New Therapeutical Perspectives in Cases of Phonological Disorders

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.

Study Overview

• Status: Completed
• Conditions: Speech Sound Disorders
• Intervention / Treatment: Behavioral: Traditional Phonological Therapy; Behavioral: Software Phonological Therapy- SIFALA; Behavioral: Placebo Therapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Santa Maria, Rio Grande Do Sul, Brazil, 97015-372
      • Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.
    • Santa Maria, Rio Grande Do Sul, Brazil, 97060-500
      • Federal University of Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Phonological Therapy; 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.	Behavioral: Traditional Phonological Therapy; Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
Experimental: 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.	Behavioral: 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 Comparator: 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.	Behavioral: Placebo Therapy; No intervention to improve speech.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Maria
• Investigators: Study Director: Marcia Keske-Soares, PhD, Universidade Federal de Santa Maria

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Speech; Phonological Disorders; Auditory Perception; Speech Sound Disorders; Speech Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Speech Disorders; Disease; Speech Sound Disorder; Articulation Disorders
• Other Study ID Numbers: 28053914.1.0000.5346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Results were exposed for three years
• IPD Sharing Access Criteria: Researchers with access to Clinical Trials and those who wish to contact the responsible researcher.
• IPD Sharing Supporting Information Type: ICF