- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818428
Randomized Clinical Trial of Phonological Interventions (ECRIP)
September 22, 2009 updated by: McGill University
The Contribution of a Speech Perception Intervention to the Prevention of Phonological Awareness Deficits in Children With Speech Sound Disorders
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.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- Recruiting
- Montreal Children's Hospital
-
Principal Investigator:
- Susan Rvachew, Ph.D.
-
Contact:
- Francoise Brosseau-Lapre, M.Sc.(A)
- Phone Number: 514-412-4400
- Email: francoise.brosseau-lapre@mail.mcgill.ca
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Montreal, Quebec, Canada, H3G 1A8
- Recruiting
- McGill University
-
Contact:
- Francoise Brosseau-Lapre, M.Sc. (A)
- Phone Number: 514-398-4137
- Email: francoise.brosseau-lapre@mail.mcgill.ca
-
Principal Investigator:
- Susan Rvachew, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Speech Production Intervention + Articulation Parent Group
|
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.
Other Names:
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.
|
|
Experimental: 2
Speech Production Intervention + Dialogic Reading Parent Group
|
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.
Other Names:
Parents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills.
|
|
Experimental: 3
Speech Perception Intervention + 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.
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.
|
|
Experimental: 4
Speech Perception Intervention + Dialogical 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French])
Time Frame: 12 months post treatment onset
|
12 months post treatment onset
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Articulation Accuracy (Test Francophone de Phonologie, Paul et Rvachew [Test of French Phonology)
Time Frame: 6 weeks post treatment onset; 12 weeks post-treatment onset; 12 months post-treatment onset
|
6 weeks post treatment onset; 12 weeks post-treatment onset; 12 months post-treatment onset
|
|
Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition)
Time Frame: 12 months post-treatment onset
|
12 months post-treatment onset
|
|
Phonological Awareness (Test de Conscience Phonologique, Brosseau-Lapre et Rvachew [Phonological Awareness Test - French Version])
Time Frame: 6 weeks post-treatment onset; 12 weeks post-treatment onset
|
6 weeks post-treatment onset; 12 weeks post-treatment onset
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Rvachew, Ph.D., McGill University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Anticipated)
July 1, 2010
Study Completion (Anticipated)
July 1, 2010
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
September 23, 2009
Last Update Submitted That Met QC Criteria
September 22, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 410-2008-0503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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