NCT05137353

Brief Summary

With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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 15, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

November 28, 2021

Last Update Submit

October 25, 2022

Conditions

Keywords

reading disordersmusic interventionrhythmic stimulationsphonological processingEvent-Related Brain Potentials

Outcome Measures

Primary Outcomes (9)

  • Reading test

    For the assessment of the ability to read aloud series of high frequency words, low frequency words and pseudowords, is applied from the shortened 3DM-H (Differential Diagnostics of Dyslexia Maastricht - Hungarian adaptation). With this test, reading speed, fluency and accuracy and pseudoword accuracy are measured.

    4 minutes

  • Spelling test

    For the assessment of spelling, the present subtest is applied from the shortened version of the 3DM-H. Both spelling accuracy and reaction time are measured.

    4-7 minutes

  • Phoneme deletion test

    For the assessment of phoneme deletion, the present subtest is applied from the shortened version of the 3DM-H. Both accuracy and reaction time are measured.

    3-7 minutes

  • Letter-sound identification test

    For the assessment of letter-sound identification, the present subtest is applied from the shortened version of the 3DM-H. Both accuracy and reaction time are measured.

    2-3 minutes

  • Letter-sound discrimination test

    For the assessment of letter-sound discrimination, the present subtest is applied from the shortened version of the 3DM-H. Both accuracy and reaction time are measured.

    2 - 4 minutes

  • Rapid Automatized Naming (RAN) test

    To assess rapid naming of letters, digits and objects, the present subtest is applied from the shortened version of the 3DM-H. Here, the processing speed is measured.

    3-5 minutes

  • Choice reaction time test

    The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.

    1 - 2 minutes

  • Lexical decision task

    To assess lexical decision, the present test is applied. Here, accuracy is measured.

    12- 15 minutes

  • Auditory discrimination of acoustic and phonetic alteration of pseudowords

    This is an Event-Related Potentials (ERPs) task where a speech multifeature paradigm is applied. In the current task, the amplitudes of the Mismatch Negativity (MMN) responses - which are elicited in certain time windows - are measured in every condition.

    20 minutes

Study Arms (2)

Music Training (RitMoZ Training)

EXPERIMENTAL

12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions

Behavioral: Music Training (RitMoZ Training)

Spelling Training

ACTIVE COMPARATOR

12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions

Behavioral: Spelling Training

Interventions

This training is inspired by intervention concepts followed in SUVAG Polyclinic in Zagreb, Croatia and Kodaly pedagogy in Hungary. RitMoZ Training programme consists of 6 main activities: matching activity, nursery rhymes, rhythmic stimulations, music shapes, music writing and music reading. The training focuses on the perceptual overlap between language and music, embodiment and entrainment. The aim of the training is to improve characteristic features of reading disorders such as phonological awareness, perception of rhythm, phonological working memory and perception of speech sounds.

Music Training (RitMoZ Training)

This training consists of activities which focus on practicing spelling words in a computer task; the aim is to train orthographic processing which is suggested to improve phonological awareness and phonological working memory.

Spelling Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of reading disorder
  • Hungarian as native language

You may not qualify if:

  • comorbidities (e.g., Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD))
  • sensory impairment (e.g., hearing loss, low vision)
  • cognitive impairment (e.g., panic disorder, low IQ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre for Natural Sciences

Budapest, 1117, Hungary

Location

Related Links

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

  • Ferenc Honbolygó, PhD

    Research Centre for Natural Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior Research Fellow

Study Record Dates

First Submitted

November 28, 2021

First Posted

November 30, 2021

Study Start

November 15, 2021

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations