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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. Identifier: NCT00685074
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : October 14, 2011
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven J. Ondersma, 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.

Condition or disease Intervention/treatment Phase
Substance Abuse Behavioral: Computer-based Motivational Interviewing Behavioral: Time control Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Drug use at 3 months [ Time Frame: 3 months ]
  2. Drug use at 6 months [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00685074

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United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Steven J. Ondersma, PhD Wayne State University
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Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University Identifier: NCT00685074    
Other Study ID Numbers: MES-III
5R01DA021329-04 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011
Keywords provided by Steven J. Ondersma, Wayne State University:
Motivational Interview
Computer based intervention
Substance abuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders