DyslexiaNCT02429739
Working Memory Training for Children With Dyslexia
A study testing Working memory Training in people with Dyslexia, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The main aim of this interventional study is to investigate whether the effects of computerized working memory training improves reading abilities for children, i.e. ages 9 - 16 years, diagnosed with dyslexia. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Working memory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Apr 2016
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dyslexia
Who cannot join
- Mental retardation (IQ below 70)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computerized Working Memory Training for Children With Dyslexia
The main aim of this interventional study is to investigate whether the effects of computerized working memory training improves reading abilities for children, i.e. ages 9 - 16 years, diagnosed with dyslexia.
Read the detailed description
Dyslexia is a specific learning difficulty which mainly affects the development of literacy and language related skills. It is characterized by difficulties with phonological processing, rapid naming, working memory, processing speed and the automatic development of skills that may not match up to an individual's other cognitive abilities. Phonological processing deficit is well established as one of the main causes of dyslexia. Working memory (WM) is today considered to be a cognitive system that strongly relates to a person's ability to think and learn. Over the last decade an increasing body of evidence indicates that WM deficits may cause particular problems for individuals with dyslexia. This is consistent with many of the every day problems reported by dyslexics and those around them. WM deficits are frequent in children with reading deficits. A major question is whether the WM impairment is secondary to phonological core deficit affecting the phonological loop only, or caused by an additional deficit involving central executive. Exploratory findings from fMRI studies indicates that impaired WM processes in dyslexia have a unique neuronal signature which may be associated with central executive processes. However there are conflicting findings and further studies are needed.
The children in the study, all diagnosed with dyslexia, will be divided into two subgroups (16/16 children). They are randomly allocated to either the adaptive training group or the treatment as usual control group after the baseline assessment. Both groups will meet for baseline testing and re-testing 4 weeks after completed training. Those that serve as non-trained controls will be offered to participate in training after completion of the study.
The intervention in this study aim to increase WM of children with dyslexia. We hypothesise that intensive computerized working memory training will improve reading fluency, speed and comprehension for children with dyslexia.
- Conditions
- Dyslexia
- Being tested
- Working memory Training
- Keywords
- Working Memory Training, computerized, Dyslexia, Reading fluency, Reading comprehension
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory TrainingBehavioural
The child will use the computer program at home under parental supervision for 25 sessions, each lasting 30 - 45 minutes and the family has 6 weeks to complete the training. Each session consist 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information.
Other name: Cogmed RoboMemo
| Study group | Role | What they receive |
|---|---|---|
| Working Memory Training | Experimental | Behavioral: Cogmed RM working memory training. After baseline assessment participants will be randomized to active training or treatment as usual (waiting). The active group will start immediately and will have 6 weeks to perform the 25 training sessions. Receives: Behavioral: Working memory Training |
| Passive control group | No intervention | The control group will receive "treatment as usual" (Ordinary school days, special education if normally received). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading fluency, comprehension and speed
LOGOS (http://www.logos-test.no) is a standardized Norwegian computerized test for reading processes. 6 subtest; reading fluency, reading comprehension, word recognition, phonological reading, orthographic reading, rapid naming of common objects
Measured: Change from Baseline assessment to follow-up testing in 14 weeks
Secondary outcomes (1)
Working Memory Capacity
WISC-IV: The sum of letter-number sequences and Digit Span, WMS-III Spatial Span, Språk 6-16 (Standardized Norwegian Screening-test for Language Impairment (Ottem \&frost, 2011)Subtest: Sentence memory
Measured: Change from Baseline assessment to follow-up testing in 14 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gro CC Lohaugen, Phd, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429739
- Sponsor's protocol ID
- Sorlandet Hospital 2014/1057
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Baddeley A. The episodic buffer: a new component of working memory? Trends Cogn Sci. 2000 Nov 1;4(11):417-423. doi: 10.1016/s1364-6613(00)01538-2.
