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ACTIVATE: A Computerized Training Program for Children With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562469
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Anil Chacko, New York University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
ADHD Other: ACTIVATE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACTIVATE: A Computerized Training Program for Children With ADHD
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562469


Locations
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United States, New York
New York University
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
Additional Information:
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Responsible Party: Dr. Anil Chacko, Associate Professor, Department of Applied Psychology, New York University
ClinicalTrials.gov Identifier: NCT02562469    
Other Study ID Numbers: ACTIVATE
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018