Play2Sleep: A Sequential Explanatory Mixed Methods Study of Using Infant Play to Improve Infant Sleep in Families Experiencing Infant Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 18
- 主要终点
- Infant night wakings using the Brief Infant Sleep Questionnaire
研究概览
简要总结
The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on families of infants with infant sleep disturbances.
详细描述
RESEARCH OBJECTIVE AND QUESTIONS:
The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on families of infants with infant sleep disturbances.
The quantitative research question is: Does one dose of Play2Sleep delivered during home visits with mothers and fathers of 5-month-old infants with infant sleep disturbances reduce the number of night wakings at age 7 months? The qualitative phase will focus on explaining the quantitative findings by asking: What are parental perceptions of family experiences, processes, and contexts related to Play2Sleep and infant sleep? The overarching mixed methods research question is: How do parental perceptions of family experiences, processes, and contexts related to infant sleep explain the effectiveness of Play2Sleep?
METHODS:
An explanatory sequential mixed methods design will be used. The quantitative phase will be a pilot randomized controlled trial and the subsequent qualitative phase will employ Thematic Analysis of parental interviews to understand their perspectives on the effectiveness and acceptability of Play2Sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •co-habiting mothers and fathers of full-term, healthy, singleton, 4-month old infants
- •first-time parents
- •able to read, write, and speak English
- •perceive that their infant has sleep disturbances
- •whose infant experiences one of the following: (a) greater than 3 night wakings per night; (b) awake greater than 60 minutes during the night; or (c) less than 9 hours total day and night time sleep.
排除标准
- •a known or suspected medical or physiological cause of sleep problems in either parent or infant
研究组 & 干预措施
Play2Sleep
For the experimental intervention, Play2Sleep consists of video-recording the mother and father separately while engaged in a structured play session. Immediately following the play session, the home visitor will review the video recording with each parent separately to provide positive feedback on parental behaviors that promotes contingent interaction and identification of infant cues. At the end of the visit, standard public health handouts on infant sleep will be provided to both parents.
干预措施: Play2Sleep (Behavioral)
Comparison
In the comparison group, only standard public health handouts on infant sleep will be reviewed with parents.
干预措施: Comparison (Behavioral)
结局指标
主要结局
Infant night wakings using the Brief Infant Sleep Questionnaire
时间窗: 2 months
As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire
次要结局
- Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire(2 months)
- Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)(2 months)
- Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale(2 months)
- Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)(2 months)
- Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)(2 months)
- Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)(2 months)
研究者
Karen Benzies
Dr.
University of Calgary