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临床试验/NCT00685074
NCT00685074已完成1 期

Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse

Wayne State University1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2007年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
143
试验地点
1
主要终点
Drug use at 3 months

研究概览

简要总结

The purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.

详细描述

The purpose of this Stage I/II intervention study (that is, Stage II for drug use and Stage I for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. The study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. Inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken English, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting T-ACE criteria for problem alcohol use, or smoking in past month. Exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment).

Lab-based follow-up will occur at 3- and 6-months postpartum. The primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath CO at 3 and 6 month follow-up, hair analysis at 6-month follow-up). Secondary outcome measures include HIV risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Hospitalized women in immediate post-partum period
  • •Self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy

排除标准

  • •Frank psychosis or other cognitive impairment
  • •Inability to communicate in English
  • •No sleep since giving birth
  • •Recent receipt of narcotic pain medication
  • •Grieving over medically compromised infant

研究组 & 干预措施

Brief computer-delivered intervention for drug use

Experimental

A single interactive computer intervention based primarily on Motivational Interviewing principles.

干预措施: Computer-based Motivational Interviewing (Behavioral)

Time control for drug use

Placebo Comparator

An series of innocuous and therapeutically inactive computer segments.

干预措施: Time control (Behavioral)

结局指标

主要结局

Drug use at 3 months

时间窗: 3 months

Drug use at 6 months

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Steven J. Ondersma

Associate Professor

Wayne State University

研究点 (1)

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