Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Treatment Effect Size
研究概览
简要总结
The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.
详细描述
Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The children and their caregivers will not be told which condition they are assigned to. However, the Augmentative and Alternative Communication device is quite obvious, so although caregivers will not be explicitly told, it is likely they will be aware their child is in that arm.
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 at start of study
- •MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale <10th percentile
排除标准
- •Parental report 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 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.)