- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160586
Stuttering and Anxiety
Stuttering Severity and Anxiety in Egyptian School-age Children
Stuttering was defined as a common neurodevelopmental speech disorder characterized by repetitions, prolongations, and interruptions in the flow of speech. In other words, stuttering is a speech disorder characterized by involuntary disruptions to speech which impede the capacity to communicate effectively.
Physiological and emotional anxiety has been reported in persons who stutter. It has been reported that as high as 44% of clients seeking treatment for stuttering could be assigned a co-occurring social phobia or social anxiety diagnosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the Diagnostic and Statistical Manual of Mental Disorders, social anxiety disorder is characterized by marked or intense fear of social or performance-based situations where scrutiny or evaluation by others may occur. Feared situations often include speaking in public, meeting new people, and talking with authority figures.
There are several reasons to expect that stuttering may be associated with social anxiety disorder. To begin with, stuttering is accompanied by numerous negative consequences across the lifespan which may increase vulnerability to social and psychological difficulties. These consequences are intensified during the school years when children become more involved in social and speaking situations. As a result, children and adolescents who stutter frequently experience peer victimization, social isolation and rejection, and they may also be less popular than their non-stuttering peers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 70001
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 6 years to 16 years
- Gender: both sex is included in the study
- Intelligence quotient ≥ 85
Exclusion Criteria:
- Intelligence quotient < 85
- Age below 6 years or above 16 years
- Presence of other speech, language or physical disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Stutter
Children who stuttering
|
To measure of degree of stuttering in child
To measure of percent of anxiety in child by ask parents about his or her behaviour
|
Active Comparator: Control
Children who non stuttering
|
To measure of percent of anxiety in child by ask parents about his or her behaviour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stuttering severity index
Time Frame: 30 minutes
|
Score of stuttering severity index a ranging from 1 to 40.
It grades was divided into (very mild- mild- moderate- severe- very severe)
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Behavior Checklist for age 4-18
Time Frame: 30 minutes
|
Questionnaire for detect presence of anxiety in children
|
30 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Iverach L, Rapee RM. Social anxiety disorder and stuttering: current status and future directions. J Fluency Disord. 2014 Jun;40:69-82. doi: 10.1016/j.jfludis.2013.08.003. Epub 2013 Sep 2.
- Smith KA, Iverach L, O'Brian S, Kefalianos E, Reilly S. Anxiety of children and adolescents who stutter: a review. J Fluency Disord. 2014 Jun;40:22-34. doi: 10.1016/j.jfludis.2014.01.003. Epub 2014 Feb 9.
- Blood GW, Blood IM, Maloney K, Meyer C, Qualls CD. Anxiety levels in adolescents who stutter. J Commun Disord. 2007 Nov-Dec;40(6):452-69. doi: 10.1016/j.jcomdis.2006.10.005. Epub 2006 Nov 28.
- Alm PA. Stuttering in relation to anxiety, temperament, and personality: review and analysis with focus on causality. J Fluency Disord. 2014 Jun;40:5-21. doi: 10.1016/j.jfludis.2014.01.004. Epub 2014 Feb 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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