PubMed 11058819Baddeley A. Working memory and language: an overview. J Commun Disord. 2003 May-Jun;36(3):189-208. doi: 10.1016/s0021-9924(03)00019-4.
PubMed 12742667Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
PubMed 20630350Klingberg, T (2012). Slik lærer hjernen. Oslo: Pax forlag
Gathercole SE, Alloway TP. Practitioner review: short-term and working memory impairments in neurodevelopmental disorders: diagnosis and remedial support. J Child Psychol Psychiatry. 2006 Jan;47(1):4-15. doi: 10.1111/j.1469-7610.2005.01446.x.
PubMed 16405635Beneventi H, Tonnessen FE, Ersland L, Hugdahl K. Executive working memory processes in dyslexia: behavioral and fMRI evidence. Scand J Psychol. 2010 Jun 1;51(3):192-202. doi: 10.1111/j.1467-9450.2010.00808.x. Epub 2010 Mar 15.
PubMed 20338015Holmes J, Gathercole SE, Dunning DL. Adaptive training leads to sustained enhancement of poor working memory in children. Dev Sci. 2009 Jul;12(4):F9-15. doi: 10.1111/j.1467-7687.2009.00848.x.
PubMed 19635074Cogmed Working Memory Training (2012) Pearson assesment.no
Hulme, C & Snowling, M.J.(2009) Developmental Disorders and Language Learning and Cognition, Chichester, WS.: Wiley - Blackwell
Høien, T (2012) LOGOS; Teoribasert diagnostisering av lesevansker, Logometrica
Ottem, E og Frost, J (2010) Språk 6-16 Screeningtest, Statped, Bredtvet kompetansesenter
Swanson, H.L. (2006). Working memory and reading disabilities. I Alloway, T. & Gathercole, S (Red), Working Memory and Neurodevelopmental Disorders. (s. 59 - 88 9, Hove (UK): Psychology Press
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Working Memory Training for Children With Dyslexia
- ClinicalTrials.gov ID
- NCT02429739
- Acronym / sponsor ID
- Sorlandet Hospital 2014/1057
- Conditions
- Dyslexia
- Keywords
- Working Memory Training, computerized, Dyslexia, Reading fluency, Reading comprehension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Apr 2015 (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 main aim of this interventional study is to investigate whether the effects of computerized working memory training improves reading abilities for children, i.e. ages 9 - 16 years, diagnosed with dyslexia.
Detailed description
Dyslexia is a specific learning difficulty which mainly affects the development of literacy and language related skills. It is characterized by difficulties with phonological processing, rapid naming, working memory, processing speed and the automatic development of skills that may not match up to an individual's other cognitive abilities. Phonological processing deficit is well established as one of the main causes of dyslexia. Working memory (WM) is today considered to be a cognitive system that strongly relates to a person's ability to think and learn. Over the last decade an increasing body of evidence indicates that WM deficits may cause particular problems for individuals with dyslexia. This is consistent with many of the every day problems reported by dyslexics and those around them. WM deficits are frequent in children with reading deficits. A major question is whether the WM impairment is secondary to phonological core deficit affecting the phonological loop only, or caused by an additional deficit involving central executive. Exploratory findings from fMRI studies indicates that impaired WM processes in dyslexia have a unique neuronal signature which may be associated with central executive processes. However there are conflicting findings and further studies are needed.
The children in the study, all diagnosed with dyslexia, will be divided into two subgroups (16/16 children). They are randomly allocated to either the adaptive training group or the treatment as usual control group after the baseline assessment. Both groups will meet for baseline testing and re-testing 4 weeks after completed training. Those that serve as non-trained controls will be offered to participate in training after completion of the study.
The intervention in this study aim to increase WM of children with dyslexia. We hypothesise that intensive computerized working memory training will improve reading fluency, speed and comprehension for children with dyslexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working Memory Training | Experimental | Behavioral: Working memory TrainingBehavioral: Cogmed RM working memory training. After baseline assessment participants will be randomized to active training or treatment as usual (waiting). The active group will start immediately and will have 6 weeks to perform the 25 training sessions. |
| Passive control group | No intervention | –The control group will receive "treatment as usual" (Ordinary school days, special education if normally received). |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Dyslexia
Key exclusion criteria (1 listed)
- Mental retardation (IQ below 70)
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 |
|---|---|---|
| Working memory TrainingThe child will use the computer program at home under parental supervision for 25 sessions, each lasting 30 - 45 minutes and the family has 6 weeks to complete the training. Each session consist 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information. Other name: Cogmed RoboMemo | Behavioural | Working Memory Training |
Primary outcome
Reading fluency, comprehension and speed
Time frame: Change from Baseline assessment to follow-up testing in 14 weeks
LOGOS (http://www.logos-test.no) is a standardized Norwegian computerized test for reading processes. 6 subtest; reading fluency, reading comprehension, word recognition, phonological reading, orthographic reading, rapid naming of common objects
1 secondary outcome
Working Memory Capacity
Time frame: Change from Baseline assessment to follow-up testing in 14 week
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 26 Apr 2016.
- Background: PubMed 11058819Baddeley A. The episodic buffer: a new component of working memory? Trends Cogn Sci. 2000 Nov 1;4(11):417-423. doi: 10.1016/s1364-6613(00)01538-2.
- Background: PubMed 12742667Baddeley A. Working memory and language: an overview. J Commun Disord. 2003 May-Jun;36(3):189-208. doi: 10.1016/s0021-9924(03)00019-4.
- Background: PubMed 20630350Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
- BackgroundKlingberg, T (2012). Slik lærer hjernen. Oslo: Pax forlag
- Results publication: PubMed 16405635Gathercole SE, Alloway TP. Practitioner review: short-term and working memory impairments in neurodevelopmental disorders: diagnosis and remedial support. J Child Psychol Psychiatry. 2006 Jan;47(1):4-15. doi: 10.1111/j.1469-7610.2005.01446.x.
- Results publication: PubMed 20338015Beneventi H, Tonnessen FE, Ersland L, Hugdahl K. Executive working memory processes in dyslexia: behavioral and fMRI evidence. Scand J Psychol. 2010 Jun 1;51(3):192-202. doi: 10.1111/j.1467-9450.2010.00808.x. Epub 2010 Mar 15.
- Results publication: PubMed 19635074Holmes J, Gathercole SE, Dunning DL. Adaptive training leads to sustained enhancement of poor working memory in children. Dev Sci. 2009 Jul;12(4):F9-15. doi: 10.1111/j.1467-7687.2009.00848.x.
- Results publicationCogmed Working Memory Training (2012) Pearson assesment.no
- Results publicationHulme, C & Snowling, M.J.(2009) Developmental Disorders and Language Learning and Cognition, Chichester, WS.: Wiley - Blackwell
- Results publicationHøien, T (2012) LOGOS; Teoribasert diagnostisering av lesevansker, Logometrica
- Results publicationOttem, E og Frost, J (2010) Språk 6-16 Screeningtest, Statped, Bredtvet kompetansesenter
- Results publicationSwanson, H.L. (2006). Working memory and reading disabilities. I Alloway, T. & Gathercole, S (Red), Working Memory and Neurodevelopmental Disorders. (s. 59 - 88 9, Hove (UK): Psychology Press
- Computerized Working Memory Training, RoboMemoLink provided by the sponsor.
- Standardized Norwegian computerized test for reading processesLink provided by the sponsor.
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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.
Gro CC Lohaugen, Phd principal investigator
Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory Training in people with Dyslexia, run by Sorlandet Hospital HF at 1 site in Norway.
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 26 Apr 2016. 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 Norway. 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?
Reading fluency, comprehension and speed (time frame: Change from Baseline assessment to follow-up testing in 14 weeks). 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 NCT02429739, which also lists 12 linked publications.
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 26 Apr 2016.