Идёт набор NCT06381713

Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Без фазы С лечением Cleft Palate Children Speech Therapy Speech Disorders in Children Cleft Lip and Palate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: High intensive combined phonetic-phonological intervention, Low intensive combined phonetic-phonological intervention.
Кому может быть актуально: Состояния в реестре: Cleft Palate Children, Speech Therapy, Speech Disorders in Children, Cleft Lip and Palate. Базовые параметры: 4 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Обзор

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.

Подробное описание

Objective 1: Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) on the speech and quality of life in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Speech intervention will be provided by first-line speech language pathologists in private practices who will receive thorough training before the onset of the trial.

Hypothesis 1: Based on the state-of-the-art and our proof-of-concept, it is assumed that 20 hours of high intensity speech intervention will lead to superior speech outcomes and health-related quality of life compared to 20 hours of low intensity speech intervention.

Objective 2: To compare the cost-utility in quality-adjusted life years of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Demonstrating the cost-effectiveness of high intensity speech intervention will facilitate implementation and utilization of this protocol in clinical practice as less money has to be spent in order to gain one life year in full health (QALY) when providing high intensity speech intervention compared to low intensity speech intervention.

Hypothesis 2: Besides the superior speech outcomes and health related quality of life in a shorter intervention time (cfr. hypothesis 1), it is hypothesized that less money has to be spent in order to gain one life year in full health (QALY) in the high intensity intervention group. In other words, it is hypothesized that high intensity intervention will be more cost-effective compared to low intensity speech intervention.

Вмешательства

Поведенческое High intensive combined phonetic-phonological intervention
Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next lev
Поведенческое Low intensive combined phonetic-phonological intervention
Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next lev

Первичные конечные точки

Consonant proficiency [Срок оценки: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention]
Incremental cost-utility ratio [Срок оценки: After a 12-week rest period (high intensity arm), at 3 months post-intervention]
Incremental cost-effectiveness ratio [Срок оценки: After a 12-week rest period (high intensity arm), at 3 months post-intervention]

Вторичные конечные точки (6)

Intelligibility in Context [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]
Health-related quality of life [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]
Speech Function [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]
Speech Distress [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]
Communication attitudes of children aged 4 and 5 years [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]
Communication attitudes of children aged 6 years and older [Срок оценки: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention]

Критерии участия

Критерии включения

Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
Aged between 4 and 12 years,
Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist