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Completed

NCT Number: NCT02917109

LearningRx Cognitive Training for ADHD

The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

15 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gibson Institute of Cognitive Research

Colorado Springs, Colorado, 80919, United States

About this study

Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for ADHD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 15-22 previously diagnosed with ADHD
  • High school students or college students with a prior diagnosis of ADHD living in the greater Colorado Springs area

Exclusion criteria

  • No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Treatment and study plan

LearningRx cognitive training

Behavioral

A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.

Primary outcomes

  1. Evidence of overall cognitive function improvement

    Time frame: within 14 days after completing the intervention

    Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities

Secondary outcomes

  1. Evidence of change in brain activity

    Time frame: within 30 days after completing the intervention

    As confirmed by pretest to post-test changes in electrical activity measured by qEEG

  2. Evidence of reduction in ADHD symptoms

    Time frame: within 14 days after completing the intervention

    As confirmed by pretest to post-test changes on the ADHD Rating Scale

  3. Evidence of change in brain structure

    Time frame: within 30 days after completing the intervention

    Confirmed by change in pretest to post-test neuroimaging using MRI

  4. Evidence of improvement in visual or auditory attention

    Time frame: with 14 days after completing the intervention

    Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3) and Auditory Attention Test (CATA)

Sponsors and collaborators

Lead sponsor

Gibson Institute of Cognitive Research

Industry

Registry information

Official study title

LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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