NCT02791841

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 an intervention resulting from the combination of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of only AVG is intended to be compared to other treatments. All interventions are administered for 13 hours over 9 days to a group of Italian students with DD aged 8-12.

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
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
10 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

1.4 years

First QC Date

May 26, 2016

Last Update Submit

January 23, 2018

Conditions

Keywords

ReadingDevelopmental Dyslexia,MusicRhythmAction Video GamesHemisphere-Specific Stimulation

Outcome Measures

Primary Outcomes (3)

  • Text reading

    The ability to read aloud a text was assessed using the Italian standardized test 'New MT reading tests for junior high school' (Nuove prove di lettura MT per la scuola media inferiore), which provides accuracy and speed scores in reading aloud age-normed texts.

    3 weeks

  • Word reading

    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).

    3 weeks

  • Pseudo-word reading

    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).

    3 weeks

Secondary Outcomes (5)

  • Lexical access

    3 weeks

  • Phonological awareness: phonemic blending

    3 weeks

  • Phonological awareness: phonemic elision

    3 weeks

  • Auditory attention

    3 weeks

  • Rhythm perception and reproduction

    3 weeks

Study Arms (3)

RRT

EXPERIMENTAL

Rhythmic Reading Training, administered for 13 hours over 9 days (two 45-minute training sessions per day).

Behavioral: Rhythmic Reading Training

VHSS+AVG

EXPERIMENTAL

Visual Hemispheric-Specific Stimulation + Action Video Games, administered for 13 hours over 9 days (two 45-minute training sessions per day).

Behavioral: Visual Hemispheric-Specific Stimulation + Action Video Games

AVG

EXPERIMENTAL

Action Video Games only, administered for 13 hours over 9 days (two 45-minute training sessions per day).

Behavioral: Action Video Games

Interventions

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.

Also known as: RRT
RRT

This training combines Visual Hemisphere-Specific Stimulation (VHSS) according to Bakker's Balance Model, and Action Video-Games (AVG). Hemispheric-specific stimulation is carried out by tachistoscopic presentation of words to a visual hemifield in order to selectively stimulate right-hemisphere perceptual analysis or left-hemisphere linguistic anticipation. A computerized program is used, in which the word is flashed and presented for less than 350 ms only if the child clicks on the mouse at the exact moment a dot is crossing a central target (control of eye position and fixation). AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used.

Also known as: VHSS+AVG
VHSS+AVG

AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used.

Also known as: AVG
AVG

Eligibility Criteria

Age8 Years - 12 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)
  • having been involved in previous reading intervention programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea'

Bosisio Parini, 23842, Italy

RECRUITING

Related Publications (1)

  • Cancer A, Bonacina S, Antonietti A, Salandi A, Molteni M, Lorusso ML. The Effectiveness of Interventions for Developmental Dyslexia: Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games. Front Psychol. 2020 Jun 3;11:1158. doi: 10.3389/fpsyg.2020.01158. eCollection 2020.

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

  • Alice Cancer, MD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Cancer, MD

CONTACT

Alessandro Antonietti, 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
PhD candidate

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 7, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

April 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations