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

NCT07779759 | Recruiting DMC

• 1 other identifier: ONZ-2025-0439
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Consonant proficiency (percentage correctly produced consonants)

  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

  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

  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

Secondary Outcomes (5)

• Intelligibility in Context Scale (ICS)

  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)

  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)

  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

  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)

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

Study Arms (2)

High-intensity Speech Intervention

EXPERIMENTAL

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

Low-intensity Speech Intervention

ACTIVE COMPARATOR

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

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.

High-intensity Speech Intervention

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.

Low-intensity Speech Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Presence of a language disorder
• Presence of hearing disorders
• Presence of neurological or neuromuscular disorders
• Presence of craniofacial anomalies (e.g., a cleft palate)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Communication Disorders; Articulation Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Speech Disorders; Language Disorders

Study Officials

• Kristiane Van Lierde

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fien Allemeersch

CONTACT

+32474128135; fien.allemeersch@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: August 21, 2026
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)