Clinical Trials Directory

Trials / Completed

CompletedNCT00685074

Computer-based Brief Intervention for Perinatal Substance Abuse

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
143 (actual)
Sponsor
Wayne State University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALComputer-based Motivational InterviewingThe software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
BEHAVIORALTime controlA series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.

Timeline

Start date
2007-09-01
Primary completion
2011-03-01
Completion
2011-03-01
First posted
2008-05-28
Last updated
2011-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00685074. Inclusion in this directory is not an endorsement.