary Outcome
Title Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population - all randomized participants
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: z-score
0.93  (3.2) 0.03  (3.2)
2.Secondary Outcome
Title ADHD-RS Total (Change From Baseline to Posttreatment)
Hide Description 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.
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 173 164
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.2  (7.6) -5.7  (8.2)
3.Secondary Outcome
Title ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment)
Hide Description

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.

Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 173 164
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.6  (4.8) -3.2  (5.0)
4.Secondary Outcome
Title ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment)
Hide Description

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.

Time Frame Study Day 0 to Study Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population - all randomized participants
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 175 164
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.6  (4.2) -2.5  (4.5)
5.Secondary Outcome
Title BRIEF Working Memory Percentile (Change From Baseline to Posttreatment)
Hide Description

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.

Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 166 155
Mean (Standard Deviation)
Unit of Measure: percentile
-3.1  (8.0) -3.3  (9.4)
6.Secondary Outcome
Title BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)
Hide Description

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.

Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 166 155
Mean (Standard Deviation)
Unit of Measure: percentile
-2.8  (13.3) -3.5  (9.2)
7.Secondary Outcome
Title Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment)
Hide Description

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.

Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 171 161
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.5  (1.4) -0.4  (1.2)
8.Secondary Outcome
Title CGI-I (at Posttreatment)
Hide Description

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.

Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population - all randomized participants
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description:

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, 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 Number of Participants Analyzed 175 164
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.4  (0.9) 3.4  (0.9)
Time Frame 28 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Hide Arm/Group Description

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, 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

All-Cause Mortality
AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/168 (0.00%) 
Hide Serious Adverse Events
AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/168 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AKL-T01 (EVO Multi) AKL-T09 (EVO Words)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/180 (6.67%)   3/168 (1.79%) 
Gastrointestinal disorders     
Nausea * 1  1/180 (0.56%)  0/168 (0.00%) 
Nervous system disorders     
Headache * 1  3/180 (1.67%)  2/168 (1.19%) 
Dizziness * 1  1/180 (0.56%)  0/168 (0.00%) 
Psychiatric disorders     
Frustration tolerance decreased * 1  5/180 (2.78%)  0/168 (0.00%) 
Emotional disorder * 1 [1]  2/180 (1.11%)  1/168 (0.60%) 
Aggression * 1  1/180 (0.56%)  0/168 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
[1]
The lower level term 'emotional reaction' better describes the verbatim term reported from the site.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn Jenkins
Organization: Akili Interactive Labs
Phone: 8572543399
EMail: kjenkins@akiliinteractive.com
Layout table for additonal information
Responsible Party: Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier: NCT02674633    
Other Study ID Numbers: Akili-001R
First Submitted: February 2, 2016
First Posted: February 4, 2016
Results First Submitted: July 9, 2020
Results First Posted: July 24, 2020
Last Update Posted: August 14, 2020