Influence - Intervention Break - Children - Speech Sound Disorders

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.

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Caritas Österreich, Caritas für Kinder und Jugendliche
        • Contact:
          • Barbara Kraxberger
          • Phone Number: +43 732 - 7844 180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12-weeks intervention break
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.

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
No Intervention: traditional therapy
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-week
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.
12-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 - 2 weeks after the target grapheme has been learned in school (0.5 - 3.5 months after school entry)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Doris Detter-Biesl, MSc, University of Applied Sciences for Health Professions Upper Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A-2019-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Speech Sound Disorder

Clinical Trials on intervention break of 12 weeks

3
Subscribe