N/A
Completed N=175
Software Treatment for Actively Reducing Severity of ADHD - Follow Up
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT02828644 ↗
Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy — -0.407 z-score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy |
-0.407 | — |
| SECONDARY Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy |
-0.407; -0.615 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02828644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.