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Influence - Intervention Break - Children - Speech Sound Disorders

Primary Purpose

Speech Sound Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
intervention break of 12 weeks
Sponsored by
University of Applied Sciences for Health Professions Upper Austria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Sound Disorder focused on measuring speech sound disorders, children

Eligibility Criteria

5 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Speech therapists:

  • Written consent to participate in the study after prior written and oral education
  • At least 2 years activity in the field of children's speech therapy / therapy of infantile speech sound disorders with sufficient practical experience

Children:

  • Phonological delay of one of these phonological process: palatal fronting / sch / to / s / or / ch / to / s /, velar fronting / k g / to / t d / or contact assimilation / dr / to / gr kr / and max. two phonological processes
  • The treated sound can be formed correctly during therapy in the spontaneous speech situations to 70 - 80%
  • The phonological process has not yet been treated by another colleague (the therapy should be carried out by a speech therapist from the beginning)
  • Parental participation is given (recorded in the regular therapeutic process via anamnesis interview)
  • Therapy frequency: regular once a week, but at least once every 2 weeks (so that short-term outages due to illness do not lead to exclusion from the study)
  • Physiologically developed prescriptive skills
  • almost native German language skills
  • Written consent of the parent or guardian to participate in the study after previous oral and written information

Exclusion Criteria:

Speech therapists:

  • Lack of written consent
  • Practical experience in the field of children's speech therapy / therapy of infantile speech sound disorders of less than 2 years

Children:

  • Younger than 5 years of age
  • Therapy sounds are less than 70% correct in a spontaneous speech situation
  • Inconsistent phonological disorder
  • Consistent phonological disorder
  • Childhood apraxia of speech
  • Myofunctional disorders
  • Isolated articulation disorder (e.g. lateral or interdental articulation)
  • Auditory processing disorders
  • Disorders of speech understanding
  • Autism spectrum disorders
  • Cognitive developmental disorders
  • Deficits in prescriptive skills
  • Missing written consent of the parents

Sites / Locations

  • Caritas Österreich, Caritas für Kinder und JugendlicheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

12-weeks intervention break

traditional therapy

Arm Description

The intervention break starts as soon as 70 - 80 % of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations during therapy. The intervention break will last for 12 weeks.

After 70 - 80 % of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations during therapy, the children will maintain their traditional therapy until more than 90% of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations (max. 12 weeks).

Outcomes

Primary Outcome Measures

Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.
Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group/in group interaction
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.

Secondary Outcome Measures

Changes in the target phoneme/ consonant cluster accuracy in spontaneous speech situations within-group
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.

Full Information

First Posted
May 13, 2019
Last Updated
November 4, 2022
Sponsor
University of Applied Sciences for Health Professions Upper Austria
Collaborators
Caritas Österreich, Volkshilfe Österreich
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1. Study Identification

