DyslexiaNCT01930500
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults
A study testing Individual neuropsychological rehabilitation and Group based neuropsychological rehabilitation in people with Dyslexia, run by Rehabilitation Foundation, Finland at 1 site in Finland.
Trial summary
The purpose of this study is to determine whether individual and/ group based neuropsychological rehabilitation focused on psychoeducation and teaching compensatory strategies has positive effects on the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Individual neuropsychological rehabilitation and Group based neuropsychological rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2012to Dec 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of dyslexia
- age 18-35
- problems in studies, work or employment relating to dyslexia
- subjective and objective need for rehabilitation
- the native language is Finnish
Who cannot join
- other neurological condition than dyslexia
- other learning disabilities than dyslexia
- overall weak cognitive capacity
- psychiatric diagnosis
- severe depression
- alcohol or drug abuse
- neuropsychological rehabilitation received at the age of 16 or later
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study
The purpose of this study is to determine whether individual and/ group based neuropsychological rehabilitation focused on psychoeducation and teaching compensatory strategies has positive effects on the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults. The hypothesis is that both individual and group based neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and perceived cognitive deficits. Another purpose of this study is to evaluate weather individual and group based neuropsychological rehabilitation have different kind of effects on the wellbeing of the participants and weather either one of the rehabilitation formats is more effective than the other.
Read the detailed description
Background: Untreated dyslexia causes problems for individuals in studies, work and employment. High quality research on the best and most cost-effective rehabilitation methods is needed.
Objective: To study whether neuropsychological rehabilitation improves the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults and to evaluate potential differences between individual and group based neuropsychological rehabilitation.
Methods: Altogether 120 young adults diagnosed with dyslexia are randomized either to one of the intervention groups (individual neuropsychological rehabilitation / group neuropsychological rehabilitation) or to a control group which will receive either one of the interventions after a 5 month waiting period. All the study subjects are assessed with a short neuropsychological test battery as well as self-rating questionnaires evaluating mood, QoL, perceived cognitive deficits, and the impact of the learning disability at baseline, after five months (immediately after interventions or control period) and after 10 months. After 20 months a shorter follow-up using only self-ratings will be done via mail. Subjects in the intervention groups are offered neuropsychological rehabilitation in 12 sessions conducted once a week or once in two weeks during five months. Subjects in the control group do not receive any intervention for the first five months.
Results: The effects of interventions on psychosocial wellbeing and perceived cognitive deficits are evaluated using appropriate statistical procedures and comparing the differences between the interventions groups and the control group.
The present status: All the interventions are completed, follow-up data is still beeing collected
- Conditions
- Dyslexia
- Being tested
- Individual neuropsychological rehabilitation, Group based neuropsychological rehabilitation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual neuropsychological rehabilitationBehavioural
Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
Group based neuropsychological rehabilitationBehavioural
Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia
| Study group | Role | What they receive |
|---|---|---|
| Individual neuropsychological rehabilitation | Experimental | 12 times 90 minutes, once per week or once per two weeks, during 5 months Receives: Behavioral: Individual neuropsychological rehabilitation |
| Group based neuropsychological rehabilitation | Experimental | 12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months Receives: Behavioral: Group based neuropsychological rehabilitation |
| Control group | No intervention | Control group does not receive neuropsychological rehabilitation or any other intervention during the first 5 months. After the control period they will be randomized to receive either individual or group based rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cognitive performance
The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)
Measured: 5 months
Subjective reading related performance
Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified
Measured: 5 months
Secondary outcomes (10)
Verbal fluency and executive control
These cognitive skills are measured using verbal fluency with category switching, Delis-Kaplan Executive Function System; D-KEFS. The score is the total number of correct words generated by the participant within the one-minute time-limit. The range for points is from 0 to as many words as can be generated by the rules within one minute. More points equals a better result.
Measured: 5 months
Goal achievement
Goal achievement is measures using Goal Attainment Scaling (GAS). The attained goals set at the beginning of the intervention and measured on a scale from -2 to +2 at the end of the intervention. The score is based on a discussion with the therapist and the participant. A score below zero means that the set goal has not been reached. A score of 0 means that the goal has been reached and scores above 0 mean that the goal was reached over expectations.
Measured: 5 months
Quality of life: QOLIBRI-OS
The effects of rehabilitation on quality of life are measured using the Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS). The score ranges from 6-30. More points equals a better quality of life.
Measured: 5 months
Mood
The effects of rehabilitation on mood are measured using Profile of Mood States (POMS). The Finnish version contains 38 questions and the total score ranges from 0 to 152. Less points means a better situation for mood.
Measured: 5 months
Social and cognitive behavioral strategies
Strategy and Attribution Questionnaire (SAQ) bref consists of 20 questions using a 7-point-scale (from 1 = "strongly disagree" to 7 = "strongly agree") to assess social and cognitive behavioral strategies.
Measured: 5 months
Processing speed and attention
These cognitive skills are measured using Symbol Digit Modalities test. The score ranges from 0 to 110. More points equals a better result.
Measured: 5 months
Verbal learning
Verbal learning is measured using Word lists subtest (Wechsler Memory Test-III, WMS-III). The total score is between 0 - 48. More points equals a better result.
Measured: 5 months
Reading comprehension
Reading comprehension is measured using V3, a part of a Finnish Ability Test Battery, "Kykytestistö AVO-9". The score ranges fron 0 to 20. More points equals a better result.
Measured: 5 months
Visual fluency and executive control
These cognitive skills are measured using design fluency, Delis-Kaplan Executive Function System; D-KEFS. The score is the total number of correct drawings produced within a minute added togehter from three different one-minute long sessions with different rules. The range for points is from 0 to as many drawings as can be generated by the rules within the three one-minute sessions. More points equals a better result.
Measured: 5 months
Working memory
Working memory is assesed using Digit span sequencing (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV). The total score is between 0 - 16. More points equals better result.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Foundation, Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Social Insurance Institution, Finland
- Responsible party
- Sponsor
- Investigators
- Erja Poutiainen, PhD, Study director, Rehabilitation FoundationJohanna Nukari, LicPsych, Principal investigator, Rehabilitation Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930500
- Sponsor's protocol ID
- Luki-40211
- Status last verified
- Apr 2019
- First submitted
- 14 Aug 2013
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01930500
- Acronym / sponsor ID
- Luki-40211
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rehabilitation Foundation, FinlandUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Social Insurance Institution, Finland
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Aug 2013 (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 determine whether individual and/ group based neuropsychological rehabilitation focused on psychoeducation and teaching compensatory strategies has positive effects on the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults. The hypothesis is that both individual and group based neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and perceived cognitive deficits. Another purpose of this study is to evaluate weather individual and group based neuropsychological rehabilitation have different kind of effects on the wellbeing of the participants and weather either one of the rehabilitation formats is more effective than the other.
Detailed description
Background: Untreated dyslexia causes problems for individuals in studies, work and employment. High quality research on the best and most cost-effective rehabilitation methods is needed.
Objective: To study whether neuropsychological rehabilitation improves the psychosocial wellbeing and perceived cognitive deficits in dyslexic young adults and to evaluate potential differences between individual and group based neuropsychological rehabilitation.
Methods: Altogether 120 young adults diagnosed with dyslexia are randomized either to one of the intervention groups (individual neuropsychological rehabilitation / group neuropsychological rehabilitation) or to a control group which will receive either one of the interventions after a 5 month waiting period. All the study subjects are assessed with a short neuropsychological test battery as well as self-rating questionnaires evaluating mood, QoL, perceived cognitive deficits, and the impact of the learning disability at baseline, after five months (immediately after interventions or control period) and after 10 months. After 20 months a shorter follow-up using only self-ratings will be done via mail. Subjects in the intervention groups are offered neuropsychological rehabilitation in 12 sessions conducted once a week or once in two weeks during five months. Subjects in the control group do not receive any intervention for the first five months.
Results: The effects of interventions on psychosocial wellbeing and perceived cognitive deficits are evaluated using appropriate statistical procedures and comparing the differences between the interventions groups and the control group.
The present status: All the interventions are completed, follow-up data is still beeing collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual neuropsychological rehabilitation | Experimental | Behavioral: Individual neuropsychological rehabilitation12 times 90 minutes, once per week or once per two weeks, during 5 months |
| Group based neuropsychological rehabilitation | Experimental | Behavioral: Group based neuropsychological rehabilitation12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months |
| Control group | No intervention | –Control group does not receive neuropsychological rehabilitation or any other intervention during the first 5 months. After the control period they will be randomized to receive either individual or group based rehabilitation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- clinical diagnosis of dyslexia
- age 18-35
- problems in studies, work or employment relating to dyslexia
- subjective and objective need for rehabilitation
- the native language is Finnish
Key exclusion criteria (7 listed)
- other neurological condition than dyslexia
- other learning disabilities than dyslexia
- overall weak cognitive capacity
- psychiatric diagnosis
- severe depression
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 |
|---|---|---|
| Individual neuropsychological rehabilitationPsychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia | Behavioural | Individual neuropsychological rehabilitation |
| Group based neuropsychological rehabilitationPsychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia | Behavioural | Group based neuropsychological rehabilitation |
Primary outcome
Subjective cognitive performance
Time frame: 5 months
The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)
Subjective reading related performance
Time frame: 5 months
Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified
10 secondary outcomes
Verbal fluency and executive control
Time frame: 5 months
Goal achievement
Time frame: 5 months
Quality of life: QOLIBRI-OS
Time frame: 5 months
Mood
Time frame: 5 months
Social and cognitive behavioral strategies
Time frame: 5 months
Processing speed and attention
Time frame: 5 months
Verbal learning
Time frame: 5 months
Reading comprehension
Time frame: 5 months
Visual fluency and executive control
Time frame: 5 months
Working memory
Time frame: 5 months
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 12 Apr 2019.
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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.
Erja Poutiainen, PhD study director
Rehabilitation Foundation
Johanna Nukari, LicPsych principal investigator
Rehabilitation Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual neuropsychological rehabilitation and Group based neuropsychological rehabilitation in people with Dyslexia, run by Rehabilitation Foundation, Finland at 1 site in Finland.
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 5 inclusion and 7 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 12 Apr 2019. 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 Finland. 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?
Subjective cognitive performance (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2019.