Software Treatment for Actively Reducing Severity of ADHD - Follow Up

NCT02828644 | Completed Results

• 1 other identifier: Akili-001R-FollowUp
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 15

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Day 0 to Day 28

Study Arms (2)

EVO Multitasking

ACTIVE COMPARATOR

EVO Multitasking is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R)

Device: EVO

EVO Words

ACTIVE COMPARATOR

EVO Words is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R)

Device: EVO

Interventions

EVO DEVICE

videogame-like digital therapy

EVO Multitasking; EVO Words

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (15)

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

Avida, Inc.

Newport Beach, California, 92660, United States

Location

University of California Davis MIND Institute

Sacramento, California, 95817, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 32401, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

South Shore Psychiatric Services

Marshfield, Massachusetts, 02050, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Neuropsychiatric Clinic at Carolina Partners

Raleigh, North Carolina, 27606, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Seattle Children's

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Kathryn Jenkins
• Organization: Akili Interactive Labs

kjenkins@akiliinteractive.com

7742666693

Study Officials

• Scott Kollins, PhD

  Duke Clinical Research Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01

Locations

US (15)