Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02828644
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2016-06-30
Brief Title:
Software Treatment for Actively Reducing Severity of ADHD - Follow Up
Sponsor:
Akili Interactive Labs Inc
Organization:
Akili Interactive Labs Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARS-ADHD2
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None