このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ベルギー
      • Ghent、ベルギー、9000
        • 募集
        • University Hospital Ghent
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：High-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.
アクティブコンパレータ：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.
行動：Low-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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Consonant proficiency (percentage correctly produced consonants)
時間枠：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 (%)
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
時間枠：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.
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
時間枠：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.
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Intelligibility in Context Scale (ICS)
時間枠：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.
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)
時間枠：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).
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)
時間枠：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).
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
時間枠：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.
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)
時間枠：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.
Assessment immediately pre-intervention, after 5 hours of therapy, after a 6-week rest period, immediately post-intervention, at 12 weeks post-intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Ghent

捜査官

  • 主任研究者：Kristiane Van Lierde、University Ghent

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月30日

一次修了 (推定)

2027年12月30日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2025年11月14日

QC基準を満たした最初の提出物

2026年8月18日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月18日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ONZ-2025-0439

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する