Randomized Clinical Trial of Phonological Interventions - Full Text View

Sponsored by:	McGill University
Information provided by:	McGill University
ClinicalTrials.gov Identifier:	NCT00818428

Purpose

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 knowlege will have a superior impact on phonological awareness in comparison with a treatment approach that focuses solely on articulation accuracy.

Condition	Intervention	Phase
Speech Articulation Disorder Developmental Articulation Disorder Phonological Impairment Dyslexia	Behavioral: Speech Production Intervention Behavioral: Speech Perception Intervention Behavioral: Articulation Parent Group Behavioral: Dialogic Reading Parent Group	Phase II Phase III

MedlinePlus related topics: Speech and Communication Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	The Contribution of a Speech Perception Intervention to the Prevention of Phonological Awareness Deficits in Children With Speech Sound Disorders

Further study details as provided by McGill University:

Primary Outcome Measures:

Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French]) [ Time Frame: 12 months post treatment onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition) [ Time Frame: 12 months post-treatment onset ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	November 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Speech Production Intervention + Articulation Parent Group	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. Behavioral: 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.
2: Experimental Speech Production Intervention + Dialogic Reading Parent Group	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. Behavioral: 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.
3: Experimental Speech Perception Intervention + Articulation Parent Group	Behavioral: 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. Behavioral: 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.
4: Experimental Speech Perception Intervention + Dialogical Reading Parent Group	Behavioral: 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. Behavioral: 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.

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.

Eligibility

Ages Eligible for Study:	48 Months to 71 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818428

Contacts

Contact: Francoise Brosseau-Lapre, M.Sc.(A)

514-398-4137

francoise.brosseau-lapre@mail.mcgill.ca

Locations

Canada, Quebec
McGill University	Recruiting
Montreal, Quebec, Canada, H3G 1A8
Contact: Francoise Brosseau-Lapre, M.Sc. (A) 514-398-4137 francoise.brosseau-lapre@mail.mcgill.ca
Principal Investigator: Susan Rvachew, Ph.D.
Montreal Children's Hospital	Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Francoise Brosseau-Lapre, M.Sc.(A) 514-412-4400 francoise.brosseau-lapre@mail.mcgill.ca
Principal Investigator: Susan Rvachew, Ph.D.

Sponsors and Collaborators

McGill University

More Information

Responsible Party:	School of Communication Sciences and Disorders, Faculty of Medicine, McGill University ( Susan Rvachew, Ph.D., S-LP(C), Associate Professor, Acting Director )
Study ID Numbers:	410-2008-0503
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00818428
Health Authority:	Canada: Social Sciences and Humanities Research Council

Keywords provided by McGill University:

Phonological Awareness
Speech Articulation Disorder
Development Articulation Disorder
Phonological Impairment

Dyslexia
Speech Therapy
School Transition

Study placed in the following topic categories:

Signs and Symptoms
Speech Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Language Disorders

Articulation Disorders
Dyslexia
Learning Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009