Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 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 word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.
详细描述
Children will be assigned to either the familiar or less-familiar word group. All children will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/wk for 30 minutes each session). The investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). This will help us know if their learning is due to treatment or maturation. The investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. Then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.
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 late talkers and their caregivers will not explicitly be told what condition 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
- •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
研究组 & 干预措施
Familiar Words
In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words.
干预措施: VAULT Phase 5 (Behavioral)
Less-Familiar Words
In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words.
干预措施: VAULT Phase 5 (Behavioral)
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 treatment.
次要结局
- Post Treatment Retention(Change from end of treatment to follow up, which will average 4-6 weeks.)