Software Treatment for Actively Reducing Severity of ADHD - Follow Up

Attention Deficit Disorder With Hyperactivity Clinical Trial

— STARS-ADHD2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828644
• Other study ID #: Akili-001R-FollowUp
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2019
• Source: Akili Interactive Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Device:
• EVO
videogame-like digital therapy

Locations

Country	Name	City	State
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Meridien Research	Bradenton	Florida
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke Child and Family Study Center	Durham	North Carolina
United States	Duke University	Durham	North Carolina
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Florida Clinical Research Center	Maitland	Florida
United States	South Shore Psychiatric Services	Marshfield	Massachusetts
United States	Avida, Inc.	Newport Beach	California
United States	The Neuropsychiatric Clinic at Carolina Partners	Raleigh	North Carolina
United States	University of California Davis MIND Institute	Sacramento	California
United States	Midwest Research Group	Saint Charles	Missouri
United States	Melmed Center	Scottsdale	Arizona
United States	Seattle Children's	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Akili Interactive Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80; where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.; The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study.	Day 0 to Day 28
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	TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80; where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.; The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study.	Day 0 to Day 28