Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995991
Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Other), ASST Fatebenefratelli Sacco (Other), Associazione La Nostra Famiglia, Como, Italy (Other)
60
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36.8
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Study Details

Study Description

Brief Summary

The main objective of the study is to evaluate the specific effect of the sub-components of the reading training program Rhythmic Reading Training (RRT) on reading speed and accuracy in a sample of Italian students with developmental dyslexia (DD). More precisely, in order to better understand the neuropsychological mechanisms involved in reading improvements following RRT, the specific contribution of the visual component of the training (presence of a visual cue) will be investigated in a study with between-groups design.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RRT rhythm only
  • Behavioral: RRT rhythm + visual cue
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rhythmic Reading Training (RRT): Comparing the Rhythmic and Visual Contributions to Reading Improvement in Developmental Dyslexia
Actual Study Start Date :
Jul 9, 2018
Actual Primary Completion Date :
Jun 27, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: RRT rhythm only

10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer

Behavioral: RRT rhythm only
RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the RRT activities comprise only a rhythm accompaniment and no visual cue.

Experimental: RRT rhythm + visual cue

10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer

Behavioral: RRT rhythm + visual cue
RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the rhythmic accompaniment is synchronize with a visual cue (the verbal stimuli are highlighted using a red font in synchrony with the rhythm).

No Intervention: No intervention

5 weeks no intervention period

Outcome Measures

Primary Outcome Measures

  1. Word reading speed - DDE-2 [5 weeks]

    Word reading speed in syllable / second

  2. Word reading accuracy - DDE-2 [5 weeks]

    Word reading accuracy in n. of errors

  3. Word reading speed - DDE-2 [3 months]

    Word reading speed in syllable / second

  4. Word reading accuracy - DDE-2 [3 months]

    Word reading accuracy in n. of errors

  5. Pseudo-word reading speed - DDE-2 [5 weeks]

    Pseudo-word reading speed in syllable / second

  6. Pseudo-word reading accuracy - DDE-2 [5 weeks]

    Pseudo-word reading accuracy in n. of errors

  7. Pseudo-word reading speed - DDE-2 [3 months]

    Pseudo-word reading speed in syllable / second

  8. Pseudo-word reading accuracy - DDE-2 [3 months]

    Pseudo-word reading accuracy in n. of errors

  9. Text reading speed - MT-3-Clinica Battery [5 weeks]

    Text reading speed in syllable / second

  10. Text reading accuracy - MT-3-Clinica Battery [5 weeks]

    Text reading accuracy in n. of errors

  11. Text reading speed - MT-3-Clinica Battery [3 months]

    Text reading speed in syllable / second

  12. Text reading accuracy - MT-3-Clinica Battery [3 months]

    Text reading accuracy in n. of errors

Secondary Outcome Measures

  1. Phonemic awareness task (Judica et al., in press) [5 weeks]

    N. of errors in phonemic blending + n. of errors in phonemic elision

  2. Phonemic awareness task (Judica et al., in press) [3 months]

    N. of errors in phonemic blending + n. of errors in phonemic elision

  3. Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) [5 weeks]

    Forward and backward digit span

  4. Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) [3 months]

    Forward and backward digit span

  5. Rapid Automatized naming task - RAN (De Luca et al., 2005) [5 weeks]

    RAN speed in seconds

  6. Rapid Automatized naming task - RAN (De Luca et al., 2005) [3 months]

    RAN speed in seconds

  7. Selective Auditory attention task - NEPSY-II [5 weeks]

    N. of errors

  8. Selective Auditory attention task - NEPSY-II [3 months]

    N. of errors

  9. Rhythm reproduction task [5 weeks]

    n. of correctly reproduced rhythmic patterns

  10. Rhythm reproduction task [3 months]

    n. of correctly reproduced rhythmic patterns

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice
Exclusion Criteria:
  • presence of comorbidity with other neuropsychiatric or psychopathological conditions

  • having been involved in previous reading intervention programs in the previous 3 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catholic University of the Sacred Heart Milan Italy 20123

Sponsors and Collaborators

  • Catholic University of the Sacred Heart
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  • ASST Fatebenefratelli Sacco
  • Associazione La Nostra Famiglia, Como, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT04995991
Other Study ID Numbers:
  • RRT-VISUALCUE
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2021