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Comparison of Interventions for Developmental Dyslexia

Primary Purpose

Developmental Dyslexia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rhythmic Reading Training
Visual Hemispheric-Specific Stimulation + Action Video Games
Action Video Games
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dyslexia focused on measuring Reading, Developmental Dyslexia,, Music, Rhythm, Action Video Games, Hemisphere-Specific Stimulation

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 (whereas comorbidity with other learning disabilities were allowed)
  • having been involved in previous reading intervention programs

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

RRT

VHSS+AVG

AVG

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Lexical access
Rapid automatized naming ability was assessed using the 'Rapid Automatized Naming test (RAN) - Colours' test (Test di denominazione rapida - Colori); in this test, matrices of 5 different colours were presented. The colours were presented in small 1 by 1 cm squares; they were black, blue (RGB 51-102-255), red (RGB 221-8-6), yellow (RGB 252-243-5), or green (RGB 31-183-20). There were 10 rows of 5 stimuli in each matrix for a total of 50 stimuli. Two different matrices for each condition were provided. In the RAN test, the child was requested to name each stimulus in the matrix as quickly and as accurately as possible. The dependent measure was the mean time in seconds/syllable. Naming errors were also recorded.
Phonological awareness: phonemic blending
Phoneme Blending assesses the capacity to derive a phonemic pattern from distinct phonemic units. The examiner presents each of 20 words, letter by letter, and the child is requested to mentally assemble them and report the resulting word. For both tasks, the scores refer to the total number of errors. Only age means (as raw scores) are provided.
Phonological awareness: phonemic elision
Phonemic Elision assesses the ability to recognize and isolate the phonemic constituents of 20 words (in this specific case, the initial constituents). The child is asked to delete the first two phonemes in the word read by the examiner and to report the resulting pseudo-word.
Auditory attention
Auditory selective attention was assessed using the Selective Auditory Attention Test from 'NEPSY-II'. In this task, the child listens to a pre-recorded list of words and touches the appropriate circle in the stimulus book when he or she hears a target word. This subtest has two parts. Auditory Attention is designed to assess selective auditory attention and the ability to sustain it (vigilance). Response Set is designed to assess the ability to shift and maintain a new and complex set involving both inhibition of previously learned responses and correctly responding to matching or contrasting stimuli. The child listens to a series of words and touches the appropriate circle when he or she hears a target word. Points are awarded only if the child responds correctly within 2 seconds of the target word presentation. Standard Scores are provided for the sum of Auditory Attention and Response Set.
Rhythm perception and reproduction
Rhythm and sound length discrimination abilities were assessed using the Rhythm Task from the 'Q1 VATA Assessment Battery for Cross-domain Learning Abilities' (Batteria per la valutazione delle abilità trasversali all'apprendimento, Q1 VATA). Subtest 'Duration' proposes sequences of tones for which the child has to identify and indicate the tone differing from the others in duration (being shorter or longer than the other tones). There are 4-5 tones in a sequence. In the 'Rhythm' subtest, the child listens to sequences of 6 to 10 tones that can be either identical or different in the rhythmic pattern, and he has to decide whether the two sequences are the same or different. Rhythm reproduction ability was measured using the 'Rhythm reproduction task' test (Tre prove di ritmo), which consists of the request to reproduce a set of rhythmic patterns of increasing complexity. The child has to reproduce a sequence of beats (with the top of a pencil) as demonstrated by the examiner.

