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IRCT20230219057445N1 IRCT 2023-03-08 University of social welfare and rehabilitation sciences The effectiveness of Phonological Processing Treatment on the fluency of speech of pre-school Persian-speaking children with stuttering: a Randomized Controlled Trial Investigating the effectiveness of Phonological Processing Treatment on the fluency of speech of pre-school Persian-speaking children with stuttering: a Randomized Controlled Trial 2023-04-04 anticipated 30 Complete https://irct.ir/trial/68790 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, 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 double blocks); In this way, according to the sample size of 30 participants and two intervention and control group, we will have 15 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 description: Given the nature of the intervention and the control group (which received no treatment), blinding of participants and therapists was not possible. However, the study was designed as an assessor-blinded study. The assessor, who will assess the main outcomes at pretest, posttest, and follow-up, will be unaware of the group assignment of participants. To maintain assessor blinding: 1. Before each assessment session, participants will be strictly reminded not to discuss the type of treatment they received with the assessor. 2. The data analyst will also be blinded to the coding of the groups. 3. The success of assessor blinding will be assessed at the end of the study by asking the assessor directly about their guess at group assignment. N/A Stuttering. Intervention 1: 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. Intervention 2: Control group: During the treatment period, the control group will not receive any treatment, and after the treatment is completed, a speech sample will be taken from this group and then their SS% will be calculated. Parents will also be asked to complete the SR form to determine the severity of stuttering. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Akram Valizadeh
Rahmati, Block 12, Research institute of meteorology and atmospheric sciences, Pajuhesh Blvd
Tehran Iran (Islamic Republic of) 1497716385 021‏22180043‏ akramvalizadeh59@yahoo.com University of social welfare and rehabilitation sciences scientific Talieh Zarifian
Speech therapy department, University of social welfare and rehabilitation sciences, kodakyar st, Daneshju Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 2218 0043 ta.zarifian@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 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 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. 4 years 6 years Both 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. F98.5 Adult onset fluency disorder Rehabilitation Treatment - Other 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. Control group: During the treatment period, the control group will not receive any treatment, and after the treatment is completed, a speech sample will be taken from this group and then their SS% will be calculated. Parents will also be asked to complete the SR form to determine the severity of stuttering. 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: A speech sample is taken (the child should speak continuously about a topic while the child's voice is recorded). The amount of the speech sample should be at least 200 syllables. Then the total number of syllables is counted. The number of stuttered syllables is also determined. To obtain the ss%, the number of stuttered syllables is divided by the total number of syllables spoken and multiplied by 100. Stuttering severity(SR). 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: To measure this variable, parents complete a stuttering severity form. This form is scored using a Likert-type scoring system from 1 to 10, with 1 being when the child does not stutter at all and 10 being the most severe form of stuttering. 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: To assess this outcome, the Preschool Children's Communication Attitude Test (KiddyCAT) is used. It is a 12-question questionnaire that the child answers with yes or no. University of social welfare and rehabilitation sciences Approved 2023-03-02 Ethics committee of university of social welfare and rehabilitation sciences University of social welfare and rehabilitation sciences, Kodakyar St , Daneshju Blvd Tehran Tehran Iran (Islamic Republic of)