Interactive Motivational Media for Perinatal Drug Abuse - 3

Interactive Motivational Media for Perinatal Drug Abuse

Interactive Motivational Media for Perinatal Drug Abuse

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Brief computer-delivered intervention

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
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48207
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Treatment Engagement	Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.	3 months

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (ACTUAL): February 1, 2006
• Study Completion (ACTUAL): February 1, 2006

Study Registration Dates

• First Submitted: September 29, 2005
• First Submitted That Met QC Criteria: September 29, 2005
• First Posted (ESTIMATE): September 30, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: NIDA-14621-3; R21DA014621 (U.S. NIH Grant/Contract)