Childhood Apraxia of SpeechNCT03238677
Treating Childhood Apraxia of Speech
A study testing Speech Motor Chaining without Biofeedback, Biofeedback and Distributed Practice in people with Childhood Apraxia of Speech, run by Syracuse University at 1 site in United States.
Trial summary
The study will test two modifications to speech therapy for 40 school-age children with childhood apraxia of speech to determine how to improve treatment outcomes. The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Childhood Apraxia of Speech
- What is being tested?
- Speech Motor Chaining without Biofeedback, Biofeedback and Distributed Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 7 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Native English speakers who hear English as the dominant language in their home setting.
- Must pass a hearing screening.
- Score at or better than -2 standard deviations from the mean on the Matrix Reasoning Task of the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-2; t-score ≥ 30), Peabody Picture Vocabulary Test - 4th Edition (PPVT-4; standard score ≥ 70), and the Following Directions subtest of the Clinical Evaluation of Language Fundamentals - 5th Edition (CELF-5; scaled score ≥ 3).
- Goldman-Fristoe Test of Articulation - 3rd Edition (GFTA-3) percentile ≤ 5th).
- A diagnosis of CAS will be verified based on a polysyllable picture naming task, diadochokinetic task (puh-tuh-kuh), and syllable repetition task.
Who cannot join
- Parent report or direct evaluation reveals oral-facial structural abnormalities (e.g., cleft palate).
- Parental report of neurobehavioral disorders (e.g., autism spectrum disorders, ADHD, obsessive-compulsive disorder), or vision problems that are corrected with glasses/contacts.
- Fail a hearing screening, or failure to meet criteria listed above as Inclusionary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Childhood Apraxia of Speech: Role of Biofeedback & Practice Distribution
The study will test two modifications to speech therapy for 40 school-age children with childhood apraxia of speech to determine how to improve treatment outcomes. The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not include ultrasound visual feedback. Additionally, some children will be treated with a traditional schedule of 2 sessions per week, whereas others will be provided with treatment that begins with intensive training (10 hours of therapy in one week) and progresses to a more distributed treatment schedule.
Read the detailed description
Childhood apraxia of speech is a developmental speech sound disorder that may lead to persisting speech errors, often despite years of treatment. Such impairments may lead to social, academic, and vocational limitations. Thus, there is a need to explore alternate treatment approaches. This study will explore how to improve speech sound production in school-age children with CAS by modifying a standard speech therapy program. Two adaptations to speech therapy will be tested in a 2 x 2 randomized group design.
In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared against a treatment sequence beginning with an intensive therapy schedule (10 hrs of treatment in one week), which will then transition to a more distributed practice schedule. This treatment modification is intended to minimize erred practice between training sessions in the early stages of learning, then foster generalization through increased time between practice sessions.
In Aim 2, a standard treatment that includes only verbal feedback to the client during speech practice will be compared against a treatment sequence that initially includes real-time ultrasound visual feedback of the tongue during speech, which will be faded over the course of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may enhance children's understanding of the articulatory goals of speech movement patterns by comparing executed tongue movements with intended movements. Prior case reports and single subject experimental designs have shown that speech sound production may be enhanced by including ultrasound visual feedback, although no prior randomized group studies have been conducted.
Beside these modifications, the other aspects of treatment will be held constant. Outcomes will be evaluated by tracking changes in percent consonants correct from a large speech sample, scored by individuals who are blind to treatment status. The four groups will be compared to determine the extent to which speech sound therapy can be enhanced through a treatment sequence that begins with intensive practice and/or with ultrasound visual feedback.
- Conditions
- Childhood Apraxia of Speech
- Being tested
- Speech Motor Chaining without Biofeedback, Biofeedback, Distributed Practice, Massed --> Distributed Practice
- Keywords
- speech sound disorder
- Medical subject headings
- Apraxias, Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Motor Chaining without BiofeedbackBehavioural
These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html
BiofeedbackBehavioural
Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.
Distributed PracticeBehavioural
2 sessions per week for 10 weeks
Massed --> Distributed PracticeBehavioural
Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback, Massed->Distributed | Experimental | Sequenced biofeedback Mass Practice--> Distributed Scheduling Receives: Behavioral: Biofeedback; Behavioral: Massed --> Distributed Practice |
| No Biofeedback, Distributed | Active comparator | Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks Receives: Behavioral: Speech Motor Chaining without Biofeedback; Behavioral: Distributed Practice |
| Biofeedback, Distributed | Experimental | Sequenced biofeedback, 2 sessions/wk for 10 weeks Receives: Behavioral: Biofeedback; Behavioral: Distributed Practice |
| No Biofeedback, Massed-> Distributed | Experimental | Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling Receives: Behavioral: Speech Motor Chaining without Biofeedback; Behavioral: Massed --> Distributed Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Sound Accuracy
Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund \& Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.
Measured: 10 weeks from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2017
- Primary completion9 May 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood Apraxia of SpeechStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 design Scheduling: Mass--\>Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Jonathan Preston, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238677
- Sponsor's protocol ID
- 17-177
- Other IDs
- R15DC016426
- Status last verified
- May 2023
- First submitted
- 1 Aug 2017
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016.
