Investigation and comparison of the effect of the Gradual Increase Length and Complexity of Utterance (GILCU) program and the Phonological Processing Treatment and the "gradual increase of the length and complexity of speech and phonological processing" combined treatment method (GILCU-PPT) on fluency of speech of pre-school Persian speaking children with stuttering.
A comparison of the effect of the gradual increase length and complexity of utterance program and the phonological processing treatment and the "gradual increase of the length and complexity of utterance and phonological processing" combined treatment on fluency of speech of pre-school Persian speaking children with stuttering.
Design
Clinical trial with three groups of participants, each receiving one type of treatment, double-blind, randomized on 33 patients, to randomize blocks of three together with strata according to severity
Settings and conduct
the sample size of Persian-speaking preschool children will be selected, in Tehran city. Written consent will be obtained from the participants. Then three baseline assessments will be performed and the participants will be assigned to three treatment groups randomly. Each group will receive the relevant treatment by the speech and language pathologist for 4 weeks (three sessions per week for a total of 12 sessions).Treatment sessions will be performed in speech therapy clinics in Tehran. After the completion of the intervention and in the follow-up period one month after the treatment, each group will be evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Persian-speaking preschool children with stuttering
2. No history of treatment by this treatment methods.
3. Child with stuttering
Non inclusion criteria:
1.Children who have incomplete medical documents.
2.Children with onset of stuttering less than 12 months.
Intervention groups
Group 1, gradually increasing the length and complexity of utterance program, Group 2 phonological processing treatment and Group 3, combined treatment of gradually increasing the length and complexity of utterance and phonological processing treatment will received.
Main outcome variables
Percentage of stuttered syllables or ss%
Severity of stuttering
Communication attitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057445N1
Registration date:2023-03-08, 1401/12/17
Registration timing:prospective
Last update:2023-03-08, 1401/12/17
Update count:1
Registration date
2023-03-08, 1401/12/17
Registrant information
Name
Akram Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 859 5079
Email address
akramvalizadeh59@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the effect of the Gradual Increase Length and Complexity of Utterance (GILCU) program and the Phonological Processing Treatment and the "gradual increase of the length and complexity of speech and phonological processing" combined treatment method (GILCU-PPT) on fluency of speech of pre-school Persian speaking children with stuttering.
Public title
The effect of the Gradual Increase Length and Complexity of Utterance (GILCU) program and the Phonological Processing Treatment and the "gradual increase of the length and complexity of speech and phonological processing" combined treatment method (GILCU-PPT) on children's stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 12 months have passed since the start of stuttering according to the parents' report.
Children should be in preschool age (4 to 6 years old).
Considering that the participants are selected from the waiting list, they should not have a history of stuttering treatment using the program of gradually increasing the length and complexity of utterance and phonological processing treatment in the 12 months before the start of the study, and other treatments are past, at least one month .
The child's stuttering is diagnosed based on all three diagnostic criteria of Yairi and Ambros, meaning that: a. A speech and language pathologist will diagnose the child as stuttering. b. The severity of the child's stuttering on the 8-point SR scale by the parents should be 2 or higher. c. The child should show at least three SLDs in the spontaneous speech sample of 100 syllables.
Not neurological damage, language damage, sensory and motor damage ,according to parents' reports and the relevant tests by a speech and language pathologist and medical documents .
Not social and emotional disorders according to the results of the Vineland Social Skill Scale by a psychologist.
Not using drugs that affect the results according to parents' reports and medical documents.
The child should be monolingual and Farsi speaking, according to the parents' report.
Not cognitive disorders ,according to Forward and backward digit span and Wechsler's non-verbal and cubes tests.
Based on the hearing screening test (audiometry of frequencies 2000, 250, 500, 1000 dB), the child should not have a hearing problem.
The child should be right-handed
Exclusion criteria:
The child's medical document is not complete.
According to the parents' report and the medical documents, the child has be a disease that affects the results of this study
Less than 12 months have passed since the onset of stuttering.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
For stratified randomization ,first, randomization layers are formed based on the severity of stuttering (mild, moderate, severe) (in such a way that layers are formed and randomization is done in each layer separately ), assignment of samples to treatment groups is done by the method of random blocks (using blocks of three); In this way, according to the sample size of 33 participants and three intervention groups, we will have 11 participants in each group. The randomization unit is individual and this randomization was done using statistical software. For allocation concealment, the person who does not perform any of the evaluation and treatment steps, the samples are coded. These codes are placed on opaque sealed envelopes that will not be opened until the treatment begins.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the examiner will not know about the group allocation and the type of treatment. The examiner who measures the main outcomes at baseline (before treatment), immediately after treatment, and at one-month follow-up, will not be aware of the sample allocation. Sealed opaque envelopes will be used for this purpose and each of the generated sequences randomly is recorded on a card and the cards are placed in the envelopes in order. Finally, the lids of the envelopes are glued and are placed in a box respectively. At the time of starting the treatment, one of the envelopes will be opened and the assigned group of that participant will be revealed, according to the order in which the eligible participants entered the study. The therapist who provides the treatment knows the type of treatment.
