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临床试验/NCT03490045
NCT03490045已完成不适用

Examining the Impact of an Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care

Yale University4 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
4
主要终点
Well-Child Visits

研究概览

简要总结

Well-child care is the primary source of preventative health care for children. These visits provide an opportunity for physicians to assess an infant's biomedical health, development, and behavior, as well as help ensure timely immunizations, reduce the use of acute care services, and assess and family functioning. Yet, disparities in the utilization of pediatric care exist by race, ethnicity and income in the U.S., even despite high rates of overall access to primary care. Incentives have been proposed as one way to increase utilization of preventative care for mothers and children.

Diapering is another important form of preventative health care that can be particularly difficult for low-income parents due the cost of diapers, which is $70-80 per child per month, or approximately $960 per year, on average. And government programs, such as Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF), either cannot be used to purchase diapers, or do not provide enough assistance to cover the cost of diapers and other basic needs. A family's inability to provide an adequate supply of diapers for their child is called diaper need. Nationwide, one in three families with young children report experiencing diaper need, which was found to be significantly associated with maternal stress and depression, which in turn, can have a detrimental impact on a family's health and economic success.

The primary goal of this study is to conduct a randomized controlled trial of a diaper provision intervention designed to increase utilization of, and adherence to, well-child visits and reduce diaper need among low-resourced families in New Haven, CT.

详细描述

The investigators will conduct a randomized controlled trial of a diaper incentive intervention whereby diapers will be used to achieve two separate but related aims.

First, diapers will be used as an incentive to increase utilization of, and adherence to, well-child visits, during the first year of a newborn's life. More specifically, postpartum women who receive care in the Yale New Haven Health System will be randomly assigned to receive a diaper incentive in conjunction with their attendance at regularly scheduled well-child visits, according to the American Academy of Pediatrics (AAP) recommended schedule during the first year of a child's life. Diapers will be provided at the completion of the 2- week, 2-month, 4- month and 6-month visits. A follow-up phone call assessment will also occur approximately 3 months after the family receives their final distribution of diapers or conditional cash transfer. Postpartum women randomly assigned to the control condition will receive the cash equivalent value of the diaper incentive for their participation at these same time points.

Second, diapers will be used to reduce the level of diaper need. This will be evaluated using a self-report diaper need survey that will be administered along with other surveys to women in the intervention and control conditions in accordance with the AAP well-child visit schedule. In addition to diaper need, the following domains will be assessed:

Depressive symptoms, perceived stress, maternal-child attachment, ability to meet basic needs, and demographic information including but not limited to race-ethnicity, mother's age, parity, marital status, education level, income, employment status, child(ren)'s sex, child(ren)'s age, health status, healthcare access, and use.

The investigators anticipate that this study will result in greater use of, and adherence to, the recommended schedule of pediatric well-child visits, as well as a greater reduction of diaper need among families in the intervention group. The investigators also anticipate that the reduction of diaper need will be associated with decreased parenting stress and improved diaper-related health among women and children, respectively, in the intervention group.

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
None

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

  • Postpartum women who receive care at Yale New Haven Health
  • Are about to give birth or recently gave birth to a singleton infant who is 0 to 1-week old (index child)
  • Have not received a distribution of diapers for the index child
  • English- speaking

排除标准

  • Infant admitted to the NICU during the baseline assessment time period
  • Infant admitted to the hospital at assessment visits 1-4
  • Infant is born with or develops a gastrointestinal condition or illness that will impact the health outcomes of the study

结局指标

主要结局

Well-Child Visits

时间窗: 9 Months

The proportion of well-child visits attended.

Diaper Need

时间窗: 9 Months

The proportion of families that report experiencing diaper need. Diaper need will be measured via self-report using a scale developed by Smith et al.(2013).

Incidence of Diaper Dermatitis/Rash

时间窗: 9 Months

The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians.

Incidence of Urinary Tract Infections

时间窗: 9 Months

The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians.

次要结局

  • Depressive Symptoms Among Mothers(9 Months)
  • Diaper-related Absences Among Mothers(9 Months)
  • Stress(9 Months)
  • Basic Need(9 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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