High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity Ghent
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 4 and 12 years
Presence of at least one phonological speech sound disorder.
Disqualifiers
Presence of a language disorder
Presence of hearing disorders
Presence of neurological or neuromuscular disorders
Presence of craniofacial anomalies (e.g., a cleft palate)
Trial design
Design model
Parallel
Treatments tested in this trial
High-intensity combined phonetic-phonological intervention
BehavioralChildren 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
BehavioralChildren 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: High-intensity Speech InterventionExperimental treatment 1 intervention
Group B: Low-intensity Speech InterventionActive comparator 1 intervention
Trial outcomes
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-intervention2
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-intervention3
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-interventionSecondary 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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
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Source ClinicalTrials.gov