Unique Protocol Identification Number
NCT03972891
Brief Title
Influence - Intervention Break - Children - Speech Sound Disorders
Official Title
Influence of a Intervention Break on a Treated Phonological Process in Spontaneous Speech Situations in Children Aged 5 to 6 Years With Phonologically Delayed Development
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Applied Sciences for Health Professions Upper Austria
Collaborators
Caritas Österreich, Volkshilfe Österreich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many of the children with speech and language disorders have speech sound disorders. In German-speaking countries, it is estimated that around 16% of children between the ages of three and eight are affected by school entry. The treatment of speech sound disorders aims to enable the transfer of the learned into spontaneous speech. The purpose of this study is to ascertain, whether children, by means of a break in therapy, succeed in transferring, the target phoneme or target consonant cluster - from a certain threshold - to spontaneous language. The researchers compare the effect of the transfer to spontaneous speech situations by means of a twelve-week break from therapy with a continuous therapy. In addition, the researchers would like to find out whether the acquisition of the grapheme has an additional positive influence on the generalization of the target phoneme or target consonant cluster in spontaneous speech situations. The researchers also seek to understand individual differences in the generalization effects on the production of the target phoneme / target consonant cluster in spontaneous speech situations, in which the researchers document and evaluate information on the treatment method and treatment duration before the therapy break.
Detailed Description
Early detection of language development disorders and a timely delivery of appropriate measures derived from it, can prevent secondary consequences of language learning disorders. In particular, phonologically delayed disorders can have an impact on the development of literacy and place the child at risk of dyslexia. With this knowledge, that early detection and the appropriate measures derived from it can prevent the secondary consequences of a speech sound disorder, speech and language therapists strive to carry out an effective therapeutic process based on the International Classification of Functioning, Disability and Health (ICF). In the field of effectiveness research, there is consensus that the objective, which is tailored to the disorder, is closely linked to the chosen therapeutic method. Therapeutic ICF-oriented measures should be adapted to the needs of the child. Based on the current knowledge, no therapy concept can offer this, if it is used exclusively. In effectiveness research, disagreement prevails in the area of treatment intensity and the intervention period. The therapy intensity is determined by three factors: number of properly implemented teaching episodes per session (dose), task or activity within which the teaching episodes are delivered (dose form) and the number of sessions per unit of time (e.g. once a week/once a month), It should be noted that the threshold at which speech therapy is still effective and where the intervention period is too short has mostly been derived from observations. It seems that a certain amount of developmental time is required for the consolidation of new skills. It has so far only been stated that the duration of intervention cannot be generalized for each child and that an improvement in the functional capacity of the linguistic output may be between 12 and 20 hours of intervention. In addition to the uncertainty of how high the intensity of therapy must be in order to achieve generalization effects, there is no information in science to date as to which baseline level has to be achieved for it. Therefore the desire for systematic studies on the question: Which baseline level does a child have to reach in order to transfer the treated phonological process to the spontaneous speech during the therapy break? prevails. Aim 1 will determine whether a 12-week intervention break in children between the ages of five and six with phonologically delayed development of one phonological process will lead to significant improvements in the transfer of the target phoneme / target consonant cluster in spontaneous speech. On the condition that the threshold of 70-80% correct pronunciation of the target phoneme / target consonant cluster was attained. Aim 2 will determine whether children, who at the end of the therapy, do not demonstrate 100 percent correct pronunciation of the targeted phoneme / the target consonant cluster in spontaneous speech by acquiring the grapheme/graphemes (the affected treated phoneme / the affected treated consonant cluster) see an improvement of the target phoneme / target consonant cluster in spontaneous speech?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Sound Disorder
Keywords
speech sound disorders, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study Design: randomized control trial, single-blinded Time Perspective: prospective
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
An independent biometrician created forty envelopes (i.e., 20 blue and 20 white envelopes) for group allocation. Each envelope was filled with the group assignment ("intervention break" or "continuous therapy") and signed by the biometrician. White envelopes will only be used when all blue envelopes are opened to ensure that 20 group-balanced children can be used for interims analysis. Each envelope pack (white & blue) consisted of 10 intervention ("therapy break") and control ("continuous therapy") groups. The group allocation take place after inclusion of the child in the study. The non-transparent envelope is randomly drawn and opened by the speech therapist. The randomisation result, the name of the child and the date of the assignment will be documented in the case report form (CRF). The CRFs and the envelop will be handed over to the study director at regular intervals, whereby the biometrician is not informed about the allocation of the study.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12-weeks intervention break
Arm Type
Experimental
Arm Description
The intervention break starts as soon as 70 - 80 % of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations during therapy. The intervention break will last for 12 weeks.
Arm Title
traditional therapy
Arm Type
No Intervention
Arm Description
After 70 - 80 % of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations during therapy, the children will maintain their traditional therapy until more than 90% of the target phoneme / target consonant cluster can be pronounced correctly in spontaneous speech situations (max. 12 weeks).
Intervention Type
Other
Intervention Name(s)
intervention break of 12 weeks
Intervention Description
The intervention of this study is a break of the intervention for 12 weeks under the following conditions: no therapeutic intervention during the break no language-specific specific exercises language-specific strategies in everyday life can be applied, e.g. modeling techniques
Primary Outcome Measure Information:
Title
Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group
Description
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.
Time Frame
12-week
Title
Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group/in group interaction
Description
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Changes in the target phoneme/ consonant cluster accuracy in spontaneous speech situations within-group
Description
The phoneme accuracy will be determined by a standardised diagnostic assessment for speech sound disorders, a single-word test (PLAKKS), and by elicited a continuous speech sample (non-standardized assessment) für 15 minutes. For the speech sample the researchers will use the same situation pictures in a play situation for all test times to allow for direct comparison.
Time Frame
1 - 2 weeks after the target grapheme has been learned in school (0.5 - 3.5 months after school entry)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Speech therapists: Written consent to participate in the study after prior written and oral education At least 2 years activity in the field of children's speech therapy / therapy of infantile speech sound disorders with sufficient practical experience Children: Phonological delay of one of these phonological process: palatal fronting / sch / to / s / or / ch / to / s /, velar fronting / k g / to / t d / or contact assimilation / dr / to / gr kr / and max. two phonological processes The treated sound can be formed correctly during therapy in the spontaneous speech situations to 70 - 80% The phonological process has not yet been treated by another colleague (the therapy should be carried out by a speech therapist from the beginning) Parental participation is given (recorded in the regular therapeutic process via anamnesis interview) Therapy frequency: regular once a week, but at least once every 2 weeks (so that short-term outages due to illness do not lead to exclusion from the study) Physiologically developed prescriptive skills almost native German language skills Written consent of the parent or guardian to participate in the study after previous oral and written information Exclusion Criteria: Speech therapists: Lack of written consent Practical experience in the field of children's speech therapy / therapy of infantile speech sound disorders of less than 2 years Children: Younger than 5 years of age Therapy sounds are less than 70% correct in a spontaneous speech situation Inconsistent phonological disorder Consistent phonological disorder Childhood apraxia of speech Myofunctional disorders Isolated articulation disorder (e.g. lateral or interdental articulation) Auditory processing disorders Disorders of speech understanding Autism spectrum disorders Cognitive developmental disorders Deficits in prescriptive skills Missing written consent of the parents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Detter-Biesl, MSc
Phone
+43 50 344 - 25124
Email
doris.detter-biesl@fhgooe.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Bernhard Schwartz, Dr. MSc BSc
Phone
+43 50 344- 20031
Email
bernhard.schwartz@fhgooe.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Detter-Biesl, MSc
Organizational Affiliation
University of Applied Sciences for Health Professions Upper Austria
Official's Role
Study Director
Facility Information:
Facility Name
Caritas Österreich, Caritas für Kinder und Jugendliche
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Kraxberger
Phone
+43 732 - 7844 180