PubMed 27625603Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155.
PubMed 28715554
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Childhood Apraxia of Speech: Role of Biofeedback & Practice Distribution
- ClinicalTrials.gov ID
- NCT03238677
- Acronym / sponsor ID
- 17-177
- Conditions
- Childhood Apraxia of Speech
- Keywords
- speech sound disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test two modifications to speech therapy for 40 school-age children with childhood apraxia of speech to determine how to improve treatment outcomes. The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not include ultrasound visual feedback. Additionally, some children will be treated with a traditional schedule of 2 sessions per week, whereas others will be provided with treatment that begins with intensive training (10 hours of therapy in one week) and progresses to a more distributed treatment schedule.
Detailed description
Childhood apraxia of speech is a developmental speech sound disorder that may lead to persisting speech errors, often despite years of treatment. Such impairments may lead to social, academic, and vocational limitations. Thus, there is a need to explore alternate treatment approaches. This study will explore how to improve speech sound production in school-age children with CAS by modifying a standard speech therapy program. Two adaptations to speech therapy will be tested in a 2 x 2 randomized group design.
In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared against a treatment sequence beginning with an intensive therapy schedule (10 hrs of treatment in one week), which will then transition to a more distributed practice schedule. This treatment modification is intended to minimize erred practice between training sessions in the early stages of learning, then foster generalization through increased time between practice sessions.
In Aim 2, a standard treatment that includes only verbal feedback to the client during speech practice will be compared against a treatment sequence that initially includes real-time ultrasound visual feedback of the tongue during speech, which will be faded over the course of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may enhance children's understanding of the articulatory goals of speech movement patterns by comparing executed tongue movements with intended movements. Prior case reports and single subject experimental designs have shown that speech sound production may be enhanced by including ultrasound visual feedback, although no prior randomized group studies have been conducted.
Beside these modifications, the other aspects of treatment will be held constant. Outcomes will be evaluated by tracking changes in percent consonants correct from a large speech sample, scored by individuals who are blind to treatment status. The four groups will be compared to determine the extent to which speech sound therapy can be enhanced through a treatment sequence that begins with intensive practice and/or with ultrasound visual feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2 x 2 design Scheduling: Mass-->Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
| Arm | Type | Receives |
|---|---|---|
| Biofeedback, Massed->Distributed | Experimental | Behavioral: Biofeedback, Behavioral: Massed --> Distributed PracticeSequenced biofeedback Mass Practice--> Distributed Scheduling |
| No Biofeedback, Distributed | Active comparator | Behavioral: Speech Motor Chaining without Biofeedback, Behavioral: Distributed PracticeSpeech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks |
| Biofeedback, Distributed | Experimental | Behavioral: Biofeedback, Behavioral: Distributed PracticeSequenced biofeedback, 2 sessions/wk for 10 weeks |
| No Biofeedback, Massed-> Distributed | Experimental | Behavioral: Speech Motor Chaining without Biofeedback, Behavioral: Massed --> Distributed PracticeSpeech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Native English speakers who hear English as the dominant language in their home setting.
- Must pass a hearing screening.
- Score at or better than -2 standard deviations from the mean on the Matrix Reasoning Task of the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-2; t-score ≥ 30), Peabody Picture Vocabulary Test - 4th Edition (PPVT-4; standard score ≥ 70), and the Following Directions subtest of the Clinical Evaluation of Language Fundamentals - 5th Edition (CELF-5; scaled score ≥ 3).
- Goldman-Fristoe Test of Articulation - 3rd Edition (GFTA-3) percentile ≤ 5th).
- A diagnosis of CAS will be verified based on a polysyllable picture naming task, diadochokinetic task (puh-tuh-kuh), and syllable repetition task.
Key exclusion criteria (3 listed)
- Parent report or direct evaluation reveals oral-facial structural abnormalities (e.g., cleft palate).
- Parental report of neurobehavioral disorders (e.g., autism spectrum disorders, ADHD, obsessive-compulsive disorder), or vision problems that are corrected with glasses/contacts.
- Fail a hearing screening, or failure to meet criteria listed above as Inclusionary
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 Motor Chaining without BiofeedbackThese procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html | Behavioural | No Biofeedback, Distributed, No Biofeedback, Massed-> Distributed |
| BiofeedbackReal-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference. | Behavioural | Biofeedback, Distributed, Biofeedback, Massed->Distributed |
| Distributed Practice2 sessions per week for 10 weeks | Behavioural | Biofeedback, Distributed, No Biofeedback, Distributed |
| Massed --> Distributed PracticeWeek 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment | Behavioural | Biofeedback, Massed->Distributed, No Biofeedback, Massed-> Distributed |
Primary outcome
Speech Sound Accuracy
Time frame: 10 weeks from the start of treatment
Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund \& Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27625603Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016.
- Background: PubMed 28715554Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155.
- Speech Motor Chaining Procedural manualLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Motor Chaining without Biofeedback, Biofeedback and Distributed Practice in people with Childhood Apraxia of Speech, run by Syracuse University at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Sound Accuracy (time frame: 10 weeks from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238677, which also lists 2 linked publications.
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 22 Jun 2023.