NCT03260062已完成不适用
Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in parental sensitivity
研究概览
简要总结
The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children who are severely to profoundly deaf and a cochlear implant candidate,
- •children who are 12 to 48 months,
- •English or Spanish as primary language spoken at home,
- •families educating their children in spoken language,
- •children who pass the cognitive screening, scoring 75 or above on the screening measure
排除标准
- •parents who do not consent to being videotaped,
- •children with moderate to severe developmental delays (as assessed using the Battelle Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the Leiter International Performance Scale-Revised),
- •children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities,
- •families who do not receive their auditory-verbal therapy from University of Miami (UM). Further, children who have already completed the BDI-2 within the past year as part of their Early Steps (Florida Early Intervention) program will not have it re-administered.
结局指标
主要结局
Change in parental sensitivity
时间窗: Baseline, Week 10
Parent sensitivity (warmth, positive regard, respect for child autonomy) will be coded from video-taped parent-child interactions during two play activities. Sensitivity will be coded on a 1 to 7 Likert scale, with higher scores indicating higher sensitivity.
次要结局
- Change in parental involvement and self-efficacy(Baseline, Week 10)
- Change in Auditory Skills(Baseline, Week 10)
- Change in use of higher-level versus lower-level language strategies(Baseline, Week 10)
研究者
Ivette Cejas
Associate Professor
University of Miami
研究点 (2)
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