Speech Sound DisorderNCT03972891
Influence - Intervention Break - Children - Speech Sound Disorders
A study testing intervention break of 12 weeks in people with Speech Sound Disorder, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- intervention break of 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Caritas Österreich, Caritas für Kinder und Jugendliche
Linz, Upper Austria, 4020
About this study
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
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.
Read the 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?
- Conditions
- Speech Sound Disorder
- Being tested
- intervention break of 12 weeks
- Keywords
- speech sound disorders, children
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention break of 12 weeksOther
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
| Study group | Role | What they receive |
|---|---|---|
| 12-weeks intervention break | Experimental | 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. Receives: Other: intervention break of 12 weeks |
| traditional therapy | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-week
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.
Measured: 12-week
Secondary outcomes (1)
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.
Measured: 1 - 2 weeks after the target grapheme has been learned in school (0.5 - 3.5 months after school entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: Due to the changed working conditions in the participating institutions after the covid-19- pandemic, the clientele of the institutions has changed. Therefore, the calculated number of cases cannot be achieved in the planned study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Speech Sound DisorderStudies 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
- Model description
- Study Design: randomized control trial, single-blinded Time Perspective: prospective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences for Health Professions Upper Austria
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas Austria, Volkshilfe Upper Austria
- Responsible party
- Sponsor
- Investigators
- Doris Detter-Biesl, MSc, Study director, University of Applied Sciences for Health Professions Upper Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972891
- Sponsor's protocol ID
- A-2019-035
- Status last verified
- May 2024
- First submitted
- 13 May 2019
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22646316Warren 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.
PubMed 17326112Baker 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.
PubMed 22974107Allen 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.
PubMed 23275415Williams 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.
PubMed 22686582
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03972891
- Acronym / sponsor ID
- A-2019-035
- Conditions
- Speech Sound Disorder
- Keywords
- speech sound disorders, children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the changed working conditions in the participating institutions after the covid-19- pandemic, the clientele of the institutions has changed. Therefore, the calculated number of cases cannot be achieved in the planned study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Applied Sciences for Health Professions Upper AustriaUniversity, hospital or other
- Collaborators
- Caritas Austria, Volkshilfe Upper Austria
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study Design: randomized control trial, single-blinded Time Perspective: prospective
| Arm | Type | Receives |
|---|---|---|
| 12-weeks intervention break | Experimental | Other: intervention break of 12 weeksThe 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. |
| traditional therapy | No intervention | –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). |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
- 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)
Key exclusion criteria (17 listed)
- 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
- Younger than 5 years of age
- Therapy sounds are less than 70% correct in a spontaneous speech situation
- Inconsistent phonological disorder
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 |
|---|---|---|
| intervention break of 12 weeksThe 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 | Other | 12-weeks intervention break |
Primary outcome
Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group
Time frame: 12-week
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
Time frame: 12-week
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.
1 secondary outcome
Changes in the target phoneme/ consonant cluster accuracy in spontaneous speech situations within-group
Time frame: 1 - 2 weeks after the target grapheme has been learned in school (0.5 - 3.5 months after school entry)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 22646316Yoder 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.
- Background: PubMed 17326112Warren 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.
- Background: PubMed 22974107Baker 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.
- Background: PubMed 23275415Allen 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.
- Background: PubMed 22686582Williams 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.
- Individual participant dataSharing planned: No
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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.
Doris Detter-Biesl, MSc study director
University of Applied Sciences for Health Professions Upper Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention break of 12 weeks in people with Speech Sound Disorder, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
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 12 inclusion and 17 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: withdrawn, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes in the target phoneme / target consonant cluster accuracy in spontaneous speech situations within-group (time frame: 12-week). 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?
On the ClinicalTrials.gov record for NCT03972891, which also lists 5 linked publications.
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 29 May 2024.