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RecruitingNCT07779759Updated Aug 21, 2026

High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders

An interventional study of High-intensity combined phonetic-phonological intervention and Low-intensity combined phonetic-phonological intervention in Speech Therapy, Speech Disorders in Children and Phonological (Speech) Disorder, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by University Ghent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
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Study summary

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

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Conditions studied

  • Speech Therapy
  • Speech Disorders in Children
  • Phonological (Speech) Disorder

Keywords

  • Speech Therapy
  • Randomized Controlled Trial
  • Children with Speech Sound Disorders
  • Cost-effectiveness
03

In context

Communication Disorders

149 studies on the registry are indexed under Communication Disorders; 44 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 124 interventional studies indexed under Communication Disorders.

Browse Communication Disorders studies →

Lead sponsor

University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 4 and 12 years
  • Presence of at least one phonological speech sound disorder.

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: High-intensity combined phonetic-phonological intervention

  • Active comparator
    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.

    Behavioral: Low-intensity combined phonetic-phonological intervention

Interventions

  • BehavioralHigh-intensity combined phonetic-phonological 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.

  • BehavioralLow-intensity combined phonetic-phonological 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.

06

What researchers measure

Primary outcomes

  1. Consonant proficiency (percentage correctly produced consonants)

    Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

    Time frame: 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

  2. Incremental cost-utility ratio

    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.

    Time frame: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

  3. Incremental cost-effectiveness ratio

    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.

    Time frame: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

Secondary outcomes

  1. Intelligibility in Context Scale (ICS)

    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.

    Time frame: 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

  2. Communication attitudes of children aged 4 and 5 years (KiddyCAT)

    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).

    Time frame: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

  3. Communication attitudes Test (CAT)

    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).

    Time frame: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

  4. Phonological Awareness subtest from the CELF-Preschool-II-NL

    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.

    Time frame: Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

  5. Dutch Phonological Awareness Test (Proef Fonologisch Bewustzijn)

    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.

    Time frame: 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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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07779759
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Nov 30, 2025
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Fien Allemeersch
Contact
fien.allemeersch@ugent.be
+32474128135
Kristiane Van Lierde
principal investigator · University Ghent

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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