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临床试验/NCT02337361
NCT02337361已完成不适用

Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial

Public Health Institute, California4 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2016年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
185
试验地点
4
主要终点
Number of Participants Reporting Weekly Alcohol Use

研究概览

简要总结

An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.

详细描述

This study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (SBI). The bilingual (English and Spanish) electronic SBI or "e-SBI" will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. The effects of drink size assessment by itself and of depression as a modifier of e-SBI efficacy will also be studied. Study findings will help design a larger trial of e-SBI's efficacy for reducing prenatal alcohol use.

An experimental design will be used for the proposed small trial. Two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-SBI or usual care. Participants will complete baseline, 3-month and 6-month follow-up assessments. These assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-SBI. To address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-SBI at the 3-month follow up. This allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,

排除标准

  • not fluent in english or spanish,

结局指标

主要结局

Number of Participants Reporting Weekly Alcohol Use

时间窗: baseline, 3 month, 6 month

weekly alcohol use is defined as at least drinking once a week or more often

Number of Participants Reporting Risky Alcohol Use

时间窗: baseline, 3 months, 6 months

Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day. Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol

Number of Participants Reporting Heavy Alcohol Use

时间窗: baseline, 3 month, 6 month

heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks

次要结局

  • Number of Participants Reporting Any Tobacco Use(baseline , 3 months, 6 months)
  • Number of Participants Reporting Any Drug Use(baseline, 3 month, 6 month)
  • Number of Participants Reporting Frequent Sugar Sweetened Beverage Use(baseline, 3 months, 6 months)
  • Number of Participants Reporting Significant Depression(baseline, 3 months, 6 months)

研究者

发起方
Public Health Institute, California
申办方类型
Other
责任方
Sponsor

研究点 (4)

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