Computer-based Brief Intervention for Perinatal Substance Abuse
|Substance Abuse||Behavioral: Computer-based Motivational Interviewing Behavioral: Time control||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse|
- Drug use at 3 months [ Time Frame: 3 months ]
- Drug use at 6 months [ Time Frame: 6 months ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Brief computer-delivered intervention for drug use
A single interactive computer intervention based primarily on Motivational Interviewing principles.
Behavioral: Computer-based Motivational Interviewing
The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
Other Name: Motivation Enhancement System
Placebo Comparator: Time control for drug use
An series of innocuous and therapeutically inactive computer segments.
Behavioral: Time control
A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685074
|United States, Michigan|
|Hutzel Women's Hospital|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Steven J. Ondersma, PhD||Wayne State University|