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The aim of this study is to verify phonological and auditory aspects of children submitted to traditional phonological therapy, phonological therapy using a software and placebo therapy in children with phonological disorders.
The study will provide different therapeutic approaches for cases of phonological disorders, the classical approach would be mediated by Cycles Model, innovated approach is performed by means of an intervention speech software-SIFALA, there will still be the group that does not receive any of the proposals therapies that will be the placebo group.The study will provide 25 sessions for each group, with 30 minutes in each group. At the end of these sessions, the placebo group will receive one of the therapeutic approaches. With these three study groups, the investigators understand in what manner to obtain correct sounds is more effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Phonological Therapy | Active Comparator | This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process. |
|
| Software Phonological Therapy- SIFALA | Experimental | This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments. |
|
| Placebo Therapy | Placebo Comparator | No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Phonological Therapy | Behavioral | Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | The percentage of correct consonants corresponds to the number of phonemes produced by the child, evaluated initially before starting treatment and at the end of treatment. The variable of this calculation is based on the percentage which is determined at what phonological level of disorder the child is at. It is expected that at the end of treatment the percentage of correct consonants will increase due to the therapy stimuli offered. | 10 weeks |
| P300- Long-latency Auditory Evoked Potential | Electrophysiological evaluation of the auditory pathway through the protocol, Pretreatment and Post-treatment P300 waves were analyzed by the latency according to the parameters of MacPherson (1996). The electrophysiological protocol was performed before and after therapy. The marking of the waves was judged by specialist judges in the field of audiology. The variable that predicts P300 latency is quantified in milliseconds (ms | 10 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia Keske-Soares, PhD | Universidade Federal de Santa Maria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709. | Santa Maria | Rio Grande do Sul | 97015-372 | Brazil | ||
The plan to make the individual data available is in accordance with the criteria adopted in the research and the research ethics committee of the educational institution, which developed the study.
The results, placed on the platform of this randomized clinical trial, can be used by other researchers.
Results were exposed for three years
Researchers with access to Clinical Trials and those who wish to contact the responsible researcher.
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| ID | Title | Description |
|---|---|---|
| FG000 | Software Phonological Therapy- SIFALA | This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments. Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. |
| FG001 | Traditional Phonological Therapy- CYCLES | This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process. Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words. |
| FG002 | Placebo Therapy | No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities. Placebo Therapy: No intervention to improve speech. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Software Phonological Therapy- SIFALA | This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments. Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | The percentage of correct consonants corresponds to the number of phonemes produced by the child, evaluated initially before starting treatment and at the end of treatment. The variable of this calculation is based on the percentage which is determined at what phonological level of disorder the child is at. It is expected that at the end of treatment the percentage of correct consonants will increase due to the therapy stimuli offered. | The population is described by the age and using the variables of PCC, phonemes acquired The numbers shows the meand and standard deviation after the treatment. | Posted | Mean | Standard Deviation | PCC - (%) | 10 weeks |
|
10 weeks
No adverse events, fortunately, were observed during the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Software Phonological Therapy- SIFALA | This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments. Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. |
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Limitations:
Small number of the sample, since the study requires treatment, so there are few researchers for the treatments. Also some limitations regarding the human subjectivity of results. However the participants adhered to the treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Márcia Keske-Soares | Federal University of Santa Maria | 55 55 999726370 | marcia-keske.soares@ufsm.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2018 | Oct 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D066229 | Speech Sound Disorder |
| D013060 | Speech |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
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| Software Phonological Therapy- SIFALA | Behavioral | The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. |
|
| Placebo Therapy | Behavioral | No intervention to improve speech. |
|
| Federal University of Santa Maria |
| Santa Maria |
| Rio Grande do Sul |
| 97060-500 |
| Brazil |
| BG001 | Traditional Phonological Therapy- CYCLES | This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process. Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words. |
| BG002 | Placebo Therapy | No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities. Placebo Therapy: No intervention to improve speech. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Software Phonological Therapy- SIFALA | This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments. Software Phonological Therapy- SIFALA: The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. |
| OG002 | Placebo Therapy | No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities. Placebo Therapy: No intervention to improve speech. |
|
|
|
| Primary | P300- Long-latency Auditory Evoked Potential | Electrophysiological evaluation of the auditory pathway through the protocol, Pretreatment and Post-treatment P300 waves were analyzed by the latency according to the parameters of MacPherson (1996). The electrophysiological protocol was performed before and after therapy. The marking of the waves was judged by specialist judges in the field of audiology. The variable that predicts P300 latency is quantified in milliseconds (ms | The same sample was evaluated with this P300 variable, quantified in milliseconds (ms), which corresponds to the P300 electrophysiological wave latency. | Posted | Mean | Standard Deviation | (ms) milliseconds | 10 weeks. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Traditional Phonological Therapy- CYCLES | This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process. Traditional Phonological Therapy: Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Placebo Therapy | No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities. Placebo Therapy: No intervention to improve speech. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D001519 |
| Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|