Comparison of Interventions for Developmental Dyslexia

Developmental Dyslexia Clinical Trial

Official title:

The Effectiveness of Intervention for Developmental Dyslexia: The Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02791841
• Other study ID #: RRT-VHSS-AVG
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2016
• Last updated: January 23, 2018
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Catholic University of the Sacred Heart
• Contact: Alice Cancer, MD
• Email: alice.cancer[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: April 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

Behavioral:
• Rhythmic Reading Training
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.
• Visual Hemispheric-Specific Stimulation + Action Video Games
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.
• Action Video Games
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.

Locations

Country	Name	City	State
Italy	Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea'	Bosisio Parini

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks