NCT02927197

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

October 5, 2016

Last Update Submit

February 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Evidence of improvement in school performance

    Within two years after completing the intervention

  • Evidence of improvement in working memory

    within 14 days after completing the intervention

  • Evidence of improvement in long-term memory

    within 14 days after completing the intervention

  • Evidence of improvement in fluid reasoning

    within 14 days after completing the intervention

  • Evidence of improvement in processing speed

    within 14 days after completing the intervention

  • +3 more secondary outcomes

Study Arms (2)

LearningRx Cognitive Training

EXPERIMENTAL

The intervention is a 60-hour one-on-one cognitive training program

Behavioral: LearningRx cognitive training

Waitlist Control

NO INTERVENTION

The treatment-as-usual control group will begin the intervention when the experimental arm has completed the intervention.

Interventions

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.

Also known as: ThinkRx
LearningRx Cognitive Training

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between 8-14 years of age, living in the greater Colorado Springs area, screening GIA score between 70 and 130

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gibson Institute of Cognitive Research

Colorado Springs, Colorado, 80919, United States

Location

Related Publications (1)

  • Carpenter DM, Ledbetter C, Moore AL. LearningRx Cognitive Training Effects in Children Ages 8-14: A Randomized Controlled Trial. Appl Cogn Psychol. 2016 Sep-Oct;30(5):815-826. doi: 10.1002/acp.3257. Epub 2016 Aug 2.

Study Officials

  • Dick M Carpenter, PhD

    University of Colorado, Colorado Springs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Harvard Dataverse

Locations