High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders
18 sierpnia 2026 zaktualizowane przez: 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
Przegląd badań
Status
Rekrutacyjny
Typ studiów
Interwencyjne
Zapisy (Szacowany)
80
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Fien Allemeersch
- Numer telefonu: +32474128135
- E-mail: fien.allemeersch@ugent.be
Lokalizacje studiów
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Ghent, Belgia, 9000
- Rekrutacyjny
- University Hospital Ghent
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Kontakt:
- Kristiane Van Lierde
- Numer telefonu: +3293320530
- E-mail: hiruz.ctu@uzgent.be
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Nie
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Consonant proficiency (percentage correctly produced consonants)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Intelligibility in Context Scale (ICS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Kristiane Van Lierde, University Ghent
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
30 listopada 2025
Zakończenie podstawowe (Szacowany)
30 grudnia 2027
Ukończenie studiów (Szacowany)
30 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
14 listopada 2025
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
21 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ONZ-2025-0439
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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