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Completed

NCT Number: NCT00685074

Computer-based Brief Intervention for Perinatal Substance Abuse

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Computer-based Motivational Interviewing

Behavioral

The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.

Other names: Motivation Enhancement System

Time control

Behavioral

A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.

Primary outcomes

  1. Drug use at 3 months

    Time frame: 3 months

  2. Drug use at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 28, 2008
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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