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Идёт набор NCT06895395

High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists

Наблюдательное Cleft Lip and Palate Speech Disorders in Children

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 Lip and Palate, Speech Disorders in Children. 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
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Обзор

A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.

Вмешательства

  • Поведенческое High intensive combined phonetic-phonological intervention
    High intensity speech intervention 5 times 30' per week for 2 times 4 weeks
  • Поведенческое Low intensive combined phonetic-phonological intervention
    low intensity speech intervention 2 times 30' per week for 20 weeks

Первичные конечные точки

  • Perceptions and acceptability of low/high intensive speech intervention [Срок оценки: 20 weeks]

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

Критерии исключения

  • Children with syndromic clefts
  • Oronasal fistula
  • Velopharyngeal insufficiency
  • Hearing disabilities based on pure tone audiometry (>25 dB HL)
  • Cognitive and/or related learning disabilities or neuromuscular disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Бельгия · 1 центр
  • Ghent University Hospital — Ghent

Идентификаторы

NCT: NCT06895395 · ONZ-2024-0191

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