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The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Individual neuropsychological rehabilitation
Group based neuropsychological rehabilitation
Sponsored by
Rehabilitation Foundation, Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Individual neuropsychological rehabilitation

Group based neuropsychological rehabilitation

Control group

Arm Description

12 times 90 minutes, once per week or once per two weeks, during 5 months

12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months

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.

Outcomes

Primary Outcome Measures

Subjective cognitive performance
The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)
Subjective reading related performance
Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 14, 2013
Last Updated
April 11, 2019
Sponsor
Rehabilitation Foundation, Finland
Collaborators
Helsinki University Central Hospital, Social Insurance Institution, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01930500
Brief Title
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults
Official Title
The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehabilitation Foundation, Finland
Collaborators
Helsinki University Central Hospital, Social Insurance Institution, Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual neuropsychological rehabilitation
Arm Type
Experimental
Arm Description
12 times 90 minutes, once per week or once per two weeks, during 5 months
Arm Title
Group based neuropsychological rehabilitation
Arm Type
Experimental
Arm Description
12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual neuropsychological rehabilitation
Intervention Description
Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
Intervention Type
Behavioral
Intervention Name(s)
Group based neuropsychological rehabilitation
Intervention Description
Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia
Primary Outcome Measure Information:
Title
Subjective cognitive performance
Description
The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)
Time Frame
5 months
Title
Subjective reading related performance
Description
Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Verbal fluency and executive control
Description
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.
Time Frame
5 months
Title
Goal achievement
Description
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.
Time Frame
5 months
Title
Quality of life: QOLIBRI-OS
Description
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.
Time Frame
5 months
Title
Mood
Description
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.
Time Frame
5 months
Title
Social and cognitive behavioral strategies
Description
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.
Time Frame
5 months
Title
Processing speed and attention
Description
These cognitive skills are measured using Symbol Digit Modalities test. The score ranges from 0 to 110. More points equals a better result.
Time Frame
5 months
Title
Verbal learning
Description
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.
Time Frame
5 months
Title
Reading comprehension
Description
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.
Time Frame
5 months
Title
Visual fluency and executive control
Description
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.
Time Frame
5 months
Title
Working memory
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erja Poutiainen, PhD
Organizational Affiliation
Rehabilitation Foundation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johanna Nukari, LicPsych
Organizational Affiliation
Rehabilitation Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Foundation
City
Helsinki
State/Province
Malminkartano
ZIP/Postal Code
00410
Country
Finland

12. IPD Sharing Statement

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The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults

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