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Stuttering and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03160586
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Marwa Abdelraheem, Assiut University

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.

Condition or disease Intervention/treatment Phase
Stuttering, Childhood Anxiety Disorders Diagnostic Test: Stuttering severity instrument-3 Diagnostic Test: Child Behavior Checklist for age 4-18 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Stuttering Severity and Anxiety in Egyptian School-age Children
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Stuttering

Arm Intervention/treatment
Active Comparator: Stutter
Children who stuttering
Diagnostic Test: Stuttering severity instrument-3
To measure of degree of stuttering in child

Diagnostic Test: Child Behavior Checklist for age 4-18
To measure of percent of anxiety in child by ask parents about his or her behaviour

Active Comparator: Control
Children who non stuttering
Diagnostic Test: Child Behavior Checklist for age 4-18
To measure of percent of anxiety in child by ask parents about his or her behaviour

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Child Behavior Checklist for age 4-18 [ Time Frame: 30 minutes ]
    Questionnaire for detect presence of anxiety in children

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03160586

Contact: Emad K Abd El-haleem, Prof. 01064228598
Contact: Eman S Hassan, Prof. 01004082014

Assiut University Recruiting
Assiut, Egypt, 70001
Contact: Marwa Abd Elrahim, M.B.B.Ch         
Sponsors and Collaborators
Assiut University

Responsible Party: Marwa Abdelraheem, Principal Investigator, Assiut University Identifier: NCT03160586     History of Changes
Other Study ID Numbers: SSI
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marwa Abdelraheem, Assiut University:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms