Software Treatment for Actively Reducing Severity of ADHD - Follow Up (STARS-ADHD2)

Akili Interactive Labs

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Device: EVO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02828644

Akili-001R-FollowUp

Details and patient eligibility

About

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.

Full 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).

Enrollment: 175 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups

EVO Multitasking

Active Comparator group

Description:

EVO Multitasking is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R)

Treatment:

Device: EVO

EVO Words

Active Comparator group

Description:

EVO Words is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R)

Treatment:

Device: EVO