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Randomized Clinical Trial of Phonological Interventions (ECRIP)

Primary Purpose

Speech Articulation Disorder, Developmental Articulation Disorder, Phonological Impairment

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Speech Production Intervention
Speech Perception Intervention
Articulation Parent Group
Dialogic Reading Parent Group
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Speech Articulation Disorder focused on measuring Phonological Awareness, Speech Articulation Disorder, Development Articulation Disorder, Phonological Impairment, Dyslexia, Speech Therapy, School Transition

Eligibility Criteria

48 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • McGill UniversityRecruiting
  • Montreal Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Speech Production Intervention + Articulation Parent Group

Speech Production Intervention + Dialogic Reading Parent Group

Speech Perception Intervention + Articulation Parent Group

Speech Perception Intervention + Dialogical Reading Parent Group

Outcomes

Primary Outcome Measures

Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French])

Secondary Outcome Measures

Articulation Accuracy (Test Francophone de Phonologie, Paul et Rvachew [Test of French Phonology)
Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition)
Phonological Awareness (Test de Conscience Phonologique, Brosseau-Lapre et Rvachew [Phonological Awareness Test - French Version])

Full Information

First Posted
January 5, 2009
Last Updated
September 22, 2009
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT00818428
Brief Title
Randomized Clinical Trial of Phonological Interventions
Acronym
ECRIP
Official Title
The Contribution of a Speech Perception Intervention to the Prevention of Phonological Awareness Deficits in Children With Speech Sound Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Articulation Disorder, Developmental Articulation Disorder, Phonological Impairment, Dyslexia
Keywords
Phonological Awareness, Speech Articulation Disorder, Development Articulation Disorder, Phonological Impairment, Dyslexia, Speech Therapy, School Transition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Speech Production Intervention + Articulation Parent Group
Arm Title
2
Arm Type
Experimental
Arm Description
Speech Production Intervention + Dialogic Reading Parent Group
Arm Title
3
Arm Type
Experimental
Arm Description
Speech Perception Intervention + Articulation Parent Group
Arm Title
4
Arm Type
Experimental
Arm Description
Speech Perception Intervention + Dialogical Reading Parent Group
Intervention Type
Behavioral
Intervention Name(s)
Speech Production Intervention
Other Intervention Name(s)
Articulation therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speech Perception Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Articulation Parent Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialogic Reading Parent Group
Intervention Description
Parents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills.
Primary Outcome Measure Information:
Title
Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French])
Time Frame
12 months post treatment onset
Secondary Outcome Measure Information:
Title
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
Title
Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition)
Time Frame
12 months post-treatment onset
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francoise Brosseau-Lapre, M.Sc.(A)
Phone
514-398-4137
Email
francoise.brosseau-lapre@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Rvachew, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francoise Brosseau-Lapre, M.Sc. (A)
Phone
514-398-4137
Email
francoise.brosseau-lapre@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Susan Rvachew, Ph.D.
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francoise Brosseau-Lapre, M.Sc.(A)
Phone
514-412-4400
Email
francoise.brosseau-lapre@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Susan Rvachew, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Randomized Clinical Trial of Phonological Interventions

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