A Pediatric Emergency Department-based Intervention to Increase Infant Adherence to Safe Sleep Practices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Change in proportion of infants who are fully adherent to 4 AAP safe sleep guidelines.
研究概览
简要总结
Safe sleep recommendations from the American Academy of Pediatrics (AAP) are designed to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. These recommendations include placing infants on their backs to sleep, using a crib or bassinet, avoiding soft bedding, and not sharing a sleep space with other people.
Many families do not consistently follow all recommended safe sleep practices, particularly when infants are sick. Research has shown that educational programs provided in pediatric emergency departments can improve some safe sleep behaviors, but improvements have been limited and may not continue over time. Additional strategies are needed to help families adopt and maintain safe sleep practices.
The purpose of this study is to determine whether a daily safe sleep tracking tool, used together with brief safe sleep education, can improve caregivers' adherence to recommended safe sleep practices compared with education alone. The information learned from this study may help healthcare providers develop more effective ways to promote safe sleep and reduce the risk of sleep-related infant deaths.
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
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal guardian of infants ages 0 to < 4 months , evaluated in GCHB PED ages 0 to < 4 months
- •English speaking primary caregiver of infant
- •Infant ED triaged ESI 2-5
- •Able to complete follow-up surveys via phone or email
- •Family not completely adherent to all 4 pre-determined safe sleep guideline recommended behaviors. If they are adherent to 3 out of 4 guidelines, they are eligible for the study.
排除标准
- •Infants requiring intensive interventions where PED education is not feasible
- •Non-English-speaking primary caregiver
- •Legal guardian unable to complete baseline survey or provide follow-up contact
- •Legal guardian completely adherent to safe sleep guidelines
研究组 & 干预措施
Safe Sleep Education
Families will watch a brief (1 minute) educational video on safe sleep in the pediatric emergency department and then receive a handout summarized infant safe sleep practices.
干预措施: Safe Sleep Education (Behavioral)
Behavior Habit Tracking Plus Safe Sleep Education
Families will watch a brief (1 minute) educational video on safe sleep in the pediatric emergency department and then receive a handout summarized infant safe sleep practices. After this, they will receive brief information on habit tracking for behavioral change and a form to take home to track their infant's sleep behaviors.
干预措施: Safe Sleep Education (Behavioral)
Behavior Habit Tracking Plus Safe Sleep Education
Families will watch a brief (1 minute) educational video on safe sleep in the pediatric emergency department and then receive a handout summarized infant safe sleep practices. After this, they will receive brief information on habit tracking for behavioral change and a form to take home to track their infant's sleep behaviors.
干预措施: Behavior habit tracking (Behavioral)
结局指标
主要结局
Change in proportion of infants who are fully adherent to 4 AAP safe sleep guidelines.
时间窗: Will be evaluated at 2 and 4 weeks after initial emergency department visit / intervention time.
The investigators will assess whether providing a brief, evidence-based safe-sleep education video alone versus an evidence-based safe-sleep education video plus habit tracking increases full adherence to 4 pre-determined AAP safe sleep guideline recommended behaviors among caregivers of infants 0-4 months.
次要结局
- Change in proportion of infants who are fully adherent to each individual AAP safe sleep guideline.(Will be evaluated at 2 weeks and 4 weeks following initial emergency department visit and intervention.)
- Evaluate the change in caregiver safe sleep knowledge score before and after the educational intervention.(This will occur at the initial emergency department visit, as well as the 2 and 4 week follow-ups.)
- Change in Reported Infant Sleep Duration Before and After the Intervention(This will occur at the initial emergency department visit, 2 and 4 week follow-ups.)
- Association Between Safe Sleep Practices and Number of Nighttime Infant Awakenings(Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.)
- Caregiver Acceptability of the Self-Tracking Tool(Assessed at the end of the emergency department intervention portion of the study.)
- Differences in Intervention Effectiveness Across Caregiver and Infant Demographic Characteristics(Demographic and clinical characteristics will be collected at enrollment, and intervention effectiveness will be assessed through the 4-week follow-up.)
- Change in Reported Infant Sleep Duration Before and After the Intervention(Assessed at the initial emergency department visit (baseline), 2-week follow-up, and 4-week follow-up.)
- Association Between Safe Sleep Practices and Caregiver-Reported Infant Sleep Quality(Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.)
- Association Between Safe Sleep Practices and Infant Sleep Onset Latency(Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.)
研究者
Sarah Anne Ehrenberg
Pediatric Emergency Medicine Fellow
State University of New York at Buffalo