Computer-based Brief Intervention for Perinatal Substance Abuse

Phase 1

Completed

• Conditions: Substance Abuse

• Registration Number: NCT00685074
• Lead Sponsor: Wayne State University

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-28
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Drug use at 3 months	3 months
Drug use at 6 months	6 months

Trial Locations

Locations (1)

Hutzel Women's Hospital; 🇺🇸 Detroit, Michigan, United States