This study aimed to evaluate the efficacy of the Fluency Rules Program(FRP) with parent-child interaction training in the experimental group and compare it with the FRP without parent-child interaction training in the control group.
Design
This study consists of the experimental group and the control group and the sample size in each group is 26 individuals.
All eligible individuals will be divided into two groups using the Block Randomization Method with the size of 4 blocks with and without parent-child interaction training. To generate a randomization list the online randomization service Sealed Envelope Ltd. 2019 will be used.
Settings and conduct
At first, the preschool children with stuttering who go to the clinics of speech-therapy in Yazd or are on a waiting list will be evaluated by a speech-language pathologist. According to the results of the stuttering severity test, if the child is diagnosed with stuttering and meets other inclusion criteria, he / she will be included in the study. The subjects will be divided into Fluency Rules Program(FRP) groups with/without parent-child interaction training. Therapy in each group consists of two 45-minute sessions per week for 3 months.
Participants/Inclusion and exclusion criteria
Inclusion: Children with stuttering in the age range of 3 to 7 years
Passing six months or more since the onset of stuttering .
Exclusion: Use of any psychiatric medications
The hearing impairment, speech-language, and neurological disorders
Intervention groups
A therapy session in the control group consists of working with the child according to the instructions of the Fluency Rules Program(FRP) .
A therapy session in the experimental group consists of working with the child according to the instructions of the FRP, using the parent-centered and interactive strategies.
Main outcome variables
In this study, the severity of stuttering is the main outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210403050816N1
Registration date:2021-10-31, 1400/08/09
Registration timing:prospective
Last update:2021-10-31, 1400/08/09
Update count:0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
Ebrahim Barzegar Bafrooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3231 8251
Email address
slp.barzegar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Fluency Rules Program with and without parent-child interaction training in pre-school children who stutter
Public title
The effects of parent-child interaction training on children's stuttering severity.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with stuttering in the age range of 3 to 7 years old.
Having stutter at a speech-language pathologist's discretion based on the Stuttering Severity Instrument-Third Edition (SSI-3)
Passing six months or more since the onset of stuttering.
The child is monolingual and Persian-speaking.
Not having any other treatment plan for stuttering while studying
Literate parent
The parent has enough time and necessary cooperation to read book and educational video files
Exclusion criteria:
Use of any psychiatric medications as reported by parents and clients' record
The hearing impairment, speech-language, and neurological disorders
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible individuals will be divided equally into two groups of the Fluency Rules Program with and without parent-child interaction training using a simple block randomization method with a size of four blocks (including two individuals in each group). The online randomization service Sealed Envelope Ltd will be used to generate the randomization allocation sequence. sequentially numbered, opaque, sealed envelopes (SNOSE) will also be used to conceal the allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
No. 14, 25rd Street, Resalat Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8963116116
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.USWR.REC.1399.260
Health conditions studied
1
Description of health condition studied
Stuttering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The child’s stuttering severity score is an initial outcome and it is determined by using the stuttering severity instrument test.
Timepoint
The severity of children’s stuttering will be measured before the intervention and at the end of the study.
Method of measurement
The stuttering measurement instrument of this study is the Stuttering Severity Instrument (SSI), which determines the severity of stuttering.
Secondary outcomes
1
Description
The impact of stuttering on your child
Timepoint
The impacts of stuttering on the child will be assessed at the beginning and end of the study.
Method of measurement
It will be measured by using the Palin Parent Rating Scales.
2
Description
The impact of stuttering on parents
Timepoint
The impact of stuttering on parents will be assessed at the beginning and end of the study.
Method of measurement
It will be measured by using the Palin Parent Rating Scales.
3
Description
Parents’ knowledge and confidence about managing stuttering
Timepoint
It will be assessed at the beginning and end of the study.
Method of measurement
It will be measured by using the Palin Parent Rating Scales.
Intervention groups
1
Description
Intervention group: A treatment session in the experimental group includes working with the child according to the instructions of the Fluency Rules Program (FRP) using parent-centered and interactive strategies. The parent-child interaction training package will be provided to the parents in the experimental group. At the beginning of each session, the therapist uses parent-centered strategies to train the parents about stuttering and controlling their concerns, then trains the interactive strategies for the parents. At the end of the session, the child will be treated according to the instructions of the FRP . Treatment in this group includes two 45-minute sessions per week for three months
Category
Rehabilitation
2
Description
Control group: A treatment session in the control group includes working with the child according to the instructions of the Fluency Rules Program (FRP). Treatment in this group includes two 45-minute sessions per week for three months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Negah No Speech Therapy Clinic
Full name of responsible person
Shahab Hosseini
Street address
No. 1, 12rd Street, Jomhoori Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8962016345
Phone
+98 35 3235 3841
Email
shahab.slp14.mui@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khorram Khorshid
Street address
No. 14, 25rd Street, Resalat Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8963116116
Phone
+98 35 3233 8251
Email
slp.barzegar@yahoo.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
Ebrahim Barzegar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 14, 25rd Street, Resalat Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8963116116
Phone
+98 35 3233 8251
Email
slp.barzegar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ebrahim Barzegar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 14, 25rd Street, Resalat Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8963116116
Phone
+98 35 3233 8251
Email
slp.barzegar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ebrahim Barzegar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 14, 25rd Street, Resalat Avenue, Yazd Town
City
Yazd
Province
Yazd
Postal code
8963116116
Phone
+98 35 3233 8251
Email
slp.barzegar@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
The individual data of the research participants: All of the data could be shared after making the individuals unidentifiable.
Study execution protocol: The detailed study execution protocol could be shared in both the control and experimental groups.
Statistical analysis map: The statistical analysis plan of the present study could be published without any restrictions.
Informed consent form: The informed consent form which is designed for this study could be shared after making the individuals unidentifiable.
Clinical reports of this study: After the end of the study, the clinical reports which are related to this study could be published without any restrictions.
Analysis codes of this study: After the end of the study, the analysis codes of this study could be published without any restrictions.
Data coding systems: After the study, the data coding systems could be published without any restrictions.
When the data will become available and for how long
All documents related to this study are available 6 months after the publication of the results.
To whom data/document is available
Academic researchers and speech-language pathologists could request the documentation of this study.
Under which criteria data/document could be used
There are no restrictions on using the data and analysis.
Any research or clinical use of the data is allowed.
From where data/document is obtainable
first author:slp.barzegar@yahoo.com
Corresponding Author:adarouie@hotmail.com
What processes are involved for a request to access data/document
The applicant must send the application to the e-mail of the lead or the corresponding author. After reviewing the email and consulting with the research team, the files will be provided to the applicant within 10 days.