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临床试验/NCT00230048
NCT00230048已完成2 期

Interactive Motivational Media for Perinatal Drug Abuse

Wayne State University2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2001年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
107
试验地点
2
主要终点
Number of Participants With Drug Use at 3 Months

研究概览

简要总结

Interactive Motivational Media for Perinatal Drug Abuse

详细描述

The goal of this exploratory/developmental proposal is to develop a low-cost, highly adaptable brief motivational intervention for perinatal drug abuse via embedding motivational principles in a self-contained interactive computer system. The Motivation Enhancement System (MES) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide women in the immediate post-partum period through evaluation (thus facilitating self-report) and a one-time motivational intervention. A taxi voucher will be provided to further facilitate entry into treatment, and multiple tailored self-help mailings will be issued following discharge. If validated, this intervention could offer a highly cost-effective, replicable, and prescriptive method for increasing self-change and treatment involvement in drug abusers. Following development of the MES, a preliminary pilot phase will study the use of the MES with post-partum drug-using women and make necessary modifications, using data from participant debriefings and a single-case research design. After optimization of the MES, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects on drug use and treatment involvement. Toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. Participants will be lower socioeconomic status urban women.

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

入选标准

  • Screen positive for drug use (self-report)

排除标准

  • Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English

结局指标

主要结局

Number of Participants With Drug Use at 3 Months

时间窗: 3 months

The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.

Treatment Engagement

时间窗: 3 months

Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 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 (2)

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