Placebo
Not used
Assignment
Other
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
university of Social Welfare and Rehabilitation Sciences,kodakyar St ,Daneshju Blvd
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2023-03-02, 1401/12/11
Ethics committee reference number
IR.USWR.REC.1401.235
Health conditions studied
1
Description of health condition studied
Stuttering
ICD-10 code
F98.5
ICD-10 code description
Adult onset fluency disorder
Primary outcomes
1
Description
Stuttering severity, percentage of stuttered syllables or ss%
Timepoint
Three times before the start of the intervention and once after the end of the intervention and once in the follow-up phase one month after the intervention
Method of measurement
Speech Sample and counting, Stuttering severity instrument-3
Secondary outcomes
1
Description
Communication attitude
Timepoint
Before the start of the intervention, after the end of the intervention, in the follow-up phase one month after the end of the intervention
Method of measurement
Answer to the question
Intervention groups
1
Description
Intervention group: The recipient of the gradually increasing the length and complexity of the utterance program . This program is a form of operant conditioning that is executed precisely and controlled in 54 steps in three speech situations of monologue and reading and conversation according to the three phases such as establishment, transfer and maintenance. For the sentences, pictures are used instead of reading according to the syntactic level defined for the the gradually increasing the length and complexity of the utterance (GILCU) program; because children are preschool age. Protocol of program: Step 1: the child must say the single words fluently 12 times to go to the next step. Step 2: the child must speak 2 words fluently. Step 3 to 6: the child should be able to say three words fluently. Step 7: The child must say a sentence fluently. Step 8 to 11: The child should be able to express two sentences fluently. Step 11 to 18: The child can speak for 30 seconds fluently . Step 18: The child should speak for 5 minutes fluently. Step 19 to 54: the child must repeat the first 18 steps in monologue and dialogue situations.
Category
Rehabilitation
2
Description
Intervention group: The recipient of the phonological processing treatment The phonological processing treatment is designed to support the phonological system to produce speech in Persian-speaking children with stuttering. According to literatures, three sources of non-word packets, phonological priming and phoneme monitoring are used to treat phonological processing skills. The non-word packages contain 60 types of non-words that are selected from the non-word repetition test of Yazdani et al. These non-words will be used in non-word packages in 12 sessions. The order of presentation of non-words is from simple to complex so that it starts with two-syllable non-words and gradually the number and complexity of non-words increases until end with the repetition of four-syllable non-words. Phonological priming has been used during picture naming to investigate phonological encoding. In this task, the speaker first says the onset syllable or first consonant and or the offset syllable of the word, and the listener must name the image related to the target word from the images presented. Phoneme monitoring is also used to investigate the encoding of sounds. In this task, a word (in visual or audio form) is presented to the person, Then the speaker presents a phoneme or syllable to the patient or person, the person must answer whether that phoneme or syllable is present in the presented word or not. The given phoneme or syllable can be anywhere in the word. This treatment method aims to strengthen working memory and phonological encoding.
Category
Rehabilitation
3
Description
Intervention group: The recipient of the gradually increased the length and complexity of utterance and phonological processing combined therapy The gradually increasing the length and complexity of utterance (GILCU) and phonological processing therapy (PPT) combined treatment method is designed to help the phonological system of production and syntactic skills of Persian speaking children who stutter. This treatment method is obtained from the combination of two treatment methods "gradual increase of length and complexity of utterance " and "phonological processing treatment".
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech therapy clinics in Tehran
Full name of responsible person
Akram Valizadeh
Street address
Rahmati,Block 12,Manazel Organization,Meteorology and Atmospheric Sciences Research Institute, pajuhesh Blvd
City
Tehran
Province
Tehran
Postal code
1497716385
Phone
+98 916 859 5079
Email
akramvalizadeh59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
Rahmati, Block 12,Research Institute of Meteorology and Atmospheric Sciences, Pajuhesh Blvd
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Email
ha.khankeh@uswr.ac.ir
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
Akram Valizadeh
Position
ُStudent
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Rahmati, Block 12, Research institute of meteorology and atmospheric sciences, Pajuhesh Blvd
City
Tehran
Province
Tehran
Postal code
1497716385
Phone
02122180043
Email
akramvalizadeh59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Talieh Zarifian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, University of social welfare and rehabilitation sciences, kodakyar st, Daneshju Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
ta.zarifian@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Valizadeh
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
University of social welfare and rehabilitation sciences, Kodakyar st, Daneshju Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 916 859 5079
Fax
Email
akramvalizdeh59@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the conditions of the participants, in the informed consent section, the participants have been given a commitment not to publish their personal information.
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only outcome data will be published and there are no plans to publish individual participant data.
When the data will become available and for how long
From 2026 to 2 years after the article was published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data will be used only in educational, research and therapeutic situations
From where data/document is obtainable
first author
What processes are involved for a request to access data/document
The applicant can submit his application via email or by visiting the University of Social Health and Rehabilitation Sciences , Speech Therapy Department