Diaper Distribution in Low-Income Infants

Stress Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03425851
• Other study ID #: H-37185
• Secondary ID: T32HP10028
• Status: Withdrawn
• Phase: N/A
• First received: January 26, 2018
• Last updated: April 10, 2018
• Start date: March 14, 2018
• Est. completion date: January 2019

Study information

• Verified date: April 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• Baseline: At the initial visit, the survey will obtain baseline data from the child's caregiver on prior history of diaper need, current employment and income, government benefits, and other material hardships. The survey will also include the Protective Factors Strength Level and Patient Health Questionnaire (PHQ-9), both validated measures. The survey will take approximately 15-20 minutes to complete. Baseline surveys will be completed in person.

• Follow-up: At the 2 month, 4 month, 6 month, and 9 month well-child visits (as applicable based on age of enrollment), all enrolled families will complete a survey repeating the measures of diaper need, the Protective Factors Strength Level, and PHQ-9. Additional questions will ask about episodes of diaper rashes and economic impact of diaper need. Families in the intervention group will be asked about acceptability of the intervention at the conclusion of the study.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Months

Eligibility

Inclusion Criteria:

• Infants born at Boston Medical Center and seen in BMC pediatric primary care clinic at any outpatient visit between birth and 2 months of age.

• Caregivers of enrolled infants, including parents and legal guardians.

• Plan to obtain pediatric primary care at BMC for nine months.

• Have public insurance or Medicaid as their primary source of health insurance.

Exclusion Criteria:

• Caregivers who are minors (under age 18).

• Infants in the foster care system.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Diaper Rash
• Stress
• UTI

Intervention

Other:
• Diapers
Receive 600 diapers.
• Resources of diaper banks
Caregivers will receive resources of diaper banks.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survey completion time	Average time in minutes to complete surveys	9 months
Primary	Caregiver acceptability of receiving diapers	Qualitative interviews with caregivers to assess acceptability of intervention delivery from a clinic setting.	9 months
Primary	Rate of enrollment by eligible families	Proportion of caregivers enrolled and proportion of caregivers declined enrollment out of total number of eligible families approached.	9 months
Primary	Rate of declination of enrollment by eligible families	Proportion of caregivers declined enrollment out of total number of eligible families approached.	9 months
Secondary	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.	9 months
Secondary	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.	9 months
Secondary	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	9 months
Secondary	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.	9 months
Secondary	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.	baseline, 2 months, 4 months, 6 months, and 9 months
Secondary	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.	baseline, 2 months, 4 months, 6 months, and 9 months