Stuttering and Anxiety
Primary Purpose
Stuttering, Childhood, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stuttering severity instrument-3
Child Behavior Checklist for age 4-18
Sponsored by
About this trial
This is an interventional diagnostic trial for Stuttering, Childhood focused on measuring Stuttering, Anxiety
Eligibility Criteria
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
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stutter
Control
Arm Description
Children who stuttering
Children who non stuttering
Outcomes
Primary Outcome Measures
Stuttering severity index
Score of stuttering severity index a ranging from 1 to 40. It grades was divided into (very mild- mild- moderate- severe- very severe)
Secondary Outcome Measures
Child Behavior Checklist for age 4-18
Questionnaire for detect presence of anxiety in children
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03160586
Brief Title
Stuttering and Anxiety
Official Title
Stuttering Severity and Anxiety in Egyptian School-age Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Childhood, Anxiety Disorders
Keywords
Stuttering, Anxiety
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stutter
Arm Type
Active Comparator
Arm Description
Children who stuttering
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Children who non stuttering
Intervention Type
Diagnostic Test
Intervention Name(s)
Stuttering severity instrument-3
Intervention Description
To measure of degree of stuttering in child
Intervention Type
Diagnostic Test
Intervention Name(s)
Child Behavior Checklist for age 4-18
Intervention Description
To measure of percent of anxiety in child by ask parents about his or her behaviour
Primary Outcome Measure Information:
Title
Stuttering severity index
Description
Score of stuttering severity index a ranging from 1 to 40. It grades was divided into (very mild- mild- moderate- severe- very severe)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Child Behavior Checklist for age 4-18
Description
Questionnaire for detect presence of anxiety in children
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
70001
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24929468
Citation
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.
Results Reference
background
PubMed Identifier
24929464
Citation
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.
Results Reference
background
PubMed Identifier
17126361
Citation
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.
Results Reference
background
PubMed Identifier
24929463
Citation
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.
Results Reference
background
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Stuttering and Anxiety
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