ClinicalTrials.gg
RecruitingNCT05908123Updated Jun 22, 2023

Exploring the Nature, Assessment and Treatment of Stuttering

An interventional study of The Blank Center CARE Model(TM) for Individuals who Stutter in Stuttering, Stuttering, Adult and Stuttering, Childhood, sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 2 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years after the study started (first participant enrolled May 2015, registered May 2023).
  • Started May 2015; still recruiting 11 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Ages
2 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Stuttering with a site in United States — 17 open to participants now, 18 under way, none of them phase 3. Stuttering · United States.

Planned enrollment
Largest of 27
3,000 · median 68
Started
2015
the only one that year
No phase
18 of 35
13 open now
Primary completion
2035-05
later than 17 of 17 live
Registered
21st of 35
by date

Among the 35 studies in Stuttering with a site in United States, this one has the largest planned enrollment of the 27 interventional ones, is the only one that started in 2015, is one of 18 with no phase, reaches primary completion later than 17 of the 17 other live ones, and was the 21st registered.

By phase

35 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 13 open
Observational7 · 1 open
Phase 25 · 2 open
Phase 12 · 1 open
Phase 2/32 · 0 open
Phase 31 · 0 open

By the year they started

First in 1992; this study’s year is marked. 1 started in 2015.

Size and results

Median enrollment 68 across the 27 interventional studies, 411 across the 7 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 35 studies in Stuttering with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Stuttering
  • Stuttering, Adult
  • Stuttering, Childhood
  • Stuttering, Developmental

Browse trials for

Keywords

  • stuttering, communication competence, adult, treatment
04

Who can participate

Ages eligible
2 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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,
  • 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).

Exclusion criteria

Exclusion Criteria:

  • There are no exclusion criteria for persons who stutter.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    Blank Center CARE Model (Communication, Advocacy, Resilience, Education)

    Behavioral: The Blank Center CARE Model(TM) for Individuals who Stutter

Interventions

  • BehavioralThe Blank Center CARE Model(TM) for Individuals who Stutter

    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.

    Also known as: Communication-Centered Treatment (CCT)

06

What researchers measure

Primary outcomes

  1. Communication Competence

    psychometric measures of communication competence (e.g., CARE Assessment: Communication Subscale)

    Time frame: 11-weeks

  2. Advocacy

    psychometric measures of self-advocacy (e.g., CARE Assessment: Advocacy Subscale)

    Time frame: 11-weeks

  3. Resilience

    psychometric measures of resilience (e.g., CARE Assessment: Resilience Subscale)

    Time frame: 11-weeks

  4. Education

    psychometric measures of education about stuttering (e.g., CARE Assessment: Education Subscale)

    Time frame: 11-weeks

07

Study locations

1 of 1 sites recruiting
  • Arthur M. Blank Center for Stuttering Education and Research
    Austin, Texas 78712, United States
    Recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2015 (actual). Primary completion is estimated for May 2035, 240 months after the start.

Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 240 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2023
First posted
Jun 18, 2023
StartActual
May 22, 2015
Primary completionEst.
May 22, 2035
CompletionEst.
May 22, 2035
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05908123
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
May 22, 2015
Primary completion
May 22, 2035 (estimated)
Completion
May 22, 2035 (estimated)
Last update
Jun 22, 2023

Study contacts

Courtney T Byrd, PhD
Contact
courtney.byrd@austin.utexas.edu
512 475 6174
Geoffrey A Coalson, PhD
Contact
geoffrey.coalson@austin.utexas.edu
512 232 2999
Courtney T Byrd, PhD
principal investigator · The University of Texas at Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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