Learning ProblemsNCT02927197
LearningRx Brain Training for Children 8-14
A study testing LearningRx cognitive training in people with Learning Problems, run by Gibson Institute of Cognitive Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Problems
- What is being tested?
- LearningRx cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 8-14 years of age, living in the greater Colorado Springs area, screening GIA score between 70 and 130
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, 80919
About this study
Official title: 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.
Read the 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.
- Conditions
- Learning Problems
- Being tested
- LearningRx cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LearningRx cognitive trainingBehavioural
Also called ThinkRx
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.
| Study group | Role | What they receive |
|---|---|---|
| LearningRx Cognitive Training | Experimental | The intervention is a 60-hour one-on-one cognitive training program Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 14 days after completing the intervention
Secondary outcomes (8)
Evidence of improvement in school performance
Confirmed by improvement in school achievement tests and grade reports
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 14 days after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gibson Institute of Cognitive Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dick M Carpenter, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927197
- Sponsor's protocol ID
- GICR-1005
- Status last verified
- Feb 2018
- First submitted
- 5 Oct 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Harvard Dataverse
Publications
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.
PubMed 27867257
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study on the Effects of LearningRx Brain Training for Improving Cognitive Skills in Students Ages 8-14
- ClinicalTrials.gov ID
- NCT02927197
- Acronym / sponsor ID
- GICR-1005
- Conditions
- Learning Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gibson Institute of Cognitive ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LearningRx Cognitive Training | Experimental | Behavioral: LearningRx cognitive trainingThe intervention is a 60-hour one-on-one cognitive training program |
| Waitlist Control | No intervention | –The treatment-as-usual control group will begin the intervention when the experimental arm has completed the intervention. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Between 8-14 years of age, living in the greater Colorado Springs area, screening GIA score between 70 and 130
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LearningRx cognitive trainingAlso: ThinkRxA 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. | Behavioural | LearningRx Cognitive Training |
Primary outcome
Evidence of overall cognitive function improvement
Time frame: within 14 days after completing the intervention
Confirmed by pretest to post-test change on the Woodcock Johnson III - Tests of Cognitive Abilities (WJ III): General Intellectual Ability composite score
8 secondary outcomes
Evidence of improvement in school performance
Time frame: Within two years after completing the intervention
Evidence of improvement in working memory
Time frame: within 14 days after completing the intervention
Evidence of improvement in long-term memory
Time frame: within 14 days after completing the intervention
Evidence of improvement in fluid reasoning
Time frame: within 14 days after completing the intervention
Evidence of improvement in processing speed
Time frame: within 14 days after completing the intervention
Evidence of improvement in visual processing
Time frame: within 14 days after completing the intervention
Evidence of improvement in auditory processing
Time frame: within 14 days after completing the intervention
Evidence of improvement in attention
Time frame: within 14 days after completing the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Results publication: PubMed 27867257Carpenter 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.
- Individual participant dataSharing planned: Yes. Harvard Dataverse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dick M Carpenter, PhD principal investigator
University of Colorado, Colorado Springs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LearningRx cognitive training in people with Learning Problems, run by Gibson Institute of Cognitive Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of overall cognitive function improvement (time frame: within 14 days after completing the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.