Protocol summary

Study aim
The investigation of the effect of auditory temporal processing on speech fluency of developmental stuttering
Design
The clinical trail with control group, double blind study, randomized with the intervention group of 15 children with developmental stuttering
Settings and conduct
This study will be performed in Tehran, Iran in order to improve auditory temporal processing deficit in stuttering children and investigate the effect of training on stuttering severity. Actually both participants and therapist that evaluate the final results will be unaware of group allocation.
Participants/Inclusion and exclusion criteria
Children with developmental stuttering ranging in age from 7-12 years old
Intervention groups
The intervention of auditory temporal processing training in children with developmental stuttering
Main outcome variables
Riley Stuttering severity instrument-3 (SSI-3)

General information

Reason for update
Acronym
TPTS
IRCT registration information
IRCT registration number: IRCT20180305038967N1
Registration date: 2018-08-07, 1397/05/16
Registration timing: registered_while_recruiting

Last update: 2018-08-07, 1397/05/16
Update count: 0
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
Zahra Hosseini dastgerdi
Name of organization / entity
University of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0100
Email address
za.Hosseini@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auditory temporal processing training on speech fluency of children with developmental stuttering
Public title
The effect of auditory temporal processing training on stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have developmental stuttering Normal hearing Normal IQ
Exclusion criteria:
Learning disorder Attention disorder Neurological disorder History of otitis media with effusion
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization by software in order to equivalent distribution of different age in two control and intervention groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocation of patients with inclusion criteria will be done in different days to minimize the chance of talking patients together. Final results will be gathered by therapist that will not aware of groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of university of social welfare and rehabilitation sciences
Street address
University of social welfare and rehabilitation sciences, evin, daneshjo blvd, kodakyar deadend
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.USWR.REC.1397.3

Health conditions studied

1

Description of health condition studied
Developmental stuttering
ICD-10 code
F98.5
ICD-10 code description
Speech that is characterized by frequent repetition or prolongation of sounds or syllables or words, or by frequent hesitations or pauses that disrupt the rhythmic flow of speech. It should be classified as a disorder only if its severity is such as to ma

Primary outcomes

1

Description
Riley Stuttering severity instrument-3(SSI-3)
Timepoint
At the beginning of the study and after 12 session training and 3 months after training
Method of measurement
Riley Stuttering severity instrument - 3 score by interviewing and observation of child verbal behavior

2

Description
Stuttering severity index includes frequency of stuttering( percent of syllable and words that stuttered) and observation of secondary behavior
Timepoint
At the beginning of the study, 12 session after training , 3 months after training
Method of measurement
Riley Stuttering severity instrument - 3 score by interviewing and observation of child verbal behavior

Secondary outcomes

1

Description
Score of auditory temporal processing tests
Timepoint
At the beginning of the study- after 12 session training- 3 months after training
Method of measurement
Includes duration pattern test-gap in noise test-backward masking

Intervention groups

1

Description
Intervention group: 15 children with developmental stuttering that have abnormal function in auditory temporal processing that will receive auditory temporal processing training along with speech therapy
Category
Rehabilitation

2

Description
Control group: 15 children with developmental stuttering and abnormal function in the auditory temporal processing that will only receive traditional speech therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rofeydeh Rehabilitation hospital
Full name of responsible person
Morteza Farazi
Street address
Rofeydeh Rehabilitation hospital, Nemati allay, Shahid Baradaran Soleymani St., Gheytariyeh
City
Tehran
Province
Tehran
Postal code
19585713834
Phone
+98 21 2220 5326
Fax
Email
zahra.au46@yahoo.com
Web page address
http://rofeideh.uswr.ac.ir/index.jsp?fkeyid=&siteid=17&pageid=2670

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Yones Lotfi
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
Yones1333@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Hoseini Dastgerdi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
zahra.au46@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Hosseini Dastgerdi
Position
PhD satudent
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
Zahra.au46@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Hosseini Dastgerdi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar St., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
Zahra.au46@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual information and information about main results is publishable
When the data will become available and for how long
The access period 6 months after publishing the results
To whom data/document is available
Only available to student and academic researcher
Under which criteria data/document could be used
Only under conditions that cite to the article
From where data/document is obtainable
zahra hosseini dastgerdi
What processes are involved for a request to access data/document
The purpose of their studies should be clear. and citation must be done
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