Influence - Intervention Break - Children - Speech Sound Disorders

NCT03972891 | Withdrawn

• 1 other identifier: A-2019-035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Speech Sound Disorder

Keywords

speech sound disorders; children

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12-week

Secondary Outcomes (1)

• Changes in the target phoneme/ consonant cluster accuracy in spontaneous speech situations within-group

  1 - 2 weeks after the target grapheme has been learned in school (0.5 - 3.5 months after school entry)

Study Arms (2)

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.

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).

Interventions

intervention break of 12 weeks OTHER

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

12-weeks intervention break

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Applied Sciences for Health Professions Upper Austria: lead
• Caritas Austria: collaborator
• Volkshilfe Upper Austria: collaborator

Study Sites (1)

Caritas Österreich, Caritas für Kinder und Jugendliche

Linz, Upper Austria, 4020, Austria

Location

Related Publications (5)

• 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.

  PMID: 22646316 BACKGROUND

• 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.

  PMID: 17326112 BACKGROUND

• 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.

  PMID: 22974107 BACKGROUND

• 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.

  PMID: 23275415 BACKGROUND

• 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.

  PMID: 22686582 BACKGROUND

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Doris Detter-Biesl, MSc

  University of Applied Sciences for Health Professions Upper Austria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design: randomized control trial, single-blinded Time Perspective: prospective

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 4, 2019
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)