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临床试验/NCT03070639
NCT03070639已完成不适用

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2015年10月最近更新:
适应症
干预措施

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

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

No Intervention

The Standard of Care control group will not receive any additional services at the newborn visit.

Attention-Matched Control Condition

Active Comparator

The Attention-Matched Control Condition will include the Scald Prevention Intervention.

干预措施: Scald Prevention Intervention (Behavioral)

Safe Sleep Intervention Condition

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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