StutteringNCT05908123
Exploring the Nature, Assessment and Treatment of Stuttering
A study testing The Blank Center CARE Model(TM) for Individuals who Stutter in people with Stuttering and Stuttering, Adult, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purposes of this study are to 1) investigate potential speech, language, and psychosocial contributions to the experience of stuttering in monolingual and multilingual speakers, and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training specific to… Read more about this study
- Who is it for?
- Ages 2 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Stuttering, Adult, Stuttering, Childhood
- What is being tested?
- The Blank Center CARE Model(TM) for Individuals who Stutter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2015to 22 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A participant will be considered a child who stutters (ages 2-17 years) if
- their parent/caregiver reports concern that their child is a person who stutters,
- they exhibit three of more stuttering-like disfluencies (e.g., sound/syllable repetitions, (in)audible sound prolongations, whole-word repetitions) per 300-word speech sample, or
- they present with an overall score of 11 or higher on the Stuttering Severity Instrument - 4th Edition (SSI-4).
- A participant will be considered an adult who stutters (18+ years) if
- they report they are a person who stutters,
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- they have received a formal diagnosis of stuttering from a certified speech-language pathologist,
- they exhibit three of more stuttering-like disfluencies (e.g., sound/syllable repetitions, (in)audible sound prolongations, whole-word repetitions) per 300-word speech sample, or
- they present with an overall score of 11 or higher on the Stuttering Severity Instrument - 4th Edition (SSI-4).
Who cannot join
- There are no exclusion criteria for persons who stutter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arthur M. Blank Center for Stuttering Education and Research
Austin, Texas, 78712
Geoffrey A Coalson, PhD, 512-232-2999, geoffrey.coalson@austin.utexas.edu
About this study
Official title: The Blank Center CARE Model™: An Anti-Ableist Approach to Treatment
The purposes of this study are to 1) investigate potential speech, language, and psychosocial contributions to the experience of stuttering in monolingual and multilingual speakers, and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training specific to fluency disorders.
Read the detailed description
Stuttering is a neurophysiological communication disorder characterized by a disruption in the forward flow of speech. Stuttering is multifactorial in nature, meaning there are several factors that likely to contribute to the development of stuttering in children and persistence of stuttering into adulthood. About 1% of the worldwide population stutters. In the United States, over 3 million people stutter. Research suggests people who stutter present with negative cognitive and affective components of the disorder, and that the general population holds negative perceptions of stuttering. Historically, people who stutter spend thousands of dollars on treatment that is not effective in mitigating the negative impact of stuttering on their overall communication and quality of life.
Speech-language pathologists evaluate and treat persons who stutter across the lifespan. Research suggests speech-language pathologists report fluency disorders (stuttering and cluttering) as the communication disorders with which they feel least competent and comfortable.
Thus, the purposes of this study are to 1) investigate potential speech, language, psychosocial, and motor contributions to stuttered speech production in monolingual and multilingual speakers and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training tools specific to fluency disorders.
- Being tested
- The Blank Center CARE Model(TM) for Individuals who Stutter
- Keywords
- stuttering, communication competence, adult, treatment
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Blank Center CARE Model(TM) for Individuals who StutterBehavioural
Also called Communication-Centered Treatment (CCT)
The over-arching goal of the Blank Center CARE Model is to ensure individuals who stutter communicate effectively, advocate for themselves in a manner that maintains agency, and ensure their quality of life does not depend on producing, or attempting to control, stuttered speech.
