Computer-based Brief Intervention for Perinatal Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
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
  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
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, see Learn About Clinical Studies.

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
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 July 20, 2014