Speech Sound Disorders
Conditions
Keywords
Speech, Speech Therapy, Speech Sound Disorders, Phonological Disorders, Auditory Perception
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTraditional Phonological Therapy
Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
BEHAVIORALSoftware 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.
BEHAVIORALPlacebo Therapy
No intervention to improve speech.
Sponsors
Universidade Federal de Santa Maria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Parents/guardians and child agree to participate and have signed the Informed Consent Form; * Have age between 4:0 to 8:11 (years:months); * Present diagnosis of phonological disorders; * Present hearing thresholds within the normal range
Exclusion criteria
* Present neurological impairment, emotional and/or cognitive clearly diagnosed, or have complaint; * Present any degree of hearing loss is the type conductive, mixed or sensorineural, and middle ear disorders in time of selection, as well as having presented otitis complaints; * Present language impairment associated with speech sound disorder; * Present commitment in the stomatognathic system that can interfere in the speech production; * Have been received speech and language therapy before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | 10 weeks | 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. |
| P300- Long-latency Auditory Evoked Potential | 10 weeks. | 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 |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Software Phonological Therapy- SIFALA | Total | Placebo Therapy | Traditional Phonological Therapy- CYCLES |
|---|---|---|---|---|
| Age, Continuous | 7.81 years | 7.26 years | 6.51 years | 7.48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 21 Participants | 6 Participants | 8 Participants |
| Region of Enrollment Brazil | 8 participants | 24 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 14 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
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
Time frame: 10 weeks.
Population: The same sample was evaluated with this P300 variable, quantified in milliseconds (ms), which corresponds to the P300 electrophysiological wave latency.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclos- Therapy | P300- Long-latency Auditory Evoked Potential | P300- Pre-Treatment | 383.60 (ms) milliseconds | Standard Deviation 25.15 |
| Ciclos- Therapy | P300- Long-latency Auditory Evoked Potential | P300- Pos-Treatment | 344.00 (ms) milliseconds | Standard Deviation 20.09 |
| Software Phonological Therapy- SIFALA | P300- Long-latency Auditory Evoked Potential | P300- Pre-Treatment | 373.28 (ms) milliseconds | Standard Deviation 50.45 |
| Software Phonological Therapy- SIFALA | P300- Long-latency Auditory Evoked Potential | P300- Pos-Treatment | 362.66 (ms) milliseconds | Standard Deviation 29.67 |
| Placebo Therapy | P300- Long-latency Auditory Evoked Potential | P300- Pre-Treatment | 357.33 (ms) milliseconds | Standard Deviation 10.21 |
| Placebo Therapy | P300- Long-latency Auditory Evoked Potential | P300- Pos-Treatment | 353.23 (ms) milliseconds | Standard Deviation 29.15 |
p-value: 0.011t-test, 1 sided
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.
Time frame: 10 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclos- Therapy | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pre-treatment | 70.63 PCC - (%) | Standard Deviation 17.77 |
| Ciclos- Therapy | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pos-treatment | 79.88 PCC - (%) | Standard Deviation 19.86 |
| Software Phonological Therapy- SIFALA | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pre-treatment | 68.13 PCC - (%) | Standard Deviation 12.53 |
| Software Phonological Therapy- SIFALA | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pos-treatment | 80.63 PCC - (%) | Standard Deviation 14.11 |
| Placebo Therapy | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pre-treatment | 75.5 PCC - (%) | Standard Deviation 8.6 |
| Placebo Therapy | Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument | PCC Pos-treatment | 82.88 PCC - (%) | Standard Deviation 10.68 |
p-value: 0.001t-test, 1 sided