High-intensity vs Low-intensity Speech Intervention in Children With Phonological Speech Sound Disorders
2026年8月18日 更新者：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
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fien Allemeersch
- 电话号码：+32474128135
- 邮箱：fien.allemeersch@ugent.be
学习地点
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Ghent、比利时、9000
- 招聘中
- University Hospital Ghent
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接触：
- Kristiane Van Lierde
- 电话号码：+3293320530
- 邮箱：hiruz.ctu@uzgent.be
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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有源比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Consonant proficiency (percentage correctly produced consonants)
大体时间：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
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
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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
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Incremental cost-utility ratio
大体时间：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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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.
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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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Incremental cost-effectiveness ratio
大体时间：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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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.
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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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intelligibility in Context Scale (ICS)
大体时间：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
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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.
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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
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Communication attitudes of children aged 4 and 5 years (KiddyCAT)
大体时间：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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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).
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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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Communication attitudes Test (CAT)
大体时间：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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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).
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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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Phonological Awareness subtest from the CELF-Preschool-II-NL
大体时间：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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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.
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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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Dutch Phonological Awareness Test (Proef Fonologisch Bewustzijn)
大体时间：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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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.
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kristiane Van Lierde、University Ghent
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月30日
初级完成 (估计的)
2027年12月30日
研究完成 (估计的)
2027年12月30日
研究注册日期
首次提交
2025年11月14日
首先提交符合 QC 标准的
2026年8月18日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.