NCT04082104

Brief Summary

The aim of this study is to assess stuttering severity in both narration and conversation in adults and adolescences in order to determine which situation is more stressful so that more reliable and accurate measures for diagnosis can be done. Also this study will help in determining the best line of management of stuttering.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

August 31, 2019

Last Update Submit

December 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • measuring the stuttering severity index in narrative and conversational contexts by using Stuttering Severity Instrument version 3 (scale ranges from very mild to very severe)

    Using SSI-3 to evaluate stuttering in both conversational and narrative contexts

    baseline

Secondary Outcomes (1)

  • Comparison between the stuttering severity indices in narrative and conversational contexts (comparing the results of the primary outcome) by using the Statistical Package for the Social Sciences

    baseline

Interventions

Riley's Stuttering Severity Instrument is used for the objective assessment of severity and in other examinations of stuttered speech. Current versions of the instrument measures three parameters: 1) stuttering frequency; 2) duration of selected stutters; 3) observed physical concomitants.

Eligibility Criteria

Age11 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Stuttering adults and adolescences will be referred from the outpatient clinic of Phoniatric Unit at Assiut University Hospital

You may qualify if:

  • Age :11-50
  • Gender : both sex will be included in the study
  • IQ \>85
  • No previous therapy

You may not qualify if:

  • \. Presence of any other speech, language, physical or neuropsychatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

Related Publications (2)

  • Byrd CT, Logan KJ, Gillam RB. Speech disfluency in school-age children's conversational and narrative discourse. Lang Speech Hear Serv Sch. 2012 Apr;43(2):153-63. doi: 10.1044/0161-1461(2011/10-0068). Epub 2012 Jan 23.

    PMID: 22269580BACKGROUND
  • Constantino CD, Leslie P, Quesal RW, Yaruss JS. A preliminary investigation of daily variability of stuttering in adults. J Commun Disord. 2016 Mar-Apr;60:39-50. doi: 10.1016/j.jcomdis.2016.02.001. Epub 2016 Feb 23.

    PMID: 26945438BACKGROUND

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 9, 2019

Study Start

October 1, 2020

Primary Completion

June 14, 2022

Study Completion

August 1, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations