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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02562469
Other study ID # ACTIVATE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date August 2017

Study information

Verified date September 2018
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
ACTIVATE
A home-based computerized brain training intervention for youth.

Locations

Country Name City State
United States New York University New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ADHD symptoms on the Disruptive Behavior Rating Scale 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
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