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

Attention Deficit Disorder With Hyperactivity Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis
Clinical Trial Details
NCT number NCT02828644
Study type Interventional
Source Akili Interactive Labs, Inc.
Contact
Status Completed
Phase N/A
Start date August 2016
Completion date February 2018
View Details
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