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临床试验/NCT06416306
NCT06416306招募中1 期

Speech Intervention for Bilingual Children

Philip Combiths2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年5月8日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
16
试验地点
2
主要终点
Comprehensive Probe or Monitored Sounds Probe

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Outcomes will be determined from phonetic transcription of participants' speech during assessment sessions. All transcriptions will be completed by research assistants unaware of the condition (simple or complex treatment target), arm of the study (English or Spanish language of intervention) or phase of the intervention study (Pre, Post, or Follow-up).

The participant will be unaware of the relative complexity of their treatment target (i.e., condition: simple or complex).

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Comprehensive Probe or Monitored Sounds Probe

时间窗: 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

Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech generalization probes in English and Spanish. Both protocols elicit \~300 word productions and sample each singleton consonant and consonant cluster in the respective language a minimum of three times in every permissible word position. 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. All transcriptions will be completed by research assistants unaware of the condition (simple or complex treatment target), arm of the study (English or Spanish language of intervention) or phase of the intervention study (Pre, Post, or Follow-up).

次要结局

未报告次要终点

研究者

发起方
Philip Combiths
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philip Combiths

Assistant Professor

University of Iowa

研究点 (2)

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