Enhancing Safe Sleep Practices of Urban Low-Income Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
研究概览
简要总结
The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.
详细描述
This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 years of age) or emancipated minor.
- •Parent or legal guardian of the child.
- •Child is receiving care at the Harriet Lane Clinic.
- •Child's primary care provider is participating in the study.
- •English-speaking.
- •Lives in Baltimore City or Baltimore County.
- •Not homeless or not living in a shelter or in an established transitional housing facility.
排除标准
- •Not an adult or emancipated minor.
- •Not the parent or legal guardian of the child.
- •Child is not receiving care at the Harriet Lane Clinic.
- •Child's primary care provider is not participating in the study.
- •Non English-speaker.
- •Does not live in Baltimore City or Baltimore County.
- •Homeless or living in a shelter or other established transitional housing facility.
研究组 & 干预措施
Standard Care Study Condition
The Standard of Care control group will not receive any additional services at the newborn visit.
Attention-Matched Control Condition
The Attention-Matched Control Condition will include the Scald Prevention Intervention.
干预措施: Scald Prevention Intervention (Behavioral)
Safe Sleep Intervention Condition
The Intervention Condition will include the Safe Sleep Intervention.
干预措施: Safe Sleep Intervention (Behavioral)
结局指标
主要结局
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
时间窗: Follow-up #1 (3-6 weeks)
Assessed with a 125-item questionnaire.
次要结局
- Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home(Follow-up #1 (3-6 weeks))
- Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics(2-week well-child visit and 2-month well-child visit)
