LearningRx Brain Training for Children 8-14
February 13, 2018 updated by: Gibson Institute of Cognitive Research
A Randomized, Controlled Study on the Effects of LearningRx Brain Training for Improving Cognitive Skills in Students Ages 8-14
The purpose of this study is to examine changes in multiple cognitive skills after completing 60 hours of cognitive training with ThinkRx, a LearningRx program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a two-phase randomized controlled study, investigators will examine the effects of a one-on-one cognitive training program on memory, visual and auditory processing, processing speed, reasoning, attention, and General Intellectual Ability (GIA) score for students ages 8-14.
In Phase 1, participants will be randomly assigned to either an experimental group to complete 60 hours of one-on-one cognitive training or to a wait-list control group.
In Phase 2, the wait-list control group will complete the intervention using an alternative delivery model: 50% clinician delivered and 50% digital delivery.
Study Type
Interventional
Enrollment (Actual)
39
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
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Colorado
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Colorado Springs, Colorado, United States, 80919
- Gibson Institute of Cognitive Research
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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
8 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 8-14 years of age, living in the greater Colorado Springs area, screening GIA score between 70 and 130
Exclusion Criteria:
- None
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: LearningRx Cognitive Training
The intervention is a 60-hour one-on-one cognitive training program
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A clinician will deliver forty 90-minute cognitive training sessions over 12-14 weeks for a total of 60 training hours.
There are 23 different categories of training procedures sequenced in intensity and difficulty for a total of more than 1000 training tasks.
Other Names:
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No Intervention: Waitlist Control
The treatment-as-usual control group will begin the intervention when the experimental arm has completed the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evidence of overall cognitive function improvement
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to post-test change on the Woodcock Johnson III - Tests of Cognitive Abilities (WJ III): General Intellectual Ability composite score
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within 14 days after completing the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evidence of improvement in school performance
Time Frame: Within two years after completing the intervention
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Confirmed by improvement in school achievement tests and grade reports
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Within two years after completing the intervention
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Evidence of improvement in working memory
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Numbers Reversed test
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within 14 days after completing the intervention
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Evidence of improvement in long-term memory
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Visual-Auditory Learning Delayed test
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within 14 days after completing the intervention
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Evidence of improvement in fluid reasoning
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Concept Formation test
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within 14 days after completing the intervention
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Evidence of improvement in processing speed
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Visual Matching test
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within 14 days after completing the intervention
|
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Evidence of improvement in visual processing
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Spatial Relations test
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within 14 days after completing the intervention
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Evidence of improvement in auditory processing
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the WJ III: Sound Blending test
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within 14 days after completing the intervention
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Evidence of improvement in attention
Time Frame: within 14 days after completing the intervention
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Confirmed by pretest to posttest change on the National Institutes of Health (NIH) Cognition Toolbox attention test
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within 14 days after completing the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dick M Carpenter, PhD, University of Colorado, Colorado Springs
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
June 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 5, 2016
First Submitted That Met QC Criteria
October 5, 2016
First Posted (Estimate)
October 6, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 13, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- GICR-1005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Harvard Dataverse
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.