Clinical trial NCT01930500: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Lead sponsor: Rehabilitation Foundation, Finland
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Social Insurance Institution, Finland
First posted: 2013-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Subjective cognitive performance
timeFrame: 5 months
measure: Subjective reading related performance
timeFrame: 5 months
Secondary outcomes:
measure: Verbal fluency and executive control
timeFrame: 5 months
measure: Goal achievement
timeFrame: 5 months
measure: Quality of life: QOLIBRI-OS
timeFrame: 5 months
measure: Mood
timeFrame: 5 months
measure: Social and cognitive behavioral strategies
timeFrame: 5 months
measure: Processing speed and attention
timeFrame: 5 months
measure: Verbal learning
timeFrame: 5 months
measure: Reading comprehension
timeFrame: 5 months
measure: Visual fluency and executive control
timeFrame: 5 months
measure: Working memory
timeFrame: 5 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Rehabilitation Foundation
state: Malminkartano
Study officials:
affiliation: Rehabilitation Foundation
name: Erja Poutiainen, PhD
role: STUDY_DIRECTOR
affiliation: Rehabilitation Foundation
name: Johanna Nukari, LicPsych
role: PRINCIPAL_INVESTIGATOR
References: