Software Treatment for Actively Reducing Severity of ADHD - Follow Up

NCT ID: NCT02828644

Last Updated: 2019-02-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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).

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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EVO Multitasking

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)

Group Type ACTIVE_COMPARATOR

EVO

Intervention Type DEVICE

videogame-like digital therapy

EVO Words

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)

Group Type ACTIVE_COMPARATOR

EVO

Intervention Type DEVICE

videogame-like digital therapy

Interventions

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EVO

videogame-like digital therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akili Interactive Labs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Kollins, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institution

Locations

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Melmed Center

Scottsdale, Arizona, United States

Site Status

Avida, Inc.

Newport Beach, California, United States

Site Status

University of California Davis MIND Institute

Sacramento, California, United States

Site Status

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Site Status

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Site Status

Meridien Research

Bradenton, Florida, United States

Site Status

Florida Clinical Research Center

Maitland, Florida, United States

Site Status

South Shore Psychiatric Services

Marshfield, Massachusetts, United States

Site Status

Midwest Research Group

Saint Charles, Missouri, United States

Site Status

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

Site Status

Duke Child and Family Study Center

Durham, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

The Neuropsychiatric Clinic at Carolina Partners

Raleigh, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Seattle Children's

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Akili-001R-FollowUp

Identifier Type: -

Identifier Source: org_study_id

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