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Exploring the Nature, Assessment and Treatment of Stuttering

Primary Purpose

Stuttering, Stuttering, Adult, Stuttering, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Blank Center CARE Model(TM) for Individuals who Stutter
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering focused on measuring stuttering, communication competence, adult, treatment

Eligibility Criteria

2 Years - 85 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arthur M. Blank Center for Stuttering Education and ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Communication Competence
psychometric measures of communication competence (e.g., CARE Assessment: Communication Subscale)
Advocacy
psychometric measures of self-advocacy (e.g., CARE Assessment: Advocacy Subscale)
Resilience
psychometric measures of resilience (e.g., CARE Assessment: Resilience Subscale)
Education
psychometric measures of education about stuttering (e.g., CARE Assessment: Education Subscale)

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
June 20, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05908123
Brief Title
Exploring the Nature, Assessment and Treatment of Stuttering
Official Title
The Blank Center CARE Model™: An Anti-Ableist Approach to Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2015 (Actual)
Primary Completion Date
May 22, 2035 (Anticipated)
Study Completion Date
May 22, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Stuttering, Adult, Stuttering, Childhood, Stuttering, Developmental
Keywords
stuttering, communication competence, adult, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blank Center CARE Model (Communication, Advocacy, Resilience, Education)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
The Blank Center CARE Model(TM) for Individuals who Stutter
Other Intervention Name(s)
Communication-Centered Treatment (CCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Communication Competence
Description
psychometric measures of communication competence (e.g., CARE Assessment: Communication Subscale)
Time Frame
11-weeks
Title
Advocacy
Description
psychometric measures of self-advocacy (e.g., CARE Assessment: Advocacy Subscale)
Time Frame
11-weeks
Title
Resilience
Description
psychometric measures of resilience (e.g., CARE Assessment: Resilience Subscale)
Time Frame
11-weeks
Title
Education
Description
psychometric measures of education about stuttering (e.g., CARE Assessment: Education Subscale)
Time Frame
11-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: • There are no exclusion criteria for persons who stutter.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney T Byrd, PhD
Phone
512 475 6174
Email
courtney.byrd@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffrey A Coalson, PhD
Phone
512 232 2999
Email
geoffrey.coalson@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney T Byrd, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur M. Blank Center for Stuttering Education and Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey A Coalson, PhD
Phone
512-232-2999
Email
geoffrey.coalson@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://blankcenterforstuttering.org/
Description
primary website for research center [Arthur M. Blank Center for Stuttering Education and Research]

Learn more about this trial

Exploring the Nature, Assessment and Treatment of Stuttering

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