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Идёт набор NCT06416306

Treatment Targets in Spanish and English Bilingual Speech Intervention

Фаза I С лечением Speech Sound Disorder

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: Speech Intervention.
Кому может быть актуально
Состояния в реестре: Speech Sound Disorder. Базовые параметры: 3 лет — 8 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
США
Следующий шаг
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Официальное название

Speech Intervention for Bilingual Children

Обзор

The goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in Spanish-English bilingual children with speech sound disorders. The main questions it aims to answer are: * Does linguistic complexity of the treatment target increase the amount of generalized learning within the treated language? * Does linguistic complexity of the treatment target increase the amount of generalized speech across languages? Researchers will compare intervention effects across treatment provided in English and Spanish to see if the effect differs according to the language of intervention. Participants will: * Attend between 12 and 18 45-minute speech intervention sessions in Spanish or English for up to 6 weeks * Attend assessment visits before and after intervention * Attend follow-up assessment visits 1 month and 2 months after intervention

Подробное описание

This study is a single-subject experimental design with staggered multiple baselines examining speech intervention for Spanish-English bilingual children with speech sound disorders. The study includes two arms based on the language of intervention (Spanish or English). Within each arm are two conditions that manipulate the linguistic complexity of the speech treatment target (simple consonant singleton or complex consonant cluster). Participants will be pseudo-randomly assigned to these arms and conditions.

The primary outcome is system-wide generalization; specifically, a) within-language and b) across-language generalization to untreated sounds. Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech probes in English and Spanish. The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment.

Вмешательства

  • Поведенческое Speech Intervention
    The treatment will begin with imitation, whereby the child will produce target words following the study clinician's verbal model with 1:1 clinician feedback for the accuracy of the child's productions. This will include explicit articulatory instruction (i.e., verbal and visual cues) to elicit correct target forms. When a child achieves 75% accuracy following a verbal model across 2 consecutive sessions or completes the 9th session (whichever is first), treatment will shift to spontaneous produ

Первичные конечные точки

  • Comprehensive Probe or Monitored Sounds Probe [Срок оценки: At initial visit, 2-4 times across the 2 weeks prior to intervention, once per week during the 6-week intervention, within 1 week after intervention, 1 month after intervention, and 2 months after intervention]

Критерии участия

Критерии включения

  • Participants will be regularly exposed to English for at least 3 months in one of the following ways: a) an English-speaking caregiver or sibling who interacts with the child on a daily basis in English, b) attendance at an English-speaking daycare, preschool, or elementary school.
  • Caregivers will have reported concern with their child's speech development and/or reduced intelligibility on the Intelligibility in Context Scale in Spanish or English.
  • Participants will present with 5 or more consonants or clusters missing from their phonetic inventories in each language to confirm presence of a speech sound disorder and sufficient gaps in phonological knowledge to warrant treatment.

Критерии исключения

  • Participants receiving speech or language treatment elsewhere during their participation in this project.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Iowa — Iowa City

Идентификаторы

NCT: NCT06416306 · 202109072 · R21DC021249

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