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临床试验/NCT01303458
NCT01303458已完成不适用

Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project

Boston Medical Center9 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
336
试验地点
9
主要终点
Enrollment in new community-based resources and services

研究概览

简要总结

This research project is aimed to address low-income families' basic social needs (housing, food, employment, education, childcare, utilities) within the context of pediatric primary care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive impact of a similar intervention on pediatric residents' screening and referral to community agencies. This study will specifically test whether a further strengthened intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal enrollment in community resources and receipt of eligible benefits. In addition, we will measure the intervention's impact on maternal well-being, and compliance with well-child care (WCC) visits.

The project will take place at eight community health centers in the Greater Boston Area. The centers will be randomized to either an intervention or control site. Mothers who bring their infant in for a WCC visit from birth to 6 months will be eligible. They will be followed until their child is one year of age. Study subjects will complete two self-administered surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9 months old). Pediatric providers will also be subjects; and will fill out a demographic questionnaire at the time of enrollment.

The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers.

Families attending the control health centers will receive standard of care. Enrolled mothers will be offered the intervention at the end of the 12-month follow-up interview. When follow-up data collection is complete, the PI will offer the control sites the opportunity to implement the BNS protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Mothers (18 yrs or older) who bring their infant between the ages of birth and 6 months for a well-child care visit
  • •Medical providers who provide care to pediatric patients at the participating community health centers

排除标准

  • •Foster parent
  • •Mothers who anticipate changing their infant's site for care
  • •Mothers who are non-English or non-Spanish speaking
  • •Infants with hx of prematurity (born before 32 weeks)
  • •Infants with chronic cardiac or respiratory diseases
  • •Previously enrolled mother

研究组 & 干预措施

Intervention arm

Experimental

Study subjects will receive the Basic Needs Surveillance (BNS) intervention.

干预措施: Basic Needs Surveillance (BNS) protocol (Behavioral)

Control arm

No Intervention

Study subjects in the control arm will receive the standard of care.

结局指标

主要结局

Enrollment in new community-based resources and services

时间窗: when index child is 1 yr of age

次要结局

  • Food insecurity(when index child is one yr of age)
  • Maternal depression(when index child is one yr of age)
  • preventative care adherence, child health, child maltreatment(when index child is one yr of age)
  • referrals received by mother at index well-child care visit(1st well-child care visit)
  • contact of community resource(child is 9 months of age)
  • unmet basic needs(12 month follow-up)
  • parenting stress, maternal life satisfaction(12 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arvin Garg

Assistant Professor of Pediatrics

Boston Medical Center

研究点 (9)

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