Prediction and Intervention in Developmental Dyslexia (LEXI)

Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia

The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.

Study Overview

• Status: Unknown
• Conditions: Developmental Dyslexia
• Intervention / Treatment: Other: Computerized reading training

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Brem, PhD; Phone Number: +41 43 499 2760; Email: sbrem@kjpd.uzh.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Clinics for Child and Adolescent Psychiatry, University of Zurich
    • Principal Investigator: Silvia Brem, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for all groups:

• Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) >=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
• Additional criteria for subgroups:
• Recruitment of preschoolers (aged 5.5-7.5 years):
• Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
• Recruitment of children in first grade (aged 6.5-8.5years):
• Children showing impairments in learning to read (first/second grade).
• Adults (aged 20-40 years):
• Healthy, normal reading

Exclusion Criteria for all groups:

• MRI contraindications
• No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized reading training first; Cross-over design: group first receives the intervention	Other: Computerized reading training
Experimental: Waiting Control First; Cross-over design: group first serves as waiting control	Other: Computerized reading training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in reading and spelling performance	Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training	Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developmental and training induced changes in functional brain activation and brain structure	Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training	Participants will be tested after an expected average of 8, 12 and 16 months
Accuracy of prediction on reading performance outcome	Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures. Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)	Participants will be tested at T1 and on average 8 months later

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Brem, PhD, University Clinics for Child and Adolescent Psychiatry, University of Zurich

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Intervention; Development; Prediction; Magnetic Resonance Imaging (MRI); Electroencephalography (EEG); Multimodal Neuroimaging
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: LEXI SNF32003B_141201/1; 32003B_141201/1 (Other Grant/Funding Number: SNF)