Software Treatment for Actively Reducing Severity of ADHD - Follow Up
Status: | Completed |
---|---|
Conditions: | Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 8 - 12 |
Updated: | 2/14/2019 |
Start Date: | August 2016 |
End Date: | February 2018 |
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)
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.
and symptoms) following 4 weeks of at-home digital therapy in ADHD children.
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 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).
Inclusion Criteria:
- Completed Akili Study Akili-001R including all clinical assessments at DAY28 per the
study protocol
- Ability to comply with all the testing and requirements per this protocol
Exclusion Criteria:
- Participant is currently considered a suicide risk in the opinion of the Investigator,
has previously made a suicide attempt, or has a prior history of, or is currently
demonstrating active suicidal ideation or self-injurious behavior as measured by
C-SSRS at screening
- Participant has demonstrated clinically significant deterioration in functioning as
assessed by PI and other study staff that would contraindicate continued participation
in the follow-up study
We found this trial at
14
sites
8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Principal Investigator: Andrew Cutler
Phone: 941-747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Jeff Epstein, Ph.D.
Phone: 513-803-8913
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Scottt H Kollins, PhD
Phone: 919-681-0014
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Click here to add this to my saved trials
Click here to add this to my saved trials
Durham, North Carolina 27705
Principal Investigator: Naomi Davis
Phone: 919-681-0013
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Principal Investigator: Ann Childress, MD
Phone: 702-838-0742
Click here to add this to my saved trials
Maitland, Florida 32751
Principal Investigator: Andrea Marraffino
Phone: 407-644-1165
Click here to add this to my saved trials
Marshfield, Massachusetts 02050
Principal Investigator: Mary Ann McDonnell, Ph.D., RNCS
Phone: 774-275-4013
Click here to add this to my saved trials
Click here to add this to my saved trials
Raleigh, North Carolina 27606
Principal Investigator: Sandeep Vaishnavi, MD, PhD
Phone: 919-763-7064
Click here to add this to my saved trials
Sacramento, California 95817
Principal Investigator: Julie Schweitzer, Ph.D
Phone: 916-703-0294
Click here to add this to my saved trials
4801 Weldon Spring Parkway
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Principal Investigator: Greg Mattingly, MD
Phone: 636-946-8032
Click here to add this to my saved trials
Click here to add this to my saved trials
Seattle, Washington 98115
Principal Investigator: Mark Stein, PhD
Phone: 206-884-1488
Click here to add this to my saved trials