NCT02674633

Software Treatment for Actively Reducing Severity of ADHD

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	AKL-T01	Videogame-like digital therapy
DEVICE	AKL-T09	Videogame-like digital therapy

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-07-31
• Completion: 2017-08-31
• First posted: 2016-02-04
• Last updated: 2020-08-14
• Results posted: 2020-07-24

Locations

20 sites across 1 country: United States