NCT03160586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

May 17, 2017

Last Update Submit

July 1, 2019

Conditions

Keywords

StutteringAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 minutes

Secondary Outcomes (1)

  • Child Behavior Checklist for age 4-18

    30 minutes

Study Arms (2)

Stutter

ACTIVE COMPARATOR

Children who stuttering

Diagnostic Test: Stuttering severity instrument-3Diagnostic Test: Child Behavior Checklist for age 4-18

Control

ACTIVE COMPARATOR

Children who non stuttering

Diagnostic Test: Child Behavior Checklist for age 4-18

Interventions

To measure of degree of stuttering in child

Stutter

To measure of percent of anxiety in child by ask parents about his or her behaviour

ControlStutter

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ≥ 6 years to 16 years
  • Gender: both sex is included in the study
  • Intelligence quotient ≥ 85

You may not qualify if:

  • Intelligence quotient \< 85
  • Age below 6 years or above 16 years
  • Presence of other speech, language or physical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 70001, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 24929468BACKGROUND
  • 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.

    PMID: 24929464BACKGROUND
  • 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.

    PMID: 17126361BACKGROUND
  • 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.

    PMID: 24929463BACKGROUND

MeSH Terms

Conditions

StutteringAnxiety Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

May 17, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations