- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930500
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malminkartano
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Helsinki, Malminkartano, Finland, 00410
- Rehabilitation Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Individual neuropsychological rehabilitation
12 times 90 minutes, once per week or once per two weeks, during 5 months
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Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
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|
EXPERIMENTAL: Group based neuropsychological rehabilitation
12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months
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Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia
|
|
NO_INTERVENTION: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective cognitive performance
Time Frame: 5 months
|
The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)
|
5 months
|
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Subjective reading related performance
Time Frame: 5 months
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Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verbal fluency and executive control
Time Frame: 5 months
|
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.
|
5 months
|
|
Goal achievement
Time Frame: 5 months
|
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.
|
5 months
|
|
Quality of life: QOLIBRI-OS
Time Frame: 5 months
|
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.
|
5 months
|
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Mood
Time Frame: 5 months
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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.
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5 months
|
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Social and cognitive behavioral strategies
Time Frame: 5 months
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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.
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5 months
|
|
Processing speed and attention
Time Frame: 5 months
|
These cognitive skills are measured using Symbol Digit Modalities test.
The score ranges from 0 to 110.
More points equals a better result.
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5 months
|
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Verbal learning
Time Frame: 5 months
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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.
|
5 months
|
|
Reading comprehension
Time Frame: 5 months
|
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.
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5 months
|
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Visual fluency and executive control
Time Frame: 5 months
|
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.
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5 months
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Working memory
Time Frame: 5 months
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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.
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5 months
|
Collaborators and Investigators
Investigators
- Study Director: Erja Poutiainen, PhD, Rehabilitation Foundation
- Principal Investigator: Johanna Nukari, LicPsych, Rehabilitation Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Luki-40211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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