Clinical trial NCT02674633: Software Treatment for Actively Reducing Severity of ADHD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 348
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Minimum number of subjects = 300, Anticipated number of subjects = 330, Maximum number of subjects = 1,000
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test of Variables of Attention-Attention Performance Index (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: ADHD-RS Total (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
measure: ADHD-RS Inattentive Subscale (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
measure: ADHD-RS Hyperactivity Subscale (Change From Baseline to Posttreatment)
timeFrame: Study Day 0 to Study Day 28
measure: BRIEF Working Memory Percentile (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
measure: BRIEF Inhibit Percentile (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
measure: Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment)
timeFrame: Day 0 to Day 28
measure: CGI-I (at Posttreatment)
timeFrame: Day 28
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Newport Beach
country: United States
facility: Avida, Inc.
state: California
city: Sacramento
country: United States
facility: University of California Davis MIND Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Marshfield
country: United States
facility: South Shore Psychiatric Services
state: Massachusetts
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: Nevada
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
city: Raleigh
country: United States
facility: The Neuropsychiatric Clinic at Carolina Partners
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Duke Clinical Research Institution
name: Scott Kollins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kollins SH, DeLoss DJ, Canadas E, Lutz J, Findling RL, Keefe RSE, Epstein JN, Cutler AJ, Faraone SV. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health. 2020 Apr;2(4):e168-e178. doi: 10.1016/S2589-7500(20)30017-0. Epub 2020 Feb 24.