NCT02828644

Software Treatment for Actively Reducing Severity of ADHD - Follow Up

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	EVO	videogame-like digital therapy

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2016-07-11
• Last updated: 2019-02-12
• Results posted: 2019-02-12

Locations

15 sites across 1 country: United States