Stuttering, ChildhoodNCT03160586
Stuttering and Anxiety
A study testing Stuttering severity instrument-3 and Child Behavior Checklist for age 4-18 in people with Stuttering, Childhood and Anxiety Disorders, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Childhood, Anxiety Disorders
- What is being tested?
- Stuttering severity instrument-3 and Child Behavior Checklist for age 4-18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2017to 1 Jan 2019
- Phase
- Interventional
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 6 years to 16 years
- Gender: both sex is included in the study
- Intelligence quotient ≥ 85
Who cannot join
- Intelligence quotient < 85
- Age below 6 years or above 16 years
- Presence of other speech, language or physical disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stuttering, Childhood, Anxiety Disorders
- Being tested
- Stuttering severity instrument-3, Child Behavior Checklist for age 4-18
- Keywords
- Stuttering, Anxiety
- Medical subject headings
- Stuttering, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stuttering severity instrument-3Diagnostic test
To measure of degree of stuttering in child
Child Behavior Checklist for age 4-18Diagnostic test
To measure of percent of anxiety in child by ask parents about his or her behaviour
| Study group | Role | What they receive |
|---|---|---|
| Stutter | Active comparator | Children who stuttering Receives: Diagnostic Test: Stuttering severity instrument-3; Diagnostic Test: Child Behavior Checklist for age 4-18 |
| Control | Active comparator | Children who non stuttering Receives: Diagnostic Test: Child Behavior Checklist for age 4-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes
Secondary outcomes (1)
Child Behavior Checklist for age 4-18
Questionnaire for detect presence of anxiety in children
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start17 May 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stuttering, ChildhoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160586
- Sponsor's protocol ID
- SSI
- Status last verified
- Jul 2019
- First submitted
- 17 May 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24929468Smith 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.
PubMed 24929464Blood 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.
PubMed 17126361Alm 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.
PubMed 24929463
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stuttering Severity and Anxiety in Egyptian School-age Children
- ClinicalTrials.gov ID
- NCT03160586
- Acronym / sponsor ID
- SSI
- Conditions
- Stuttering, Childhood, Anxiety Disorders
- Keywords
- Stuttering, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 May 2017 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stutter | Active comparator | Diagnostic Test: Stuttering severity instrument-3, Diagnostic Test: Child Behavior Checklist for age 4-18Children who stuttering |
| Control | Active comparator | Diagnostic Test: Child Behavior Checklist for age 4-18Children who non stuttering |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ≥ 6 years to 16 years
- Gender: both sex is included in the study
- Intelligence quotient ≥ 85
Key exclusion criteria (3 listed)
- Intelligence quotient < 85
- Age below 6 years or above 16 years
- Presence of other speech, language or physical 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 instrument-3To measure of degree of stuttering in child | Diagnostic test | Stutter |
| Child Behavior Checklist for age 4-18To measure of percent of anxiety in child by ask parents about his or her behaviour | Diagnostic test | Control, Stutter |
Primary outcome
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)
1 secondary outcome
Child Behavior Checklist for age 4-18
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 24929468Iverach 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.
- Background: PubMed 24929464Smith 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.
- Background: PubMed 17126361Blood 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.
- Background: PubMed 24929463Alm 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.
- Individual participant dataSharing planned: No
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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?
A study testing Stuttering severity instrument-3 and Child Behavior Checklist for age 4-18 in people with Stuttering, Childhood and Anxiety Disorders, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stuttering severity index (time frame: 30 minutes). 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 NCT03160586, which also lists 4 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 2 Jul 2019.