STARS-ADHD: Software Treatment for Actively Reducing Severity of ADHD

• Sponsor: Akili Interactive Labs, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02674633
• Collaborator: (none)
• Enrollment: 348
• Locations: 20
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 17.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Device: AKL-T01; Device: AKL-T09	N/A

Detailed Description

The study will be a randomized, parallel group, controlled trial of two videogame-like (iPad-based) digital therapies. The study will consist of 3 primary phases: Screening, Washout/Baseline, and Treatment. During the Screening Phase (Day -28 to Day -7), participants will undergo screening to evaluate eligibility for the study. Screening may take place up to 28 days before the Baseline Visit (Day 0). For those children currently on medication for ADHD the Washout period will begin 7 days prior to Baseline where treatment will be discontinued. On Day 0, the Baseline visit will occur wherein additional eligibility criteria will be established. The Treatment Phase (Day 1 to Day 27) will involve using the digital therapy at home for each participant followed by an In-Clinic assessment on Day 28 to assess key outcomes. Compliance with treatment/use requirements will be monitored remotely during this phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Parallel-group, Intervention Study to Assess At-home, Game-based Digital Therapy for Treating Pediatric Participants Ages 8 to 12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: AKL-T01; Videogame-like digital therapy; Other Names: EVO Multi
Active Comparator: 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.	Device: AKL-T09; Videogame-like digital therapy; Other Names: EVO Words

Outcome Measures

Primary Outcome Measures

1. Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment) [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 Outcome Measures

1. ADHD-RS Total (Change From Baseline to Posttreatment) [Day 0 to Day 28]

   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.

2. ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment) [Day 0 to Day 28]

   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.

3. ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment) [Study Day 0 to Study Day 28]

   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.

4. BRIEF Working Memory Percentile (Change From Baseline to Posttreatment) [Day 0 to Day 28]

   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.

5. BRIEF Inhibit Percentile (Change From Baseline to Posttreatment) [Day 0 to Day 28]

   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.

6. Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) [Day 0 to Day 28]

   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.

7. CGI-I (at Posttreatment) [Day 28]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Confirmed ADHD diagnosis, any presentation, at Screening based on the Diagnostic and Statistical Manual of Mental Health-Fifth Edition criteria and established via the MINI-International Neuropsychiatric Interview for Children and Adolescents administered by a trained clinician

Screening/Baseline score on the clinician-rated ADHD-RS-IV score >= 28

Screening/Baseline score on the TOVA 8 API <= -1.8

Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen

Ability to follow written and verbal instructions (English), as assessed by the PI

Estimated Intelligence Quotient score >= 80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)

Ability to comply with all the testing and requirements.

Exclusion Criteria:

Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments. Participants with clinical history of learning disorders will be allowed to participate, provided the disorder does not impact their ability to participate in the trial based on PI judgment

Participants who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine clonidine, guanfacine)

Initiation within the last 4 weeks of behavioral therapy. Participants who have been in behavior therapy consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Participants planning on changing or initiating behavior therapy during the course of the study will be excluded

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 Columbia Suicide Severity Rating Scale at screening

Motor condition (e.g., physical deformity of the hands/arms; prostheses) that prevents game playing as reported by the parent or observed by the investigator

Recent history (within the past 6 months) of suspected substance abuse or dependence

History of seizures (exclusive of febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder

Has participated in a clinical trial within 90 days prior to screening

Diagnosis of or parent-reported color blindness (Confirmed in-clinic via ICBT)

Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the intervention)

Regular use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments

Any other medical condition that in the opinion of the investigator may confound study data/assessments

Has a sibling also enrolled/currently participating in the same study

Has previously participated in a study of Akili's EVO videogame-like digital therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research	Dothan	Alabama	United States	36303
2	Melmed Center	Scottsdale	Arizona	United States	85254
3	Avida, Inc.	Newport Beach	California	United States	92660
4	University of California Davis MIND Institute	Sacramento	California	United States	95817
5	University of California, San Francisco	San Francisco	California	United States	94143
6	Meridien Research	Bradenton	Florida	United States	34208
7	Florida Clinical Research Center	Maitland	Florida	United States	32751
8	Capstone Clinical Research	Libertyville	Illinois	United States	60048
9	Kennedy Krieger Institute	Baltimore	Maryland	United States	21205
10	South Shore Psychiatric Services	Marshfield	Massachusetts	United States	02050
11	Midwest Research Group	Saint Charles	Missouri	United States	63304
12	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada	United States	89128
13	Duke Child and Family Study Center	Durham	North Carolina	United States	27705
14	The Neuropsychiatric Clinic at Carolina Partners	Raleigh	North Carolina	United States	27606
15	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
16	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
17	FutureSearch Trials	Dallas	Texas	United States	75231
18	Bayou City Research, Ltd	Houston	Texas	United States	77007
19	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
20	Seattle Children's	Seattle	Washington	United States	98121

Sponsors and Collaborators

• Akili Interactive Labs, Inc.

Investigators

• Principal Investigator: Scott Kollins, PhD, Duke Clinical Research Institution

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 4, 2016

More Information

Publications

None provided.

• Responsible Party: Akili Interactive Labs, Inc.
• ClinicalTrials.gov Identifier: NCT02674633
• Other Study ID Numbers: Akili-001R
• First Posted: Feb 4, 2016
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Akili Interactive Labs, Inc.: ADHD
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Pre-assignment Detail	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)
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

Baseline Characteristics

Arm/Group Title	AKL-T01 (EVO Multi)	AKL-T09 (EVO Words)	Total
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 Participants	180	168	348
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.711 (1.322)	9.601 (1.341)	9.658 (1.331)
Sex: Female, Male (Count of Participants)
Female	55 30.6%	45 26.8%	100 28.7%
Male	125 69.4%	123 73.2%	248 71.3%
Race/Ethnicity, Customized (Count of 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 (participants) [Number]
United States	180 100%	168 100%	348 100%

Outcome Measures

1. Primary Outcome

Title	Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)
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

Outcome Measure Data

Analysis Population Description

Intent to Treat Population - all randomized participants

Arm/Group Title	AKL-T01 (EVO Multi)	AKL-T09 (EVO Words)
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
Measure Participants	180	168
Mean (Standard Deviation) [z-score]	0.93 (3.2)	0.03 (3.2)

2. Secondary Outcome

Title	ADHD-RS Total (Change From Baseline to Posttreatment)
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

Outcome Measure Data

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)
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
Measure Participants	173	164
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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)
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
Measure Participants	173	164
Mean (Standard Deviation) [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)
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

Outcome Measure Data

Analysis Population Description

Intent to Treat Population - all randomized participants

Arm/Group Title	AKL-T01 (EVO Multi)	AKL-T09 (EVO Words)
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
Measure Participants	175	164
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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)
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
Measure Participants	166	155
Mean (Standard Deviation) [percentile]	-3.1 (8.0)	-3.3 (9.4)

6. Secondary Outcome

Title	BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)
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

Outcome Measure Data

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)
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
Measure Participants	166	155
Mean (Standard Deviation) [percentile]	-2.8 (13.3)	-3.5 (9.2)

7. Secondary Outcome

Title	Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment)
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

Outcome Measure Data

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)
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
Measure Participants	171	161
Mean (Standard Deviation) [score on a scale]	-0.5 (1.4)	-0.4 (1.2)

8. Secondary Outcome

Title	CGI-I (at Posttreatment)
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

Outcome Measure Data

Analysis Population Description

Intent to Treat Population - all randomized participants

Arm/Group Title	AKL-T01 (EVO Multi)	AKL-T09 (EVO Words)
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
Measure Participants	175	164
Mean (Standard Deviation) [score on a scale]	3.4 (0.9)	3.4 (0.9)

Adverse Events

Time Frame	28 Days
Arm/Group Title	AKL-T01 (EVO Multi)		AKL-T09 (EVO Words)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/168 (0%)
Serious Adverse Events
	AKL-T01 (EVO Multi)		AKL-T09 (EVO Words)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/168 (0%)
Other (Not Including Serious) Adverse Events
	AKL-T01 (EVO Multi)		AKL-T09 (EVO Words)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/180 (6.7%)		3/168 (1.8%)
Gastrointestinal disorders
Nausea	1/180 (0.6%)		0/168 (0%)
Nervous system disorders
Headache	3/180 (1.7%)		2/168 (1.2%)
Dizziness	1/180 (0.6%)		0/168 (0%)
Psychiatric disorders
Frustration tolerance decreased	5/180 (2.8%)		0/168 (0%)
Emotional disorder	2/180 (1.1%)		1/168 (0.6%)
Aggression	1/180 (0.6%)		0/168 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.