An interventional study of Diapers and Resources of diaper banks in Diaper Rash, UTI and Depressive Symptoms, sponsored by Boston Medical Center. Withdrawn at 1 site in United States. Open to participants aged 2 Days to 9 Months. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Prevention
The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship.
Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.
Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled visit at Boston Medical Center's primary care clinic between birth and 2 months of age. Eligible caregivers will complete a baseline survey and provide consent for the study investigators to perform a prospective chart review. The infant-caregiver pair will be randomized to the intervention group or the control group. The intervention group will receive 600 diapers, distributed in packs of 200 to the families at the conclusion of the 2 month, 4 month, and 6 month old well-child visits. The control group will receive resources of diaper banks in the greater Boston area.
Surveys:
Chart review: After the completion of the 2 month, 4 month, 6 month, and 9 month well-child visits, study staff will review the medical record for attendance at planned well-child visits, adherence to the immunization schedule, number of urgent care and ED visits, and incidence of diaper dermatitis and urinary tract infections requiring treatment. Demographic information extracted will include sex, race/ethnicity, and confirmation of insurance status.
All survey and chart review data will be de-identified and entered into REDCap with a unique study identification number.
Exclusion Criteria:
Receive 600 diapers.
Other: Diapers
Receive resources of diaper banks as requested.
Other: Resources of diaper banks
Receive 600 diapers.
Caregivers will receive resources of diaper banks.
Caregiver acceptability of receiving diapers
Qualitative interviews with caregivers to assess acceptability of intervention delivery from a clinic setting.
Time frame: 9 months
Rate of enrollment by eligible families
Proportion of caregivers enrolled and proportion of caregivers declined enrollment out of total number of eligible families approached.
Time frame: 9 months
Rate of declination of enrollment by eligible families
Proportion of caregivers declined enrollment out of total number of eligible families approached.
Time frame: 9 months
Incidence of diaper dermatitis
Episodes of diaper dermatitis diagnosed by clinicians at Boston Medical Center during a well-child, urgent care, or emergency department visit.
Time frame: 9 months
Incidence of UTIs
Episodes of urinary tract infections diagnosed by urine culture during a well-child, urgent care, or emergency department visit at Boston Medical Center.
Time frame: 9 months
Attendance at planned well-child visits
Proportion of attended well-child visits; expected to have 4-5 visits over 9 months based on age of enrollment
Time frame: 9 months
Adherence to the immunization schedule
Received all required vaccines through 6 months of age according to the published CDC schedule by 7 months of age.
Time frame: 9 months
Change in caregiver well-being indices
The Parents' Assessment of Protective Factors Instrument is used to measure the presence and magnitude of self-reported beliefs and behaviors that are indicators of the Strengthening Families protective factors, which can be used to mitigate risk factors and actively enhance family well-being. The instrument contains 36 items with a total score (Protective Factors Strength Index) and subscale scores for parental resilience, social connections, concrete support in times of need, social emotional competence of children. PFSI scores and subscales can range from 0 to 4, higher scores are more favorable. The change in PFSI scores compared to baseline score and immediately prior score at each time point will be measured.
Time frame: baseline, 2 months, 4 months, 6 months, and 9 months
Change in depressive symptoms of caregivers
Patient Health Questionnaire (PHQ 9) is a multipurpose instrument for screening, measuring, and monitoring depressive symptoms. It contains 9 questions with response options referenced to the past 2 weeks from 0 to 3 where 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores can range form 0 to 27, lower scores are more favorable. The change in PHQ 9 scores compared to baseline score and immediately prior score at each time point will be measured.
Time frame: baseline, 2 months, 4 months, 6 months, and 9 months
Survey completion time
Average time in minutes to complete surveys
Time frame: 9 months
Plan to share: No
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This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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