跳至主要内容
临床试验/NCT06250101
NCT06250101进行中(未招募)不适用

Study 5: Effects of Semantic Support

University of Arizona1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
Change in the Use of Treated Grammatical Forms in Untreated Contexts

研究概览

简要总结

This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. Children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.

详细描述

Children between 4 years, 0 months and 6 years 11 months are eligible. A diagnosis of developmental language disorders will be confirmed as normal nonverbal cognitive function, passing a pure-tone audiometric screening, and a test score consistent with developmental language disorder on a standardized language test, and parent report of no other diagnosed handicapping condition. Speech skills and vocabulary skills will be described via standardized testing.

Children enrolled in treatment are seen for up to 28 consecutive weekdays. The study starts with three days of baseline assessment of morpheme use for potential treatment targets. Two are selected for study, with one treated and one tracked over the course of treatment. Treatment is embedded in child-friendly activities like games, book reading, and craft activities. Children are prompted to use the treated morpheme in conversation. Immediately following this attempt, the treating clinician repeats the child's utterance, correcting any ungrammatical forms. Half of the children will also receive explanations of what the key words in sentences mean (e.g., to twirl means to turn around fast). Generalization to untreated contexts is assessed 2-3 times weekly. Retention of learning is measured about six weeks after the end of 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 (Care Provider, Outcomes Assessor)

盲法说明

Caregivers are not informed of their child's treatment target until after treatment concludes.

The clinician measuring retention of learning has not treated the children

入排标准

年龄范围
48 Months 至 83 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning

排除标准

  • •hearing loss Intellectual disability Other handicapping conditions

研究组 & 干预措施

Grammar treatment including semantic support

Experimental

Children receiving grammatical treatment will also receive a simple explanation concerning the meaning of verbs used to elicit grammatical forms.

干预措施: Enhanced Conversational Recast treatment (Behavioral)

Grammatical treatment excluding semantic support

Active Comparator

Children receiving grammatical treatment will not receive any explanation concerning the meaning of verbs used to elicit grammatical forms.

干预措施: Enhanced Conversational Recast treatment (Behavioral)

结局指标

主要结局

Change in the Use of Treated Grammatical Forms in Untreated Contexts

时间窗: Three days over the course of the final week (week 5) of treatment

Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects for the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.

Change in the Use of Untreated Grammatical Forms in Untreated Contexts

时间窗: Three days over the course of the final week (week 5) of treatment

Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.

Retention of Trained Grammatical Forms

时间窗: 1 day, 1-2 months after the end of treatment

Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.

Retention of Untrained Grammatical Forms

时间窗: 1 day, 1-2 months from the end of treatment

Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Plante

Professor

University of Arizona

研究点 (1)

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