NCT05908123

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
111mo left

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2015May 2035

Study Start

First participant enrolled

May 22, 2015

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2035

Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

20 years

First QC Date

May 30, 2023

Last Update Submit

June 20, 2023

Conditions

Keywords

stuttering, communication competence, adult, treatment

Outcome Measures

Primary Outcomes (4)

  • Communication Competence

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

    11-weeks

  • Advocacy

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

    11-weeks

  • Resilience

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

    11-weeks

  • Education

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

    11-weeks

Study Arms (1)

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

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

Interventions

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

Eligibility Criteria

Age2 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur M. Blank Center for Stuttering Education and Research

Austin, Texas, 78712, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Courtney T Byrd, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 18, 2023

Study Start

May 22, 2015

Primary Completion (Estimated)

May 22, 2035

Study Completion (Estimated)

May 22, 2035

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations