LearningRx Brain Training for Children 8-14

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled Study on the Effects of LearningRx Brain Training for Improving Cognitive Skills in Students Ages 8-14

Conditions
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Learning Problems

Intervention / Treatment
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* Behavioral: LearningRx cognitive training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LearningRx Cognitive Training<br>The intervention is a 60-hour one-on-one cognitive training program | Behavioral: LearningRx cognitive training<br>* 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.<br>* Other names: ThinkRx;|
| No Intervention: Waitlist Control<br>The treatment-as-usual control group will begin the intervention when the experimental arm has completed the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of overall cognitive function improvement | Confirmed by pretest to post-test change on the Woodcock Johnson III - Tests of Cognitive Abilities (WJ III): General Intellectual Ability composite score | within 14 days after completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improvement in school performance | Confirmed by improvement in school achievement tests and grade reports | Within two years after completing the intervention | 
| Evidence of improvement in working memory | Confirmed by pretest to posttest change on the WJ III: Numbers Reversed test | within 14 days after completing the intervention | 
| Evidence of improvement in long-term memory | Confirmed by pretest to posttest change on the WJ III: Visual-Auditory Learning Delayed test | within 14 days after completing the intervention | 
| Evidence of improvement in fluid reasoning | Confirmed by pretest to posttest change on the WJ III: Concept Formation test | within 14 days after completing the intervention | 
| Evidence of improvement in processing speed | Confirmed by pretest to posttest change on the WJ III: Visual Matching test | within 14 days after completing the intervention | 
| Evidence of improvement in visual processing | Confirmed by pretest to posttest change on the WJ III: Spatial Relations test | within 14 days after completing the intervention | 
| Evidence of improvement in auditory processing | Confirmed by pretest to posttest change on the WJ III: Sound Blending test | within 14 days after completing the intervention | 
| Evidence of improvement in attention | Confirmed by pretest to posttest change on the National Institutes of Health (NIH) Cognition Toolbox attention test | within 14 days after completing the intervention |