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Administrative data

NCT number NCT00818428
Other study ID # 410-2008-0503
Secondary ID
Status Unknown status
Phase Phase 2/Phase 3
First received January 5, 2009
Last updated September 22, 2009
Start date November 2008
Est. completion date July 2010

Study information

Verified date September 2009
Source McGill University
Contact Francoise Brosseau-Lapre, M.Sc.(A)
Phone 514-398-4137
Email francoise.brosseau-lapre@mail.mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent research reveals genetic and symptomatic overlap among children with speech sound disorders (i.e., those who (misarticulate more sounds than would be expected for their age) and children with dyslexia (i.e., those who struggle to learn to read). Children who have speech sound disorders as preschoolers are at risk for the later emergence of dyslexia, a risk that often reveals itself in the form of poor phonological awareness skills during the preschool period. Traditional speech therapy methods focus on articulation accuracy and do not focus on the child's more abstract knowledge of the sound system of the language. The ultimate objective of this research program is to prevent reading disability in children who present with speech sounds disorders. The relative effectiveness of different interventions to help these children achieve age-appropriate phonological processing skills prior to school entry will be investigated. It is expected that a combination of treatment approaches that focus on speech perception skills and vocabulary knowledge will have a superior impact on phonological awareness in comparison with a treatment approach that focuses solely on articulation accuracy.


Description:

The 72 children participating in the study will be randomly assigned (with concealment of the randomization sequence from study staff) to one of two Child Speech Interventions: Speech Perception or Speech Production. These interventions will be provided in individualized one-hour treatment sessions once per week for six consecutive weeks during the first treatment block. During the second 6 week treatment block all children will receive a group phonological awareness intervention. Concurrently their parents will be randomly assigned to receive instruction in the provision of a home program, either Articulation Therapy or Dialogic Reading. This will result in 4 groups of 18 children with each group receiving one of four combinations of intervention: Speech Production Intervention + Articulation Parent Group; Speech Production Intervention + Dialogic Reading Parent Group; Speech Perception Intervention + Articulation Parent Group; and Speech Perception Intervention + Dialogic Reading Parent Group. Assessments will occur pretreatment, after the first treatment block, after the second treatment block, and 9 months after the end of the second treatment block.


Recruitment information / eligibility

Status Unknown status
Enrollment 96
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 48 Months to 71 Months
Eligibility Inclusion Criteria:

- primary diagnosis of speech articulation disorder/phonological impairment

- age 4 to 5 years of age at onset of treatment

- maternal language Canadian French (at least 75% exposure)

- must misarticulate at least two phonemes that would typically be mastered by their normally developing age peers

Exclusion Criteria:

- speech disorder is secondary to a primary condition (e.g., hearing impairment, cleft palate, autism, Down syndrome etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speech Production Intervention
Individual speech therapy directed at teaching the child to articulation specific speech sounds or word shapes accurately using traditional procedures such as phonetic placement and imitated and spontaneous speech production practice with feedback from the clinician about accuracy of articulatory gestures and knowledge of results.
Speech Perception Intervention
Individualized intervention in which the Speech Assessment and Interactive Learning System is used to teach the child to identify recordings of words as either correct or incorrect pronunciations of the target word. In the event that the child is completely unable to pronounce the target speech sounds or word shapes focused stimulation activities are used to provide the child with further auditory exposure to the target forms. If the child stimulable for the target forms, the child is given opportunities the produce the target speech sounds or word shapes in the context of minimal pair games in which the child receives feedback about the communicative effectiveness of his or her attempts to produce the target words.
Articulation Parent Group
Parents are taught to carry out home practice activities that focus on the child's ability to correctly articulate target speech sounds and word shapes.
Dialogic Reading Parent Group
Parents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills.

Locations

Country Name City State
Canada McGill University Montreal Quebec
Canada Montreal Children's Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French]) 12 months post treatment onset
Secondary Articulation Accuracy (Test Francophone de Phonologie, Paul et Rvachew [Test of French Phonology) 6 weeks post treatment onset; 12 weeks post-treatment onset; 12 months post-treatment onset
Secondary Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition) 12 months post-treatment onset
Secondary Phonological Awareness (Test de Conscience Phonologique, Brosseau-Lapre et Rvachew [Phonological Awareness Test - French Version]) 6 weeks post-treatment onset; 12 weeks post-treatment onset
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