The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Helsinki University Central Hospital
Social Insurance Institution, Finland
Information provided by (Responsible Party):
Rehabilitation Foundation, Finland
ClinicalTrials.gov Identifier:
NCT01930500
First received: August 14, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Dyslexia
Behavioral: Individual neuropsychological rehabilitation
Behavioral: Group based neuropsychological rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Neuropsychological Rehabilitation in Young Dyslexic Adults - a Single Blind, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Rehabilitation Foundation, Finland:

Primary Outcome Measures:
  • Subjective cognitive performance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)

  • Subjective reading related performance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified


Secondary Outcome Measures:
  • Objective cognitive performance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Effects of rehabilitation on objective cognitive performance: a neuropsychological test battery (verbal and design fluency, SDMT, WAIS-IV Digit span, WMS-III Word list, V3/AVO-9, WMS-III Logical Memory I, WMS-III Visual Reproduction, TM-a, TM-b, RAS)

  • Goal achievement [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Goal achievement: Goal Attainment Scaling (GAS)

  • Quality of life [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on QoL: QOLIBRI bref.

  • Mood [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on mood: Profile of Mood States (POMS)

  • Social and cognitive behavioral strategies [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Strategy and Attribution Questionnaire (SAQ) bref


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual neuropsychological rehabilitation
12 times 90 minutes, once per week or once per two weeks, during 5 months
Behavioral: Individual neuropsychological rehabilitation
Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
Experimental: Group based neuropsychological rehabilitation
12 times 120 minutes + a brake, once per week or once per two weeks, during 5 months
Behavioral: Group based neuropsychological rehabilitation
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.

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: The baseline assessments and the first interventions will start in August 2013.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930500

Locations
Finland
Rehabilitation Foundation
Helsinki, Malminkartano, Finland, 00410
Sponsors and Collaborators
Rehabilitation Foundation, Finland
Helsinki University Central Hospital
Social Insurance Institution, Finland
Investigators
Study Director: Erja Poutiainen, PhD Rehabilitation Foundation
Principal Investigator: Johanna Nukari, LicPsych Rehabilitation Foundation
  More Information

No publications provided

Responsible Party: Rehabilitation Foundation, Finland
ClinicalTrials.gov Identifier: NCT01930500     History of Changes
Other Study ID Numbers: Luki-40211
Study First Received: August 14, 2013
Last Updated: October 7, 2014
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on October 23, 2014