NCT03199092

Brief Summary

The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of a multimodal intervention comprising different methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5 months, in 60 minutes biweekly sessions.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

June 20, 2017

Last Update Submit

January 23, 2018

Conditions

Keywords

ReadingDevelopmental DyslexiaMusicRhythmIntervention

Outcome Measures

Primary Outcomes (12)

  • Text reading accuracy expressed in number of errors change

    Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.

    1 month

  • Text reading speed expressed in syllables per seconds change

    The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.

    1 month

  • Word reading speed expressed in syllables per seconds change

    The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

    1 month

  • Word reading accuracy expressed in number of errors change

    The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

    1 month

  • Pseudo-word reading speed expressed in syllables per seconds change

    The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

    1 month

  • Pseudo-word reading accuracy expressed in number of errors change

    The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

    1 month

  • Text reading accuracy expressed in number of errors change

    Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.

    2.5 months

  • Text reading speed expressed in syllables per seconds change

    The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.

    2.5 months

  • Word reading speed expressed in syllables per seconds change

    The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

    2.5 months

  • Word reading accuracy expressed in number of errors change

    The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

    2.5 months

  • Pseudo-word reading speed expressed in syllables per seconds change

    The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

    2.5 months

  • Pseudo-word reading accuracy expressed in number of errors change

    The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

    2.5 months

Study Arms (2)

RRT+sat

EXPERIMENTAL

RRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions).

Behavioral: RRT+sat

Abilmente

EXPERIMENTAL

Abilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions).

Behavioral: Abilmente

Interventions

RRT+satBEHAVIORAL

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. For this study, RRT was delivered in combination with a specific auditory training involving several music games specifically designed for improving auditory processing abilities typically compromised in children with DD.

RRT+sat
AbilmenteBEHAVIORAL

'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features.

Abilmente

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University of the Sacred Heart

Milan, 20123, Italy

Location

Studio Abilmente

Milan, Italy

Location

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

  • Alessandro Antonietti, PhD

    Catholic University of the Sacred Heart

    STUDY DIRECTOR

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 candidate

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 26, 2017

Study Start

June 26, 2017

Primary Completion

October 12, 2017

Study Completion

April 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations