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A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)

Primary Purpose

Reading Disorder

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Music Training (RitMoZ Training)
Spelling Training
Sponsored by
Research Centre for Natural Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Disorder focused on measuring reading disorders, music intervention, rhythmic stimulations, phonological processing, Event-Related Brain Potentials

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of reading disorder
  • Hungarian as native language

Exclusion Criteria:

  • 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)

Sites / Locations

  • Research Centre for Natural Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Training (RitMoZ Training)

Spelling Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Choice reaction time test
The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
Lexical decision task
To assess lexical decision, the present test is applied. Here, accuracy is measured.
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2021
Last Updated
October 25, 2022
Sponsor
Research Centre for Natural Sciences
Collaborators
University of Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT05137353
Brief Title
A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)
Official Title
RitMoZ Training: A Randomized Control Trial Study to Assess a Multisensory Music Intervention for Children With Reading Disorders in Hungary
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Centre for Natural Sciences
Collaborators
University of Rijeka

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.
Detailed Description
Studies have shown that music in the form of training (i.e., intervention) is able to facilitate linguistic processes (e.g., phonological encoding/decoding, categorical perception) and cognitive functions (e.g., working memory) in children that have dyslexia or reading difficulties. In addition to this, music trainings with a focus on entrainment can improve phonological as well as reading skills. In line with the above, we have designed and developed a music training programme. This programme, which is called RitMoZ Training (i.e., from Ritmus és Mozgás és Zene: meaning Rhythm and Movement and Music in Hungarian language), is designed for (Hungarian) children who have dyslexia or reading difficulties. In order to assess the efficacy of the music training, we are going to conduct a randomized controlled trial which consists of a pre-training phase, a training phase and a post-training phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Disorder
Keywords
reading disorders, music intervention, rhythmic stimulations, phonological processing, Event-Related Brain Potentials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Training (RitMoZ Training)
Arm Type
Experimental
Arm Description
12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions
Arm Title
Spelling Training
Arm Type
Active Comparator
Arm Description
12 sessions spread in the course of 1.5 months: each session has a duration of 90 minutes; each week will have 2 sessions
Intervention Type
Behavioral
Intervention Name(s)
Music Training (RitMoZ Training)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spelling Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reading test
Description
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.
Time Frame
4 minutes
Title
Spelling test
Description
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.
Time Frame
4-7 minutes
Title
Phoneme deletion test
Description
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.
Time Frame
3-7 minutes
Title
Letter-sound identification test
Description
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.
Time Frame
2-3 minutes
Title
Letter-sound discrimination test
Description
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.
Time Frame
2 - 4 minutes
Title
Rapid Automatized Naming (RAN) test
Description
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.
Time Frame
3-5 minutes
Title
Choice reaction time test
Description
The present subtest is applied from the shortened version of the 3DM-H; here, the reaction time is measured.
Time Frame
1 - 2 minutes
Title
Lexical decision task
Description
To assess lexical decision, the present test is applied. Here, accuracy is measured.
Time Frame
12- 15 minutes
Title
Auditory discrimination of acoustic and phonetic alteration of pseudowords
Description
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.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of reading disorder Hungarian as native language Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferenc Honbolygó, PhD
Organizational Affiliation
Research Centre for Natural Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre for Natural Sciences
City
Budapest
ZIP/Postal Code
1117
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ritmozintervention.com/
Description
This is the website which provides information and details about the intervention and the study procedure.

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A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)

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