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22646316
Citation
Yoder P, Fey ME, Warren SF. Studying the impact of intensity is important but complicated. Int J Speech Lang Pathol. 2012 Oct;14(5):410-3. doi: 10.3109/17549507.2012.685890. Epub 2012 May 31.
Results Reference
background
PubMed Identifier
17326112
Citation
Warren SF, Fey ME, Yoder PJ. Differential treatment intensity research: a missing link to creating optimally effective communication interventions. Ment Retard Dev Disabil Res Rev. 2007;13(1):70-7. doi: 10.1002/mrdd.20139.
Results Reference
background
PubMed Identifier
22974107
Citation
Baker E. Optimal intervention intensity in speech-language pathology: discoveries, challenges, and unchartered territories. Int J Speech Lang Pathol. 2012 Oct;14(5):478-85. doi: 10.3109/17549507.2012.717967.
Results Reference
background
PubMed Identifier
23275415
Citation
Allen MM. Intervention efficacy and intensity for children with speech sound disorder. J Speech Lang Hear Res. 2013 Jun;56(3):865-77. doi: 10.1044/1092-4388(2012/11-0076). Epub 2012 Dec 28.
Results Reference
background
PubMed Identifier
22686582
Citation
Williams AL. Intensity in phonological intervention: is there a prescribed amount? Int J Speech Lang Pathol. 2012 Oct;14(5):456-61. doi: 10.3109/17549507.2012.688866. Epub 2012 Jun 11.
Results Reference
background

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Influence - Intervention Break - Children - Speech Sound Disorders

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