Prediction and Intervention in Developmental Dyslexia

NCT02217696 | Unknown DMC

• 2 other identifiers: LEXI SNF32003B_141201/132003B_141201/1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Dyslexia

Keywords

Electroencephalography (EEG); Magnetic Resonance Imaging (MRI); Multimodal Neuroimaging; Development; Prediction; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Developmental and training induced changes in functional brain activation and brain structure

  Participants will be tested after an expected average of 8, 12 and 16 months

• Accuracy of prediction on reading performance outcome

  Participants will be tested at T1 and on average 8 months later

Study Arms (2)

Computerized reading training first

EXPERIMENTAL

Cross-over design: group first receives the intervention

Other: Computerized reading training

Waiting Control First

EXPERIMENTAL

Cross-over design: group first serves as waiting control

Other: Computerized reading training

Interventions

Computerized reading training OTHER

Computerized reading training first; Waiting Control First

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Clinics for Child and Adolescent Psychiatry, University of Zurich

Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Silvia Brem, PhD

  University Clinics for Child and Adolescent Psychiatry, University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Brem, PhD

CONTACT

+41 43 499 2760; sbrem@kjpd.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

CH (1)