Speech Articulation DisorderPhase 2/3ECRIPNCT00818428
Randomized Clinical Trial of Phonological Interventions
A Phase 2/3 study testing Speech Production Intervention, Speech Perception Intervention and Articulation Parent Group in people with Speech Articulation Disorder and Developmental Articulation Disorder, run by McGill University at 2 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 48 to 71 months
- Conditions the study is for
- Speech Articulation Disorder, Developmental Articulation Disorder, Phonological Impairment
- What is being tested?
- Speech Production Intervention, Speech Perception Intervention and Articulation Parent Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2008to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- speech disorder is secondary to a primary condition (e.g., hearing impairment, cleft palate, autism, Down syndrome etc.)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
McGill University
Montreal, Quebec, H3G 1A8
Francoise Brosseau-Lapre, M.Sc. (A), 514-398-4137, francoise.brosseau-lapre@mail.mcgill.ca
Susan Rvachew, Ph.D.
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Francoise Brosseau-Lapre, M.Sc.(A), 514-412-4400, francoise.brosseau-lapre@mail.mcgill.ca
Susan Rvachew, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Speech Articulation Disorder, Developmental Articulation Disorder, Phonological Impairment, Dyslexia
- Being tested
- Speech Production Intervention, Speech Perception Intervention, Articulation Parent Group, Dialogic Reading Parent Group
- Keywords
- Phonological Awareness, Speech Articulation Disorder, Development Articulation Disorder, Phonological Impairment, Dyslexia, Speech Therapy, School Transition
- Medical subject headings
- Articulation Disorders, Dyslexia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Production InterventionBehavioural
Also called Articulation therapy
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 InterventionBehavioural
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 GroupBehavioural
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 GroupBehavioural
Parents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Speech Production Intervention + Articulation Parent Group Receives: Behavioral: Speech Production Intervention; Behavioral: Articulation Parent Group |
| 2 | Experimental | Speech Production Intervention + Dialogic Reading Parent Group Receives: Behavioral: Speech Production Intervention; Behavioral: Dialogic Reading Parent Group |
| 3 | Experimental | Speech Perception Intervention + Articulation Parent Group Receives: Behavioral: Speech Perception Intervention; Behavioral: Articulation Parent Group |
| 4 | Experimental | Speech Perception Intervention + Dialogical Reading Parent Group Receives: Behavioral: Speech Perception Intervention; Behavioral: Dialogic Reading Parent Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French])
Measured: 12 months post treatment onset
Secondary outcomes (3)
Articulation Accuracy (Test Francophone de Phonologie, Paul et Rvachew [Test of French Phonology)
Measured: 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)
Measured: 12 months post-treatment onset
Phonological Awareness (Test de Conscience Phonologique, Brosseau-Lapre et Rvachew [Phonological Awareness Test - French Version])
Measured: 6 weeks post-treatment onset; 12 weeks post-treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Articulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Investigators
- Susan Rvachew, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818428
- Sponsor's protocol ID
- 410-2008-0503
- Acronym
- ECRIP
- Status last verified
- Sep 2009
- First submitted
- 5 Jan 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of a Speech Perception Intervention to the Prevention of Phonological Awareness Deficits in Children With Speech Sound Disorders
- ClinicalTrials.gov ID
- NCT00818428
- Acronym / sponsor ID
- ECRIP / 410-2008-0503
- Conditions
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Speech Production Intervention, Behavioral: Articulation Parent GroupSpeech Production Intervention + Articulation Parent Group |
| 2 | Experimental | Behavioral: Speech Production Intervention, Behavioral: Dialogic Reading Parent GroupSpeech Production Intervention + Dialogic Reading Parent Group |
| 3 | Experimental | Behavioral: Speech Perception Intervention, Behavioral: Articulation Parent GroupSpeech Perception Intervention + Articulation Parent Group |
| 4 | Experimental | Behavioral: Speech Perception Intervention, Behavioral: Dialogic Reading Parent GroupSpeech Perception Intervention + Dialogical Reading Parent Group |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- speech disorder is secondary to a primary condition (e.g., hearing impairment, cleft palate, autism, Down syndrome etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Production InterventionAlso: Articulation therapyIndividual 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. | Behavioural | 1, 2 |
| Speech Perception InterventionIndividualized 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. | Behavioural | 3, 4 |
| Articulation Parent GroupParents are taught to carry out home practice activities that focus on the child's ability to correctly articulate target speech sounds and word shapes. | Behavioural | 1, 3 |
| Dialogic Reading Parent GroupParents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills. | Behavioural | 2, 4 |
Primary outcome
Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French])
Time frame: 12 months post treatment onset
3 secondary outcomes
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
Vocabulary Knowledge (Échelle de Vocabulaire en Image Peabody [Peabody Picture Vocabulary Test - French Edition)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Rvachew, Ph.D. principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Speech Production Intervention, Speech Perception Intervention and Articulation Parent Group in people with Speech Articulation Disorder and Developmental Articulation Disorder, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francoise Brosseau-Lapre, M.Sc.(A) (514-398-4137, francoise.brosseau-lapre@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phonological Awareness (Test d'Analyse Auditive en Français [Auditory Analysis Test in French]) (time frame: 12 months post treatment onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.