NCT04995991

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 9, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

August 9, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

July 16, 2021

Last Update Submit

July 30, 2021

Conditions

Outcome Measures

Primary Outcomes (12)

  • Word reading speed - DDE-2

    Word reading speed in syllable / second

    5 weeks

  • Word reading accuracy - DDE-2

    Word reading accuracy in n. of errors

    5 weeks

  • Word reading speed - DDE-2

    Word reading speed in syllable / second

    3 months

  • Word reading accuracy - DDE-2

    Word reading accuracy in n. of errors

    3 months

  • Pseudo-word reading speed - DDE-2

    Pseudo-word reading speed in syllable / second

    5 weeks

  • Pseudo-word reading accuracy - DDE-2

    Pseudo-word reading accuracy in n. of errors

    5 weeks

  • Pseudo-word reading speed - DDE-2

    Pseudo-word reading speed in syllable / second

    3 months

  • Pseudo-word reading accuracy - DDE-2

    Pseudo-word reading accuracy in n. of errors

    3 months

  • Text reading speed - MT-3-Clinica Battery

    Text reading speed in syllable / second

    5 weeks

  • Text reading accuracy - MT-3-Clinica Battery

    Text reading accuracy in n. of errors

    5 weeks

  • Text reading speed - MT-3-Clinica Battery

    Text reading speed in syllable / second

    3 months

  • Text reading accuracy - MT-3-Clinica Battery

    Text reading accuracy in n. of errors

    3 months

Secondary Outcomes (10)

  • Phonemic awareness task (Judica et al., in press)

    5 weeks

  • Phonemic awareness task (Judica et al., in press)

    3 months

  • Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)

    5 weeks

  • Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)

    3 months

  • Rapid Automatized naming task - RAN (De Luca et al., 2005)

    5 weeks

  • +5 more secondary outcomes

Study Arms (3)

RRT rhythm only

EXPERIMENTAL

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

Behavioral: RRT rhythm only

RRT rhythm + visual cue

EXPERIMENTAL

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

Behavioral: RRT rhythm + visual cue

No intervention

NO INTERVENTION

5 weeks no intervention period

Interventions

RRT rhythm onlyBEHAVIORAL

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.

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 rhythmic accompaniment is synchronize with a visual cue (the verbal stimuli are highlighted using a red font in synchrony with the rhythm).

RRT rhythm + visual cue

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • presence of comorbidity with other neuropsychiatric or psychopathological conditions
  • having been involved in previous reading intervention programs in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Milan, 20123, Italy

RECRUITING

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

Central Study Contacts

Alice Cancer, PhD

CONTACT

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
Principal Investigator

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 9, 2021

Study Start

July 9, 2018

Primary Completion

June 27, 2021

Study Completion

August 1, 2021

Last Updated

August 9, 2021

Record last verified: 2021-07

Locations