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Interactive Motivational Media for Perinatal Drug Abuse - 3

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief computer-delivered intervention
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Woman in immediate postpartum period Inclusion Criteria: Screen positive for drug use (self-report) Exclusion Criteria: Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment only

Brief intervention

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Drug Use at 3 Months
The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.
Treatment Engagement
Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2005
Last Updated
October 29, 2012
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00230048
Brief Title
Interactive Motivational Media for Perinatal Drug Abuse - 3
Official Title
Interactive Motivational Media for Perinatal Drug Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (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
No

5. Study Description

Brief Summary
Interactive Motivational Media for Perinatal Drug Abuse
Detailed Description
The goal of this exploratory/developmental proposal is to develop a low-cost, highly adaptable brief motivational intervention for perinatal drug abuse via embedding motivational principles in a self-contained interactive computer system. The Motivation Enhancement System (MES) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide women in the immediate post-partum period through evaluation (thus facilitating self-report) and a one-time motivational intervention. A taxi voucher will be provided to further facilitate entry into treatment, and multiple tailored self-help mailings will be issued following discharge. If validated, this intervention could offer a highly cost-effective, replicable, and prescriptive method for increasing self-change and treatment involvement in drug abusers. Following development of the MES, a preliminary pilot phase will study the use of the MES with post-partum drug-using women and make necessary modifications, using data from participant debriefings and a single-case research design. After optimization of the MES, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects on drug use and treatment involvement. Toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. Participants will be lower socioeconomic status urban women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Assessment only
Arm Type
No Intervention
Arm Title
Brief intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brief computer-delivered intervention
Intervention Description
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
Primary Outcome Measure Information:
Title
Number of Participants With Drug Use at 3 Months
Description
The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.
Time Frame
3 months
Title
Treatment Engagement
Description
Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.
Time Frame
3 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
Woman in immediate postpartum period Inclusion Criteria: Screen positive for drug use (self-report) Exclusion Criteria: Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Ondersma, Ph.D.
Organizational Affiliation
ACT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15925264
Citation
Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.
Results Reference
result
PubMed Identifier
17236741
Citation
Ondersma SJ, Svikis DS, Schuster CR. Computer-based brief intervention a randomized trial with postpartum women. Am J Prev Med. 2007 Mar;32(3):231-8. doi: 10.1016/j.amepre.2006.11.003. Epub 2007 Jan 22. Erratum In: Am J Prev Med. 2007 Jun;32(6):549.
Results Reference
result

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Interactive Motivational Media for Perinatal Drug Abuse - 3

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