NCT01930500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

August 14, 2013

Last Update Submit

April 11, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Subjective cognitive performance

    The effects of rehabilitation on subjective cognitive performance: Everyday Memory Questionnaire (EMQ)

    5 months

  • Subjective reading related performance

    Effects of rehabilitation on subjective reading related performance: Adult Reading History Questionnaire (ARHQ) modified

    5 months

Secondary Outcomes (10)

  • Verbal fluency and executive control

    5 months

  • Goal achievement

    5 months

  • Quality of life: QOLIBRI-OS

    5 months

  • Mood

    5 months

  • Social and cognitive behavioral strategies

    5 months

  • +5 more secondary outcomes

Study Arms (3)

Individual neuropsychological rehabilitation

EXPERIMENTAL

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

Behavioral: Individual neuropsychological rehabilitation

Group based neuropsychological rehabilitation

EXPERIMENTAL

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

Behavioral: Group based neuropsychological rehabilitation

Control group

NO INTERVENTION

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.

Interventions

Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia

Individual neuropsychological rehabilitation

Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia

Group based neuropsychological rehabilitation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Foundation

Helsinki, Malminkartano, 00410, Finland

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Erja Poutiainen, PhD

    Rehabilitation Foundation

    STUDY DIRECTOR
  • Johanna Nukari, LicPsych

    Rehabilitation Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 29, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2017

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations