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Computer-based Brief Intervention for Perinatal Substance Abuse

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-based Motivational Interviewing
Time control
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Motivational Interview, Computer based intervention, Substance abuse, post-partum

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hutzel Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brief computer-delivered intervention for drug use

Time control for drug use

Arm Description

A single interactive computer intervention based primarily on Motivational Interviewing principles.

An series of innocuous and therapeutically inactive computer segments.

Outcomes

Primary Outcome Measures

Drug use at 3 months
Drug use at 6 months

Secondary Outcome Measures

Full Information

First Posted
May 23, 2008
Last Updated
October 12, 2011
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00685074
Brief Title
Computer-based Brief Intervention for Perinatal Substance Abuse
Official Title
Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Motivational Interview, Computer based intervention, Substance abuse, post-partum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief computer-delivered intervention for drug use
Arm Type
Experimental
Arm Description
A single interactive computer intervention based primarily on Motivational Interviewing principles.
Arm Title
Time control for drug use
Arm Type
Placebo Comparator
Arm Description
An series of innocuous and therapeutically inactive computer segments.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based Motivational Interviewing
Other Intervention Name(s)
Motivation Enhancement System
Intervention Description
The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
Intervention Type
Behavioral
Intervention Name(s)
Time control
Intervention Description
A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.
Primary Outcome Measure Information:
Title
Drug use at 3 months
Time Frame
3 months
Title
Drug use at 6 months
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J. Ondersma, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hutzel Women's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

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Computer-based Brief Intervention for Perinatal Substance Abuse

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