Full Information

First Posted
May 26, 2016
Last Updated
January 23, 2018
Sponsor
Catholic University of the Sacred Heart
Collaborators
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT02791841
Brief Title
Comparison of Interventions for Developmental Dyslexia
Official Title
The Effectiveness of Intervention for Developmental Dyslexia: The Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
IRCCS Eugenio Medea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
Keywords
Reading, Developmental Dyslexia,, Music, Rhythm, Action Video Games, Hemisphere-Specific Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RRT
Arm Type
Experimental
Arm Description
Rhythmic Reading Training, administered for 13 hours over 9 days (two 45-minute training sessions per day).
Arm Title
VHSS+AVG
Arm Type
Experimental
Arm Description
Visual Hemispheric-Specific Stimulation + Action Video Games, administered for 13 hours over 9 days (two 45-minute training sessions per day).
Arm Title
AVG
Arm Type
Experimental
Arm Description
Action Video Games only, administered for 13 hours over 9 days (two 45-minute training sessions per day).
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic Reading Training
Other Intervention Name(s)
RRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visual Hemispheric-Specific Stimulation + Action Video Games
Other Intervention Name(s)
VHSS+AVG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Action Video Games
Other Intervention Name(s)
AVG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Text reading
Description
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.
Time Frame
3 weeks
Title
Word reading
Description
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).
Time Frame
3 weeks
Title
Pseudo-word reading
Description
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).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Lexical access
Description
Rapid automatized naming ability was assessed using the 'Rapid Automatized Naming test (RAN) - Colours' test (Test di denominazione rapida - Colori); in this test, matrices of 5 different colours were presented. The colours were presented in small 1 by 1 cm squares; they were black, blue (RGB 51-102-255), red (RGB 221-8-6), yellow (RGB 252-243-5), or green (RGB 31-183-20). There were 10 rows of 5 stimuli in each matrix for a total of 50 stimuli. Two different matrices for each condition were provided. In the RAN test, the child was requested to name each stimulus in the matrix as quickly and as accurately as possible. The dependent measure was the mean time in seconds/syllable. Naming errors were also recorded.
Time Frame
3 weeks
Title
Phonological awareness: phonemic blending
Description
Phoneme Blending assesses the capacity to derive a phonemic pattern from distinct phonemic units. The examiner presents each of 20 words, letter by letter, and the child is requested to mentally assemble them and report the resulting word. For both tasks, the scores refer to the total number of errors. Only age means (as raw scores) are provided.
Time Frame
3 weeks
Title
Phonological awareness: phonemic elision
Description
Phonemic Elision assesses the ability to recognize and isolate the phonemic constituents of 20 words (in this specific case, the initial constituents). The child is asked to delete the first two phonemes in the word read by the examiner and to report the resulting pseudo-word.
Time Frame
3 weeks
Title
Auditory attention
Description
Auditory selective attention was assessed using the Selective Auditory Attention Test from 'NEPSY-II'. In this task, the child listens to a pre-recorded list of words and touches the appropriate circle in the stimulus book when he or she hears a target word. This subtest has two parts. Auditory Attention is designed to assess selective auditory attention and the ability to sustain it (vigilance). Response Set is designed to assess the ability to shift and maintain a new and complex set involving both inhibition of previously learned responses and correctly responding to matching or contrasting stimuli. The child listens to a series of words and touches the appropriate circle when he or she hears a target word. Points are awarded only if the child responds correctly within 2 seconds of the target word presentation. Standard Scores are provided for the sum of Auditory Attention and Response Set.
Time Frame
3 weeks
Title
Rhythm perception and reproduction
Description
Rhythm and sound length discrimination abilities were assessed using the Rhythm Task from the 'Q1 VATA Assessment Battery for Cross-domain Learning Abilities' (Batteria per la valutazione delle abilità trasversali all'apprendimento, Q1 VATA). Subtest 'Duration' proposes sequences of tones for which the child has to identify and indicate the tone differing from the others in duration (being shorter or longer than the other tones). There are 4-5 tones in a sequence. In the 'Rhythm' subtest, the child listens to sequences of 6 to 10 tones that can be either identical or different in the rhythmic pattern, and he has to decide whether the two sequences are the same or different. Rhythm reproduction ability was measured using the 'Rhythm reproduction task' test (Tre prove di ritmo), which consists of the request to reproduce a set of rhythmic patterns of increasing complexity. The child has to reproduce a sequence of beats (with the top of a pencil) as demonstrated by the examiner.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (whereas comorbidity with other learning disabilities were allowed) having been involved in previous reading intervention programs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Cancer, MD
Email
alice.cancer@unicatt.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Antonietti, PhD
Email
alessandro.antoniett@unicatt.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Cancer, MD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea'
City
Bosisio Parini
ZIP/Postal Code
23842
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Luisa Lorusso, PhD
Email
marialuisa.lorusso@bp.lnf.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32581961
Citation
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.
Results Reference
derived

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Comparison of Interventions for Developmental Dyslexia

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