ACTIVATE: A Computerized Training Program for Children With ADHD

October 31, 2022 updated by: New York University
A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In an open clinical trial, ACTIVATE, a computer-based neurocognitive intervention will be evaluated to determine its effectiveness in improving symptoms of attention-deficit/hyperactivity disorder (ADHD) and related impairments. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). Youth between the ages of 7-11 will be recruited and assessed for ADHD and assigned to the ACTIVATE intervention. Assessment of outcomes will occur before, weekly during treatment, and immediately post-treatment.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 7-11 with a diagnosis of ADHD
  • Parent and child must be fluent English speakers
  • Family has access to desktop/laptop computer at home with internet access (in order to implement the ACTIVATE intervention component, which is an online-based computer program)

Exclusion Criteria:

  • Developmental delay or psychosis that impacts the child's ability to function and engage in the computerized intervention
  • If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home)
  • If the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Intelligence Scale for Children - Fourth Edition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACTIVATE
ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see: www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e., sustained attention, working memory (WM), response inhibition, speed of information processing, cognitive flexibility and control, multiple simultaneous attention, category formation, and pattern recognition and inductive thinking). ACTIVATE Is completed at home via computer with parent support. ACTIVATE intervention is conducted 3-5 times per week for between 20-30 minutes over the course or 3-4 months.
Other: ACTIVATE
A home-based computerized brain training intervention for youth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADHD symptoms on the Disruptive Behavior Rating Scale
Time Frame: Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment
Change in ADHD symptoms over the course of treatment
Change in ADHD symptoms at postreatment, which is expected to occur betwen 12-18 weeks from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ACTIVATE (Immune Tolerance Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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