Speech Sound DisordersNCT02935062
New Therapeutical Perspectives in Cases of Phonological Disorders
A study testing Traditional Phonological Therapy and Software Phonological Therapy- SIFALA in people with Speech Sound Disorders, run by Universidade Federal de Santa Maria at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Sound Disorders
- What is being tested?
- Traditional Phonological Therapy and Software Phonological Therapy- SIFALA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.
Santa Maria, Rio Grande do Sul, 97015-372
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97060-500
About this study
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.
Read the 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.
- Conditions
- Speech Sound Disorders
- Being tested
- Traditional Phonological Therapy, Software Phonological Therapy- SIFALA, Placebo Therapy
- Keywords
- Speech, Speech Therapy, Speech Sound Disorders, Phonological Disorders, Auditory Perception
- Medical subject headings
- Speech Sound Disorder, Speech, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Phonological TherapyBehavioural
Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
Software Phonological Therapy- SIFALABehavioural
The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds.
Placebo TherapyBehavioural
No intervention to improve speech.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Traditional Phonological Therapy |
| 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. Receives: Behavioral: Software Phonological Therapy- SIFALA |
| 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. Receives: Behavioral: Placebo Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Speech Sound DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Keske Soares, Universidade Federal de Santa Maria
- Investigators
- Marcia Keske-Soares, PhD, Study director, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935062
- Sponsor's protocol ID
- 28053914.1.0000.5346
- Status last verified
- Nov 2019
- First submitted
- 15 Sep 2016
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutical Perspectives in Cases of Phonological Disorders
- ClinicalTrials.gov ID
- NCT02935062
- Acronym / sponsor ID
- 28053914.1.0000.5346
- Conditions
- Speech Sound Disorders
- Keywords
- Speech, Speech Therapy, Speech Sound Disorders, Phonological Disorders, Auditory Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Phonological Therapy | Active comparator | Behavioral: Traditional Phonological TherapyThis 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 | Behavioral: Software Phonological Therapy- SIFALAThis 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 | Behavioral: Placebo TherapyNo 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. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Phonological TherapyPhonological therapy based on generalizing the sounds presented by figures, repetition and naming words. | Behavioural | Traditional Phonological Therapy |
| Software Phonological Therapy- SIFALAThe phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds. | Behavioural | Software Phonological Therapy- SIFALA |
| Placebo TherapyNo intervention to improve speech. | Behavioural | Placebo Therapy |
Primary outcome
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Speech Sound Disorders
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Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
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Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Keske-Soares, PhD study director
Universidade Federal de Santa Maria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Phonological Therapy and Software Phonological Therapy- SIFALA in people with Speech Sound Disorders, run by Universidade Federal de Santa Maria at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.