High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders
18 agosto 2026 aggiornato da: University Ghent
The Short- and Long-Term Effects and Cost-Effectiveness of High-Intensity Versus Low-Intensity Speech Intervention in Children With Phonological Speech Sound Disorders.
Achieving speech that is understandable and acceptable to others is the key outcome in the treatment of phonological speech sound disorders. Therefore, speech therapy provided by a speech-language pathologist is essential. Traditionally, this intervention has been delivered twice per week for 30 minutes, often over the course of several months or even years, by first-line speech-language pathologists. Unfortunately, this low-intensity approach is largely based on historical practice rather than scientific evidence.
The current study aims to provide stronger evidence regarding the optimal intensity of intervention. Specifically, this project will compare the effects of high-intensity and low-intensity speech intervention in children with phonological speech sound disorders in terms of speech outcomes, quality of life, and cost-utility. The interventions will be provided by first-line speech-language pathologists within a large-scale randomized controlled trial. The ultimate goal is to implement this program in clinical practice and raise awareness among stakeholders about its benefits for children with phonological speech sound disorders
Panoramica dello studio
Stato
Reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Fien Allemeersch
- Numero di telefono: +32474128135
- Email: fien.allemeersch@ugent.be
Luoghi di studio
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Ghent, Belgio, 9000
- Reclutamento
- University Hospital Ghent
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Contatto:
- Kristiane Van Lierde
- Numero di telefono: +3293320530
- Email: hiruz.ctu@uzgent.be
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age between 4 and 12 years
- Presence of at least one phonological speech sound disorder.
Exclusion Criteria:
- Presence of a language disorder
- Presence of hearing disorders
- Presence of neurological or neuromuscular disorders
- Presence of craniofacial anomalies (e.g., a cleft palate)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: High-intensity Speech Intervention
To investigate the (cost-)effectiveness of speech therapy for children with phonological speech sound disorders, a community based SLP will provide a high-intensity speech intervention.
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Children will receive phonological speech therapy supplemented by phonetic principles.
A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist.
Multiple errors will be targeted simultaneously by focusing on a process.
Child-friendly games will be played to illustrate the contrast between concepts.
Exercises will be embedded in meaningful language contexts such as minimal pairs.
Therapy will be provided 5 times 30' per week for 2 times 2 weeks.
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Comparatore attivo: Low-intensity Speech Intervention
To investigate the (cost-)effectiveness of speech therapy for children with phonological speech sound disorders, a community based SLP will provide a low-intensity speech intervention.
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Children will receive phonological speech therapy supplemented by phonetic principles.
A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist.
Multiple errors will be targeted simultaneously by focusing on a process.
Child-friendly games will be played to illustrate the contrast between concepts.
Exercises will be embedded in meaningful language contexts such as minimal pairs.
Therapy will be provided 5 times 30' per week for 10 consecutive weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Consonant proficiency (percentage correctly produced consonants)
Lasso di tempo: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 2 weeks post-intervention, at 12 weeks post-intervention
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
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Assessment 2 weeks pre-intervention, immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 2 weeks post-intervention, at 12 weeks post-intervention
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Incremental cost-utility ratio
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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The cost-utility of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (QALYs) called the incremental cost-utility ratio (ICUR), calculated as Cost intervention - Cost control / Effect intervention - Effect control.
The EQ-5D-Youth version will be used for children aged 8-12 years and the EQ-5D proxy version for children aged 4-7 years to collect information on HRQoL ("utilities").
Cost information will be obtained using a self-reported questionnaire on health care use.
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Incremental cost-effectiveness ratio
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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The cost-effectiveness of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (percentage correctly produced consonants) called the incremental cost-effectiveness ratio (ICER), calculated as Cost intervention - Cost control / Effect intervention - Effect control.
The effectiveness will be estimated using the primary outcome (percentage correctly produced consonants) obtained from the randomized controlled trial.
Cost information will be obtained using a self-reported questionnaire on health care use.
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Intelligibility in Context Scale (ICS)
Lasso di tempo: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 2 weeks post-intervention, at 12 weeks post-intervention
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To assess possible transfer of learned speech skills to contexts outside the therapy setting, the Intelligibility in Context Scale (ICS) will be administered.
The ICS rates the degree to which children's speech is understood by different partners (caregivers, immediate and extended family, friends, acquaintances, teachers, and strangers) on a 5-point scale (1 - never intelligible to 5 - always intelligible) with a minimum score of 7 and a maximum score of 35.
The higher the score, the better the result.
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Assessment 2 weeks pre-intervention, immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 2 weeks post-intervention, at 12 weeks post-intervention
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Communication attitudes of children aged 4 and 5 years (KiddyCAT)
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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To evaluate the change in communication attitudes of children aged 4 and 5 years during the intervention, the KiddyCAT will be administered before, during and after the intervention.
This questionnaire evaluates the extent to which the child has a negative attitude toward speaking.
The higher the score, the more negative the attitude toward speaking.
the scores range from 0 (no negative communication attitudes) to 14 (negative communication attitudes only).
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Communication attitudes Test (CAT)
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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To evaluate the change in communication attitudes of children aged 6 years and older during the intervention, the Communication Attitudes Test (CAT) will be administered before, during and after the intervention.
This questionnaire evaluate the extent to which the child has a negative attitude toward speaking.
The higher the score, the more negative the attitude toward speaking.
the scores range from 0 (no negative communication attitudes) to 33 (negative communication attitudes only).
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Phonological Awareness subtest from the CELF-Preschool-II-NL
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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The instrument targets two hierarchical levels of phonological awareness and consists of 6 subtests of 4 test items.
Minimum raw score is 0 and maximum possible score is 24, with higher scores reflecting better phonological awareness skills.
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Dutch Phonological Awareness Test (Proef Fonologisch Bewustzijn)
Lasso di tempo: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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The instrument targets three hierarchical levels of phonological awareness and consists of four subtests of 10 test items.
Children are asked to rhyme, to segment words in syllables, to combine phonemes into words and the repeat non-words.
Minimum raw score is 0 and maximum possible score is 40, with higher scores reflecting better phonological awareness skills.
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Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Kristiane Van Lierde, University Ghent
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 novembre 2025
Completamento primario (Stimato)
30 dicembre 2027
Completamento dello studio (Stimato)
30 dicembre 2027
Date di iscrizione allo studio
Primo inviato
14 novembre 2025
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2026
Primo Inserito (Effettivo)
21 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ONZ-2025-0439
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .