Interactive Motivational Media for Perinatal Drug...
Date First Received: September 29, 2005
Last Updated: November 3, 2005
Verified by: National Institute on Drug Abuse (NIDA), September 2005
Clinical Trial Phase: Phase 1 | Start Date: September 2001
Overall Status: Active, not recruiting
Estimated Enrollment: 121
Brief Summary
Official Title: “
Interactive Motivational Media for Perinatal Drug Abuse
”Condition Keyword(s):
Intervention(s):
Interactive Motivational Media for Perinatal Drug Abuse
Study Type: Interventional
Study Design: Treatment
Detailed Clinical Trial 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, readiness to change, and consequences of drug use. Toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. Participants will be lower socioeconomic status urban women recruited from WSU's Hutzel Hospital, where universal meconium screening has revealed a 44% rate of prenatal drug exposure.
Intervention(s) in this Clinical Trial
- Behavioral: Behavior Therapy
Outcome Measures for this Clinical Trial
Primary Measures
- Amount of drug use
- Treatment engagement
Criteria for Participation in this Clinical Trial
- Woman in immediate postpartum period
- Screen positive for drug use (self-report)
- Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English
Inclusion Criteria:
Exclusion Criteria:
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Steven J Ondersma, Ph.D. Principal Investigator ACT
Related Publications
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230048
Study ID Number: NIDA-14621-3
ClinicalTrials.gov Identifier: NCT00230048
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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