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Computer-based Brief Intervention for Perinatal Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00685074
First received: May 23, 2008
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Substance Abuse
 Behavioral: Computer-based Motivational Interviewing
Behavioral: Time control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Drug use at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Drug use at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685074

Locations
United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Steven J. Ondersma, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00685074     History of Changes
Other Study ID Numbers: MES-III, 5R01DA021329-04, DA021329-01
Study First Received: May 23, 2008
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Wayne State University:
Motivational Interview
Computer based intervention
Substance abuse
post-partum

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013