| Study group | Role | What they receive |
|---|---|---|
| Blank Center CARE Model (Communication, Advocacy, Resilience, Education) | Experimental | Not described Receives: Behavioral: The Blank Center CARE Model(TM) for Individuals who Stutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Competence
psychometric measures of communication competence (e.g., CARE Assessment: Communication Subscale)
Measured: 11-weeks
Advocacy
psychometric measures of self-advocacy (e.g., CARE Assessment: Advocacy Subscale)
Measured: 11-weeks
Resilience
psychometric measures of resilience (e.g., CARE Assessment: Resilience Subscale)
Measured: 11-weeks
Education
psychometric measures of education about stuttering (e.g., CARE Assessment: Education Subscale)
Measured: 11-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start22 May 2015
- Primary completion22 May 2035 (estimated)
- Study completion22 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney T Byrd, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908123
- Sponsor's protocol ID
- 2015050044
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- The Blank Center CARE Model™: An Anti-Ableist Approach to Treatment
- ClinicalTrials.gov ID
- NCT05908123
- Acronym / sponsor ID
- 2015050044
- Keywords
- stuttering, communication competence, adult, treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 22 May 2015 (actual)
- Primary completion
- 22 May 2035 (estimated)
- Study completion
- 22 May 2035 (estimated)
- First posted
- 18 Jun 2023 (actual)
- 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.
The purposes of this study are to 1) investigate potential speech, language, and psychosocial contributions to the experience of stuttering in monolingual and multilingual speakers, and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training specific to fluency disorders.
Detailed description
Stuttering is a neurophysiological communication disorder characterized by a disruption in the forward flow of speech. Stuttering is multifactorial in nature, meaning there are several factors that likely to contribute to the development of stuttering in children and persistence of stuttering into adulthood. About 1% of the worldwide population stutters. In the United States, over 3 million people stutter. Research suggests people who stutter present with negative cognitive and affective components of the disorder, and that the general population holds negative perceptions of stuttering. Historically, people who stutter spend thousands of dollars on treatment that is not effective in mitigating the negative impact of stuttering on their overall communication and quality of life.
Speech-language pathologists evaluate and treat persons who stutter across the lifespan. Research suggests speech-language pathologists report fluency disorders (stuttering and cluttering) as the communication disorders with which they feel least competent and comfortable.
Thus, the purposes of this study are to 1) investigate potential speech, language, psychosocial, and motor contributions to stuttered speech production in monolingual and multilingual speakers and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training tools specific to fluency disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blank Center CARE Model (Communication, Advocacy, Resilience, Education) | Experimental | Behavioral: The Blank Center CARE Model(TM) for Individuals who Stutter |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- A participant will be considered a child who stutters (ages 2-17 years) if
- their parent/caregiver reports concern that their child is a person who stutters,
- they exhibit three of more stuttering-like disfluencies (e.g., sound/syllable repetitions, (in)audible sound prolongations, whole-word repetitions) per 300-word speech sample, or
- they present with an overall score of 11 or higher on the Stuttering Severity Instrument - 4th Edition (SSI-4).
- A participant will be considered an adult who stutters (18+ years) if
Key exclusion criteria (1 listed)
- There are no exclusion criteria for persons who stutter.
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 |
|---|---|---|
| The Blank Center CARE Model(TM) for Individuals who StutterAlso: Communication-Centered Treatment (CCT)The over-arching goal of the Blank Center CARE Model is to ensure individuals who stutter communicate effectively, advocate for themselves in a manner that maintains agency, and ensure their quality of life does not depend on producing, or attempting to control, stuttered speech. | Behavioural | Blank Center CARE Model (Communication, Advocacy, Resilience, Education) |
Primary outcome
Communication Competence
Time frame: 11-weeks
psychometric measures of communication competence (e.g., CARE Assessment: Communication Subscale)
Advocacy
Time frame: 11-weeks
psychometric measures of self-advocacy (e.g., CARE Assessment: Advocacy Subscale)
Resilience
Time frame: 11-weeks
psychometric measures of resilience (e.g., CARE Assessment: Resilience Subscale)
Education
Time frame: 11-weeks
psychometric measures of education about stuttering (e.g., CARE Assessment: Education Subscale)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- primary website for research center \[Arthur M. Blank Center for Stuttering Education and Research\]Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Courtney T Byrd, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Blank Center CARE Model(TM) for Individuals who Stutter in people with Stuttering and Stuttering, Adult, run by University of Texas at Austin 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 9 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney T Byrd, PhD (512 475 6174, courtney.byrd@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Competence (time frame: 11-weeks). The study lists 4 primary outcomes in all. 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 22 Jun 2023.