The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults

Dyslexia Clinical Trial

Official title:

The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930500
• Other study ID #: Luki-40211
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Rehabilitation Foundation, Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslexia

Intervention

Behavioral:
• Individual neuropsychological rehabilitation
Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
• Group based neuropsychological rehabilitation
Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia

Locations

Country	Name	City	State
Finland	Rehabilitation Foundation	Helsinki	Malminkartano

Sponsors (3)

Lead Sponsor	Collaborator
Rehabilitation Foundation, Finland	Helsinki University Central Hospital, Social Insurance Institution, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective cognitive performance	The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)	5 months
Primary	Subjective reading related performance	Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months