Computer-based Brief Intervention for Perinatal Substance Abuse
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00685074|
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : October 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse||Behavioral: Computer-based Motivational Interviewing Behavioral: Time control||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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.
- Drug use at 3 months [ Time Frame: 3 months ]
- Drug use at 6 months [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685074
|United States, Michigan|
|Hutzel Women's Hospital|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Steven J. Ondersma, PhD||Wayne State University|