跳至主要内容
临床试验/NCT01726062
NCT01726062已完成2 期

Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
360
试验地点
2
主要终点
Infant Second-Hand Smoke Exposure via Urine Cotinine

研究概览

简要总结

A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital (CMHH)
  • Report at least one person living in the home who smokes
  • Agree to attend intervention sessions and to invite other household members
  • Live within 50 miles of our center
  • Have access to a telephone.

排除标准

  • Severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
  • Inability to read, write, and speak English or Spanish
  • Inability or unwillingness to provide signed consent for participation
  • Inability or unwillingness to meet study requirements, including home visits for data collection and intervention purposes.

研究组 & 干预措施

Motivational Interviewing plus Incentives

Experimental

干预措施: Motivational Interviewing plus Incentives (Behavioral)

Conventional Care (CC)

Other

干预措施: Conventional Care (CC) (Behavioral)

结局指标

主要结局

Infant Second-Hand Smoke Exposure via Urine Cotinine

时间窗: Follow-up visit 4 months post-treatment

Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.

次要结局

  • Secondhand Smoke Exposure outcomes(Change from Baseline to the 4 months post-treatment followup)

研究者

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

Angela Stotts

Associate Professor - Family Medicine

The University of Texas Health Science Center, Houston

研究点 (2)

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