Clinical trial NCT02828644: Software Treatment for Actively Reducing Severity of ADHD - Follow Up
Official title: An Exploratory Study to Assess the Sustained Effects of Digital Therapy in Pediatric Subjects 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: 2016-07-11
Enrollment: 175
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: 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
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
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: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
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: Durham
country: United States
facility: Duke University
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: 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: