The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are:
- To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
- To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
- To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
- To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Participants will complete three questionnaires that include demographic information, home literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age.
Researchers will compare the control group (standard care) and a group that receives Reach Out and Read education to see whether exposure to Reach Out and Read affects literacy behaviors, parental anxiety, and parent-infant bonding.
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
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families of subjects born between 24w0d and 33w6d gestation
- •Primary language is English or Spanish
排除标准
- •Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation
结局指标
主要结局
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
时间窗: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
时间窗: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
时间窗: Between enrollment and 3 months corrected gestational age for infant
To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
时间窗: At enrollment
次要结局
未报告次要终点
研究者
Devin McKissic
Fellow, Neonatology
University of Washington