Computer-based Brief Intervention for Perinatal Substance Abuse

Phase 1

Completed

• Conditions: Substance Abuse
• Interventions: Behavioral: Computer-based Motivational Interviewing; Behavioral: Time control

• 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

Arm && Interventions

Group	Intervention	Description
Brief computer-delivered intervention for drug use	Computer-based Motivational Interviewing	A single interactive computer intervention based primarily on Motivational Interviewing principles.
Time control for drug use	Time control	An series of innocuous and therapeutically inactive computer segments.

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