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NCT Number: NCT07779759

High-intensity vs 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

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Kristiane Van Lierde

CONTACT

[email protected]

+3293320530

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High-intensity combined phonetic-phonological intervention

Behavioral

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.

Low-intensity combined phonetic-phonological intervention

Behavioral

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.

Primary outcomes

  1. Consonant proficiency (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

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

  2. Incremental cost-utility ratio

    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

    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.

  3. Incremental cost-effectiveness ratio

    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

    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.

Secondary outcomes

  1. Intelligibility in Context Scale (ICS)

    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

    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.

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

    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

    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).

  3. Communication attitudes Test (CAT)

    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

    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).

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

    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

    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.

  5. Dutch Phonological Awareness Test (Proef Fonologisch Bewustzijn)

    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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fien Allemeersch

CONTACT

[email protected]

+32474128135

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

The Short- and Long-Term Effects and Cost-Effectiveness of High-Intensity Versus Low-Intensity Speech Intervention in Children With Phonological Speech Sound Disorders.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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