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临床试验/NCT06593236
NCT06593236进行中(未招募)不适用

Association of Digital Aid Use With Infant Sleep and Maternal Mental Health

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Infant sleep quality

研究概览

简要总结

The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.

详细描述

This study aims to understand the impact of the Huckleberry app, a scalable low-cost solution to problematic child sleep patterns, on pediatric sleep and maternal mental health, especially in the Medicaid population.

A secondary aim for this study is to determine if Medicaid Accountable Care Organizations (ACO) goals are improved according to stakeholder interviews.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Is at least 18 years old
  • Has a child between the age of 0-12 months
  • Receives healthcare through UMass Memorial Health
  • Is a part of the Medicaid Accountable Care Organizations (ACO) population

排除标准

  • Lacks capacity to consent
  • Does not understand English
  • Does not have internet access on their smartphone or at home
  • If the infant is in Department of Children and Families (DCF) custody or is admitted into the Neonatal Intensive Care Unit (NICU)

结局指标

主要结局

Infant sleep quality

时间窗: Baseline and 3 months

Infant sleep quality will be assessed using the Brief Infant Sleep Questionnaire (BISQ) and will measure the quality and frequency of infant sleep. The BISQ will be delivered to participants at the baseline and endpoint of enrollment.

Maternal mental health

时间窗: Baseline and 3 months

Maternal mental health will be assessed using the Depression, Anxiety \& Stress Scale (DASS21) and will assess maternal mental health. The DASS21 will be delivered to participants at the baseline and endpoint of enrollment.

Maternal bonding assessment

时间窗: Baseline and 3 months

Maternal bonding will be assessed using the Postpartum Bonding Assessment (PBQ) and will measure maternal-infant bonding. The PBQ will be delivered to participants at baseline and endpoint of enrollment.

Infant and parent sleep practices

时间窗: Baseline and 3 months.

Infant and parent sleep practices will be assessed using the Infant Sleep Practices Questionnaire. This will be a tool in assessing sleep practices. This questionnaire will be delivered to participants at baseline and endpoint of enrollment.

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nisha Fahey

Assistant Professor

University of Massachusetts, Worcester

研究点 (1)

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