High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders
18. august 2026 opdateret af: 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
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fien Allemeersch
- Telefonnummer: +32474128135
- E-mail: fien.allemeersch@ugent.be
Studiesteder
-
-
-
Ghent, Belgien, 9000
- Rekruttering
- University Hospital Ghent
-
Kontakt:
- Kristiane Van Lierde
- Telefonnummer: +3293320530
- E-mail: hiruz.ctu@uzgent.be
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Consonant proficiency (percentage correctly produced consonants)
Tidsramme: 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
|
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
|
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
|
|
Incremental cost-utility ratio
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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.
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
|
Incremental cost-effectiveness ratio
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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.
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intelligibility in Context Scale (ICS)
Tidsramme: 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
|
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.
|
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
|
|
Communication attitudes of children aged 4 and 5 years (KiddyCAT)
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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).
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
|
Communication attitudes Test (CAT)
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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).
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
|
Phonological Awareness subtest from the CELF-Preschool-II-NL
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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.
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
|
Dutch Phonological Awareness Test (Proef Fonologisch Bewustzijn)
Tidsramme: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
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.
|
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kristiane Van Lierde, University Ghent
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. november 2025
Primær færdiggørelse (Anslået)
30. december 2027
Studieafslutning (Anslået)
30. december 2027
Datoer for studieregistrering
Først indsendt
14. november 2025
Først indsendt, der opfyldte QC-kriterier
18. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ONZ-2025-0439
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .