Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Treatment Effect Size
研究概览
简要总结
The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.
详细描述
Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The children in the study and their caregivers will not be told which treatment group their child is in.
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native English Speaking
- •Pass pure tone hearing screening or medical report of normal hearing
- •2-3 Years of age at start of study
- •MCDI expressive scales <10th percentile
排除标准
- •Parental reports of other diagnoses
- •Enrolled in concurrent treatment elsewhere
- •Nonverbal IQ <75 as measured by the Bayley scales
- •Parents unable to consistently bring child to treatment sessions
结局指标
主要结局
Treatment Effect Size
时间窗: Change from baseline through treatment, which will average an 8-week time frame.
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Number/Rate of Words Learned
时间窗: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
The investigators will measure the number of words learned and the rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment.
次要结局
- Post Treatment Retention(Change from end of treatment to follow up, which will average 4-6 weeks.)