Software Treatment for Actively Reducing Severity of ADHD — STARS-ADHD  

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

• NCT number: NCT02674633
• Study type: Interventional
• Source: Akili Interactive Labs, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: August 31, 2017