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LearningRx Cognitive Training for ADHD

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ClinicalTrials.gov Identifier: NCT02917109
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gibson Institute of Cognitive Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Behavioral: LearningRx cognitive training Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases
Study Start Date : September 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: LearningRx cognitive training
The intervention is a 60-hour, clinician-delivered cognitive training program.
Behavioral: LearningRx cognitive training
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 Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   15 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02917109


Locations
United States, Colorado
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, United States, 80919
Sponsors and Collaborators
Gibson Institute of Cognitive Research
Investigators
Principal Investigator: Christina Ledbetter, PhD Gibson Institute of Cognitive Research
Study Director: Amy L Moore, PhD Gibson Institute of Cognitive Research

Responsible Party: Gibson Institute of Cognitive Research
ClinicalTrials.gov Identifier: NCT02917109     History of Changes
Other Study ID Numbers: GICR-0916-A
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will add to Harvard Dataverse

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders