Trial Outcomes & Findings for New Therapeutical Perspectives in Cases of Phonological Disorders (NCT NCT02935062)

Last Updated: 2019-12-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

10 weeks

Results posted on

2019-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Therapeutical Perspectives in Cases of Phonological Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Software Phonological Therapy- SIFALA n=8 Participants 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.	Traditional Phonological Therapy- CYCLES n=8 Participants 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.	Placebo Therapy n=8 Participants 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.	Total n=24 Participants Total of all reporting groups
Age, Continuous	7.81 years n=5 Participants	7.48 years n=7 Participants	6.51 years n=5 Participants	7.26 years n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Brazil	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ciclos- Therapy n=8 Participants 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.	Software Phonological Therapy- SIFALA n=8 Participants 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.	Placebo Therapy n=8 Participants 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.
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument PCC Pre-treatment	70.63 PCC - (%) Standard Deviation 17.77	68.13 PCC - (%) Standard Deviation 12.53	75.5 PCC - (%) Standard Deviation 8.60
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument PCC Pos-treatment	79.88 PCC - (%) Standard Deviation 19.86	80.63 PCC - (%) Standard Deviation 14.11	82.88 PCC - (%) Standard Deviation 10.68

PRIMARY outcome

Timeframe: 10 weeks.

Population: The same sample was evaluated with this P300 variable, quantified in milliseconds (ms), which corresponds to the P300 electrophysiological wave latency.

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

Outcome measures

Outcome measures
Measure	Ciclos- Therapy n=8 Participants 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.	Software Phonological Therapy- SIFALA n=8 Participants 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.	Placebo Therapy n=8 Participants 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.
P300- Long-latency Auditory Evoked Potential P300- Pre-Treatment	383.60 (ms) milliseconds Standard Deviation 25.15	373.28 (ms) milliseconds Standard Deviation 50.45	357.33 (ms) milliseconds Standard Deviation 10.21
P300- Long-latency Auditory Evoked Potential P300- Pos-Treatment	344.00 (ms) milliseconds Standard Deviation 20.09	362.66 (ms) milliseconds Standard Deviation 29.67	353.23 (ms) milliseconds Standard Deviation 29.15

Adverse Events

Software Phonological Therapy- SIFALA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Phonological Therapy- CYCLES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Márcia Keske-Soares

Federal University of Santa Maria

Phone: 55 55 999726370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place