Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stress, Infection, Diaper Dermatitis, Urinary Tract Infections, Depressive Symptoms

Intervention / Treatment
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* Other: Diaper Incentive
* Other: Conditional Cash Transfer Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br>Postpartum women and their infants will be randomly assigned to the treatment condition and receive a diaper incentive for their participation. | Other: Diaper Incentive<br>* A diaper incentive will be distributed to participants in the Intervention condition at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final distribution of diapers.<br>|
| Active Comparator: Comparison Condition<br>Postpartum women and their infants will be randomly assigned to the control condition and will receive a conditional cash transfer of equivalent value of the diapers provided to the intervention group. | Other: Conditional Cash Transfer Condition<br>* Participants in the control condition will receive the cash equivalent value of the diapers distributed to the Experimental Condition for their participation at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final conditional cash transfer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-Child Visits | The proportion of well-child visits attended. | 9 Months | 
| Diaper Need | 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). | 9 Months | 
| Incidence of Diaper Dermatitis/Rash | The number of episodes of diaper dermatitis/rash recorded by Yale New Haven Health physicians. | 9 Months | 
| Incidence of Urinary Tract Infections | The number of episodes of urinary tract infections (UTIs) recorded by Yale New Haven Health physicians. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms Among Mothers | A change in depressive symptom score between baseline and each time point. Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) | 9 Months | 
| Diaper-related Absences Among Mothers | The proportion of mothers who report a decrease in diaper-related absences from work or school. | 9 Months | 
| Stress | A change in general stress scores between baseline and each time point. Stress will be measured by the Perceived Stress Scale 4 (PSS-4) | 9 Months | 
| Basic Need | Difference in basic need as measured by the U.S. Department of Agriculture Household Food Security Scale (2-item version) and Investigator-developed questionnaire | 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaper Need, Well-Child Care, Infant Immunizations, Incentives, Basic Needs