NCT02316873

Brief Summary

The purpose of this study is to determine whether music training is an effective treatment of reading disorders

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

December 9, 2014

Last Update Submit

December 11, 2014

Conditions

Keywords

music training, rhythm

Outcome Measures

Primary Outcomes (1)

  • Pseudoword reading test

    The primary outcome variable was the performance in the pseudoword reading test measured in terms of accuracy (percentile of number of errors).

    six months

Secondary Outcomes (3)

  • Reading text

    six months

  • Phonological awareness

    six months

  • Word reading

    six months

Study Arms (2)

Music training

EXPERIMENTAL

twice a week one hour for 30 weeks, music training

Behavioral: Music training

Visual arts

ACTIVE COMPARATOR

twice a week one hour for 30 weeks, visual arts training

Behavioral: Visual arts

Interventions

Music trainingBEHAVIORAL

This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.

Music training
Visual artsBEHAVIORAL

This program emphasized visual-spatial and hand skills as well as creativity.

Visual arts

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Italian native language
  • Reading performance (accuracy and/or speed) failed on at least two of three school grade standardized Italian tests: text, words, pseudowords (cut-offs: z-score \<-1.8 standard deviations from the mean for speed scores, a score \<5th percentile in the accuracy scores).
  • Hearing and neurological examination within normal range
  • Normal or corrected-to-normal visual acuity
  • General IQ \>85 at Wechsler Intelligence Scale for Children III.

You may not qualify if:

  • Presence of comorbidity involving Attentional Deficit Disorders with Hyperactivity (ADHD)
  • Presence of comorbidity involving Specific Language Impairment (SLI)
  • Presence of comorbidity involving Oppositional Defiant Disorder (ODD)
  • Severe emotional-relational impairments
  • Previous formal musical or painting education for more than one year, other on-going treatment.
  • Presence of other diseases (i.e. diabetes , cystic fibrosis, asthma...) that could influence the performance in cognitive and executive functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Flaugnacco E, Lopez L, Terribili C, Montico M, Zoia S, Schon D. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial. PLoS One. 2015 Sep 25;10(9):e0138715. doi: 10.1371/journal.pone.0138715. eCollection 2015.

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 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

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 15, 2014

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

December 15, 2014

Record last verified: 2014-12