Interactive Motivational Media for Perinatal Drug Abuse - 3

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: NCT00230048
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : August 16, 2012
Last Update Posted : October 31, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University

Brief Summary:
Interactive Motivational Media for Perinatal Drug Abuse

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Brief computer-delivered intervention Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Motivational Media for Perinatal Drug Abuse
Study Start Date : September 2001
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Assessment only
Experimental: Brief intervention Behavioral: Brief computer-delivered intervention
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.

Primary Outcome Measures :
  1. Number of Participants With Drug Use at 3 Months [ Time Frame: 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.

  2. Treatment Engagement [ Time Frame: 3 months ]
    Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.

Information from the National Library of Medicine

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

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

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): NCT00230048

United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven J Ondersma, Ph.D. ACT

Publications of Results:
Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University Identifier: NCT00230048     History of Changes
Other Study ID Numbers: NIDA-14621-3
R21DA014621 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2005    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: October 31, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders