Effectiveness of Reach Out and Read Program on Neurodevelopment at 1 year in High risk infants A Randomized Controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Bayley Scales of Infant and Toddler Development - IV
研究概览
简要总结
The study, titled "Effectiveness of Reach Out and Read program on Neurodevelopment at 1 year in High-risk Infants: A Randomized Controlled Trial," aims to evaluate the impact of the Reach Out and Read (ROR) program on the neurodevelopment of high-risk infants at one year of age. The ROR program is an early literacy intervention designed to promote early language and cognitive development through parent-child reading activities. This study aims to determine the effectiveness of the Reach Out and Read programme on Neurodevelopment at 1 year in high risk infants. The hypothesis is that high-risk infants who participate in the ROR program will demonstrate better neurodevelopmental outcomes at one year of age, as measured by the Bayley Scales of Infant and Toddler Development-IV (BSID-4) or the Oxford Neurodevelopment Assessment (OX-NDA), compared to those who do not receive the intervention.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Male and female Infants who visit the High Risk clinic, at tertiary care hospital, Belagavi
- •Infants whose mothers are able to read and comprehend in vernacular language
- •Parents who are willing to participate.
排除标准
- •Infants who are critically ill.
- •Infants who are referred for any surgeries in next 6 months.
- •Infant with genetic disorders, congenital anomalies, metabolic diseases
- •Infants with known neuromotor disabilities.
结局指标
主要结局
Bayley Scales of Infant and Toddler Development - IV
时间窗: T0 at baseline at 6 months of age | T1 at 8 months of age | T2 at 10 months of age | T3 post assessment at 12 months of age
次要结局
未报告次要终点
研究者
Ketaki Karnik
KLE Institute of Physiotherapy Belgaum