Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse
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
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
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
Steven J. Ondersma
Associate Professor
Wayne State University
