StutteringNCT04082104
Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts
An observational study of Stuttering, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 50 years
- Conditions the study is for
- Stuttering
- What is being tested?
- Stuttering Severity Instument version 3
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 11 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Stuttering adults and adolescences will be referred from the outpatient clinic of Phoniatric Unit at Assiut University Hospital
Who may be able to join
- Age :11-50
- Gender : both sex will be included in the study
- IQ >85
- No previous therapy
Who cannot join
- 1. Presence of any other speech, language, physical or neuropsychatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions and prolongations of sounds, syllables, words or phrases as well as involuntary silent pauses or blocks.
In the world, approximately 1% of the adult population suffer from stuttering. Stuttering has severe impact on the overall quality of the person's life such as anxiety, stress, shame, low self-esteem and negative affectivity .It also affects his educational attainment, his attractiveness and work life as he avoids employment.
Stuttering varies in severity, frequency and duration from situation to situation. So its dynamics are best understood within discourse contexts that involve interactions with other people. Clinicians typically rely on spontaneous conversational samples for analyzing speech disfluencies. They have good validity, but the use of a more structured form of speech may allow for more efficient, reliable elicitation of stuttering related behaviours and better understanding of the nature of stuttering.
Narration offers a more structured context than conversation because storytellers must weave together information about the characters, the circumstances and actions. Also, narration often contains more complex language than conversation and put the whole responsibility on the speaker for planning and conveying the information to the listener, compared to conversation where two or more speakers co-construct the stream of topics and comments. Thus, narration places more linguistic, cognitive and communicative demands on speakers than does conversation.
A research was done on six adult participants and showed that some of them stuttered more during conversation and others stuttered more during narration.
- Conditions
- Stuttering
- Being tested
- Stuttering Severity Instument version 3
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stuttering Severity Instument version 3Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Oct 2020
- Primary completion14 Jun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StutteringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Alfons Fouad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082104
- Sponsor's protocol ID
- Stuttering
- Status last verified
- Dec 2021
- First submitted
- 31 Aug 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22269580Constantino 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.
PubMed 26945438
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts
- ClinicalTrials.gov ID
- NCT04082104
- Acronym / sponsor ID
- Stuttering
- Conditions
- Stuttering
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 9 Sep 2019 (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 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.
Detailed description
Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions and prolongations of sounds, syllables, words or phrases as well as involuntary silent pauses or blocks.
In the world, approximately 1% of the adult population suffer from stuttering. Stuttering has severe impact on the overall quality of the person's life such as anxiety, stress, shame, low self-esteem and negative affectivity .It also affects his educational attainment, his attractiveness and work life as he avoids employment.
Stuttering varies in severity, frequency and duration from situation to situation. So its dynamics are best understood within discourse contexts that involve interactions with other people. Clinicians typically rely on spontaneous conversational samples for analyzing speech disfluencies. They have good validity, but the use of a more structured form of speech may allow for more efficient, reliable elicitation of stuttering related behaviours and better understanding of the nature of stuttering.
Narration offers a more structured context than conversation because storytellers must weave together information about the characters, the circumstances and actions. Also, narration often contains more complex language than conversation and put the whole responsibility on the speaker for planning and conveying the information to the listener, compared to conversation where two or more speakers co-construct the stream of topics and comments. Thus, narration places more linguistic, cognitive and communicative demands on speakers than does conversation.
A research was done on six adult participants and showed that some of them stuttered more during conversation and others stuttered more during narration.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Stuttering adults and adolescences will be referred from the outpatient clinic of Phoniatric Unit at Assiut University Hospital
Key inclusion criteria (4 listed)
- Age :11-50
- Gender : both sex will be included in the study
- IQ >85
- No previous therapy
Key exclusion criteria (1 listed)
- 1. Presence of any other speech, language, physical or neuropsychatric disorders.
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 |
|---|---|---|
| Stuttering Severity Instument version 3Riley'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. | Diagnostic test | – |
Primary outcome
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)
Time frame: baseline
Using SSI-3 to evaluate stuttering in both conversational and narrative contexts
1 secondary outcome
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
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 22269580Byrd 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.
- Background: PubMed 26945438Constantino 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stuttering, run by Assiut University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082104, which also lists 2 linked publications.
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 11 Jan 2022.