Thirty Million Words Initiative Newborn Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,701
- 试验地点
- 6
- 主要终点
- SPEAK Survey (Baby Subscales)
研究概览
简要总结
The purpose of the proposed research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods.
The investigators hypothesize that the TMW-Newborn intervention will:
- Significantly impact parent knowledge regarding the importance of universal newborn hearing screen (UNHS) follow-up
- Significantly impact parent knowledge of child development
Additionally,the investigators hypothesize that: 3. The 7-minute version of the video with questions interspersed will most significantly improve parent knowledge of child development 4. There will be no significant differences in effectiveness of the Spanish and English versions of the TMW-Newborn intervention
The hypotheses rely on the existing research data supporting the idea that parental understanding and beliefs will alter parental behavior, and consequently, that increased parental linguistic input will impact child cognitive development.
详细描述
The investigators propose to perform a randomized implementation trial to evaluate the efficacy of various implementation methods of the TMW-Newborn educational intervention. The study will be conducted in temporal proximity to the administration of the universal newborn hearing screen.
After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72 hours. A hearing screening technician of the Sacred Heart Hospital will deliver the tablet that houses the intervention to every mother whose child is receiving the hearing screening. The technician will give each mother a tablet set up to the HIPAA Compliant TMW-Newborn Web Platform that houses the randomization tool, the welcome video, the tablet based consent passage, the surveys, and the educational intervention videos. First, the participant will watch the welcome video and complete the tablet based consent. Then, the participant will be randomized into one of four conditions: 15 minute version of the TMW-Newborn intervention video without questions interspersed, the 15 minute version of the TMW-Newborn intervention video with questions interspersed, the 7 minute version of the TMW-Newborn intervention video without questions interspersed, or the 7 minute version of the TMW-Newborn intervention video with questions interspersed.
After randomization, the participant will be brought to the screen with the SPEAK III to complete. Then, they will answer a few non-identifying demographics questions. These surveys takes approximately 10 minutes to complete will be followed by either a 15-minute or 7-minute video.
After watching their assigned video, all participants will repeat the SPEAK questionnaire for a second time. Then, the hearing screener will pick up the tablet from the participant. No identifying information is being collected within the TMW-Newborn web platform, and the hearing screening technicians will not be able to see or access any of the participants' responses.
After all surveys are complete, the hearing screening technician will pick up the tablet from the participant and answer any remaining questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.
排除标准
- •Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will not be eligible for this study.
结局指标
主要结局
SPEAK Survey (Baby Subscales)
时间窗: 48-72 after routine delivery
measures an individuals expectations and knowledge about child development
次要结局
未报告次要终点